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<p>Bharat: /* Key Artifacts */</p>
<hr />
<div>[[Wiki section]]<br />
== Phase 1: Landscape overview ==<br />
=== Ureteral Stent: Concept ===<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of fiiction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
=== Background === <br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used to facilitate drainage in<br />
conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation. <br />
<br />
The advent of ESWL and the more recent barrage of endourological techniques have increased the indications for ureteral stents (Candela and Bellman 1997). Indications for use include:<br />
* Treatment of ureteral or kidney stones<br />
* Ureteral trauma or stricture<br />
* Genitourinary reconstructive surgery<br />
* Hydronephrosis during pregnancy<br />
* Obstruction due to malignancy<br />
* Retroperitoneal fibrosis<br />
<br />
The need for ureteral stents range from a few days to several months. For patients with serious urological problems, ureteral stent maintenance may become a life-long necessity. Unfortunately, there are many problems associated with using ureteral stents.<br />
<br />
=== Ureteric stenting difficulties ===<br />
[[Image:Ureteral stent.jpg|thumb|right|350px|Double-J and Pigtail ureteral stents]]<br />
{|border="2" cellspacing="2" cellpadding="4" width="50%"<br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Common'''</font><br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Rare'''</font><br />
<br />
|-<br />
|<br />
* Trigonal irritation<br />
* Haematuria<br />
* Fever<br />
* Infection<br />
* Tissue inflammation<br />
* Encrustation<br />
* Biofilm formation<br />
|<br />
* Obstruction<br />
* Kinking<br />
* Ureteric rupture<br />
* Ureteric perforation<br />
* Stent misplacement<br />
* Stent migration<br />
* Stent misfit<br />
* Stent forgotten<br />
* Tissue hyperplasia<br />
|}<br />
<br />
Today, elastomeric materials, such as silicones, polyurethanes and hydrogel-coated polyolefins are used, with no clear winner, which can withstand the urinary environment. <br />
* Although silicone has better long-term stability than other stent materials, its extreme flexibility makes it difficult to pass over guidewires and through narrow or tortuous ureters. <br />
* Polyethylene is stiffer and easier to use for patients with strictures; however, it has been known to become brittle with time leading to breakage and is no longer commercially available. * Polyurethane has properties that fall in between polyethylene and silicone; however, stent fracture also has been an issue with polyurethanes.<br />
<br />
Attempts have been made to develop polymers with a combination of the best of all properties. The key players are C-Flex (Concept Polymer Technologies), Silitek and Percuflex (Boston Scientific).<br />
* C-Flex is proprietary silicone oil and mineral oil interpenetrated into a styrenelolefin block copolymer with the hope of reduced encrustation.<br />
* Silitek (Medical Engineering Corporation) is another silicone-based copolymer. <br />
* Percuflex is a proprietary olefinic block copolymer. <br />
<br />
Metallic stents have been used recently to treat extrinsic ureteric obstructions. The effect of synthetic polymers on the urothelium of the urinary tract seems to be dependent on the bulk chemical composition of the polymer, the chemical composition of its surface, coatings on the device<br />
surface, smoothness of the surface and coefficient of friction.<br />
<br />
Typically, most ureteral stents are made of relatively smooth catheters. [http://www.ncbi.nlm.nih.gov/pubmed/10772512 Koleski et al., (2000)] tested a longitudinally grooved ureteral stent made by Circon in the pig ureter. The results indicated that the grooved stent led to better drainage than a conventional stent. Their opinion is that the ureter wall has a better chance of collapsing over a<br />
smooth surface than a grooved surface, especially when debris is present. Stoller (2000) had the same experience with the SpiraStent(Urosurge Corp.). This helical stent was superior at passing stones than a conventional smooth stent.<br />
<br />
There are a variety of ureteral stent configurations with different anchoring systems. Most stents today have a double [http://linkinghub.elsevier.com/retrieve/pii/S014067360002674X pigtail anchoring system]. (Tolley, 2000), Dunn et al, (2000) conducted a randomized, single-blind study comparing a Tail stent (proximal pigtail with a shaft which tapers to a lumenless straight tail) to a double pigtail stent. The Tail stent was found to be better tolerated than the double-pigtail concerning<br />
lower urinary tract irritative symptoms. A double-J ureteral stent and a flexible ureteropyeloscope are shown in the first diagram. The other two diagrams show a pigtail ureteral stent in place; the end of the pigtail is facing away fiom the ureteral opening in the second of these two diagrams.<br />
<br />
Early adverse effects of ureteral stenting include lower abdominal pain, dysuria, fever, urinary frequency, nocturia and hematuria. Patient discomfort and microscopic hematuria happen often. Major late complications include stent migration, stent fragmentation or more serious hydronephrosis with flank pain and infections. <br />
<br />
Late complications occurred in one third of the patients in a prospective study using both silicone and polyurethane double pigtail stents (110 stents) in 90 patients. Stent removal was necessary in these patients. Others also have found this percentage of late complications. Device-related urinary tract infection and encrustation can lead to significant morbidity and even death and are the primary factors limiting long-term use of indwelling devices in the urinary tract. Microbial biofilm and encrustation may lead to stone formation. This is typically not a problem when stents are used<br />
for short-term indications. Problems of biofilm formation, encrustation and stent fracture occur in patients with long-term indwelling stents.<br />
<br />
Typically, manufacturers advise periodic stent evaluation. Cook polyurethane stent removal is recommend at 6 months and 12 months for silicone (Cook product literature). However, stents that are intended for long-term use are usually changed at regular intervals, as frequently as every 3 months.<br />
<br />
Forgotten stents are a problem. Monga et al., 1995 found that 68% of stents forgotten more than 6 months were calcified and 10% were fragmented. Multiple urologic procedures were necessary to remove the stones. Long-term effects of these forgotten stents may lead to voiding dysfunction and renal insufficiency. Schlick, et al., 1998 are developing a biodegradable stent that will preclude the need for stent removal. <br />
<br />
==== Encrustation ====<br />
The urinary system presents a challenge because of its chemically unstable environment. Long-term biocompatibility and biodurability of devices have been problems due to the supersaturation of uromucoids and crystalloids at the interface between urine and the device. Encrustation of ureteral stents is a well-known problem, which can be treated easily if recognized early. However, severe encrustation leads to renal failure and is difficult to manage (Mohan-Pillai et al., 1999). All biomaterials currently used become encrusted to some extent when exposed to urine.<br />
<br />
The encrusted deposits can harbor bacterial biofilms. In addition, they can render the biomaterial brittle which causes fracture in-situ, a serious problem especially associated with the use of polyethylene and polyurethane ureteral stents (although silicone stents have also been<br />
reported to fracture). Stent fragments can migrate to the bladder or renal pelvis with serious repercussions.<br />
<br />
Surface science techniques were used to study three stent types after use in patients. The stent type, duration of insertion and age or sex of the patient did not correlate significantly with the amount of encrustation (Wollin et al., 1998). However, it has been suggested that factors which affect the amount of encrustation include the composition or the urine, the type of invading and colonizing bacteria and the structure and surface properties of the biomaterial used (Gorman 1995). A low surface energy surface seems to resist encrustation compared with a high surface energy surface (Denstedt et al., 1998).<br />
<br />
Many different types of stone can form in the urinary tract. Calcium oxalate, calcium phosphate, uric acid and cystine stones are metabolic stones because they form as a result of metabolic dysfunction. They usually are excreted from the urinary tract. Struvite (magnesium ammonium phosphate) and hydroxyapatite (calcium phosphate) are associated with infection (infection stones). These account for 1520% of urinary calculi. ESWL is used to break up the larger infection stones because they don't pass; recurrence of the problem occurs with incomplete removal. Infection stones can manifest as poorly mineralized matrix stones, highly mineralized staghorn calculi or as bladder stones which often form in the presence of ureteral stents. Urea-splitting bacteria colonize the surface and cause alkalinization of the urine, which lowers the solubility of struvite and hydroxyapatite, and they deposit on the surface. Bacterial biofilm associated with encrustation is a common clinical occurrence. (Gorman and Tunney, 1997). It has been suggested that prevention of bacterial colonization would prevent encrustation because of their ultimate responsibility for its formation (Bibby et al., 1995).<br />
<br />
An in vitro model was developed that produces encrustation similar to those seen in vivo (Tunney et al., 1996a). An experiment was conducted to compare the encrustation potential of various ureteral stent materials. The long-term struvite and hydroxyapatite encrustation of silicone, polyurethane, hydrogel-coated polyurethane, Silitek and Percuflex were compared. All of the materials developed encrustation, however, it was found by image analysis that the rates of encrustation varied on the different materials. Silicone had less encrustation (69% at 10 weeks) compared to the other materials (1 00%) at the same time point (Tunney et al., 1996b). Continuous flow models have also been developed which are more representative of conditions in the upper urinary tract. They are discussed by Gorman and Tunney, (1 997). Efforts to reduce encrustation using new materials, smoother<br />
surfaces and hydrogel coatings have been attempted. <br />
<br />
A hydrogel-coated C-flex stent (Hydroplus, Boston Scientific) was shown to have less epithelial cell damage and encrustation than other biomaterials and was recommended by the investigators for long-term use (Cormio, 1995). In addition, a poly(ethy1ene oxide)/polyurethane composite hydrogel (Aquavenem, J & J) resisted intraluminal blockage in a urine flow model compared with silicone and polyurethane (Gorman et al., 1997a). Another advantage with Aquavene is that it is rigid in the dry state, which facilitates insertion past obstructions in the ureter and becomes soft on hydration providing comfort (Gorman and Tunney, 1997). Gorman et al. (1997b) concluded that the chance of stent fracture would be reduced if the ureteral stent side holes were eliminated. Urinary tract infection is another common major problem with the usage of ureteral stents. Initially, a conditioning film is deposited on the ureteral stent surface. The film is made up of proteins, electrolyte materials and other unidentified materials that obscure the surface properties of the stent material. Electrostatic interactions, the ionic strength and pH of the urine and differences in fluid surface tensions affect bacterial adhesion to the conditioning film. Subsequently, a microbial biofilm forms over time. The biofilm is composed of bacterial cells embedded in a hydrated, predominantly anionic mixture of bacterial exopolysaccharides and trapped host extracellular macromolecules.<br />
<br />
====Obstruction====<br />
Obstruction of urine flow and urinary tract sepsis can result in continued growth of the biofilm. Colonization of devices implanted in the urinary tract can lead to dysfunction, tissue intolerance, pain, subclinical or overt infection and even urosepsis. Device related infections are difficult to<br />
treat and device removal is usually necessary. The biofilm has been found to impede the diffusion of antibiotics; in addition, the bacteria in the biofilm have a decreased metabolic rate , which also protects them against the effects of antibiotics (Wollin et al., 1998). Riedl, et al. (1 999) found 100% ureteral stent colonization rates in permanent and 69.3% in temporary stents. Antibiotic prophylaxis did not prevent bacterial colonization and it was recommended that it not be used.<br />
On the other hand, Tieszer, et al. (1 998) believe that fluoroquinolones can prevent infection. They also have found that some stents have denser encrustation than others, however, the stent material did not change the elements of the "conditioning film" adsorbed or alter its receptivity to<br />
bacterial biofilms.<br />
<br />
====Infection====<br />
The predictive value of urine cultures in the assessment of stent colonization was examined in 65 patients with indwelling ureteral stents. It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et al., 1999). Patients with sterile urine culture<br />
may benefit from prophylactic antibiotics; however, the authors contended that the antibiotics must work against gram-negative uropathogens and gram-positive bacteria including enterococci.<br />
It is obvious that there is controversy in the literature whether prophylactic systemic antibiotics are useful with ureteral stent implant. However, antibiotics do not seem to prevent stent colonization. Denstedt et al. (1998) have found that ciprofloxacin, with a 3 day burst every 2<br />
weeks, actually is adsorbed onto the stent which makes longer term treatment possible with reduced risk of bacterial resistance. There has been research targeted at coating or impregnating urinary catheters with antimicrobials and products are on the market, however, there are no antimicrobial ureteral stents approved by the FDA.<br />
<br />
=== The market need ===<br />
It is clear that there is a need for a new material that will be able to resist encrustation and infection in the urinary tract. According to Merrill Lynch, ureteral stents represent an $80 MM<br />
US market. Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player. There are a number of other small contenders. <br />
<br />
The use of ureteral stents is increasing; the indications for ureteral stenting have broadened from temporary or permanent relief or ureteric obstruction to include temporary urinary diversion following surgical procedures such as endopyelotomy and ureteroscopy and facilitation of stone clearance after ESWL (Tolley, 2000). <br />
<br />
The use of ureteral stents for patients having ESWL for renal calculi is however controversial and seems to be related to the size of the stones and invasiveness of the procedure. According to survey results reported by Hollowell, et al. (2000), there is a significant difference in opinion concerning the use of stents with ESWL. <br />
<br />
The number of ureteral stents used in patients with stones 2 cm or less treated with ESWL is significant in spite of the lack scientific evidence in support of this practice. Of 1,029 urologists returning surveys, for patients with renal pelvic stones 10, 15 or 20 rnm treated with ESWL, routine stent placement was preferred by 25.3%, 57.1 % and 87.1 %, respectively. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5-1 0 mm.<br />
<br />
=== Intellectual property ===<br />
==== Search strategy ====<br />
* Databases searched: US-G, US-A, EP-A, EP-B, WO, JP, DE, GB, FR<br />
* Search scope: Title, Abstract or Claims<br />
* Years: 1981-July 2008<br />
* Search query: (ureter* OR urether* OR ureth* OR uretr*) AND (stent*) AND (*microb* OR *bacter*)<br />
* Results: '''177 patents (82 unique patent families)'''<br />
<br />
==== Sample patents ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF"|Patent<br />
!bgcolor = "#00CCFF"|Assignee<br />
!bgcolor = "#00CCFF"|Title<br />
!bgcolor = "#00CCFF"|Abstract<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=6468649.PN.&OS=PN/6468649&RS=PN/6468649 US6468649 B1]<br />
| SCIMED LIFE SYSTEMS INC<br />
| Antimicrobial adhesion surface<br />
| The present invention provides an implantable medical device having a substrate with a hydrophilic coating composition to limit in vivo colonization of bacteria and fungi. The hydrophilic coating composition includes a hydrophilic polymer with a molecular weight in the range from about 100, 000 to about 15 million selected from copolymers acrylic acid, methacrylic acid, isocrotonic acid and combinations thereof.<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=5554147.PN.&OS=PN/5554147&RS=PN/5554147 US5554147 A]<br />
| CApHCO, Inc. <br />
| Compositions and devices for controlled release of active ingredients <br />
| A method for the controlled release of a biologically active agent wherein the agent is released from a hydrophobic, pH-sensitive polymer matrix is disclosed and claimed. The polymer matrix swells when the environment reaches pH 8.5, releasing the active agent. A polymer of hydrophobic and weakly acidic comonomers is disclosed for use in the controlled release system. Further disclosed is a specific embodiment in which the controlled release system may be used. The pH-sensitive polymer is coated onto a latex catheter used in ureteral catheterization. A common problem with catheterized patients is the infection of the urinary tract with urease-producing bacteria. In addition to the irritation caused by the presence of the bacteria, urease produced by these bacteria degrade urea in the urine, forming carbon dioxide and ammonia. The ammonia causes an increase in the pH of the urine. Minerals in the urine begin to precipitate at this high pH, forming encrustations which complicate the functioning of the catheter. A ureteral catheter coated with a pH-sensitive polymer having an antibiotic or urease inhibitor trapped within its matrix will release the active agent when exposed to the high pH urine as the polymer gel swells. Such release can be made slow enough so that the drug remains at significant levels for a clinically useful period of time. <br />
|-<br />
![http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220030153983%22.PGNR.&OS=DN/20030153983&RS=DN/20030153983 US20030153983 A1]<br />
| SCIMED LIFE SYSTEMS INC<br />
|Implantable or insertable medical device resistant to microbial growth and biofilm formation <br />
| Disclosed are implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the invention discloses implantable or insertable medical devices that comprise at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device. Also disclosed are methods of manufacturing such devices under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of the biocompatible matrix polymer and substantially prevent chemical modification of said bioactive agents <br />
|-<br />
|}<br />
<br />
==Urinary Problems in men and women==<br />
* Both men and women have an increased risk for urinary incontinence as they get older, with men's rates rising steadily and women's rates peaking during menopause. <br />
* The prevalence of incontinence in men of all ages is certainly lower than that for women. <br />
* Women over 70, however, are twice as likely to have urinary incontinence as men of the same age.<br />
<br />
[http://www.ehow.com/facts_5664964_urinary-prevalence-men-vs_-women.html Source: Urinary prevalence men Vs women]<br />
<br />
<br />
==Market Analysis==<br />
* We determined market data to have an idea about the market potential for ureteral stents.<br />
* We have done this modeling for female population in US as women has the higher prevalence rate for urinary incontinence than men in all age groups.<br />
* Prevalence increased with age, from 28% for 30- to 39-year-old women to 55% for 80- to 90-year-old women.<br />
* 18% of respondents reported severe UI.<br />
* The prevalence of severe UI also increased notably with age, from 8% for 30- to 39-year-old women to 33% for 80- to 90-year-old women.<br />
* Among all, 9% reported slight UI, 15% reported moderate UI, 18% reported severe UI, and 58% reported no UI.<br />
<BR><br />
===Methodology===<br />
[[Image:methodology-ureteral stents.jpg|center|650px]]<br />
<br />
===Prevalence rate in US (women)===<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "2"|<font color="#FFFFFF">'''Prevalence of Urinary Incontinence in US (women)'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|Age (in yrs)<br />
|align = "center" bgcolor = "#D3DFEE"|Population with Urinary incontinence (in %)<br />
|-<br />
|align = "center"|30-39<br />
|align = "center"|28%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|40-49<br />
|align = "center" bgcolor = "#D3DFEE"|41%<br />
|-<br />
|align = "center"|50-59<br />
|align = "center"|48%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|60-69<br />
|align = "center" bgcolor = "#D3DFEE"|51%<br />
|-<br />
|align = "center"|70-79<br />
|align = "center"|55%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|80-90<br />
|align = "center" bgcolor = "#D3DFEE"|54%<br />
|-<br />
|}<br />
<br />
[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]<br />
<br />
===Urinary incontinence severity among different age groups in US women===<br />
<br />
[[Image:urinary incontinence severity.jpg|center|500px|thumb|[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]]]<br />
<br />
===Market potential for ureteral stent in US (women)===<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "6"|<font color="#FFFFFF">'''Market potential for ureteral stents in US women, 2009'''</font><br />
|-<br />
|bgcolor = "#D3DFEE"|1. Age groups<br><br />
|bgcolor = "#D3DFEE"|2. Female population<br>(from US census data)<br />
|bgcolor = "#D3DFEE"|3. Prevalence rate in female (%)<br />
|align = "center" bgcolor = "#D3DFEE"|4. Market potential<br>(total prevalence)<br>(2<nowiki>*</nowiki>3)<br />
|bgcolor = "#D3DFEE"|5. Catherization rate (%)<br><br />
|align = "center" bgcolor = "#D3DFEE"|6. Stent market based on catherization rate<br>(4<nowiki>*</nowiki>5)<br />
|-<br />
|30-39<br />
|20128402<br />
|28%<br />
|5635953<br />
|0.043%<br />
|2423<br />
|-<br />
|bgcolor = "#D3DFEE"|40-49<br />
|bgcolor = "#D3DFEE"|22074384<br />
|bgcolor = "#D3DFEE"|41%<br />
|bgcolor = "#D3DFEE"|9050497<br />
|bgcolor = "#D3DFEE"|0.123%<br />
|bgcolor = "#D3DFEE"|11132<br />
|-<br />
|50-59<br />
|20929761<br />
|48%<br />
|10046285<br />
|0.124%<br />
|12457<br />
|-<br />
|bgcolor = "#D3DFEE"|60-69<br />
|bgcolor = "#D3DFEE"|14605565<br />
|bgcolor = "#D3DFEE"|51%<br />
|bgcolor = "#D3DFEE"|7448838<br />
|bgcolor = "#D3DFEE"|0.160%<br />
|bgcolor = "#D3DFEE"|11918<br />
|-<br />
|70-79<br />
|9046207<br />
|55%<br />
|4975414<br />
|0.172%<br />
|8558<br />
|-<br />
|bgcolor = "#D3DFEE"|≥ 80<br />
|bgcolor = "#D3DFEE"|7216598<br />
|bgcolor = "#D3DFEE"|54%<br />
|bgcolor = "#D3DFEE"|3896963<br />
|bgcolor = "#D3DFEE"|0.044%<br />
|bgcolor = "#D3DFEE"|1715<br />
|-<br />
|'''Total'''<br />
|&nbsp;<br />
|&nbsp;<br />
|'''41053950'''<br />
|&nbsp;<br />
|'''48203'''<br />
|-<br />
|}<br />
<br />
<br />
* Prevalence rate in US women is growing at a CAGR of 1.19%<br />
* Ureteral stent market is growing at a CAGR of 1.47%<br />
<Br><br />
<br />
===Ureteral stent market forecast in US (women)===<br />
[[Image:stent market forecast1.jpg|center|600px]]<br />
<br />
[[Media:Detailed calculation workbook.xls|'''Detailed model workbook''']]<br />
<br />
===Ureteral stent companies===<br />
Various companies offering ureteral stents are:<br />
<br />
* [http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific Corporation]<br />
* [http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Group]<br />
* [http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Applied Medicals]<br />
* [http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Redi-Tech Medical Products]<br />
<br />
====Ureteral stents of various companies====<br />
=====Boston Scientific=====<br />
* Contour VL Variable Length Percuflex Stents<BR><br />
Inward spiral design of Nautilus Coil minimizes tissue contact for enhanced comfort. Dual variable length coil geometry permits balanced stent positioning to minimize the risk of migration. HydroPlus Coating provides unequalled surface lubricity which reduces friction to minimize risk of buckling during introduction and placement and to reduce risk of trauma and encrustation.<br />
<br />
[[Image:Contour VL variable length percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Percuflex Stents<Br><br />
:* High coil strength pigtail shape prevent stent migration <br />
:* Thin wall promotes drainage and patency <br />
:* Multiple, large side ports promote drainage <br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
[[Image:percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Polaris Ultra Ureteral Stent<br />
:* Ultra Ureteral Stent provides the ease of placement benefits of a firm stent graduated into a soft bladder coil<br />
:* Co-extrusion combines a firm durometer Percuflex Plus Material and a soft durometer Percuflex Material in the same stent <br />
:* Nautilus bladder coil potentially reduce bladder irritation, and a relaxed renal coil facilitate ease of removal <br />
<br />
[[Image:Polaris Ultra Ureteral Stent.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
=====Cook Group=====<br />
* Bander Ureteral Diversion Stent Set<br />
It is used for intraoperative placement to stent the ureter during ureteroileal conduit construction and continent urinary diversions. Set includes: 2 stents, 2 catheter retainers and wire guide.<br />
<br />
[[Image:Bander Ureteral Diversion Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* C-Flex Double Pigtail Ureteral Stent Set<br />
