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/* Dolcera Dashboard */
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.
*'''''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.
==Background==
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]
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 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.
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.
* Bacterial colonization: antimicrobial activity for up to two weeks.
* Patient Comfort: stent has a low coefficient of fiiction friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.
'''[[more on market overview...]]''' === Ureteric stenting difficulties ==Interactive Mind Map=* To access the Dashboard you have to signup. You can do so by clicking [[Imagehttps:Ureteral stent//www.jpg|thumb|right|350px|Double-J and Pigtail ureteral stents]dolcera.com/auth/index.php/login '''here''']*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' *''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''{|border="2" cellspacing="20" cellpadding="4" width="50100%"|align = "center" bgcolor = "#00CCFF"|<font color="#993366"mm>'''Common'''</font>[[Ureteral_Stent_Patent_Categorization.mm|align = "center" bgcolor = "#00CCFF"flash|<font color="#993366">'''Rare'''Patent Categorization|600pt]]</fontmm>
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==New trials == Encrustation ====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.
{| border="2" cellspacing="0" cellpadding="4" width=Infection"100%"| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center>The predictive value | style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of urine cultures in the assessment of stent colonization was examined in 65 patients with indwelling ureteral stentsApproval '''</font></center>| style="background-color:#4f81bd;padding:0. It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et al079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center>| style="background-color:#4f81bd;padding:0., 1999079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days)'''</font></center>|-| style="background-color:#dce6f1;padding:0. Patients with sterile urine culture079cm;"| <center>'''1'''</center>may benefit from prophylactic antibiotics| style="background-color:#dce6f1; however, the authors contended that the antibiotics must work against grampadding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center>| style="background-negative uropathogens and gramcolor:#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>]]]| style="background-positive bacteria including enterococcicolor:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center>It is obvious that there is controversy in the literature whether prophylactic systemic antibiotics are useful | style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center>| style="background-color:#dce6f1;padding:0.079cm;"| Silicone| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with ureteral stent implantmonofilament suture loop| style="background-color:#dce6f1;padding:0. However079cm;"| <center>365</center>|-| style="padding:0.079cm;"| <center>'''2'''</center>| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/, antibiotics do not seem to prevent stent colonization,/method/DevHome/navRelId/1000. Denstedt et al1003/seo. serve Boston Scientific]</center>| 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(1998) have found that ciprofloxacin, <center>Polaris Loop</center>]]]| style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center>| style="padding:0.079cm;"| <center>Mar 2003</center>| style="padding:0.079cm;"| Dual Durometer Percuflex with a HydroPlus Coating| style="padding:0.079cm;"| Bladder loop design| style="padding:0.079cm;"| <center>365</center>|-| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3 day burst every '''</center>| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center>| 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>]]]| 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>| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center>| style="background-color:#dce6f1;padding:0.079cm;"| Metal| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center>|-| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center>weeks, actually is adsorbed onto the stent which makes longer term treatment possible with reduced risk of bacterial resistance| style="padding:0. 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 079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center>| 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>]]]| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA510(k)]</center>| style="padding:0.079cm;"| <center>Aug 2002</center>| style="padding:0.079cm;" rowspan="2"| Polyurethane| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent| style="padding:0.079cm;" rowspan="2"| <center>13</center>|-| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center>| style="padding:0.079cm;"| <center>Sep 2005</center>
|-| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center>| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center>| style= The market need "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>]]]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| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history. According to Merrill Lynch, ureteral stents represent an $80 MMaspx CE Mark]</center>US market| style="background-color:#dce6f1;padding:0. Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player079cm;"| <center>1995</center>| style="background-color:#dce6f1;padding:0. There are a number of other small contenders079cm;"| Nickel-titanium shape memory alloy| style="background-color:#dce6f1;padding:0. 079cm;"| Double fluted ended spiral stent| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center>|}
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 procedureFDA classifies a ureteric stent as follows: * TITLE 21 - FOOD AND DRUGS* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES* SUBCHAPTER H - MEDICAL DEVICES* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES* Subpart E - Surgical Devices* Sec. According to survey results reported by Hollowell, et al876. (2000), there is a significant difference in opinion concerning the use of stents with ESWL4620 - Ureteral stent. * 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]
|-|align ="center" rowspan ="2"|'''2'''|align = Intellectual property ="center" rowspan ="2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font>|align ="center" rowspan ="2"|[http://www.google.com/url?sa=t&source= Search strategy 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]* Databases searched|align = "center"|<font color="#0000FF">[http: US//www.pnnmedical.com/about-G, USpnn-A, EPmedical/company-A, EP-B, WO, JP, DE, GB, FRhistory.aspx CE Mark]</font>* Search scope: Title, Abstract or Claims|align = "center"|1995* Years: 1981|rowspan = "2"|Nickel-July 2008titanium shape memory alloy* Search query: (ureter* OR urether* OR ureth* OR uretr*) AND (|rowspan = "2"|Double fluted ended spiral stent*) AND (*microb* OR *bacter*)* Results|align = "center" rowspan = "2"|240|rowspan = "2"|[[Image: '''177 patents (82 unique patent families)'''Memokath_051.png|thumb|center|100px|<center>Memokath 051</center>]]
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|}align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]|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>|align = "center" bgcolor = "#dce6f1"|Nov, 2003|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki>|align = "center" bgcolor = "#dce6f1" rowspan = "2"| |align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]
|-|align = "center" bgcolor ="#dce6f1"|<font color= Phase 2"#0000FF"><u>[http: Deeper Dive - Design History File Review //www.fossamedical.com/news.htm CE Mark]</u></font>|align ="center" bgcolor ="#dce6f1"|Sep, 2005|-|align ="center" bgcolor ="#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db= Scenario PMN&ID=K021140 Expanding Ureteral Stent]|align ="center" bgcolor =Client wishes to acquire a ureteral stent company"#dce6f1"|<font color