It is used for temporary internal drainage from the ureteropelvic junction to the bladder. Set includes stent, wire guide, stent positioner and catheter.<br />
<br />
[[Image:C-Flex Double Pigtail Ureteral Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* Towers Peripheral Ureteral Stent Set<br />
It is also used for temporary internal drainage from the ureteropelvic junction to the bladder. The stent configuration allows peripheral as well as luminal drainage. Set Includes: Stent, Wire Guide, Catheter, and Stent Positioner.<br />
<br />
[[Image:Towers Peripheral Ureteral Stent Set.jpg|500px|center|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
=====Applied medicals=====<br />
* 7-10 endopyelotomy stent<br />
It is used by urologists for endopyelotomy and endoureterotomy. The dual diameter promotes optimal healing while minimizing the discomfort often associated with larger diameter stents.<br />
<br />
[[Image:ureteral stent-applied.jpg|center|500px|thumb|[http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Source: www.appliedmed.com]]]<br />
<br />
=====Redi-Tech Medical Products=====<br />
* Ureteral stents set<br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
:* Multiple, large side ports promote drainage <br />
:* Radiopaque stent markings aid in placement and sizing <br />
<br />
[[Image:Ureteral stent-redi tech.jpg|center|400px|thumb|[http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Source: www.redi-tech.com]]]<br />
<br />
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<br><br />
=== Clinical Trials ===<br />
====New trials ====<br />
{| {{table}}<br />
| align="center"|'''Title'''<br />
| align="center"|'''Conditions'''<br />
| align="center"|'''Intervention'''<br />
| align="center"|'''Sponsors and Collaborators'''<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]||Renal Calculi, Ureteral Obstruction||Device: Ureteral Stent||Lawson Health Research Institute, Boston Scientific Corporation<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]||Urethral Stricture||Device: Memokath stenting||Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]||Kidney Stones||N\A||University of California, Irvine<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]||Kidney Stones||Device: Ureteral Stent||Emory University<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]||Ureteral Obstruction||Device: Memokath 051 Ureteral Stent||Mayo Clinic Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]||Kidney Disease||Device: nephrostomy tube and ureteral stent||Rabin Medical Center<br />
|-<br />
|}<br />
==== Concluded trials ====<br />
{| {{table}}<br />
| align="center" |'''Title'''<br />
| align="center" |'''Abstract'''<br />
| align="center" |'''Enrollment'''<br />
| align="center" |'''Disorder'''<br />
| align="center" |'''Conclusion'''<br />
|-<br />
| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia ||To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.||13||Detrusor-sphincter dyssynergia||Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.||A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.||201||Renal transplant recipient||Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
====Adverse Events====<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#00CCFF"|'''S. No.'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Brand Name'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Adverse Event'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Date FDA Received'''<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''1'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=660847 Cook Urologicals Cook Urological Stent]</u></font><br />
|align = "justify"|Stent broke into pieces while removing it from the patients body.<br />
|align = "center"|12/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''2'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=930422 Boston Scoientific Boston Scientific Ureteral stent System]</u></font><br />
|align = "justify"|Fractured stent seen under Fluroscopy<br />
|align = "center"|10/17/2007<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''3'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=755260 Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CM]</u></font><br />
|align = "justify"|During insertion of ureteral stent, the stent broke into multiple parts which were retained in the patient.<br />
|align = "center"|10/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''4'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=564910 Boston Scientific Corp Boston Scientific 8 FR X 28 CM Ureteral Stent System Kit]</u></font><br />
|align = "justify"|Breakage of the upper loop of the ureteral stent while trying to insert it.<br />
|align = "center"|1/5/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''5'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522129 Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stent]</u></font><br />
|align = "justify"|Broken stent observed during x-ray procedure.<br />
|align = "center"|12/12/2003<br />
|-<br />
|}<br />
[[Media: non patent upload.xls|'''Review Articles''']]<br><br />
[[Media: non patent upload1.xls|'''Non Patent Analysis''']]<br />
<br />
=== Products ===<br />
{| {{table}}<br />
| align="center"|'''Boston Scientific Scimed, Inc.'''<br />
| align="center"|'''Cook Urological Incorporated'''<br />
| align="center"|'''OptiMed Global Care'''<br />
|-<br />
| Polaris™ Ultra Ureteral Stent <br />
| Firlit-Kluge Urethral Stent<br />
| Opti-J Ureteral Stent System <br />
|-<br />
| Polaris™ Loop Ureteral Stent<br />
| Koyle Diaper Stent <br />
| Ureteral Stent Sets, ureterorenoscope <br />
|-<br />
| Stretch™ VL Variable Length Flexima® Stents <br />
| Silicone Universal Drainage Stent<br />
| Extra Strong Stent Sets (-Tumor)<br />
|-<br />
|<br />
| Tarkington Urethral Stent Set<br />
| Steerable Ureteral Stent Sets<br />
|-<br />
|<br />
| Zaontz Urethral Stent<br />
| Multilength <br />
|-<br />
|<br />
| Pediatric Urethral C-Stent<br />
|<br />
|-<br />
|}<br />
<br />
=== Startup activity ===<br />
* [http://twincities.bizjournals.com/twincities/stories/2008/07/28/story8.html AbbeyMoor Medical Inc.], a med-tech firm that’s developed devices for treating urological disorders, has raised $2.7 million in bridge financing.<br />
<br />
== Phase 2: Deeper Dive ==<br />
=== Scenario ===<br />
Client wishes to acquire a ureteral stent company.<br />
<br />
=== Deal analysis for a target company ===<br />
[[Image:DealImplications.jpg|thumb|center|700px|Deal implications]]<br />
<br />
=== Design History File Review: Review components ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|Review <br />
!bgcolor = "#00CCFF" width="30%"|Verification<br />
!bgcolor = "#00CCFF" width="40%"|Tasks<br />
!bgcolor = "#00CCFF" width="15%"|Expertise<br />
|-<br />
!rowspan="2"|Design Input<br />
| Design input documents for sufficiency<br />
| <br />
# Access electronic data room.<br />
# Check what documents are provided.<br />
# Compare document list with standard client document list.<br />
# Check whether each specified document has appropriate content.<br />
| rowspan="2"|Quality systems<br />
|-<br />
| Design input documents linked to the product performance specifications<br />
|<br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
|-<br />
!rowspan="3"|Product Performance Specifications (PPS) <br />
| Design inputs correlate adequately to the specifications; DV&V (design verification and validation) criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans<br />
| <br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
| rowspan="3"|Quality systems, CAD<br />
|-<br />
| Appropriate design verification and validations (DV&V) are performed<br />
| <br />
# Show DV&V criteria are based on risk management requirements<br />
|-<br />
| Product performance specifications correspond to appropriate design output documents<br />
| <br />
# Correlate design drawings with the specifications<br />
# Check whether maximum dimensions, sizes etc. (with tolerances) are within the specified range<br />
|-<br />
!rowspan="4"|Risk Management Documents <br />
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation<br />
| <br />
# Check whether documentation is available<br />
# Check whether it adheres to appropriate ISO 14971 standards<br />
# Check whether it adheres to appropriate client standards<br />
|rowspan="4"| Quality systems<br />
|-<br />
| DFMEA links appropriately to the PPS<br />
| <br />
# Verify whether DFMEA and product specifications are correlated<br />
|-<br />
| Appropriate DV&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEA<br />
| <br />
# Validate the process and correlate with design inputs<br />
# Validate that sizes used are within range of risk mitigation criteria<br />
|-<br />
| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA<br />
| <br />
# Validate the process protocol<br />
# Validate the inspection procedures used <br />
|-<br />
!rowspan="2"|Design Output Documents <br />
| Completeness of drawings<br />
|<br />
# Check if the CAD diagrams overlay and "fit" perfectly<br />
# Check tolerance stackups<br />
|rowspan="2"| Quality systems, CAD<br />
|-<br />
| Correlate First Article Inspection data to the dimensions on the drawings<br />
| <br />
# Obtain First Article Inspection data<br />
# Check if this data correlates with the completeness of drawings<br />
|-<br />
!rowspan="4"|Manufacturing Documents <br />
| Manufacturing procedures, component specifications, raw material specifications, incoming and in-process inspection procedures for completeness<br />
| <br />
# Verify the Bill of Materials corresponds to raw materials and manufacturing procedures<br />
# Correlate incoming and in-process inspection procedures with the process specifications<br />
| rowspan="4"|Material science, manufacturing engineering, quality systems<br />
|-<br />
| Linkage between component and raw material specifications and appropriate incoming inspection procedures<br />
| <br />
# Identify any missing documentation for inspection procedures<br />
|-<br />
|-<br />
| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials<br />
| <br />
# Review supplier audit reports for compliance<br />
|-<br />
| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations<br />
| <br />
# Check the entire equipment-related lifecycle<br />
# Check if machine operational qualification was performed<br />
# Check if the measurement equipment was validated<br />
|-<br />
!rowspan="2"|Validation Report<br />
| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports<br />
|<br />
# Ensure all reports are available and linked together appropriately<br />
# Identify all inconsistencies across different reports<br />
| rowspan="2"| Quality systems<br />
|-<br />
| Design test methods and related test method validations<br />
| <br />
# Compare test methods used to those in client and ISO standards<br />
# Identify inconsistencies across test methods<br />
|-<br />
|}<br />
<br />
=== Sample report ===<br />
==== Performance/Functional Characteristics ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" colspan = "4" |Design Input<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Output<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Verification Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Validation Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
|-<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|User Needs<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|User Need Rationale<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification Rationale<br />
|-<br />
|Provide antimicrobial resistance for up to 2 weeks<br />
|Ureteral Stent User Survey (Document #XXXXX)<br />
|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeks<br />
|Document #XXXXX<br />
|Test Document #XXXXX<br />
|Report 01-005-06-007<br />
|P<br />
|Report 01-005-06-007<br />
|P<br />
|-<br />
|}<br />
<br />
=== Potential DHF Review Outcomes ===<br />
Based on a review of the above DHF documents a potential outcome for the uretral stent acquisition project could involve the following:<br />
# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.<br />
# Creation of some new test methods for design, incoming and in-process inspections and also include recommendations for the test method validations. Creation of any new DV&V data would be highly unlikely as it could potentially trigger a new submission or a note-to-file to the regulatory agencies.<br />
# Change in raw materials to better grade materials e.g. Switching resin to a USP Class VI biocompatible resin. This would eliminate some on-going testing but require additional upfront one time biocompatibility testing.<br />
# Updating drawings based on results from the FAI data.<br />
# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw material specifications and inspection procedures.<br />
# Identifying installation, operational and process qualification requirements with the assumption that no additional design verification and validation activities are required based on the fact that the device is currently approved for sale in the US and ROW.<br />
# Recommend activities necessary for completing packaging, labeling, ship testing and shelf-life testing. Stress should be on being able to leverage existing data for shelf-life without changing the regulatory status of the device. <br />
# Company X may want to perform additional biocompatibility testing to create an internal baseline and also update their biocompatibility files.<br />
# Help streamline suppliers for components when switching over from Company Y to Company X. Search for existing Company X suppliers that can supply off the shelf items that Company Y may be sourcing from other vendors / suppliers.<br />
# Identify process improvements that can be rolled into the manufacturing transfer without changing the design and impacting the existing regulatory status for the device e.g. instead of hand mixing pigment to resin use a pre-mixer to control quality of mixing and resulting extrusion or perform the molding and over-molding steps in 1 machine instead of 2 separate molding machines.<br />
<br />
== Phase 3: Post-acquisition integration ==<br />
=== Deadlines ===<br />
'''Goal''': Switch production transparently to new facilities transparently to the distribution system<br />
<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Stage<br />
!align = "center" bgcolor = "#00CCFF" |Tasks<br />
!align = "center" bgcolor = "#00CCFF" |Milestone payment<br />
!align = "center" bgcolor = "#00CCFF" |Date<br />
|-<br />
|Design center integration plan<br />
|<br />
* Gap analysis completion (acquiree)<br />
* Gap analysis completion (acquirer)<br />
|<br />
|September 15, 2008<br />
|-<br />
|Design to manufacturing transfer<br />
|<br />
|<br />
|December 15, 2008<br />
|-<br />
|Equipment transfer<br />
|<br />
|Milestone I payment<br />
|Jan 7, 2009<br />
|-<br />
|Shut production at acquiree facility<br />
|Negotiation for contract extension<br />
|Milestone II payment<br />
|Feb 15, 2009<br />
|-<br />
|Start production in acquirer facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Switch to new SKU<br />
|<br />
|<br />
|Feb 15, 2009<br />
|-<br />
|End development of new generation product/s in old facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Restart development of new generation product/s post-acquisition<br />
|<br />
|Final milestone payment<br />
|Mar 1, 2009<br />
|-<br />
|}<br />
<br />
=== Documents and Ownership ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Document<br />
!align = "center" bgcolor = "#00CCFF" |Owner<br />
!align = "center" bgcolor = "#00CCFF" |Last update date<br />
|-<br />
|Product performance specifications<br />
|Paul Swain<br />
|07/27/2008 08:15:35 PST<br />
|-<br />
|Component specifications<br />
|Kevin Teller<br />
|06/12/2008 12:22:07 PST<br />
|-<br />
|Preclinical test results<br />
|Joanne Krannert<br />
|07/03/2008 14:17:00 PST<br />
|-<br />
|Clinical tests<br />
|Joanne Krannert<br />
|08/01/2008 08:00:55 PST<br />
|-<br />
|}<br />
<br />
==Ureteral stents regulatory issues==<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=876.4620&SearchTerm=ureter%20stent Code of Federal Regulations]<br />
<br />
===Pre-Market Notification===<br />
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance, also known as Premarket Notification. This premarket submission demonstrates to the FDA that the device to be marketed is atleast as safe and effective, that is, ''substantially equivalent'', to a legally marketed device. Parties required to submit a 510(k) to the FDA include domestic or foreign manufacturers introducing a device to the U.S. market, as well as specification developers and repackers/relabelers. <br />
<br />
A 510(k) is required when: <br />
* Introducing a device into commercial distribution (marketing) for the first time.<br />
* Proposed different intended use for a device already in commercial distribution.<br />
* Change or modification of a legally marketed device.<br />
<br />
[http://dolcera.com/upload/files/510kflowchart.pdf 510(k) “Substantial Equivalence” Decision Making Process]<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. (This is not an exhaustive list and is just a sample)<br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Sr. No. '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Company'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Device'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Date of Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Material'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Technology'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Indwelling time (days) '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Image'''</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 InLay Optima]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Silicone<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:InLay_Optima.png|thumb|center|200px|<center>InLay Optima</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() Polaris Loop]</center><br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|200px|<center>Polaris Loop</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Metal<br />
| style="background-color:#ccffff;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|200px|<center>Resonance</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]</center><br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|200px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>240</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|200px|<center>Memokath 051</center>]]<br />
<br />
|}<br />
<br />
===Timeline Sheet===<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
<br />
*References<br />
<br />
1- [http://en.wikipedia.org/wiki/Demographics_of_the_United_States http://en.wikipedia.org/wiki/Demographics_of_the_United_States]<br />
<br />
2- [http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink]<br />
<br />
3- [http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf]<br />
<br />
4- [http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html]<br />
<br />
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[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''here ''']]to download the excel file.<br />
* Mapped Patent vs Not Mapped Patents<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
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<br />
=Removed Sections=<br />
[[Removed Sections]]</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Company_Profile_-_Flash&diff=9908
Company Profile - Flash
2011-10-18T21:04:41Z
<p>Bharat: </p>
<hr />
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Backup
2011-10-18T21:04:23Z
<p>Bharat: /* Key Artifacts */</p>
<hr />
<div>[[Wiki section]]<br />
== Phase 1: Landscape overview ==<br />
=== Ureteral Stent: Concept ===<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of fiiction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
=== Background === <br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used to facilitate drainage in<br />
conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation. <br />
<br />
The advent of ESWL and the more recent barrage of endourological techniques have increased the indications for ureteral stents (Candela and Bellman 1997). Indications for use include:<br />
* Treatment of ureteral or kidney stones<br />
* Ureteral trauma or stricture<br />
* Genitourinary reconstructive surgery<br />
* Hydronephrosis during pregnancy<br />
* Obstruction due to malignancy<br />
* Retroperitoneal fibrosis<br />
<br />
The need for ureteral stents range from a few days to several months. For patients with serious urological problems, ureteral stent maintenance may become a life-long necessity. Unfortunately, there are many problems associated with using ureteral stents.<br />
<br />
=== Ureteric stenting difficulties ===<br />
[[Image:Ureteral stent.jpg|thumb|right|350px|Double-J and Pigtail ureteral stents]]<br />
{|border="2" cellspacing="2" cellpadding="4" width="50%"<br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Common'''</font><br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Rare'''</font><br />
<br />
|-<br />
|<br />
* Trigonal irritation<br />
* Haematuria<br />
* Fever<br />
* Infection<br />
* Tissue inflammation<br />
* Encrustation<br />
* Biofilm formation<br />
|<br />
* Obstruction<br />
* Kinking<br />
* Ureteric rupture<br />
* Ureteric perforation<br />
* Stent misplacement<br />
* Stent migration<br />
* Stent misfit<br />
* Stent forgotten<br />
* Tissue hyperplasia<br />
|}<br />
<br />
Today, elastomeric materials, such as silicones, polyurethanes and hydrogel-coated polyolefins are used, with no clear winner, which can withstand the urinary environment. <br />
* Although silicone has better long-term stability than other stent materials, its extreme flexibility makes it difficult to pass over guidewires and through narrow or tortuous ureters. <br />
* Polyethylene is stiffer and easier to use for patients with strictures; however, it has been known to become brittle with time leading to breakage and is no longer commercially available. * Polyurethane has properties that fall in between polyethylene and silicone; however, stent fracture also has been an issue with polyurethanes.<br />
<br />
Attempts have been made to develop polymers with a combination of the best of all properties. The key players are C-Flex (Concept Polymer Technologies), Silitek and Percuflex (Boston Scientific).<br />
* C-Flex is proprietary silicone oil and mineral oil interpenetrated into a styrenelolefin block copolymer with the hope of reduced encrustation.<br />
* Silitek (Medical Engineering Corporation) is another silicone-based copolymer. <br />
* Percuflex is a proprietary olefinic block copolymer. <br />
<br />
Metallic stents have been used recently to treat extrinsic ureteric obstructions. The effect of synthetic polymers on the urothelium of the urinary tract seems to be dependent on the bulk chemical composition of the polymer, the chemical composition of its surface, coatings on the device<br />
surface, smoothness of the surface and coefficient of friction.<br />
<br />
Typically, most ureteral stents are made of relatively smooth catheters. [http://www.ncbi.nlm.nih.gov/pubmed/10772512 Koleski et al., (2000)] tested a longitudinally grooved ureteral stent made by Circon in the pig ureter. The results indicated that the grooved stent led to better drainage than a conventional stent. Their opinion is that the ureter wall has a better chance of collapsing over a<br />
smooth surface than a grooved surface, especially when debris is present. Stoller (2000) had the same experience with the SpiraStent(Urosurge Corp.). This helical stent was superior at passing stones than a conventional smooth stent.<br />
<br />
There are a variety of ureteral stent configurations with different anchoring systems. Most stents today have a double [http://linkinghub.elsevier.com/retrieve/pii/S014067360002674X pigtail anchoring system]. (Tolley, 2000), Dunn et al, (2000) conducted a randomized, single-blind study comparing a Tail stent (proximal pigtail with a shaft which tapers to a lumenless straight tail) to a double pigtail stent. The Tail stent was found to be better tolerated than the double-pigtail concerning<br />
lower urinary tract irritative symptoms. A double-J ureteral stent and a flexible ureteropyeloscope are shown in the first diagram. The other two diagrams show a pigtail ureteral stent in place; the end of the pigtail is facing away fiom the ureteral opening in the second of these two diagrams.<br />
<br />
Early adverse effects of ureteral stenting include lower abdominal pain, dysuria, fever, urinary frequency, nocturia and hematuria. Patient discomfort and microscopic hematuria happen often. Major late complications include stent migration, stent fragmentation or more serious hydronephrosis with flank pain and infections. <br />
<br />
Late complications occurred in one third of the patients in a prospective study using both silicone and polyurethane double pigtail stents (110 stents) in 90 patients. Stent removal was necessary in these patients. Others also have found this percentage of late complications. Device-related urinary tract infection and encrustation can lead to significant morbidity and even death and are the primary factors limiting long-term use of indwelling devices in the urinary tract. Microbial biofilm and encrustation may lead to stone formation. This is typically not a problem when stents are used<br />
for short-term indications. Problems of biofilm formation, encrustation and stent fracture occur in patients with long-term indwelling stents.<br />
<br />
Typically, manufacturers advise periodic stent evaluation. Cook polyurethane stent removal is recommend at 6 months and 12 months for silicone (Cook product literature). However, stents that are intended for long-term use are usually changed at regular intervals, as frequently as every 3 months.<br />
<br />
Forgotten stents are a problem. Monga et al., 1995 found that 68% of stents forgotten more than 6 months were calcified and 10% were fragmented. Multiple urologic procedures were necessary to remove the stones. Long-term effects of these forgotten stents may lead to voiding dysfunction and renal insufficiency. Schlick, et al., 1998 are developing a biodegradable stent that will preclude the need for stent removal. <br />
<br />
==== Encrustation ====<br />
The urinary system presents a challenge because of its chemically unstable environment. Long-term biocompatibility and biodurability of devices have been problems due to the supersaturation of uromucoids and crystalloids at the interface between urine and the device. Encrustation of ureteral stents is a well-known problem, which can be treated easily if recognized early. However, severe encrustation leads to renal failure and is difficult to manage (Mohan-Pillai et al., 1999). All biomaterials currently used become encrusted to some extent when exposed to urine.<br />
<br />
The encrusted deposits can harbor bacterial biofilms. In addition, they can render the biomaterial brittle which causes fracture in-situ, a serious problem especially associated with the use of polyethylene and polyurethane ureteral stents (although silicone stents have also been<br />
reported to fracture). Stent fragments can migrate to the bladder or renal pelvis with serious repercussions.<br />
<br />
Surface science techniques were used to study three stent types after use in patients. The stent type, duration of insertion and age or sex of the patient did not correlate significantly with the amount of encrustation (Wollin et al., 1998). However, it has been suggested that factors which affect the amount of encrustation include the composition or the urine, the type of invading and colonizing bacteria and the structure and surface properties of the biomaterial used (Gorman 1995). A low surface energy surface seems to resist encrustation compared with a high surface energy surface (Denstedt et al., 1998).<br />
<br />
Many different types of stone can form in the urinary tract. Calcium oxalate, calcium phosphate, uric acid and cystine stones are metabolic stones because they form as a result of metabolic dysfunction. They usually are excreted from the urinary tract. Struvite (magnesium ammonium phosphate) and hydroxyapatite (calcium phosphate) are associated with infection (infection stones). These account for 1520% of urinary calculi. ESWL is used to break up the larger infection stones because they don't pass; recurrence of the problem occurs with incomplete removal. Infection stones can manifest as poorly mineralized matrix stones, highly mineralized staghorn calculi or as bladder stones which often form in the presence of ureteral stents. Urea-splitting bacteria colonize the surface and cause alkalinization of the urine, which lowers the solubility of struvite and hydroxyapatite, and they deposit on the surface. Bacterial biofilm associated with encrustation is a common clinical occurrence. (Gorman and Tunney, 1997). It has been suggested that prevention of bacterial colonization would prevent encrustation because of their ultimate responsibility for its formation (Bibby et al., 1995).<br />
<br />
An in vitro model was developed that produces encrustation similar to those seen in vivo (Tunney et al., 1996a). An experiment was conducted to compare the encrustation potential of various ureteral stent materials. The long-term struvite and hydroxyapatite encrustation of silicone, polyurethane, hydrogel-coated polyurethane, Silitek and Percuflex were compared. All of the materials developed encrustation, however, it was found by image analysis that the rates of encrustation varied on the different materials. Silicone had less encrustation (69% at 10 weeks) compared to the other materials (1 00%) at the same time point (Tunney et al., 1996b). Continuous flow models have also been developed which are more representative of conditions in the upper urinary tract. They are discussed by Gorman and Tunney, (1 997). Efforts to reduce encrustation using new materials, smoother<br />
surfaces and hydrogel coatings have been attempted. <br />
<br />
A hydrogel-coated C-flex stent (Hydroplus, Boston Scientific) was shown to have less epithelial cell damage and encrustation than other biomaterials and was recommended by the investigators for long-term use (Cormio, 1995). In addition, a poly(ethy1ene oxide)/polyurethane composite hydrogel (Aquavenem, J & J) resisted intraluminal blockage in a urine flow model compared with silicone and polyurethane (Gorman et al., 1997a). Another advantage with Aquavene is that it is rigid in the dry state, which facilitates insertion past obstructions in the ureter and becomes soft on hydration providing comfort (Gorman and Tunney, 1997). Gorman et al. (1997b) concluded that the chance of stent fracture would be reduced if the ureteral stent side holes were eliminated. Urinary tract infection is another common major problem with the usage of ureteral stents. Initially, a conditioning film is deposited on the ureteral stent surface. The film is made up of proteins, electrolyte materials and other unidentified materials that obscure the surface properties of the stent material. Electrostatic interactions, the ionic strength and pH of the urine and differences in fluid surface tensions affect bacterial adhesion to the conditioning film. Subsequently, a microbial biofilm forms over time. The biofilm is composed of bacterial cells embedded in a hydrated, predominantly anionic mixture of bacterial exopolysaccharides and trapped host extracellular macromolecules.<br />
<br />
====Obstruction====<br />
Obstruction of urine flow and urinary tract sepsis can result in continued growth of the biofilm. Colonization of devices implanted in the urinary tract can lead to dysfunction, tissue intolerance, pain, subclinical or overt infection and even urosepsis. Device related infections are difficult to<br />
treat and device removal is usually necessary. The biofilm has been found to impede the diffusion of antibiotics; in addition, the bacteria in the biofilm have a decreased metabolic rate , which also protects them against the effects of antibiotics (Wollin et al., 1998). Riedl, et al. (1 999) found 100% ureteral stent colonization rates in permanent and 69.3% in temporary stents. Antibiotic prophylaxis did not prevent bacterial colonization and it was recommended that it not be used.<br />
On the other hand, Tieszer, et al. (1 998) believe that fluoroquinolones can prevent infection. They also have found that some stents have denser encrustation than others, however, the stent material did not change the elements of the "conditioning film" adsorbed or alter its receptivity to<br />
bacterial biofilms.<br />
<br />
====Infection====<br />
The predictive value of urine cultures in the assessment of stent colonization was examined in 65 patients with indwelling ureteral stents. It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et al., 1999). Patients with sterile urine culture<br />
may benefit from prophylactic antibiotics; however, the authors contended that the antibiotics must work against gram-negative uropathogens and gram-positive bacteria including enterococci.<br />
It is obvious that there is controversy in the literature whether prophylactic systemic antibiotics are useful with ureteral stent implant. However, antibiotics do not seem to prevent stent colonization. Denstedt et al. (1998) have found that ciprofloxacin, with a 3 day burst every 2<br />
weeks, actually is adsorbed onto the stent which makes longer term treatment possible with reduced risk of bacterial resistance. There has been research targeted at coating or impregnating urinary catheters with antimicrobials and products are on the market, however, there are no antimicrobial ureteral stents approved by the FDA.<br />
<br />
=== The market need ===<br />
It is clear that there is a need for a new material that will be able to resist encrustation and infection in the urinary tract. According to Merrill Lynch, ureteral stents represent an $80 MM<br />
US market. Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player. There are a number of other small contenders. <br />
<br />
The use of ureteral stents is increasing; the indications for ureteral stenting have broadened from temporary or permanent relief or ureteric obstruction to include temporary urinary diversion following surgical procedures such as endopyelotomy and ureteroscopy and facilitation of stone clearance after ESWL (Tolley, 2000). <br />
<br />
The use of ureteral stents for patients having ESWL for renal calculi is however controversial and seems to be related to the size of the stones and invasiveness of the procedure. According to survey results reported by Hollowell, et al. (2000), there is a significant difference in opinion concerning the use of stents with ESWL. <br />
<br />
The number of ureteral stents used in patients with stones 2 cm or less treated with ESWL is significant in spite of the lack scientific evidence in support of this practice. Of 1,029 urologists returning surveys, for patients with renal pelvic stones 10, 15 or 20 rnm treated with ESWL, routine stent placement was preferred by 25.3%, 57.1 % and 87.1 %, respectively. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5-1 0 mm.<br />
<br />
=== Intellectual property ===<br />
==== Search strategy ====<br />
* Databases searched: US-G, US-A, EP-A, EP-B, WO, JP, DE, GB, FR<br />
* Search scope: Title, Abstract or Claims<br />
* Years: 1981-July 2008<br />
* Search query: (ureter* OR urether* OR ureth* OR uretr*) AND (stent*) AND (*microb* OR *bacter*)<br />
* Results: '''177 patents (82 unique patent families)'''<br />
<br />
==== Sample patents ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF"|Patent<br />
!bgcolor = "#00CCFF"|Assignee<br />
!bgcolor = "#00CCFF"|Title<br />
!bgcolor = "#00CCFF"|Abstract<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=6468649.PN.&OS=PN/6468649&RS=PN/6468649 US6468649 B1]<br />
| SCIMED LIFE SYSTEMS INC<br />
| Antimicrobial adhesion surface<br />
| The present invention provides an implantable medical device having a substrate with a hydrophilic coating composition to limit in vivo colonization of bacteria and fungi. The hydrophilic coating composition includes a hydrophilic polymer with a molecular weight in the range from about 100, 000 to about 15 million selected from copolymers acrylic acid, methacrylic acid, isocrotonic acid and combinations thereof.<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=5554147.PN.&OS=PN/5554147&RS=PN/5554147 US5554147 A]<br />
| CApHCO, Inc. <br />
| Compositions and devices for controlled release of active ingredients <br />
| A method for the controlled release of a biologically active agent wherein the agent is released from a hydrophobic, pH-sensitive polymer matrix is disclosed and claimed. The polymer matrix swells when the environment reaches pH 8.5, releasing the active agent. A polymer of hydrophobic and weakly acidic comonomers is disclosed for use in the controlled release system. Further disclosed is a specific embodiment in which the controlled release system may be used. The pH-sensitive polymer is coated onto a latex catheter used in ureteral catheterization. A common problem with catheterized patients is the infection of the urinary tract with urease-producing bacteria. In addition to the irritation caused by the presence of the bacteria, urease produced by these bacteria degrade urea in the urine, forming carbon dioxide and ammonia. The ammonia causes an increase in the pH of the urine. Minerals in the urine begin to precipitate at this high pH, forming encrustations which complicate the functioning of the catheter. A ureteral catheter coated with a pH-sensitive polymer having an antibiotic or urease inhibitor trapped within its matrix will release the active agent when exposed to the high pH urine as the polymer gel swells. Such release can be made slow enough so that the drug remains at significant levels for a clinically useful period of time. <br />
|-<br />
![http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220030153983%22.PGNR.&OS=DN/20030153983&RS=DN/20030153983 US20030153983 A1]<br />
| SCIMED LIFE SYSTEMS INC<br />
|Implantable or insertable medical device resistant to microbial growth and biofilm formation <br />
| Disclosed are implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the invention discloses implantable or insertable medical devices that comprise at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device. Also disclosed are methods of manufacturing such devices under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of the biocompatible matrix polymer and substantially prevent chemical modification of said bioactive agents <br />
|-<br />
|}<br />
<br />
==Urinary Problems in men and women==<br />
* Both men and women have an increased risk for urinary incontinence as they get older, with men's rates rising steadily and women's rates peaking during menopause. <br />
* The prevalence of incontinence in men of all ages is certainly lower than that for women. <br />
* Women over 70, however, are twice as likely to have urinary incontinence as men of the same age.<br />
<br />
[http://www.ehow.com/facts_5664964_urinary-prevalence-men-vs_-women.html Source: Urinary prevalence men Vs women]<br />
<br />
<br />
==Market Analysis==<br />
* We determined market data to have an idea about the market potential for ureteral stents.<br />
* We have done this modeling for female population in US as women has the higher prevalence rate for urinary incontinence than men in all age groups.<br />
* Prevalence increased with age, from 28% for 30- to 39-year-old women to 55% for 80- to 90-year-old women.<br />
* 18% of respondents reported severe UI.<br />
* The prevalence of severe UI also increased notably with age, from 8% for 30- to 39-year-old women to 33% for 80- to 90-year-old women.<br />
* Among all, 9% reported slight UI, 15% reported moderate UI, 18% reported severe UI, and 58% reported no UI.<br />
<BR><br />
===Methodology===<br />
[[Image:methodology-ureteral stents.jpg|center|650px]]<br />
<br />
===Prevalence rate in US (women)===<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "2"|<font color="#FFFFFF">'''Prevalence of Urinary Incontinence in US (women)'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|Age (in yrs)<br />
|align = "center" bgcolor = "#D3DFEE"|Population with Urinary incontinence (in %)<br />
|-<br />
|align = "center"|30-39<br />
|align = "center"|28%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|40-49<br />
|align = "center" bgcolor = "#D3DFEE"|41%<br />
|-<br />
|align = "center"|50-59<br />
|align = "center"|48%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|60-69<br />
|align = "center" bgcolor = "#D3DFEE"|51%<br />
|-<br />
|align = "center"|70-79<br />
|align = "center"|55%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|80-90<br />
|align = "center" bgcolor = "#D3DFEE"|54%<br />
|-<br />
|}<br />
<br />
[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]<br />
<br />
===Urinary incontinence severity among different age groups in US women===<br />
<br />
[[Image:urinary incontinence severity.jpg|center|500px|thumb|[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]]]<br />
<br />
===Market potential for ureteral stent in US (women)===<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "6"|<font color="#FFFFFF">'''Market potential for ureteral stents in US women, 2009'''</font><br />
|-<br />
|bgcolor = "#D3DFEE"|1. Age groups<br><br />
|bgcolor = "#D3DFEE"|2. Female population<br>(from US census data)<br />
|bgcolor = "#D3DFEE"|3. Prevalence rate in female (%)<br />
|align = "center" bgcolor = "#D3DFEE"|4. Market potential<br>(total prevalence)<br>(2<nowiki>*</nowiki>3)<br />
|bgcolor = "#D3DFEE"|5. Catherization rate (%)<br><br />
|align = "center" bgcolor = "#D3DFEE"|6. Stent market based on catherization rate<br>(4<nowiki>*</nowiki>5)<br />
|-<br />
|30-39<br />
|20128402<br />
|28%<br />
|5635953<br />
|0.043%<br />
|2423<br />
|-<br />
|bgcolor = "#D3DFEE"|40-49<br />
|bgcolor = "#D3DFEE"|22074384<br />
|bgcolor = "#D3DFEE"|41%<br />
|bgcolor = "#D3DFEE"|9050497<br />
|bgcolor = "#D3DFEE"|0.123%<br />
|bgcolor = "#D3DFEE"|11132<br />
|-<br />
|50-59<br />
|20929761<br />
|48%<br />
|10046285<br />
|0.124%<br />
|12457<br />
|-<br />
|bgcolor = "#D3DFEE"|60-69<br />
|bgcolor = "#D3DFEE"|14605565<br />
|bgcolor = "#D3DFEE"|51%<br />
|bgcolor = "#D3DFEE"|7448838<br />
|bgcolor = "#D3DFEE"|0.160%<br />
|bgcolor = "#D3DFEE"|11918<br />
|-<br />
|70-79<br />
|9046207<br />
|55%<br />
|4975414<br />
|0.172%<br />
|8558<br />
|-<br />
|bgcolor = "#D3DFEE"|≥ 80<br />
|bgcolor = "#D3DFEE"|7216598<br />
|bgcolor = "#D3DFEE"|54%<br />
|bgcolor = "#D3DFEE"|3896963<br />
|bgcolor = "#D3DFEE"|0.044%<br />
|bgcolor = "#D3DFEE"|1715<br />
|-<br />
|'''Total'''<br />
|&nbsp;<br />
|&nbsp;<br />
|'''41053950'''<br />
|&nbsp;<br />
|'''48203'''<br />
|-<br />
|}<br />
<br />
<br />
* Prevalence rate in US women is growing at a CAGR of 1.19%<br />
* Ureteral stent market is growing at a CAGR of 1.47%<br />
<Br><br />
<br />
===Ureteral stent market forecast in US (women)===<br />
[[Image:stent market forecast1.jpg|center|600px]]<br />
<br />
[[Media:Detailed calculation workbook.xls|'''Detailed model workbook''']]<br />
<br />
===Ureteral stent companies===<br />
Various companies offering ureteral stents are:<br />
<br />
* [http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific Corporation]<br />
* [http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Group]<br />
* [http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Applied Medicals]<br />
* [http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Redi-Tech Medical Products]<br />
<br />
====Ureteral stents of various companies====<br />
=====Boston Scientific=====<br />
* Contour VL Variable Length Percuflex Stents<BR><br />
Inward spiral design of Nautilus Coil minimizes tissue contact for enhanced comfort. Dual variable length coil geometry permits balanced stent positioning to minimize the risk of migration. HydroPlus Coating provides unequalled surface lubricity which reduces friction to minimize risk of buckling during introduction and placement and to reduce risk of trauma and encrustation.<br />
<br />
[[Image:Contour VL variable length percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Percuflex Stents<Br><br />
:* High coil strength pigtail shape prevent stent migration <br />
:* Thin wall promotes drainage and patency <br />
:* Multiple, large side ports promote drainage <br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
[[Image:percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Polaris Ultra Ureteral Stent<br />
:* Ultra Ureteral Stent provides the ease of placement benefits of a firm stent graduated into a soft bladder coil<br />
:* Co-extrusion combines a firm durometer Percuflex Plus Material and a soft durometer Percuflex Material in the same stent <br />
:* Nautilus bladder coil potentially reduce bladder irritation, and a relaxed renal coil facilitate ease of removal <br />
<br />
[[Image:Polaris Ultra Ureteral Stent.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
=====Cook Group=====<br />
* Bander Ureteral Diversion Stent Set<br />
It is used for intraoperative placement to stent the ureter during ureteroileal conduit construction and continent urinary diversions. Set includes: 2 stents, 2 catheter retainers and wire guide.<br />
<br />
[[Image:Bander Ureteral Diversion Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* C-Flex Double Pigtail Ureteral Stent Set<br />
It is used for temporary internal drainage from the ureteropelvic junction to the bladder. Set includes stent, wire guide, stent positioner and catheter.<br />
<br />
[[Image:C-Flex Double Pigtail Ureteral Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* Towers Peripheral Ureteral Stent Set<br />
It is also used for temporary internal drainage from the ureteropelvic junction to the bladder. The stent configuration allows peripheral as well as luminal drainage. Set Includes: Stent, Wire Guide, Catheter, and Stent Positioner.<br />
<br />
[[Image:Towers Peripheral Ureteral Stent Set.jpg|500px|center|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
=====Applied medicals=====<br />
* 7-10 endopyelotomy stent<br />
It is used by urologists for endopyelotomy and endoureterotomy. The dual diameter promotes optimal healing while minimizing the discomfort often associated with larger diameter stents.<br />
<br />
[[Image:ureteral stent-applied.jpg|center|500px|thumb|[http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Source: www.appliedmed.com]]]<br />
<br />
=====Redi-Tech Medical Products=====<br />
* Ureteral stents set<br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
:* Multiple, large side ports promote drainage <br />
:* Radiopaque stent markings aid in placement and sizing <br />
<br />
[[Image:Ureteral stent-redi tech.jpg|center|400px|thumb|[http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Source: www.redi-tech.com]]]<br />
<br />
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<br><br />
=== Clinical Trials ===<br />
====New trials ====<br />
{| {{table}}<br />
| align="center"|'''Title'''<br />
| align="center"|'''Conditions'''<br />
| align="center"|'''Intervention'''<br />
| align="center"|'''Sponsors and Collaborators'''<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]||Renal Calculi, Ureteral Obstruction||Device: Ureteral Stent||Lawson Health Research Institute, Boston Scientific Corporation<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]||Urethral Stricture||Device: Memokath stenting||Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]||Kidney Stones||N\A||University of California, Irvine<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]||Kidney Stones||Device: Ureteral Stent||Emory University<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]||Ureteral Obstruction||Device: Memokath 051 Ureteral Stent||Mayo Clinic Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]||Kidney Disease||Device: nephrostomy tube and ureteral stent||Rabin Medical Center<br />
|-<br />
|}<br />
==== Concluded trials ====<br />
{| {{table}}<br />
| align="center" |'''Title'''<br />
| align="center" |'''Abstract'''<br />
| align="center" |'''Enrollment'''<br />
| align="center" |'''Disorder'''<br />
| align="center" |'''Conclusion'''<br />
|-<br />
| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia ||To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.||13||Detrusor-sphincter dyssynergia||Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.||A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.||201||Renal transplant recipient||Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
====Adverse Events====<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#00CCFF"|'''S. No.'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Brand Name'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Adverse Event'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Date FDA Received'''<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''1'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=660847 Cook Urologicals Cook Urological Stent]</u></font><br />
|align = "justify"|Stent broke into pieces while removing it from the patients body.<br />
|align = "center"|12/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''2'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=930422 Boston Scoientific Boston Scientific Ureteral stent System]</u></font><br />
|align = "justify"|Fractured stent seen under Fluroscopy<br />
|align = "center"|10/17/2007<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''3'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=755260 Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CM]</u></font><br />
|align = "justify"|During insertion of ureteral stent, the stent broke into multiple parts which were retained in the patient.<br />
|align = "center"|10/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''4'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=564910 Boston Scientific Corp Boston Scientific 8 FR X 28 CM Ureteral Stent System Kit]</u></font><br />
|align = "justify"|Breakage of the upper loop of the ureteral stent while trying to insert it.<br />
|align = "center"|1/5/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''5'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522129 Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stent]</u></font><br />
|align = "justify"|Broken stent observed during x-ray procedure.<br />
|align = "center"|12/12/2003<br />
|-<br />
|}<br />
[[Media: non patent upload.xls|'''Review Articles''']]<br><br />
[[Media: non patent upload1.xls|'''Non Patent Analysis''']]<br />
<br />
=== Products ===<br />
{| {{table}}<br />
| align="center"|'''Boston Scientific Scimed, Inc.'''<br />
| align="center"|'''Cook Urological Incorporated'''<br />
| align="center"|'''OptiMed Global Care'''<br />
|-<br />
| Polaris™ Ultra Ureteral Stent <br />
| Firlit-Kluge Urethral Stent<br />
| Opti-J Ureteral Stent System <br />
|-<br />
| Polaris™ Loop Ureteral Stent<br />
| Koyle Diaper Stent <br />
| Ureteral Stent Sets, ureterorenoscope <br />
|-<br />
| Stretch™ VL Variable Length Flexima® Stents <br />
| Silicone Universal Drainage Stent<br />
| Extra Strong Stent Sets (-Tumor)<br />
|-<br />
|<br />
| Tarkington Urethral Stent Set<br />
| Steerable Ureteral Stent Sets<br />
|-<br />
|<br />
| Zaontz Urethral Stent<br />
| Multilength <br />
|-<br />
|<br />
| Pediatric Urethral C-Stent<br />
|<br />
|-<br />
|}<br />
<br />
=== Startup activity ===<br />
* [http://twincities.bizjournals.com/twincities/stories/2008/07/28/story8.html AbbeyMoor Medical Inc.], a med-tech firm that’s developed devices for treating urological disorders, has raised $2.7 million in bridge financing.<br />
<br />
== Phase 2: Deeper Dive ==<br />
=== Scenario ===<br />
Client wishes to acquire a ureteral stent company.<br />
<br />
=== Deal analysis for a target company ===<br />
[[Image:DealImplications.jpg|thumb|center|700px|Deal implications]]<br />
<br />
=== Design History File Review: Review components ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|Review <br />
!bgcolor = "#00CCFF" width="30%"|Verification<br />
!bgcolor = "#00CCFF" width="40%"|Tasks<br />
!bgcolor = "#00CCFF" width="15%"|Expertise<br />
|-<br />
!rowspan="2"|Design Input<br />
| Design input documents for sufficiency<br />
| <br />
# Access electronic data room.<br />
# Check what documents are provided.<br />
# Compare document list with standard client document list.<br />
# Check whether each specified document has appropriate content.<br />
| rowspan="2"|Quality systems<br />
|-<br />
| Design input documents linked to the product performance specifications<br />
|<br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
|-<br />
!rowspan="3"|Product Performance Specifications (PPS) <br />
| Design inputs correlate adequately to the specifications; DV&V (design verification and validation) criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans<br />
| <br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
| rowspan="3"|Quality systems, CAD<br />
|-<br />
| Appropriate design verification and validations (DV&V) are performed<br />
| <br />
# Show DV&V criteria are based on risk management requirements<br />
|-<br />
| Product performance specifications correspond to appropriate design output documents<br />
| <br />
# Correlate design drawings with the specifications<br />
# Check whether maximum dimensions, sizes etc. (with tolerances) are within the specified range<br />
|-<br />
!rowspan="4"|Risk Management Documents <br />
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation<br />
| <br />
# Check whether documentation is available<br />
# Check whether it adheres to appropriate ISO 14971 standards<br />
# Check whether it adheres to appropriate client standards<br />
|rowspan="4"| Quality systems<br />
|-<br />
| DFMEA links appropriately to the PPS<br />
| <br />
# Verify whether DFMEA and product specifications are correlated<br />
|-<br />
| Appropriate DV&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEA<br />
| <br />
# Validate the process and correlate with design inputs<br />
# Validate that sizes used are within range of risk mitigation criteria<br />
|-<br />
| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA<br />
| <br />
# Validate the process protocol<br />
# Validate the inspection procedures used <br />
|-<br />
!rowspan="2"|Design Output Documents <br />
| Completeness of drawings<br />
|<br />
# Check if the CAD diagrams overlay and "fit" perfectly<br />
# Check tolerance stackups<br />
|rowspan="2"| Quality systems, CAD<br />
|-<br />
| Correlate First Article Inspection data to the dimensions on the drawings<br />
| <br />
# Obtain First Article Inspection data<br />
# Check if this data correlates with the completeness of drawings<br />
|-<br />
!rowspan="4"|Manufacturing Documents <br />
| Manufacturing procedures, component specifications, raw material specifications, incoming and in-process inspection procedures for completeness<br />
| <br />
# Verify the Bill of Materials corresponds to raw materials and manufacturing procedures<br />
# Correlate incoming and in-process inspection procedures with the process specifications<br />
| rowspan="4"|Material science, manufacturing engineering, quality systems<br />
|-<br />
| Linkage between component and raw material specifications and appropriate incoming inspection procedures<br />
| <br />
# Identify any missing documentation for inspection procedures<br />
|-<br />
|-<br />
| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials<br />
| <br />
# Review supplier audit reports for compliance<br />
|-<br />
| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations<br />
| <br />
# Check the entire equipment-related lifecycle<br />
# Check if machine operational qualification was performed<br />
# Check if the measurement equipment was validated<br />
|-<br />
!rowspan="2"|Validation Report<br />
| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports<br />
|<br />
# Ensure all reports are available and linked together appropriately<br />
# Identify all inconsistencies across different reports<br />
| rowspan="2"| Quality systems<br />
|-<br />
| Design test methods and related test method validations<br />
| <br />
# Compare test methods used to those in client and ISO standards<br />
# Identify inconsistencies across test methods<br />
|-<br />
|}<br />
<br />
=== Sample report ===<br />
==== Performance/Functional Characteristics ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" colspan = "4" |Design Input<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Output<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Verification Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Validation Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
|-<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|User Needs<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|User Need Rationale<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification Rationale<br />
|-<br />
|Provide antimicrobial resistance for up to 2 weeks<br />
|Ureteral Stent User Survey (Document #XXXXX)<br />
|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeks<br />
|Document #XXXXX<br />
|Test Document #XXXXX<br />
|Report 01-005-06-007<br />
|P<br />
|Report 01-005-06-007<br />
|P<br />
|-<br />
|}<br />
<br />
=== Potential DHF Review Outcomes ===<br />
Based on a review of the above DHF documents a potential outcome for the uretral stent acquisition project could involve the following:<br />
# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.<br />
# Creation of some new test methods for design, incoming and in-process inspections and also include recommendations for the test method validations. Creation of any new DV&V data would be highly unlikely as it could potentially trigger a new submission or a note-to-file to the regulatory agencies.<br />
# Change in raw materials to better grade materials e.g. Switching resin to a USP Class VI biocompatible resin. This would eliminate some on-going testing but require additional upfront one time biocompatibility testing.<br />
# Updating drawings based on results from the FAI data.<br />
# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw material specifications and inspection procedures.<br />
# Identifying installation, operational and process qualification requirements with the assumption that no additional design verification and validation activities are required based on the fact that the device is currently approved for sale in the US and ROW.<br />
# Recommend activities necessary for completing packaging, labeling, ship testing and shelf-life testing. Stress should be on being able to leverage existing data for shelf-life without changing the regulatory status of the device. <br />
# Company X may want to perform additional biocompatibility testing to create an internal baseline and also update their biocompatibility files.<br />
# Help streamline suppliers for components when switching over from Company Y to Company X. Search for existing Company X suppliers that can supply off the shelf items that Company Y may be sourcing from other vendors / suppliers.<br />
# Identify process improvements that can be rolled into the manufacturing transfer without changing the design and impacting the existing regulatory status for the device e.g. instead of hand mixing pigment to resin use a pre-mixer to control quality of mixing and resulting extrusion or perform the molding and over-molding steps in 1 machine instead of 2 separate molding machines.<br />
<br />
== Phase 3: Post-acquisition integration ==<br />
=== Deadlines ===<br />
'''Goal''': Switch production transparently to new facilities transparently to the distribution system<br />
<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Stage<br />
!align = "center" bgcolor = "#00CCFF" |Tasks<br />
!align = "center" bgcolor = "#00CCFF" |Milestone payment<br />
!align = "center" bgcolor = "#00CCFF" |Date<br />
|-<br />
|Design center integration plan<br />
|<br />
* Gap analysis completion (acquiree)<br />
* Gap analysis completion (acquirer)<br />
|<br />
|September 15, 2008<br />
|-<br />
|Design to manufacturing transfer<br />
|<br />
|<br />
|December 15, 2008<br />
|-<br />
|Equipment transfer<br />
|<br />
|Milestone I payment<br />
|Jan 7, 2009<br />
|-<br />
|Shut production at acquiree facility<br />
|Negotiation for contract extension<br />
|Milestone II payment<br />
|Feb 15, 2009<br />
|-<br />
|Start production in acquirer facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Switch to new SKU<br />
|<br />
|<br />
|Feb 15, 2009<br />
|-<br />
|End development of new generation product/s in old facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Restart development of new generation product/s post-acquisition<br />
|<br />
|Final milestone payment<br />
|Mar 1, 2009<br />
|-<br />
|}<br />
<br />
=== Documents and Ownership ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Document<br />
!align = "center" bgcolor = "#00CCFF" |Owner<br />
!align = "center" bgcolor = "#00CCFF" |Last update date<br />
|-<br />
|Product performance specifications<br />
|Paul Swain<br />
|07/27/2008 08:15:35 PST<br />
|-<br />
|Component specifications<br />
|Kevin Teller<br />
|06/12/2008 12:22:07 PST<br />
|-<br />
|Preclinical test results<br />
|Joanne Krannert<br />
|07/03/2008 14:17:00 PST<br />
|-<br />
|Clinical tests<br />
|Joanne Krannert<br />
|08/01/2008 08:00:55 PST<br />
|-<br />
|}<br />
<br />
==Ureteral stents regulatory issues==<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=876.4620&SearchTerm=ureter%20stent Code of Federal Regulations]<br />
<br />
===Pre-Market Notification===<br />
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance, also known as Premarket Notification. This premarket submission demonstrates to the FDA that the device to be marketed is atleast as safe and effective, that is, ''substantially equivalent'', to a legally marketed device. Parties required to submit a 510(k) to the FDA include domestic or foreign manufacturers introducing a device to the U.S. market, as well as specification developers and repackers/relabelers. <br />
<br />
A 510(k) is required when: <br />
* Introducing a device into commercial distribution (marketing) for the first time.<br />
* Proposed different intended use for a device already in commercial distribution.<br />
* Change or modification of a legally marketed device.<br />
<br />
[http://dolcera.com/upload/files/510kflowchart.pdf 510(k) “Substantial Equivalence” Decision Making Process]<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. (This is not an exhaustive list and is just a sample)<br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Sr. No. '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Company'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Device'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Date of Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Material'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Technology'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Indwelling time (days) '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Image'''</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 InLay Optima]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Silicone<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:InLay_Optima.png|thumb|center|200px|<center>InLay Optima</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() Polaris Loop]</center><br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|200px|<center>Polaris Loop</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Metal<br />
| style="background-color:#ccffff;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|200px|<center>Resonance</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]</center><br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|200px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>240</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|200px|<center>Memokath 051</center>]]<br />
<br />
|}<br />
<br />
===Timeline Sheet===<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
<br />
*References<br />
<br />
1- [http://en.wikipedia.org/wiki/Demographics_of_the_United_States http://en.wikipedia.org/wiki/Demographics_of_the_United_States]<br />
<br />
2- [http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink]<br />
<br />
3- [http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf]<br />
<br />
4- [http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html]<br />
<br />
==<span style="color:#C41E3A">Like this report?</span>==<br />
<p align="center"> '''This is only a sample report with brief analysis''' <br><br />
'''Dolcera can provide a comprehensive report customized to your needs'''</p><br />
{|border="2" cellspacing="0" cellpadding="4" align="center" "<br />
|style="background:lightgrey" align = "center" colspan = "3"|'''[mailto:info@dolcera.com <span style="color:#0047AB">Buy the customized report from Dolcera</span>]''' <br />
|-<br />
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|align = "center"| [http://www.dolcera.com/website_prod/tools/patent-dashboard Purchase Patent Dashboard]<br />
|-<br />
|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/patent-search/patent-landscapes Patent Landscape Services]<br />
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|align = "center"| [http://www.dolcera.com/website_prod/tools Dolcera Tools]<br />
|-<br />
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<br><br />
<br />
==Contact Dolcera==<br />
<br />
{| style="border:1px solid #AAA; background:#E9E9E9" align="center"<br />
|-<br />
! style="background:lightgrey" | Samir Raiyani<br />
|-<br />
| '''Email''': [mailto:info@dolcera.com info@dolcera.com]<br />
|-<br />
| '''Phone''': +1-650-269-7952<br />
|}<br />
<br />
= Addition =<br />
=== Patent Categorization: Interactive mind map linked to Dolcera Dashboard ===<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
=== Product-Patent-Clinical Trials Mapping ===<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
=== Product to Patent Mapping ===<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''here ''']]to download the excel file.<br />
* Mapped Patent vs Not Mapped Patents<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=== Dolcera Dashboard ===<br />
[[Image:dashboard_features.png|center|750px|]]<br />
<br />
'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]<br />
|-<br />
|}<br />
*Flash Player is essential to view the Dolcera Dashboard<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
<br />
=== Key Artifacts ===<br />
* [[Investment Heat Map ]]<br />
* [[Revenue Heat Map ]]<br />
* [[Patent Heat Map]]<br />
* [http://www.dolcera.com/website/demos/dental/main.html Dynamic Patent Dashboard]<br />
* [http://www.dolcera.com/ipmapdemo/stent_model.swf Stent Landscape-Flash]<br />
* [[Company Profile - Flash]]<br />
<br />
=Removed Sections=<br />
[[Removed Sections]]</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Patent_Search_Strategy&diff=9906
Patent Search Strategy
2011-10-18T21:03:47Z
<p>Bharat: </p>
<hr />
<div>==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Patent_Heat_Map&diff=9905
Patent Heat Map
2011-10-18T21:03:10Z
<p>Bharat: </p>
<hr />
<div>=='''Head to Toe EBD Heat Map (Patent:Dashboard Linked)'''==<br />
<gflash>1050 825 http://dolcera.com/upload/files/Patent_Heat_Map_Dashboard_Version_01.swf</gflash><br />
<br><br />
<br />
*[[Media:Patent Heat Map datasheet1.xls|Patents data sheet]]</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Revenue_Heat_Map&diff=9904
Revenue Heat Map
2011-10-18T21:02:58Z
<p>Bharat: </p>
<hr />
<div>=='''Head to Toe EBD Heat Map (Revenue)'''==<br />
<gflash>1050 825 https://www.dolcera.com/client/cvd9/Revenue_heat_map_V3.swf</gflash><br />
<br><br />
<br />
*[[Media:Revenue Heatmap Data Sheet.xls|Revenue Heat Map Data Sheet]]</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Investment_Heat_Map&diff=9903
Investment Heat Map
2011-10-18T21:02:47Z
<p>Bharat: </p>
<hr />
<div>=='''Head to Toe EBD Heat Map (Investments)'''==<br />
<gflash>1075 825 https://www.dolcera.com/client/cvdn/Investment%20Heat%20Map%20V2.swf</gflash><br />
<br />
*[[Media:Investment Data Sheet.xls|Investment Heat Map Data Sheet]]</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Backup&diff=9902
Backup
2011-10-18T21:02:20Z
<p>Bharat: /* Removed Sections */</p>
<hr />
<div>[[Wiki section]]<br />
== Phase 1: Landscape overview ==<br />
=== Ureteral Stent: Concept ===<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of fiiction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
=== Background === <br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used to facilitate drainage in<br />
conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation. <br />
<br />
The advent of ESWL and the more recent barrage of endourological techniques have increased the indications for ureteral stents (Candela and Bellman 1997). Indications for use include:<br />
* Treatment of ureteral or kidney stones<br />
* Ureteral trauma or stricture<br />
* Genitourinary reconstructive surgery<br />
* Hydronephrosis during pregnancy<br />
* Obstruction due to malignancy<br />
* Retroperitoneal fibrosis<br />
<br />
The need for ureteral stents range from a few days to several months. For patients with serious urological problems, ureteral stent maintenance may become a life-long necessity. Unfortunately, there are many problems associated with using ureteral stents.<br />
<br />
=== Ureteric stenting difficulties ===<br />
[[Image:Ureteral stent.jpg|thumb|right|350px|Double-J and Pigtail ureteral stents]]<br />
{|border="2" cellspacing="2" cellpadding="4" width="50%"<br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Common'''</font><br />
|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Rare'''</font><br />
<br />
|-<br />
|<br />
* Trigonal irritation<br />
* Haematuria<br />
* Fever<br />
* Infection<br />
* Tissue inflammation<br />
* Encrustation<br />
* Biofilm formation<br />
|<br />
* Obstruction<br />
* Kinking<br />
* Ureteric rupture<br />
* Ureteric perforation<br />
* Stent misplacement<br />
* Stent migration<br />
* Stent misfit<br />
* Stent forgotten<br />
* Tissue hyperplasia<br />
|}<br />
<br />
Today, elastomeric materials, such as silicones, polyurethanes and hydrogel-coated polyolefins are used, with no clear winner, which can withstand the urinary environment. <br />
* Although silicone has better long-term stability than other stent materials, its extreme flexibility makes it difficult to pass over guidewires and through narrow or tortuous ureters. <br />
* Polyethylene is stiffer and easier to use for patients with strictures; however, it has been known to become brittle with time leading to breakage and is no longer commercially available. * Polyurethane has properties that fall in between polyethylene and silicone; however, stent fracture also has been an issue with polyurethanes.<br />
<br />
Attempts have been made to develop polymers with a combination of the best of all properties. The key players are C-Flex (Concept Polymer Technologies), Silitek and Percuflex (Boston Scientific).<br />
* C-Flex is proprietary silicone oil and mineral oil interpenetrated into a styrenelolefin block copolymer with the hope of reduced encrustation.<br />
* Silitek (Medical Engineering Corporation) is another silicone-based copolymer. <br />
* Percuflex is a proprietary olefinic block copolymer. <br />
<br />
Metallic stents have been used recently to treat extrinsic ureteric obstructions. The effect of synthetic polymers on the urothelium of the urinary tract seems to be dependent on the bulk chemical composition of the polymer, the chemical composition of its surface, coatings on the device<br />
surface, smoothness of the surface and coefficient of friction.<br />
<br />
Typically, most ureteral stents are made of relatively smooth catheters. [http://www.ncbi.nlm.nih.gov/pubmed/10772512 Koleski et al., (2000)] tested a longitudinally grooved ureteral stent made by Circon in the pig ureter. The results indicated that the grooved stent led to better drainage than a conventional stent. Their opinion is that the ureter wall has a better chance of collapsing over a<br />
smooth surface than a grooved surface, especially when debris is present. Stoller (2000) had the same experience with the SpiraStent(Urosurge Corp.). This helical stent was superior at passing stones than a conventional smooth stent.<br />
<br />
There are a variety of ureteral stent configurations with different anchoring systems. Most stents today have a double [http://linkinghub.elsevier.com/retrieve/pii/S014067360002674X pigtail anchoring system]. (Tolley, 2000), Dunn et al, (2000) conducted a randomized, single-blind study comparing a Tail stent (proximal pigtail with a shaft which tapers to a lumenless straight tail) to a double pigtail stent. The Tail stent was found to be better tolerated than the double-pigtail concerning<br />
lower urinary tract irritative symptoms. A double-J ureteral stent and a flexible ureteropyeloscope are shown in the first diagram. The other two diagrams show a pigtail ureteral stent in place; the end of the pigtail is facing away fiom the ureteral opening in the second of these two diagrams.<br />
<br />
Early adverse effects of ureteral stenting include lower abdominal pain, dysuria, fever, urinary frequency, nocturia and hematuria. Patient discomfort and microscopic hematuria happen often. Major late complications include stent migration, stent fragmentation or more serious hydronephrosis with flank pain and infections. <br />
<br />
Late complications occurred in one third of the patients in a prospective study using both silicone and polyurethane double pigtail stents (110 stents) in 90 patients. Stent removal was necessary in these patients. Others also have found this percentage of late complications. Device-related urinary tract infection and encrustation can lead to significant morbidity and even death and are the primary factors limiting long-term use of indwelling devices in the urinary tract. Microbial biofilm and encrustation may lead to stone formation. This is typically not a problem when stents are used<br />
for short-term indications. Problems of biofilm formation, encrustation and stent fracture occur in patients with long-term indwelling stents.<br />
<br />
Typically, manufacturers advise periodic stent evaluation. Cook polyurethane stent removal is recommend at 6 months and 12 months for silicone (Cook product literature). However, stents that are intended for long-term use are usually changed at regular intervals, as frequently as every 3 months.<br />
<br />
Forgotten stents are a problem. Monga et al., 1995 found that 68% of stents forgotten more than 6 months were calcified and 10% were fragmented. Multiple urologic procedures were necessary to remove the stones. Long-term effects of these forgotten stents may lead to voiding dysfunction and renal insufficiency. Schlick, et al., 1998 are developing a biodegradable stent that will preclude the need for stent removal. <br />
<br />
==== Encrustation ====<br />
The urinary system presents a challenge because of its chemically unstable environment. Long-term biocompatibility and biodurability of devices have been problems due to the supersaturation of uromucoids and crystalloids at the interface between urine and the device. Encrustation of ureteral stents is a well-known problem, which can be treated easily if recognized early. However, severe encrustation leads to renal failure and is difficult to manage (Mohan-Pillai et al., 1999). All biomaterials currently used become encrusted to some extent when exposed to urine.<br />
<br />
The encrusted deposits can harbor bacterial biofilms. In addition, they can render the biomaterial brittle which causes fracture in-situ, a serious problem especially associated with the use of polyethylene and polyurethane ureteral stents (although silicone stents have also been<br />
reported to fracture). Stent fragments can migrate to the bladder or renal pelvis with serious repercussions.<br />
<br />
Surface science techniques were used to study three stent types after use in patients. The stent type, duration of insertion and age or sex of the patient did not correlate significantly with the amount of encrustation (Wollin et al., 1998). However, it has been suggested that factors which affect the amount of encrustation include the composition or the urine, the type of invading and colonizing bacteria and the structure and surface properties of the biomaterial used (Gorman 1995). A low surface energy surface seems to resist encrustation compared with a high surface energy surface (Denstedt et al., 1998).<br />
<br />
Many different types of stone can form in the urinary tract. Calcium oxalate, calcium phosphate, uric acid and cystine stones are metabolic stones because they form as a result of metabolic dysfunction. They usually are excreted from the urinary tract. Struvite (magnesium ammonium phosphate) and hydroxyapatite (calcium phosphate) are associated with infection (infection stones). These account for 1520% of urinary calculi. ESWL is used to break up the larger infection stones because they don't pass; recurrence of the problem occurs with incomplete removal. Infection stones can manifest as poorly mineralized matrix stones, highly mineralized staghorn calculi or as bladder stones which often form in the presence of ureteral stents. Urea-splitting bacteria colonize the surface and cause alkalinization of the urine, which lowers the solubility of struvite and hydroxyapatite, and they deposit on the surface. Bacterial biofilm associated with encrustation is a common clinical occurrence. (Gorman and Tunney, 1997). It has been suggested that prevention of bacterial colonization would prevent encrustation because of their ultimate responsibility for its formation (Bibby et al., 1995).<br />
<br />
An in vitro model was developed that produces encrustation similar to those seen in vivo (Tunney et al., 1996a). An experiment was conducted to compare the encrustation potential of various ureteral stent materials. The long-term struvite and hydroxyapatite encrustation of silicone, polyurethane, hydrogel-coated polyurethane, Silitek and Percuflex were compared. All of the materials developed encrustation, however, it was found by image analysis that the rates of encrustation varied on the different materials. Silicone had less encrustation (69% at 10 weeks) compared to the other materials (1 00%) at the same time point (Tunney et al., 1996b). Continuous flow models have also been developed which are more representative of conditions in the upper urinary tract. They are discussed by Gorman and Tunney, (1 997). Efforts to reduce encrustation using new materials, smoother<br />
surfaces and hydrogel coatings have been attempted. <br />
<br />
A hydrogel-coated C-flex stent (Hydroplus, Boston Scientific) was shown to have less epithelial cell damage and encrustation than other biomaterials and was recommended by the investigators for long-term use (Cormio, 1995). In addition, a poly(ethy1ene oxide)/polyurethane composite hydrogel (Aquavenem, J & J) resisted intraluminal blockage in a urine flow model compared with silicone and polyurethane (Gorman et al., 1997a). Another advantage with Aquavene is that it is rigid in the dry state, which facilitates insertion past obstructions in the ureter and becomes soft on hydration providing comfort (Gorman and Tunney, 1997). Gorman et al. (1997b) concluded that the chance of stent fracture would be reduced if the ureteral stent side holes were eliminated. Urinary tract infection is another common major problem with the usage of ureteral stents. Initially, a conditioning film is deposited on the ureteral stent surface. The film is made up of proteins, electrolyte materials and other unidentified materials that obscure the surface properties of the stent material. Electrostatic interactions, the ionic strength and pH of the urine and differences in fluid surface tensions affect bacterial adhesion to the conditioning film. Subsequently, a microbial biofilm forms over time. The biofilm is composed of bacterial cells embedded in a hydrated, predominantly anionic mixture of bacterial exopolysaccharides and trapped host extracellular macromolecules.<br />
<br />
====Obstruction====<br />
Obstruction of urine flow and urinary tract sepsis can result in continued growth of the biofilm. Colonization of devices implanted in the urinary tract can lead to dysfunction, tissue intolerance, pain, subclinical or overt infection and even urosepsis. Device related infections are difficult to<br />
treat and device removal is usually necessary. The biofilm has been found to impede the diffusion of antibiotics; in addition, the bacteria in the biofilm have a decreased metabolic rate , which also protects them against the effects of antibiotics (Wollin et al., 1998). Riedl, et al. (1 999) found 100% ureteral stent colonization rates in permanent and 69.3% in temporary stents. Antibiotic prophylaxis did not prevent bacterial colonization and it was recommended that it not be used.<br />
On the other hand, Tieszer, et al. (1 998) believe that fluoroquinolones can prevent infection. They also have found that some stents have denser encrustation than others, however, the stent material did not change the elements of the "conditioning film" adsorbed or alter its receptivity to<br />
bacterial biofilms.<br />
<br />
====Infection====<br />
The predictive value of urine cultures in the assessment of stent colonization was examined in 65 patients with indwelling ureteral stents. It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et al., 1999). Patients with sterile urine culture<br />
may benefit from prophylactic antibiotics; however, the authors contended that the antibiotics must work against gram-negative uropathogens and gram-positive bacteria including enterococci.<br />
It is obvious that there is controversy in the literature whether prophylactic systemic antibiotics are useful with ureteral stent implant. However, antibiotics do not seem to prevent stent colonization. Denstedt et al. (1998) have found that ciprofloxacin, with a 3 day burst every 2<br />
weeks, actually is adsorbed onto the stent which makes longer term treatment possible with reduced risk of bacterial resistance. There has been research targeted at coating or impregnating urinary catheters with antimicrobials and products are on the market, however, there are no antimicrobial ureteral stents approved by the FDA.<br />
<br />
=== The market need ===<br />
It is clear that there is a need for a new material that will be able to resist encrustation and infection in the urinary tract. According to Merrill Lynch, ureteral stents represent an $80 MM<br />
US market. Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player. There are a number of other small contenders. <br />
<br />
The use of ureteral stents is increasing; the indications for ureteral stenting have broadened from temporary or permanent relief or ureteric obstruction to include temporary urinary diversion following surgical procedures such as endopyelotomy and ureteroscopy and facilitation of stone clearance after ESWL (Tolley, 2000). <br />
<br />
The use of ureteral stents for patients having ESWL for renal calculi is however controversial and seems to be related to the size of the stones and invasiveness of the procedure. According to survey results reported by Hollowell, et al. (2000), there is a significant difference in opinion concerning the use of stents with ESWL. <br />
<br />
The number of ureteral stents used in patients with stones 2 cm or less treated with ESWL is significant in spite of the lack scientific evidence in support of this practice. Of 1,029 urologists returning surveys, for patients with renal pelvic stones 10, 15 or 20 rnm treated with ESWL, routine stent placement was preferred by 25.3%, 57.1 % and 87.1 %, respectively. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5-1 0 mm.<br />
<br />
=== Intellectual property ===<br />
==== Search strategy ====<br />
* Databases searched: US-G, US-A, EP-A, EP-B, WO, JP, DE, GB, FR<br />
* Search scope: Title, Abstract or Claims<br />
* Years: 1981-July 2008<br />
* Search query: (ureter* OR urether* OR ureth* OR uretr*) AND (stent*) AND (*microb* OR *bacter*)<br />
* Results: '''177 patents (82 unique patent families)'''<br />
<br />
==== Sample patents ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF"|Patent<br />
!bgcolor = "#00CCFF"|Assignee<br />
!bgcolor = "#00CCFF"|Title<br />
!bgcolor = "#00CCFF"|Abstract<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=6468649.PN.&OS=PN/6468649&RS=PN/6468649 US6468649 B1]<br />
| SCIMED LIFE SYSTEMS INC<br />
| Antimicrobial adhesion surface<br />
| The present invention provides an implantable medical device having a substrate with a hydrophilic coating composition to limit in vivo colonization of bacteria and fungi. The hydrophilic coating composition includes a hydrophilic polymer with a molecular weight in the range from about 100, 000 to about 15 million selected from copolymers acrylic acid, methacrylic acid, isocrotonic acid and combinations thereof.<br />
|-<br />
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=5554147.PN.&OS=PN/5554147&RS=PN/5554147 US5554147 A]<br />
| CApHCO, Inc. <br />
| Compositions and devices for controlled release of active ingredients <br />
| A method for the controlled release of a biologically active agent wherein the agent is released from a hydrophobic, pH-sensitive polymer matrix is disclosed and claimed. The polymer matrix swells when the environment reaches pH 8.5, releasing the active agent. A polymer of hydrophobic and weakly acidic comonomers is disclosed for use in the controlled release system. Further disclosed is a specific embodiment in which the controlled release system may be used. The pH-sensitive polymer is coated onto a latex catheter used in ureteral catheterization. A common problem with catheterized patients is the infection of the urinary tract with urease-producing bacteria. In addition to the irritation caused by the presence of the bacteria, urease produced by these bacteria degrade urea in the urine, forming carbon dioxide and ammonia. The ammonia causes an increase in the pH of the urine. Minerals in the urine begin to precipitate at this high pH, forming encrustations which complicate the functioning of the catheter. A ureteral catheter coated with a pH-sensitive polymer having an antibiotic or urease inhibitor trapped within its matrix will release the active agent when exposed to the high pH urine as the polymer gel swells. Such release can be made slow enough so that the drug remains at significant levels for a clinically useful period of time. <br />
|-<br />
![http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220030153983%22.PGNR.&OS=DN/20030153983&RS=DN/20030153983 US20030153983 A1]<br />
| SCIMED LIFE SYSTEMS INC<br />
|Implantable or insertable medical device resistant to microbial growth and biofilm formation <br />
| Disclosed are implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the invention discloses implantable or insertable medical devices that comprise at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device. Also disclosed are methods of manufacturing such devices under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of the biocompatible matrix polymer and substantially prevent chemical modification of said bioactive agents <br />
|-<br />
|}<br />
<br />
==Urinary Problems in men and women==<br />
* Both men and women have an increased risk for urinary incontinence as they get older, with men's rates rising steadily and women's rates peaking during menopause. <br />
* The prevalence of incontinence in men of all ages is certainly lower than that for women. <br />
* Women over 70, however, are twice as likely to have urinary incontinence as men of the same age.<br />
<br />
[http://www.ehow.com/facts_5664964_urinary-prevalence-men-vs_-women.html Source: Urinary prevalence men Vs women]<br />
<br />
<br />
==Market Analysis==<br />
* We determined market data to have an idea about the market potential for ureteral stents.<br />
* We have done this modeling for female population in US as women has the higher prevalence rate for urinary incontinence than men in all age groups.<br />
* Prevalence increased with age, from 28% for 30- to 39-year-old women to 55% for 80- to 90-year-old women.<br />
* 18% of respondents reported severe UI.<br />
* The prevalence of severe UI also increased notably with age, from 8% for 30- to 39-year-old women to 33% for 80- to 90-year-old women.<br />
* Among all, 9% reported slight UI, 15% reported moderate UI, 18% reported severe UI, and 58% reported no UI.<br />
<BR><br />
===Methodology===<br />
[[Image:methodology-ureteral stents.jpg|center|650px]]<br />
<br />
===Prevalence rate in US (women)===<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "2"|<font color="#FFFFFF">'''Prevalence of Urinary Incontinence in US (women)'''</font><br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|Age (in yrs)<br />
|align = "center" bgcolor = "#D3DFEE"|Population with Urinary incontinence (in %)<br />
|-<br />
|align = "center"|30-39<br />
|align = "center"|28%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|40-49<br />
|align = "center" bgcolor = "#D3DFEE"|41%<br />
|-<br />
|align = "center"|50-59<br />
|align = "center"|48%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|60-69<br />
|align = "center" bgcolor = "#D3DFEE"|51%<br />
|-<br />
|align = "center"|70-79<br />
|align = "center"|55%<br />
|-<br />
|align = "center" bgcolor = "#D3DFEE"|80-90<br />
|align = "center" bgcolor = "#D3DFEE"|54%<br />
|-<br />
|}<br />
<br />
[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]<br />
<br />
===Urinary incontinence severity among different age groups in US women===<br />
<br />
[[Image:urinary incontinence severity.jpg|center|500px|thumb|[http://archinte.ama-assn.org/cgi/content/full/165/5/537 Source: Archives of internal medicine]]]<br />
<br />
===Market potential for ureteral stent in US (women)===<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4F81BD" colspan = "6"|<font color="#FFFFFF">'''Market potential for ureteral stents in US women, 2009'''</font><br />
|-<br />
|bgcolor = "#D3DFEE"|1. Age groups<br><br />
|bgcolor = "#D3DFEE"|2. Female population<br>(from US census data)<br />
|bgcolor = "#D3DFEE"|3. Prevalence rate in female (%)<br />
|align = "center" bgcolor = "#D3DFEE"|4. Market potential<br>(total prevalence)<br>(2<nowiki>*</nowiki>3)<br />
|bgcolor = "#D3DFEE"|5. Catherization rate (%)<br><br />
|align = "center" bgcolor = "#D3DFEE"|6. Stent market based on catherization rate<br>(4<nowiki>*</nowiki>5)<br />
|-<br />
|30-39<br />
|20128402<br />
|28%<br />
|5635953<br />
|0.043%<br />
|2423<br />
|-<br />
|bgcolor = "#D3DFEE"|40-49<br />
|bgcolor = "#D3DFEE"|22074384<br />
|bgcolor = "#D3DFEE"|41%<br />
|bgcolor = "#D3DFEE"|9050497<br />
|bgcolor = "#D3DFEE"|0.123%<br />
|bgcolor = "#D3DFEE"|11132<br />
|-<br />
|50-59<br />
|20929761<br />
|48%<br />
|10046285<br />
|0.124%<br />
|12457<br />
|-<br />
|bgcolor = "#D3DFEE"|60-69<br />
|bgcolor = "#D3DFEE"|14605565<br />
|bgcolor = "#D3DFEE"|51%<br />
|bgcolor = "#D3DFEE"|7448838<br />
|bgcolor = "#D3DFEE"|0.160%<br />
|bgcolor = "#D3DFEE"|11918<br />
|-<br />
|70-79<br />
|9046207<br />
|55%<br />
|4975414<br />
|0.172%<br />
|8558<br />
|-<br />
|bgcolor = "#D3DFEE"|≥ 80<br />
|bgcolor = "#D3DFEE"|7216598<br />
|bgcolor = "#D3DFEE"|54%<br />
|bgcolor = "#D3DFEE"|3896963<br />
|bgcolor = "#D3DFEE"|0.044%<br />
|bgcolor = "#D3DFEE"|1715<br />
|-<br />
|'''Total'''<br />
|&nbsp;<br />
|&nbsp;<br />
|'''41053950'''<br />
|&nbsp;<br />
|'''48203'''<br />
|-<br />
|}<br />
<br />
<br />
* Prevalence rate in US women is growing at a CAGR of 1.19%<br />
* Ureteral stent market is growing at a CAGR of 1.47%<br />
<Br><br />
<br />
===Ureteral stent market forecast in US (women)===<br />
[[Image:stent market forecast1.jpg|center|600px]]<br />
<br />
[[Media:Detailed calculation workbook.xls|'''Detailed model workbook''']]<br />
<br />
===Ureteral stent companies===<br />
Various companies offering ureteral stents are:<br />
<br />
* [http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific Corporation]<br />
* [http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Group]<br />
* [http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Applied Medicals]<br />
* [http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Redi-Tech Medical Products]<br />
<br />
====Ureteral stents of various companies====<br />
=====Boston Scientific=====<br />
* Contour VL Variable Length Percuflex Stents<BR><br />
Inward spiral design of Nautilus Coil minimizes tissue contact for enhanced comfort. Dual variable length coil geometry permits balanced stent positioning to minimize the risk of migration. HydroPlus Coating provides unequalled surface lubricity which reduces friction to minimize risk of buckling during introduction and placement and to reduce risk of trauma and encrustation.<br />
<br />
[[Image:Contour VL variable length percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Percuflex Stents<Br><br />
:* High coil strength pigtail shape prevent stent migration <br />
:* Thin wall promotes drainage and patency <br />
:* Multiple, large side ports promote drainage <br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
[[Image:percuflex stents.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
* Polaris Ultra Ureteral Stent<br />
:* Ultra Ureteral Stent provides the ease of placement benefits of a firm stent graduated into a soft bladder coil<br />
:* Co-extrusion combines a firm durometer Percuflex Plus Material and a soft durometer Percuflex Material in the same stent <br />
:* Nautilus bladder coil potentially reduce bladder irritation, and a relaxed renal coil facilitate ease of removal <br />
<br />
[[Image:Polaris Ultra Ureteral Stent.jpg|center|500px|thumb|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Source: www.bostonscientific.com]]]<br />
<br />
=====Cook Group=====<br />
* Bander Ureteral Diversion Stent Set<br />
It is used for intraoperative placement to stent the ureter during ureteroileal conduit construction and continent urinary diversions. Set includes: 2 stents, 2 catheter retainers and wire guide.<br />
<br />
[[Image:Bander Ureteral Diversion Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* C-Flex Double Pigtail Ureteral Stent Set<br />
It is used for temporary internal drainage from the ureteropelvic junction to the bladder. Set includes stent, wire guide, stent positioner and catheter.<br />
<br />
[[Image:C-Flex Double Pigtail Ureteral Stent Set.jpg|center|500px|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
* Towers Peripheral Ureteral Stent Set<br />
It is also used for temporary internal drainage from the ureteropelvic junction to the bladder. The stent configuration allows peripheral as well as luminal drainage. Set Includes: Stent, Wire Guide, Catheter, and Stent Positioner.<br />
<br />
[[Image:Towers Peripheral Ureteral Stent Set.jpg|500px|center|thumb|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Source: www.cookmedical.com]]]<br />
<br />
=====Applied medicals=====<br />
* 7-10 endopyelotomy stent<br />
It is used by urologists for endopyelotomy and endoureterotomy. The dual diameter promotes optimal healing while minimizing the discomfort often associated with larger diameter stents.<br />
<br />
[[Image:ureteral stent-applied.jpg|center|500px|thumb|[http://www.appliedmed.com/products/product_card.aspx?prodGroupID=6&catID=37&Name=Ureteral+stents Source: www.appliedmed.com]]]<br />
<br />
=====Redi-Tech Medical Products=====<br />
* Ureteral stents set<br />
:* Attached suture for positioning and subsequent removal without the need for repeat cystoscopy <br />
:* Multiple, large side ports promote drainage <br />
:* Radiopaque stent markings aid in placement and sizing <br />
<br />
[[Image:Ureteral stent-redi tech.jpg|center|400px|thumb|[http://www.redi-tech.com/products/?get=pricing&loc=main&content=0&type=pricing&items=0&item=13 Source: www.redi-tech.com]]]<br />
<br />
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<br><br />
=== Clinical Trials ===<br />
====New trials ====<br />
{| {{table}}<br />
| align="center"|'''Title'''<br />
| align="center"|'''Conditions'''<br />
| align="center"|'''Intervention'''<br />
| align="center"|'''Sponsors and Collaborators'''<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]||Renal Calculi, Ureteral Obstruction||Device: Ureteral Stent||Lawson Health Research Institute, Boston Scientific Corporation<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]||Urethral Stricture||Device: Memokath stenting||Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]||Kidney Stones||N\A||University of California, Irvine<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]||Kidney Stones||Device: Ureteral Stent||Emory University<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]||Ureteral Obstruction||Device: Memokath 051 Ureteral Stent||Mayo Clinic Engineers & Doctors Wallsten Medical Group<br />
|-<br />
| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]||Kidney Disease||Device: nephrostomy tube and ureteral stent||Rabin Medical Center<br />
|-<br />
|}<br />
==== Concluded trials ====<br />
{| {{table}}<br />
| align="center" |'''Title'''<br />
| align="center" |'''Abstract'''<br />
| align="center" |'''Enrollment'''<br />
| align="center" |'''Disorder'''<br />
| align="center" |'''Conclusion'''<br />
|-<br />
| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia ||To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.||13||Detrusor-sphincter dyssynergia||Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.||A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.||201||Renal transplant recipient||Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
====Adverse Events====<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#00CCFF"|'''S. No.'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Brand Name'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Adverse Event'''<br />
|align = "center" bgcolor = "#00CCFF"|'''Date FDA Received'''<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''1'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=660847 Cook Urologicals Cook Urological Stent]</u></font><br />
|align = "justify"|Stent broke into pieces while removing it from the patients body.<br />
|align = "center"|12/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''2'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=930422 Boston Scoientific Boston Scientific Ureteral stent System]</u></font><br />
|align = "justify"|Fractured stent seen under Fluroscopy<br />
|align = "center"|10/17/2007<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''3'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=755260 Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CM]</u></font><br />
|align = "justify"|During insertion of ureteral stent, the stent broke into multiple parts which were retained in the patient.<br />
|align = "center"|10/14/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''4'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=564910 Boston Scientific Corp Boston Scientific 8 FR X 28 CM Ureteral Stent System Kit]</u></font><br />
|align = "justify"|Breakage of the upper loop of the ureteral stent while trying to insert it.<br />
|align = "center"|1/5/2005<br />
|-<br />
|align = "center" bgcolor = "#00CCFF"|'''5'''<br />
|align = "justify"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522129 Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stent]</u></font><br />
|align = "justify"|Broken stent observed during x-ray procedure.<br />
|align = "center"|12/12/2003<br />
|-<br />
|}<br />
[[Media: non patent upload.xls|'''Review Articles''']]<br><br />
[[Media: non patent upload1.xls|'''Non Patent Analysis''']]<br />
<br />
=== Products ===<br />
{| {{table}}<br />
| align="center"|'''Boston Scientific Scimed, Inc.'''<br />
| align="center"|'''Cook Urological Incorporated'''<br />
| align="center"|'''OptiMed Global Care'''<br />
|-<br />
| Polaris™ Ultra Ureteral Stent <br />
| Firlit-Kluge Urethral Stent<br />
| Opti-J Ureteral Stent System <br />
|-<br />
| Polaris™ Loop Ureteral Stent<br />
| Koyle Diaper Stent <br />
| Ureteral Stent Sets, ureterorenoscope <br />
|-<br />
| Stretch™ VL Variable Length Flexima® Stents <br />
| Silicone Universal Drainage Stent<br />
| Extra Strong Stent Sets (-Tumor)<br />
|-<br />
|<br />
| Tarkington Urethral Stent Set<br />
| Steerable Ureteral Stent Sets<br />
|-<br />
|<br />
| Zaontz Urethral Stent<br />
| Multilength <br />
|-<br />
|<br />
| Pediatric Urethral C-Stent<br />
|<br />
|-<br />
|}<br />
<br />
=== Startup activity ===<br />
* [http://twincities.bizjournals.com/twincities/stories/2008/07/28/story8.html AbbeyMoor Medical Inc.], a med-tech firm that’s developed devices for treating urological disorders, has raised $2.7 million in bridge financing.<br />
<br />
== Phase 2: Deeper Dive ==<br />
=== Scenario ===<br />
Client wishes to acquire a ureteral stent company.<br />
<br />
=== Deal analysis for a target company ===<br />
[[Image:DealImplications.jpg|thumb|center|700px|Deal implications]]<br />
<br />
=== Design History File Review: Review components ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|Review <br />
!bgcolor = "#00CCFF" width="30%"|Verification<br />
!bgcolor = "#00CCFF" width="40%"|Tasks<br />
!bgcolor = "#00CCFF" width="15%"|Expertise<br />
|-<br />
!rowspan="2"|Design Input<br />
| Design input documents for sufficiency<br />
| <br />
# Access electronic data room.<br />
# Check what documents are provided.<br />
# Compare document list with standard client document list.<br />
# Check whether each specified document has appropriate content.<br />
| rowspan="2"|Quality systems<br />
|-<br />
| Design input documents linked to the product performance specifications<br />
|<br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
|-<br />
!rowspan="3"|Product Performance Specifications (PPS) <br />
| Design inputs correlate adequately to the specifications; DV&V (design verification and validation) criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans<br />
| <br />
# Compare product specifications to design inputs<br />
# Check whether appropriate verifications and validations are performed<br />
# Establish if all specifications are linked to design inputs<br />
| rowspan="3"|Quality systems, CAD<br />
|-<br />
| Appropriate design verification and validations (DV&V) are performed<br />
| <br />
# Show DV&V criteria are based on risk management requirements<br />
|-<br />
| Product performance specifications correspond to appropriate design output documents<br />
| <br />
# Correlate design drawings with the specifications<br />
# Check whether maximum dimensions, sizes etc. (with tolerances) are within the specified range<br />
|-<br />
!rowspan="4"|Risk Management Documents <br />
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation<br />
| <br />
# Check whether documentation is available<br />
# Check whether it adheres to appropriate ISO 14971 standards<br />
# Check whether it adheres to appropriate client standards<br />
|rowspan="4"| Quality systems<br />
|-<br />
| DFMEA links appropriately to the PPS<br />
| <br />
# Verify whether DFMEA and product specifications are correlated<br />
|-<br />
| Appropriate DV&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEA<br />
| <br />
# Validate the process and correlate with design inputs<br />
# Validate that sizes used are within range of risk mitigation criteria<br />
|-<br />
| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA<br />
| <br />
# Validate the process protocol<br />
# Validate the inspection procedures used <br />
|-<br />
!rowspan="2"|Design Output Documents <br />
| Completeness of drawings<br />
|<br />
# Check if the CAD diagrams overlay and "fit" perfectly<br />
# Check tolerance stackups<br />
|rowspan="2"| Quality systems, CAD<br />
|-<br />
| Correlate First Article Inspection data to the dimensions on the drawings<br />
| <br />
# Obtain First Article Inspection data<br />
# Check if this data correlates with the completeness of drawings<br />
|-<br />
!rowspan="4"|Manufacturing Documents <br />
| Manufacturing procedures, component specifications, raw material specifications, incoming and in-process inspection procedures for completeness<br />
| <br />
# Verify the Bill of Materials corresponds to raw materials and manufacturing procedures<br />
# Correlate incoming and in-process inspection procedures with the process specifications<br />
| rowspan="4"|Material science, manufacturing engineering, quality systems<br />
|-<br />
| Linkage between component and raw material specifications and appropriate incoming inspection procedures<br />
| <br />
# Identify any missing documentation for inspection procedures<br />
|-<br />
|-<br />
| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials<br />
| <br />
# Review supplier audit reports for compliance<br />
|-<br />
| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations<br />
| <br />
# Check the entire equipment-related lifecycle<br />
# Check if machine operational qualification was performed<br />
# Check if the measurement equipment was validated<br />
|-<br />
!rowspan="2"|Validation Report<br />
| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports<br />
|<br />
# Ensure all reports are available and linked together appropriately<br />
# Identify all inconsistencies across different reports<br />
| rowspan="2"| Quality systems<br />
|-<br />
| Design test methods and related test method validations<br />
| <br />
# Compare test methods used to those in client and ISO standards<br />
# Identify inconsistencies across test methods<br />
|-<br />
|}<br />
<br />
=== Sample report ===<br />
==== Performance/Functional Characteristics ====<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" colspan = "4" |Design Input<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Output<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Verification Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Validation Report #<br />
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)<br />
|-<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|User Needs<br />
!align = "center" bgcolor = "#00CCFF" width="15%"|User Need Rationale<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification<br />
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification Rationale<br />
|-<br />
|Provide antimicrobial resistance for up to 2 weeks<br />
|Ureteral Stent User Survey (Document #XXXXX)<br />
|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeks<br />
|Document #XXXXX<br />
|Test Document #XXXXX<br />
|Report 01-005-06-007<br />
|P<br />
|Report 01-005-06-007<br />
|P<br />
|-<br />
|}<br />
<br />
=== Potential DHF Review Outcomes ===<br />
Based on a review of the above DHF documents a potential outcome for the uretral stent acquisition project could involve the following:<br />
# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.<br />
# Creation of some new test methods for design, incoming and in-process inspections and also include recommendations for the test method validations. Creation of any new DV&V data would be highly unlikely as it could potentially trigger a new submission or a note-to-file to the regulatory agencies.<br />
# Change in raw materials to better grade materials e.g. Switching resin to a USP Class VI biocompatible resin. This would eliminate some on-going testing but require additional upfront one time biocompatibility testing.<br />
# Updating drawings based on results from the FAI data.<br />
# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw material specifications and inspection procedures.<br />
# Identifying installation, operational and process qualification requirements with the assumption that no additional design verification and validation activities are required based on the fact that the device is currently approved for sale in the US and ROW.<br />
# Recommend activities necessary for completing packaging, labeling, ship testing and shelf-life testing. Stress should be on being able to leverage existing data for shelf-life without changing the regulatory status of the device. <br />
# Company X may want to perform additional biocompatibility testing to create an internal baseline and also update their biocompatibility files.<br />
# Help streamline suppliers for components when switching over from Company Y to Company X. Search for existing Company X suppliers that can supply off the shelf items that Company Y may be sourcing from other vendors / suppliers.<br />
# Identify process improvements that can be rolled into the manufacturing transfer without changing the design and impacting the existing regulatory status for the device e.g. instead of hand mixing pigment to resin use a pre-mixer to control quality of mixing and resulting extrusion or perform the molding and over-molding steps in 1 machine instead of 2 separate molding machines.<br />
<br />
== Phase 3: Post-acquisition integration ==<br />
=== Deadlines ===<br />
'''Goal''': Switch production transparently to new facilities transparently to the distribution system<br />
<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Stage<br />
!align = "center" bgcolor = "#00CCFF" |Tasks<br />
!align = "center" bgcolor = "#00CCFF" |Milestone payment<br />
!align = "center" bgcolor = "#00CCFF" |Date<br />
|-<br />
|Design center integration plan<br />
|<br />
* Gap analysis completion (acquiree)<br />
* Gap analysis completion (acquirer)<br />
|<br />
|September 15, 2008<br />
|-<br />
|Design to manufacturing transfer<br />
|<br />
|<br />
|December 15, 2008<br />
|-<br />
|Equipment transfer<br />
|<br />
|Milestone I payment<br />
|Jan 7, 2009<br />
|-<br />
|Shut production at acquiree facility<br />
|Negotiation for contract extension<br />
|Milestone II payment<br />
|Feb 15, 2009<br />
|-<br />
|Start production in acquirer facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Switch to new SKU<br />
|<br />
|<br />
|Feb 15, 2009<br />
|-<br />
|End development of new generation product/s in old facility<br />
|<br />
|<br />
|Feb 7, 2009<br />
|-<br />
|Restart development of new generation product/s post-acquisition<br />
|<br />
|Final milestone payment<br />
|Mar 1, 2009<br />
|-<br />
|}<br />
<br />
=== Documents and Ownership ===<br />
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0" <br />
|- style="background:lightgrey"<br />
!align = "center" bgcolor = "#00CCFF" |Document<br />
!align = "center" bgcolor = "#00CCFF" |Owner<br />
!align = "center" bgcolor = "#00CCFF" |Last update date<br />
|-<br />
|Product performance specifications<br />
|Paul Swain<br />
|07/27/2008 08:15:35 PST<br />
|-<br />
|Component specifications<br />
|Kevin Teller<br />
|06/12/2008 12:22:07 PST<br />
|-<br />
|Preclinical test results<br />
|Joanne Krannert<br />
|07/03/2008 14:17:00 PST<br />
|-<br />
|Clinical tests<br />
|Joanne Krannert<br />
|08/01/2008 08:00:55 PST<br />
|-<br />
|}<br />
<br />
==Ureteral stents regulatory issues==<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=876.4620&SearchTerm=ureter%20stent Code of Federal Regulations]<br />
<br />
===Pre-Market Notification===<br />
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance, also known as Premarket Notification. This premarket submission demonstrates to the FDA that the device to be marketed is atleast as safe and effective, that is, ''substantially equivalent'', to a legally marketed device. Parties required to submit a 510(k) to the FDA include domestic or foreign manufacturers introducing a device to the U.S. market, as well as specification developers and repackers/relabelers. <br />
<br />
A 510(k) is required when: <br />
* Introducing a device into commercial distribution (marketing) for the first time.<br />
* Proposed different intended use for a device already in commercial distribution.<br />
* Change or modification of a legally marketed device.<br />
<br />
[http://dolcera.com/upload/files/510kflowchart.pdf 510(k) “Substantial Equivalence” Decision Making Process]<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. (This is not an exhaustive list and is just a sample)<br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Sr. No. '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Company'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Device'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Date of Approval'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Material'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Technology'''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Indwelling time (days) '''</center><br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''Image'''</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 InLay Optima]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Silicone<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:InLay_Optima.png|thumb|center|200px|<center>InLay Optima</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() Polaris Loop]</center><br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|200px|<center>Polaris Loop</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Metal<br />
| style="background-color:#ccffff;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|200px|<center>Resonance</center>]]<br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]</center><br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|200px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#ffcc99;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#ccffff;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#ccffff;padding:0.079cm;"| <center>240</center><br />
| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|200px|<center>Memokath 051</center>]]<br />
<br />
|}<br />
<br />
===Timeline Sheet===<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
<br />
*References<br />
<br />
1- [http://en.wikipedia.org/wiki/Demographics_of_the_United_States http://en.wikipedia.org/wiki/Demographics_of_the_United_States]<br />
<br />
2- [http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink]<br />
<br />
3- [http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf]<br />
<br />
4- [http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html]<br />
<br />
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! style="background:lightgrey" | Samir Raiyani<br />
|-<br />
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|}<br />
<br />
= Addition =<br />
=== Patent Categorization: Interactive mind map linked to Dolcera Dashboard ===<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
=== Product-Patent-Clinical Trials Mapping ===<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
=== Product to Patent Mapping ===<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''here ''']]to download the excel file.<br />
* Mapped Patent vs Not Mapped Patents<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=== Dolcera Dashboard ===<br />
[[Image:dashboard_features.png|center|750px|]]<br />
<br />
'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]<br />
|-<br />
|}<br />
*Flash Player is essential to view the Dolcera Dashboard<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
<br />
=== Key Artifacts ===<br />
* [[Investment Heat Map ]]<br />
* [[Revenue Heat Map ]]<br />
* [[Patent Heat Map]]<br />
* [http://www.dolcera.com/website/demos/dental/main.html Dynamic Patent Dashboard]<br />
* [[Taxonomy Sample]]<br />
* [[Patent Search Strategy]]<br />
* [[Clinical Timeline Visualization]]<br />
* [[Patent Product Mapping]]<br />
* [http://www.dolcera.com/ipmapdemo/stent_model.swf Stent Landscape-Flash]<br />
* [[Company Profile - Flash]]<br />
<br />
=Removed Sections=<br />
[[Removed Sections]]</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Removed_Sections&diff=9901
Removed Sections
2011-10-18T21:01:23Z
<p>Bharat: /* Technological insights */</p>
<hr />
<div>= Key Artifacts =<br />
* [[Investment Heat Map ]]<br />
* [[Revenue Heat Map ]]<br />
* [[Patent Heat Map]]<br />
* [http://www.dolcera.com/website/demos/dental/main.html Dynamic Patent Dashboard]<br />
* [[Taxonomy Sample]]<br />
* [[Patent Search Strategy]]<br />
* [[Clinical Timeline Visualization]]<br />
* [[Patent Product Mapping]]<br />
* [http://www.dolcera.com/ipmapdemo/stent_model.swf Stent Landscape-Flash]<br />
* [[Company Profile - Flash]]<br />
<br />
=Technological insights=<br />
The ideal ureteric stent biomaterial is yet to be discovered. Ongoing research with respect to material modifications and stent designs has achieved better patient comfort, and decreased stent-related complications. Drug-eluting stent technology is an interesting development which may prevent infection, encrustation and other stent related symptoms.<br />
<br />
=Reimbursements=<br />
<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|colspan = "7"|'''2011 MEDICARE REIMBURSEMENT FOR URETERAL STENT PLACEMENT OR REMOVAL - PHYSICIAN AND OUTPATIENT FACILITY'''<br />
|-<br />
|align = "center" bgcolor = "#5CB3FF" colspan = "5"|''Ambulatory Surgery Center''<br />
|align = "center" bgcolor = "#5CB3FF"|''Outpatient Facility''<br />
|align = "center" bgcolor = "#5CB3FF"|''Physician Services''<br />
|-<br />
|align = "center" bgcolor = "#5CB3FF"|CPT<br>Code<br />
|align = "center" bgcolor = "#5CB3FF"|Procedure Description<br />
|align = "center" bgcolor = "#5CB3FF"|Facility Payment<sup>1</sup><br />
|align = "center" bgcolor = "#5CB3FF"|APC<br />
|align = "center" bgcolor = "#5CB3FF"|Facility Fee Schedule<br>(National Medicare Avg)2<br />
|align = "center" bgcolor = "#5CB3FF"|Fee When Services Are Provided in the Hospital or ASC (National Medicare Avg)3<br />
|align = "center" bgcolor = "#5CB3FF"|Fee When Services Are Provided in the Office<br>(National Medicare Avg)4<br />
|-<br />
|align = "center" bgcolor = "#5CB3FF"|50393<br />
|Introduction of ureteral catheter or stent into ureter through renal pelvis for drainage and/or injection, percutaneous<br />
|align = "center"|$1,020.24<br />
|align = "center"|0162<br />
|align = "center"|$1,813.74<br />
|align = "center"|$224.92<br />
|align = "center"|N/A<nowiki>*</nowiki><br />
|-<br />
|align = "center" bgcolor = "#5CB3FF"|50605<br />
|Ureterotomy for insertion of indwelling stent, all types<br />
|align = "center" colspan = "3"|Procedure not permitted in outpatient setting<br />
|align = "center"|$982.60<br />
|align = "center"|N/A<nowiki>*</nowiki><br />
|-<br />
|align = "center" bgcolor = "#5CB3FF"|50947<br />
|Laparoscopy, surgical; ureteroneocystostomy with cystoscopy and ureteral stent placement<br />
|align = "center"|$1,853.68<br />
|align = "center"|0131<br />
|align = "center"|$3,295.39<br />
|align = "center"|$1,424.97<br />
|align = "center"|N/A<nowiki>*</nowiki><br />
|-<br />
|align = "center" bgcolor = "#5CB3FF"|51045<br />
|Cystotomy, with insertion of ureteral catheter or stent (separate procedure)<br />
|align = "center"|$288.27<br />
|align = "center"|0160<br />
|align = "center"|$512.48<br />
|align = "center"|$500.13<br />
|align = "center"|N/A<nowiki>*</nowiki><br />
|-<br />
|align = "center" bgcolor = "#5CB3FF"|52310<br />
|Cystourethroscopy, with removal of foreign body, calculus, or ureteral stent from urethra or bladder (separate procedure); simple<br />
|align = "center"|$680.87<br />
|align = "center"|0161<br />
|align = "center"|$1,210.41<br />
|align = "center"|$157.65<br />
|align = "center"|$253.80<br />
|-<br />
|align = "center" bgcolor = "#5CB3FF"|52315<br />
|Cystourethroscopy, with removal of foreign body, calculus, or ureteral stent from urethra or bladder (separate procedure); complicated<br />
|align = "center"|$1,020.24<br />
|align = "center"|0162<br />
|align = "center"|$1,813.74<br />
|align = "center"|$284.72<br />
|align = "center"|$444.41<br />
|-<br />
|align = "center" bgcolor = "#5CB3FF"|52332<br />
|Cystourethroscopy, with insertion of indwelling ureteral stent (eg, Gibbons or double-J type)<br />
|align = "center"|$1,020.24<br />
|align = "center"|0162<br />
|align = "center"|$1,813.74<br />
|align = "center"|$151.87<br />
|align = "center"|$501.15<br />
|-<br />
|align = "center" bgcolor = "#5CB3FF"|74480<br />
|Introduction of ureteral catheter or stent into ureter through renal pelvis for drainage and/or injection, percutaneous, radiological supervision and interpretation<br />
|align = "center" colspan = "3"|Imaging is included in allowance for ureteral stent placement or removal<br />
|align = "center"|$27.18<br />
|align = "center"|$112.80<br />
|-<br />
|align = "center" bgcolor = "#5CB3FF"|76942<br />
|Ultrasonic guidance for needle placement (eg, biopsy, aspiration, injection, localization device), imaging supervision and interpretation<br />
|align = "center" colspan = "3"|Imaging is included in allowance for ureteral stent placement or removal<br />
|align = "center"|$33.64<br />
|align = "center"|$198.08<br />
|-<br />
|align = "center" bgcolor = "#5CB3FF"|77002<br />
|Fluoroscopic guidance for needle placement (eg, biopsy, aspiration, injection, localization device)<br />
|align = "center" colspan = "3"|Imaging is included in allowance for ureteral stent placement or removal<br />
|align = "center"|$27.52<br />
|align = "center"|$75.77<br />
|-<br />
|align = "center" bgcolor = "#5CB3FF"|77012<br />
|Computed tomography guidance for needle placement (eg, biopsy, aspiration, injection, localization device), radiological supervision and interpretation<br><br />
|align = "center" colspan = "3"|Imaging is included in allowance for ureteral stent placement or removal<br />
|align = "center"|$57.08<br />
|align = "center"|$163.77<br />
|-<br />
|colspan = "7"|1. 2011 Medicare Ambulatory Surgery Center Fee Schedule<br>2. 2011 Medicare Hospital Outpatient Prospective Payment System Fee Schedule<br>3. 2011 Medicare Physician Fee Schedule<br />
|-<br />
|colspan = "7"|N/A<nowiki>*</nowiki> Medicare has not developed a rate for the in-office setting as these procedures are typically performed in a hospital setting. Physicians should contact the Medicare contractor to determine if the service can be performed in-office. If the contractor determines the service or procedure may be performed in-office, the physician will receive Medicare<nowiki>’</nowiki>s physician fee schedule amount for procedures performed in the hospital/ASC.<br />
|-<br />
|colspan = "7"|CPT© 2010 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.<br />
|-<br />
|}<br />
<br />
<br />
<br />
2 "Allowed Amount" is the amount Medicare determines to be the maximum allowance for any Medicare covered procedure. Actual payment will vary based on the maximum allowance less any applicable deductibles, co-insurance, etc.<br />
<br />
<sup>3 </sup>The hospital outpatient payment rates are 2011 Medicare national averages. Source: November 2, 2010 Federal Register, CMS-1504-FC.<br />
<br />
<sup>4 </sup>The ASC payments rates are 2011 Medicare national averages. ASC rates are from the 2011 Ambulatory Surgical Center Covered Procedures List – Addendum AA. Source: November 2, 2010 Federal Register, CMS-1504-FC.</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9503
Ureteral Stent
2011-08-08T19:32:54Z
<p>Bharat: /* Patent-Product-Clinical Trial Mapping */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
=Interactive Mind Map=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
=Patents=<br />
<br />
<br />
==Patent Search Strategy==<br />
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|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]<br />
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= Clinical Trials =<br />
<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
=Products=<br />
<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
[[image:stentshare.jpg |thumb|center|1000px| All figures in USD million ]]<br />
<br />
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<br />
=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9502
Ureteral Stent
2011-08-08T19:32:43Z
<p>Bharat: /* Product to Patent Mapping */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
=Interactive Mind Map=<br />
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*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
=Patents=<br />
<br />
<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
<br />
<br />
<br />
== Dolcera Dashboard ==<br />
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<br />
'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]<br />
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<br />
= Clinical Trials =<br />
<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
=Products=<br />
<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
[[Image:PatProCnt.jpg|thumb|center|300px]]<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
[[image:stentshare.jpg |thumb|center|1000px| All figures in USD million ]]<br />
<br />
=<span style="color:#C41E3A">Like this report?</span>=<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9501
Ureteral Stent
2011-08-08T19:32:33Z
<p>Bharat: /* Product to Clinical Trial Mapping */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
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=Patents=<br />
<br />
<br />
==Patent Search Strategy==<br />
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= Clinical Trials =<br />
<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
=Products=<br />
<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:PatPro.jpg|thumb|center|300px]]<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
[[Image:PatProCnt.jpg|thumb|center|300px]]<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
[[image:stentshare.jpg |thumb|center|1000px| All figures in USD million ]]<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9500
Ureteral Stent
2011-08-08T19:32:18Z
<p>Bharat: /* Products */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
=Interactive Mind Map=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
=Patents=<br />
<br />
<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
<br />
<br />
<br />
== Dolcera Dashboard ==<br />
<br />
<br />
'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]<br />
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*Flash Player is essential to view the Dolcera Dashboard<br />
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<br />
= Clinical Trials =<br />
<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
=Products=<br />
<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
= Product to Clinical Trial Mapping=<br />
[[Image:ProCnt.png|thumb|center|300px]]<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:PatPro.jpg|thumb|center|300px]]<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
[[Image:PatProCnt.jpg|thumb|center|300px]]<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
[[image:stentshare.jpg |thumb|center|1000px| All figures in USD million ]]<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9499
Ureteral Stent
2011-08-08T19:32:07Z
<p>Bharat: /* Clinical Trials */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
=Patents=<br />
<br />
<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
<br />
<br />
<br />
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<br />
'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]<br />
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<br />
= Clinical Trials =<br />
<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
=Products=<br />
[[Image:Pro.jpg|thumb|center|300px]]<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
= Product to Clinical Trial Mapping=<br />
[[Image:ProCnt.png|thumb|center|300px]]<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:PatPro.jpg|thumb|center|300px]]<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
[[Image:PatProCnt.jpg|thumb|center|300px]]<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
[[image:stentshare.jpg |thumb|center|1000px| All figures in USD million ]]<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9498
Ureteral Stent
2011-08-08T19:31:54Z
<p>Bharat: /* Patents */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
=Interactive Mind Map=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
=Patents=<br />
<br />
<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
<br />
<br />
<br />
== Dolcera Dashboard ==<br />
<br />
<br />
'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]<br />
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<br />
= Clinical Trials =<br />
[[Image:Cnt.jpg|thumb|center|300px]]<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
=Products=<br />
[[Image:Pro.jpg|thumb|center|300px]]<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
= Product to Clinical Trial Mapping=<br />
[[Image:ProCnt.png|thumb|center|300px]]<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:PatPro.jpg|thumb|center|300px]]<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
[[Image:PatProCnt.jpg|thumb|center|300px]]<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
[[image:stentshare.jpg |thumb|center|1000px| All figures in USD million ]]<br />
<br />
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'''Dolcera can provide a comprehensive report customized to your needs'''</p><br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=File:ProCnt.png&diff=9497
File:ProCnt.png
2011-08-07T04:37:01Z
<p>Bharat: </p>
<hr />
<div></div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9496
Ureteral Stent
2011-08-07T04:36:52Z
<p>Bharat: /* Product to Clinical Trial Mapping */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
=Interactive Mind Map=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
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*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
=Patents=<br />
[[Image:Pat.jpg|thumb|center|300px]]<br />
<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
<br />
<br />
<br />
== Dolcera Dashboard ==<br />
<br />
<br />
'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]<br />
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<br />
= Clinical Trials =<br />
[[Image:Cnt.jpg|thumb|center|300px]]<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
=Products=<br />
[[Image:Pro.jpg|thumb|center|300px]]<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
= Product to Clinical Trial Mapping=<br />
[[Image:ProCnt.png|thumb|center|300px]]<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:PatPro.jpg|thumb|center|300px]]<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
[[Image:PatProCnt.jpg|thumb|center|300px]]<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
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2011-08-07T04:36:16Z
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https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9491
Ureteral Stent
2011-08-07T04:35:13Z
<p>Bharat: /* Patent-Product-Clinical Trial Mapping */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
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<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
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=Patents=<br />
[[Image:Pat.jpg|thumb|center|300px]]<br />
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<br />
= Clinical Trials =<br />
[[Image:Cnt.jpg|thumb|center|300px]]<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
=Products=<br />
[[Image:Pro.jpg|thumb|center|300px]]<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
= Product to Clinical Trial Mapping=<br />
[[Image:ProCnt.jpg|thumb|center|300px]]<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:PatPro.jpg|thumb|center|300px]]<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
[[Image:PatProCnt.jpg|thumb|center|300px]]<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
[[image:stentshare.jpg |thumb|center|1000px| All figures in USD million ]]<br />
<br />
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<br />
=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9490
Ureteral Stent
2011-08-07T04:34:58Z
<p>Bharat: /* Product to Patent Mapping */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
=Interactive Mind Map=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
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*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
=Patents=<br />
[[Image:Pat.jpg|thumb|center|300px]]<br />
<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
<br />
<br />
<br />
== Dolcera Dashboard ==<br />
<br />
<br />
'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]<br />
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<br />
= Clinical Trials =<br />
[[Image:Cnt.jpg|thumb|center|300px]]<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
=Products=<br />
[[Image:Pro.jpg|thumb|center|300px]]<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
= Product to Clinical Trial Mapping=<br />
[[Image:ProCnt.jpg|thumb|center|300px]]<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:PatPro.jpg|thumb|center|300px]]<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
[[image:stentshare.jpg |thumb|center|1000px| All figures in USD million ]]<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9489
Ureteral Stent
2011-08-07T04:34:43Z
<p>Bharat: /* Product to Clinical Trial Mapping */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
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=Patents=<br />
[[Image:Pat.jpg|thumb|center|300px]]<br />
<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
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|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
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<br />
= Clinical Trials =<br />
[[Image:Cnt.jpg|thumb|center|300px]]<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
=Products=<br />
[[Image:Pro.jpg|thumb|center|300px]]<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
= Product to Clinical Trial Mapping=<br />
[[Image:ProCnt.jpg|thumb|center|300px]]<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
[[image:stentshare.jpg |thumb|center|1000px| All figures in USD million ]]<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9488
Ureteral Stent
2011-08-07T04:34:21Z
<p>Bharat: /* Products */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
=Interactive Mind Map=<br />
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*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
=Patents=<br />
[[Image:Pat.jpg|thumb|center|300px]]<br />
<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
<br />
<br />
<br />
== Dolcera Dashboard ==<br />
<br />
<br />
'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]<br />
|-<br />
|}<br />
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<br />
= Clinical Trials =<br />
[[Image:Cnt.jpg|thumb|center|300px]]<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
=Products=<br />
[[Image:Pro.jpg|thumb|center|300px]]<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
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*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
[[image:stentshare.jpg |thumb|center|1000px| All figures in USD million ]]<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9487
Ureteral Stent
2011-08-07T04:34:07Z
<p>Bharat: /* Clinical Trials */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
=Interactive Mind Map=<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
=Patents=<br />
[[Image:Pat.jpg|thumb|center|300px]]<br />
<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
<br />
<br />
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|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
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<br />
= Clinical Trials =<br />
[[Image:Cnt.jpg|thumb|center|300px]]<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
=Products=<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
[[image:stentshare.jpg |thumb|center|1000px| All figures in USD million ]]<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9486
Ureteral Stent
2011-08-07T04:33:39Z
<p>Bharat: /* Patents */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
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=Patents=<br />
[[Image:Pat.jpg|thumb|center|300px]]<br />
<br />
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= Clinical Trials =<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
<br />
<br />
=Products=<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
[[image:stentshare.jpg |thumb|center|1000px| All figures in USD million ]]<br />
<br />
=<span style="color:#C41E3A">Like this report?</span>=<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=File:Pat.jpg&diff=9485
File:Pat.jpg
2011-08-07T04:33:23Z
<p>Bharat: </p>
<hr />
<div></div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9484
Ureteral Stent
2011-08-07T04:33:14Z
<p>Bharat: /* Patents */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
=Interactive Mind Map=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
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*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
=Patents=<br />
[[Image:Pat.jpg|thumb|center|700px]]<br />
<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
<br />
<br />
<br />
== Dolcera Dashboard ==<br />
<br />
<br />
'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]<br />
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<br />
= Clinical Trials =<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
<br />
<br />
=Products=<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
[[image:stentshare.jpg |thumb|center|1000px| All figures in USD million ]]<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9483
Ureteral Stent
2011-08-07T04:32:45Z
<p>Bharat: /* Patents */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
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=Patents=<br />
[[Image:P.jpgat|700px]]<br />
<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
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= Clinical Trials =<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
<br />
<br />
=Products=<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
[[image:stentshare.jpg |thumb|center|1000px| All figures in USD million ]]<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9482
Ureteral Stent
2011-08-07T04:29:34Z
<p>Bharat: /* Patents */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
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|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
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|}<br />
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=Patents=<br />
[[Image:P.jpg|700px]]<br />
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==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
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|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
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= Clinical Trials =<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
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<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
<br />
<br />
=Products=<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
[[image:stentshare.jpg |thumb|center|1000px| All figures in USD million ]]<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9481
Ureteral Stent
2011-08-07T03:47:32Z
<p>Bharat: /* Sales */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
=Interactive Mind Map=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
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*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
=Patents=<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
<br />
<br />
<br />
== Dolcera Dashboard ==<br />
<br />
<br />
'''Dashboard Link'''<br><br />
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|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
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<br />
= Clinical Trials =<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
<br />
<br />
=Products=<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
[[image:stentshare.jpg |thumb|center|1000px| All figures in USD million ]]<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9480
Ureteral Stent
2011-08-07T03:45:23Z
<p>Bharat: /* Sales */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
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=Patents=<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
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= Clinical Trials =<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
<br />
<br />
=Products=<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
[[image:stentshare.jpg |center| All figures in USD million ]]<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9479
Ureteral Stent
2011-08-07T03:45:09Z
<p>Bharat: /* Sales */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
=Interactive Mind Map=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
=Patents=<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
<br />
<br />
<br />
== Dolcera Dashboard ==<br />
<br />
<br />
'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]<br />
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<br />
= Clinical Trials =<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
<br />
<br />
=Products=<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
[[image:stentshare.jpg |thumb|center| All figures in USD million ]]<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9478
Ureteral Stent
2011-08-07T03:44:00Z
<p>Bharat: /* Sales */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
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=Patents=<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
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= Clinical Trials =<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
<br />
<br />
=Products=<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
[[image:stentshare.jpg |center|All figures in USD million ]]<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9477
Ureteral Stent
2011-08-07T03:43:40Z
<p>Bharat: /* Sales */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
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|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
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|}<br />
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=Patents=<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
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|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
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= Clinical Trials =<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
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<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
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<br />
=Products=<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
[[image:stentshare.jpg |center|All figures in USD million| ]]<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9476
Ureteral Stent
2011-08-07T03:43:12Z
<p>Bharat: /* IP Activity */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
=Interactive Mind Map=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
=Patents=<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
<br />
<br />
<br />
== Dolcera Dashboard ==<br />
<br />
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'''Dashboard Link'''<br><br />
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|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
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<br />
= Clinical Trials =<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
<br />
<br />
=Products=<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
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<br />
<br />
All figures in USD million<br />
<br />
[[image:stentshare.jpg |center|]]<br />
All figures in USD million<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9475
Ureteral Stent
2011-08-07T03:42:48Z
<p>Bharat: /* Sales */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
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=Patents=<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
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= Clinical Trials =<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
<br />
<br />
=Products=<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px|year wise IP activity]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
All figures in USD million<br />
<br />
[[image:stentshare.jpg |center|]]<br />
All figures in USD million<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9474
Ureteral Stent
2011-08-07T03:42:23Z
<p>Bharat: /* Sales */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
=Interactive Mind Map=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
=Patents=<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
<br />
<br />
<br />
== Dolcera Dashboard ==<br />
<br />
<br />
'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]<br />
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<br />
= Clinical Trials =<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
<br />
<br />
=Products=<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px|year wise IP activity]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
All figures in USD million<br />
<br />
[[image:stentshare.jpg |center|]]<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9473
Ureteral Stent
2011-08-07T03:42:08Z
<p>Bharat: /* Sales */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
=Interactive Mind Map=<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
=Patents=<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
<br />
<br />
<br />
== Dolcera Dashboard ==<br />
<br />
<br />
'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]<br />
|-<br />
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<br />
= Clinical Trials =<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
<br />
<br />
=Products=<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px|year wise IP activity]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
All figures in USD million<br />
<br />
[[image:stentshare.jpg | center|]]<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9472
Ureteral Stent
2011-08-07T03:40:22Z
<p>Bharat: /* Sales */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
=Interactive Mind Map=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
=Patents=<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
<br />
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|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
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<br />
= Clinical Trials =<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
<br />
<br />
=Products=<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px|year wise IP activity]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
All figures in USD million<br />
<br />
[[image:stentshare.jpg | center|1000px|]]<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9471
Ureteral Stent
2011-08-07T03:38:38Z
<p>Bharat: /* Sales */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
=Interactive Mind Map=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
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*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
=Patents=<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
<br />
<br />
<br />
== Dolcera Dashboard ==<br />
<br />
<br />
'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]<br />
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<br />
= Clinical Trials =<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
<br />
<br />
=Products=<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px|year wise IP activity]]<br />
<br />
==Sales ==<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
All figures in USD million<br />
<br />
[[image:stentshare.jpg]]<br />
<br />
=<span style="color:#C41E3A">Like this report?</span>=<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9470
Ureteral Stent
2011-08-07T03:38:21Z
<p>Bharat: /* Cook Medical */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
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=Patents=<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
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= Clinical Trials =<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
<br />
<br />
=Products=<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px|year wise IP activity]]<br />
<br />
=Sales =<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
All figures in USD million<br />
<br />
[[image:stentshare.jpg]]<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9469
Ureteral Stent
2011-08-07T03:38:11Z
<p>Bharat: /* CR BARD */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
=Interactive Mind Map=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
=Patents=<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
<br />
<br />
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== Dolcera Dashboard ==<br />
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'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
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<br />
= Clinical Trials =<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
<br />
<br />
=Products=<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px|year wise IP activity]]<br />
<br />
=Sales =<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
All figures in USD million<br />
<br />
[[image:stentshare.jpg]]<br />
<br />
<br />
<br />
<br />
<br />
<br />
====Cook Medical====<br />
<br />
[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Ureteral Stent portfolio]<br />
<br />
Total Sales - USD 1.7 Billion<br />
<br />
[http://www.nytimes.com/2011/04/26/business/26cook.html?_r=1 Source]<br />
<br />
<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9468
Ureteral Stent
2011-08-07T03:38:02Z
<p>Bharat: /* Medline */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
=Patents=<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
<br />
<br />
<br />
== Dolcera Dashboard ==<br />
<br />
<br />
'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]<br />
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<br />
= Clinical Trials =<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
<br />
<br />
=Products=<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px|year wise IP activity]]<br />
<br />
=Sales =<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
All figures in USD million<br />
<br />
[[image:stentshare.jpg]]<br />
<br />
<br />
<br />
<br />
====CR BARD====<br />
<br />
[[Urology portfolio]]<br />
<br />
<br />
Net sales in 2010 – USD 2.7 Billion<br />
<br />
Share of Urology- 26%<br />
<br />
Net sales from Urology- USD 702 Million<br />
<br />
Source – CR BARD annual report<br />
<br />
====Cook Medical====<br />
<br />
[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Ureteral Stent portfolio]<br />
<br />
Total Sales - USD 1.7 Billion<br />
<br />
[http://www.nytimes.com/2011/04/26/business/26cook.html?_r=1 Source]<br />
<br />
<br />
<br />
=<span style="color:#C41E3A">Like this report?</span>=<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9467
Ureteral Stent
2011-08-07T03:37:51Z
<p>Bharat: /* Boston Scientific */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
=Interactive Mind Map=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
=Patents=<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
<br />
<br />
<br />
== Dolcera Dashboard ==<br />
<br />
<br />
'''Dashboard Link'''<br><br />
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|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
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<br />
= Clinical Trials =<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
<br />
<br />
=Products=<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px|year wise IP activity]]<br />
<br />
=Sales =<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
All figures in USD million<br />
<br />
[[image:stentshare.jpg]]<br />
<br />
<br />
<br />
<br />
====CR BARD====<br />
<br />
[[Urology portfolio]]<br />
<br />
<br />
Net sales in 2010 – USD 2.7 Billion<br />
<br />
Share of Urology- 26%<br />
<br />
Net sales from Urology- USD 702 Million<br />
<br />
Source – CR BARD annual report<br />
<br />
====Cook Medical====<br />
<br />
[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Ureteral Stent portfolio]<br />
<br />
Total Sales - USD 1.7 Billion<br />
<br />
[http://www.nytimes.com/2011/04/26/business/26cook.html?_r=1 Source]<br />
<br />
====Medline====<br />
<br />
[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Ureteral Stent Portfolio]<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9466
Ureteral Stent
2011-08-07T03:31:57Z
<p>Bharat: /* Insights */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
=Interactive Mind Map=<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
=Patents=<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
<br />
<br />
<br />
== Dolcera Dashboard ==<br />
<br />
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'''Dashboard Link'''<br><br />
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|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
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<br />
= Clinical Trials =<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
<br />
<br />
=Products=<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
== Inference ==<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px|year wise IP activity]]<br />
<br />
=Sales =<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
All figures in USD million<br />
<br />
[[image:stentshare.jpg]]<br />
<br />
<br />
====Boston Scientific====<br />
<br />
<br />
[https://dolcera.net/teamwiki_prod/index.php/Boston_Scientific_-_Company_Profile Company profile]<br />
<br />
[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Ureteral Stent portfolio]<br />
<br />
Net sales in 2010 – USD 7.8 Billion<br />
<br />
Share of Urology- 8.48 %<br />
<br />
Net sales from Urology- USD 661 Million<br />
<br />
Source [http://phx.corporate-ir.net/phoenix.zhtml?c=62272&p=irol-reportsother BSsalesdata]<br />
<br />
====CR BARD====<br />
<br />
[[Urology portfolio]]<br />
<br />
<br />
Net sales in 2010 – USD 2.7 Billion<br />
<br />
Share of Urology- 26%<br />
<br />
Net sales from Urology- USD 702 Million<br />
<br />
Source – CR BARD annual report<br />
<br />
====Cook Medical====<br />
<br />
[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Ureteral Stent portfolio]<br />
<br />
Total Sales - USD 1.7 Billion<br />
<br />
[http://www.nytimes.com/2011/04/26/business/26cook.html?_r=1 Source]<br />
<br />
====Medline====<br />
<br />
[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Ureteral Stent Portfolio]<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9465
Ureteral Stent
2011-08-07T03:31:33Z
<p>Bharat: /* Insights */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
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=Patents=<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
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= Clinical Trials =<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
<br />
<br />
=Products=<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">''' '''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''<br />
|'''Portfolio'''<br />
|8 Products<br />
|6 Products<br />
|-<br />
|'''Material'''<br />
|Percuflex - Biocompatible Polymer<br />
|Silicone<br />
|-<br />
|'''Coating'''<br />
|Hydroplus<br />
|Licensed from pHreecoat<br />
|-<br />
|'''Shape'''<br />
|Pigtailed and More<br />
|Figure 4 and more<br />
|-<br />
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''<br />
|'''Current Trials'''<br />
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)<br />
|None<br />
|-<br />
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''<br />
|'''Coating'''<br />
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion<br />
|Therapeutic coatings<br />
|-<br />
|'''Structure'''<br />
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs<br />
|Expandable stents for reducing discomfort<br />
|-<br />
|'''Material'''<br />
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness<br />
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based<br />
|-<br />
|}<br />
<br />
<br />
<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px|year wise IP activity]]<br />
<br />
=Sales =<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
All figures in USD million<br />
<br />
[[image:stentshare.jpg]]<br />
<br />
<br />
====Boston Scientific====<br />
<br />
<br />
[https://dolcera.net/teamwiki_prod/index.php/Boston_Scientific_-_Company_Profile Company profile]<br />
<br />
[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Ureteral Stent portfolio]<br />
<br />
Net sales in 2010 – USD 7.8 Billion<br />
<br />
Share of Urology- 8.48 %<br />
<br />
Net sales from Urology- USD 661 Million<br />
<br />
Source [http://phx.corporate-ir.net/phoenix.zhtml?c=62272&p=irol-reportsother BSsalesdata]<br />
<br />
====CR BARD====<br />
<br />
[[Urology portfolio]]<br />
<br />
<br />
Net sales in 2010 – USD 2.7 Billion<br />
<br />
Share of Urology- 26%<br />
<br />
Net sales from Urology- USD 702 Million<br />
<br />
Source – CR BARD annual report<br />
<br />
====Cook Medical====<br />
<br />
[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Ureteral Stent portfolio]<br />
<br />
Total Sales - USD 1.7 Billion<br />
<br />
[http://www.nytimes.com/2011/04/26/business/26cook.html?_r=1 Source]<br />
<br />
====Medline====<br />
<br />
[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Ureteral Stent Portfolio]<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9464
Ureteral Stent
2011-08-07T03:30:37Z
<p>Bharat: /* Insights */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
=Interactive Mind Map=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
=Patents=<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
<br />
<br />
<br />
== Dolcera Dashboard ==<br />
<br />
<br />
'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
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<br />
= Clinical Trials =<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
<br />
<br />
=Products=<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="82%"<br />
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font><br />
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font><br />
|-<br />
|Relatively late entrant with patents filed post mid 90s<br />
|Early mover with patents filed in mid 80s<br />
|-<br />
|Increased patent activity since 2000<br />
|Patent activity never gained traction<br />
|-<br />
|Large number of patents yet to be "productized"<br />
|Few patents yet to be "productized"<br />
|-<br />
|Some products undergoing clinical trails<br />
|No products undergoing clinical trails<br />
|-<br />
|Diverse range of products with variation in material <br>and structure<br />
|Small product portfolio<br />
|-<br />
|Seem to be strengthening they market position<br />
|Seem to be moving focus away from Ureteral stents market<br />
|-<br />
|}<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px|year wise IP activity]]<br />
<br />
=Sales =<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
All figures in USD million<br />
<br />
[[image:stentshare.jpg]]<br />
<br />
<br />
====Boston Scientific====<br />
<br />
<br />
[https://dolcera.net/teamwiki_prod/index.php/Boston_Scientific_-_Company_Profile Company profile]<br />
<br />
[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Ureteral Stent portfolio]<br />
<br />
Net sales in 2010 – USD 7.8 Billion<br />
<br />
Share of Urology- 8.48 %<br />
<br />
Net sales from Urology- USD 661 Million<br />
<br />
Source [http://phx.corporate-ir.net/phoenix.zhtml?c=62272&p=irol-reportsother BSsalesdata]<br />
<br />
====CR BARD====<br />
<br />
[[Urology portfolio]]<br />
<br />
<br />
Net sales in 2010 – USD 2.7 Billion<br />
<br />
Share of Urology- 26%<br />
<br />
Net sales from Urology- USD 702 Million<br />
<br />
Source – CR BARD annual report<br />
<br />
====Cook Medical====<br />
<br />
[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Ureteral Stent portfolio]<br />
<br />
Total Sales - USD 1.7 Billion<br />
<br />
[http://www.nytimes.com/2011/04/26/business/26cook.html?_r=1 Source]<br />
<br />
====Medline====<br />
<br />
[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Ureteral Stent Portfolio]<br />
<br />
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=[[Backup]]=</div>
Bharat
https://www.dolcera.com/wiki/index.php?title=Ureteral_Stent&diff=9463
Ureteral Stent
2011-08-07T00:45:15Z
<p>Bharat: /* Competitor Analysis */</p>
<hr />
<div>'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.<br />
''' <br />
<br />
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.<br />
<br />
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.<br />
<br />
==Background==<br />
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]<br />
<br />
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used <br />
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.<br />
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.<br />
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.<br />
* Bacterial colonization: antimicrobial activity for up to two weeks.<br />
* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.<br />
<br />
'''[[more on background...]]'''<br />
<br />
=Market Overview=<br />
<br />
Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.<br />
<br />
'''[[more on market overview...]]'''<br />
<br />
=Interactive Mind Map=<br />
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{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm><br />
<br />
|}<br />
<br />
=Patents=<br />
==Patent Search Strategy==<br />
[[Image:Patent Search Strategy.jpg|700px]]<br />
<br />
<br />
<br />
== Dolcera Dashboard ==<br />
<br />
<br />
'''Dashboard Link'''<br><br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|'''[http://client.dolcera.com/dashboard/dashboard.html?workfile_id=1008 Ureteral Stent - Dashboard] '''<br />
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]<br />
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<br />
= Clinical Trials =<br />
==New trials ==<br />
<br />
{|border "1" style="border-spacing:0;"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation <br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]<br />
| style="padding:0.079cm;"| Urethral Stricture<br />
| style="padding:0.079cm;"| Memokath stenting<br />
| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones<br />
| style="background-color:#dce6f1;padding:0.079cm;"| N\A<br />
| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine <br />
|-<br />
| style="padding:0.079cm;"| <center>4</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]<br />
| style="padding:0.079cm;"| Kidney Stones<br />
| style="padding:0.079cm;"| Ureteral Stent<br />
| style="padding:0.079cm;"| Emory University <br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction<br />
| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group <br />
|-<br />
| style="padding:0.079cm;"| <center>6</center><br />
| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]<br />
| style="padding:0.079cm;"| Kidney Disease<br />
| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent<br />
| style="padding:0.079cm;"| Rabin Medical Center <br />
|}<br />
<br />
== Concluded trials ==<br />
{| {{table}}<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.<br />
|-<br />
| style="padding:0.079cm;"| <center>2</center><br />
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.<br />
|}<br />
<br />
<br />
<br />
==Pre-Market Notification==<br />
<br />
Some of the companies active in the field of ureteral stents have been represented in the table below. <br />
<br />
{| border="2" cellspacing="0" cellpadding="4" width="100%"<br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center><br />
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Silicone<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;"| <center>'''2'''</center><br />
| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center><br />
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Mar 2003</center><br />
| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating<br />
| style="padding:0.079cm;"| Bladder loop design<br />
| style="padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Metal<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center><br />
|-<br />
| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center><br />
| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center><br />
| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center><br />
| style="padding:0.079cm;"| <center>Aug 2002</center><br />
| style="padding:0.079cm;" rowspan="2"| Polyurethane<br />
| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent<br />
| style="padding:0.079cm;" rowspan="2"| <center>13</center><br />
|-<br />
| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center><br />
| style="padding:0.079cm;"| <center>Sep 2005</center><br />
<br />
|-<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center><br />
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy<br />
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent<br />
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center><br />
|}<br />
<br />
<br />
<br />
=Products=<br />
The FDA classifies a ureteric stent as follows: <br />
* TITLE 21 - FOOD AND DRUGS<br />
* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES<br />
* SUBCHAPTER H - MEDICAL DEVICES<br />
* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES<br />
* Subpart E - Surgical Devices<br />
* Sec. 876.4620 - Ureteral stent. <br />
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Company'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Material'''<br />
|bgcolor = "#4f81bd"|'''Technology'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''<br />
|align = "center" bgcolor = "#4f81bd"|'''Image'''<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''1'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 2007<br />
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer<br />
|bgcolor = "#dce6f1"|Self-expanding stent<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]<br />
<br />
|-<br />
|align = "center" rowspan = "2"|'''2'''<br />
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font><br />
|align = "center" rowspan = "2"|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]<br />
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font><br />
|align = "center"|1995<br />
|rowspan = "2"|Nickel-titanium shape memory alloy<br />
|rowspan = "2"|Double fluted ended spiral stent<br />
|align = "center" rowspan = "2"|240<br />
|rowspan = "2"|[[Image:Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]<br />
<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font><br />
|align = "center"|Mar, 2004<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13<br />
|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Aug, 2002<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Nov, 2003<br />
|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane<br />
|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| <br />
|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]<br />
<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Sep, 2005<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jun, 2002<br />
|bgcolor = "#dce6f1"|Polyurethane<br />
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| N/A<br />
<br />
|-<br />
|align = "center" rowspan = "7"|'''4'''<br />
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font><br />
|align = "center"|<font color="#0000FF"><u>Contour</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating<br />
|Fixed and variable length; Tapered tip<br />
|align = "center"|365<br />
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font><br />
|align = "center"| <br />
|align = "center"|<br />
|align = "center"| Percuflex<br />
|Pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2001<br />
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.<br />
|Double pigtail<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 2003<br />
|Dual Durometer Percuflex with HydroPlus Coating<br />
|Bladder loop design<br />
|align = "center"|365<br />
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex material and Hydroplus coating<br />
|Endopyelotomy stent<br />
|align = "center"|Post-procedure healing<br />
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hydroplus Coating<br />
|Variable length coil on distal and proximal ends<br />
|align = "center"|90<br />
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] <br />
|-<br />
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]<br />
|align = "center"| <br />
|align = "center"| <br />
|Percuflex - proprietary polyolefin copolymer<br />
|Ketorolac trimethamine loaded stent<br />
|align = "center"|<br />
|align = "center"| N/A<br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|May, 2007<br />
|bgcolor = "#dce6f1"|Metal<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning <br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating<br />
|bgcolor = "#dce6f1"|Double pigtail<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Double Pigtail<br />
|align = "center" bgcolor = "#dce6f1"|180<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent<br />
|align = "center" bgcolor = "#dce6f1"|60<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2007<br />
|bgcolor = "#dce6f1"|Heparin-bonded stent<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|<br />
|-<br />
|align = "center"|'''6'''<br />
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font><br />
|align = "center"|Jan, 2010<br />
|Hydrogel<br />
|Differentially larger end (no pigtail)<br />
|align = "center"|30<br />
|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''7'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font><br />
|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 2010<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|30<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] <br />
|-<br />
|align = "center" rowspan = "4"|'''8'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font><br />
|align = "center"|Jul, 2001<br />
|Polyester mesh<br />
|Double-pigtail<br />
|align = "center"| <br />
|align = "center"| N/A<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Coil-reinforced; SL-6® hydrophilic coating<br />
|Patency Device<br />
|align = "center"| <br />
|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font><br />
|align = "center"|Jun, 1999<br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Unique wall construction and enlarged drainage holes <br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] <br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents 7-10 endopyelotomy]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating<br />
|Dual Diameter stent<br />
|align = "center"| <br />
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''<br />
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 2004<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop<br />
|align = "center" bgcolor = "#dce6f1"|365<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] <br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jan, 2003<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Attached with suture for ease of removal<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone/tantalum<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Three dimensional design<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Dec, 1998<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Apr, 1991<br />
|bgcolor = "#dce6f1"|Silicone<br />
|bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]<br />
|-<br />
|align = "center" rowspan = "4"|'''10'''<br />
|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Double coating for easy maneuverability as well as flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font><br />
|align = "center"|Oct, 1998<br />
|Silicone<br />
|Extreme flexibility<br />
|align = "center"| <br />
|align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Hard or soft Polyurethane<br />
|Designed for short-term use<br />
|align = "center"| 90<br />
|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font><br />
|align = "center"|Oct, 2002<br />
|Silicone<br />
|''Pyatiprofilnaya'' technology <br />
|align = "center"| <br />
|align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''11'''<br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font><br />
|align = "center" bgcolor = "#dce6f1"|Jul, 1999<br />
|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating<br />
|bgcolor = "#dce6f1"| Directable and detachable<br />
|align = "center" bgcolor = "#dce6f1"| <br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]<br />
|-<br />
|align = "center" rowspan = "9"|'''12'''<br />
|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font><br />
|align = "center"|Dec, 1986<br />
| <br />
|Classic Closed Tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex® construction<br />
|Balanced-curled double pigtail design<br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font><br />
|align = "center"|Apr, 1988<br />
|Silicone<br />
|Double-J closed-tip <br />
|align = "center"| <br />
|align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex® <br />
|Grooved design<br />
|align = "center"| <br />
|align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font><br />
|align = "center"|Nov, 1991<br />
|Tecoflex®<br />
|“Rememberance” of shape with a chemically bonded wettable solution <br />
|align = "center"| <br />
|align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Two durometers with helical kidney curls<br />
|align = "center"| <br />
|align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font><br />
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font><br />
|align = "center"|Mar, 1996<br />
|Tecoflex®<br />
|Accomodate ureteral lengths from 22cm to 28cm<br />
|align = "center"| <br />
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Tecoflex®<br />
|Dual-durometer design and exclusive soft bladder helix <br />
|align = "center"| <br />
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]<br />
|-<br />
|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font><br />
|align = "center"| <br />
|align = "center"| <br />
|Silicone<br />
|Classic Double J with open tip<br />
|align = "center"| <br />
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]<br />
|-<br />
|align = "center" bgcolor = "#dce6f1"|'''13'''<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]<br />
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]<br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"| <br />
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating<br />
|bgcolor = "#dce6f1"|Double loop stent<br />
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term<br />
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]<br />
|-<br />
|align = "center"|'''14'''<br />
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]<br />
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]<br />
|align = "center"|Jan, 1987<br />
|Nitinol<br />
|Self-expanding stent<br />
| <br />
|align = "center"|N/A<br />
|-<br />
|}<br />
<br />
<br />
<br />
= Product to Clinical Trial Mapping=<br />
<br />
==Clinical Timeline Visualization ==<br />
[[Image:Timeline.jpg]]<br />
<br />
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]<br />
<br />
= Product to Patent Mapping =<br />
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]<br />
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.<br />
== Mapped Patent vs Not Mapped Patents ==<br />
{|border="0" cellspacing="0" cellpadding="4" width="100%"<br />
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]<br />
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]<br />
|-<br />
|}<br />
<br />
=Patent-Product-Clinical Trial Mapping=<br />
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']<br />
*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''<br />
*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' <br />
*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
<br />
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm><br />
<br />
|}<br />
<br />
<br />
<br />
=Insights=<br />
<br />
==Boston Scientific==<br />
<br />
===Products===<br />
* They have '''8 ureteral stents''' in their portfolio<br />
* Boston's ureteral stent portfolio have some common features such as:<br />
#Stent '''material''' consisting of '''Percuflex'''- a Biocompatible Polymer Material<br />
#The '''coating''' on the stent may be a '''Hydroplus''' coating<br />
#Most of the stents are designed to have an '''indwelling time''' of '''365 days'''<br />
#Pigtailed shaped ureteral stent<br />
<br />
<br />
<br />
===Clinical trials===<br />
* Boston scientific is conducting clinical '''trials''' for '''Truimph Ureteral stent''' which is a ureteral '''stent''' loaded with '''Triclosan''' (used as an antimicrobial agent).The trials are currently in '''Phase II''' in '''canada'''(NCT00250406).<br />
<br />
===Patents===<br />
<br />
*The unmapped patents are analysed based on the following parameters<br />
'''1.Coating on stents:''' Boston scientific has patents on Therapeutic/ medicinal coatings on stents which releases into the vascular region. Magnetic nanoparticles which helps in imaging the ureteral stent using MRI. Lubricious coatings which help in easy insertion of the stent<br />
<br />
'''2.Structure of stent:''' Boston scientific has patents on various structures of stent . For eg: Multiple channels(Depressions) along the length of stent filled with therapeutic agent,Multiple segments on the distal side of stent which is collapsible to prevent fluid from passing from the bladder to the kidney, Stent with a renal coil with wick portion to prevent reflux of urine,Stent with beads on its surface which is of figure 8 shape having therapeutic agents, Stent with reservoir indicating its release with change in color of urine,Stents with degradable barbs,Expandable and collapsible stent to reduce patient discomfort<br />
<br />
'''3.Materials used for stent:'''Boston scientific has patents on various materials used for stent. For eg.Elastically deformable stents(polysaccharide-based hydrogels), Biodegradable polymer based stents, Porous polymer for long term implantation( poly(styrene) blocks and polyisobutylene blocks),Stent with variable hardness (ethylene vinyl acetate and hydroxypropylcellulose)<br />
<br />
==C.R.Bard==<br />
<br />
===Products===<br />
* They have '''6 products''' in their ureteral stent portfolio<br />
* C.R Bard ureteral stent portfolio have some common features such as:<br />
#Most of the stent has '''Silicone''' as their '''main material'''<br />
#They have stent with '''various''' '''designs''' and shapes eg Figure 4 ureteral stent<br />
#Some of the stent have '''coatings''' which is '''liscensed''' from third party eg."'''pHreecoat'''"<br />
<br />
<br />
<br />
===Clinical trials===<br />
There are '''no trials currently''' conducted by C.R.Bard.<br />
<br />
===Patents===<br />
C R Bard is '''not very active''' in filing patents with very '''few''' patents '''filed after 2000'''.<br />
<br />
*The unmapped patents are analysed based on the following parameters<br />
<br />
'''1.Coating on stent:'''They have a couple of patents related to therapeutic coatigs on stent surface<br />
<br />
'''2.Structure of stent:'''C R. Bard patents are related to expandable stents for reducing patent discomfort<br />
<br />
'''3.Material used on stent:''' Recent patents focuses on Biodegrable polymers, Shape memory alloys or general polymer based stent<br />
<br />
= Competitive Landscape =<br />
==Major Players==<br />
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. <br />
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]<br />
<br />
==IP Activity==<br />
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.<br />
[[Image:IPactivity3.png|thumb|center|1000px|year wise IP activity]]<br />
<br />
=Sales =<br />
<br />
Total Sales in 2010 - 4.04 Billion USD<br />
<br />
{|border="2" cellspacing="0" cellpadding="4" width="100%"<br />
|bgcolor = "#4f81bd"|'''Company'''<br />
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''<br />
|bgcolor = "#4f81bd"|'''Urological sales'''<br />
|bgcolor = "#4f81bd"|'''Percentage share'''<br />
|bgcolor = "#4f81bd"|'''Product portfolio'''<br />
|-<br />
|bgcolor = "#4f81bd"|'''Boston Scientific'''<br />
|7800<br />
|661<br />
|8.48<br />
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''CR BARD'''<br />
|2700<br />
|702<br />
|26.00<br />
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Cook Medical'''<br />
|1700<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font><br />
|-<br />
|bgcolor = "#4f81bd"|'''Medline'''<br />
|4040<br />
|<nowiki>-</nowiki><br />
|<nowiki>-</nowiki><br />
|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font><br />
|-<br />
|}<br />
<br />
<br />
All figures in USD million<br />
<br />
[[image:stentshare.jpg]]<br />
<br />
<br />
====Boston Scientific====<br />
<br />
<br />
[https://dolcera.net/teamwiki_prod/index.php/Boston_Scientific_-_Company_Profile Company profile]<br />
<br />
[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Ureteral Stent portfolio]<br />
<br />
Net sales in 2010 – USD 7.8 Billion<br />
<br />
Share of Urology- 8.48 %<br />
<br />
Net sales from Urology- USD 661 Million<br />
<br />
Source [http://phx.corporate-ir.net/phoenix.zhtml?c=62272&p=irol-reportsother BSsalesdata]<br />
<br />
====CR BARD====<br />
<br />
[[Urology portfolio]]<br />
<br />
<br />
Net sales in 2010 – USD 2.7 Billion<br />
<br />
Share of Urology- 26%<br />
<br />
Net sales from Urology- USD 702 Million<br />
<br />
Source – CR BARD annual report<br />
<br />
====Cook Medical====<br />
<br />
[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Ureteral Stent portfolio]<br />
<br />
Total Sales - USD 1.7 Billion<br />
<br />
[http://www.nytimes.com/2011/04/26/business/26cook.html?_r=1 Source]<br />
<br />
====Medline====<br />
<br />
[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Ureteral Stent Portfolio]<br />
<br />
=<span style="color:#C41E3A">Like this report?</span>=<br />
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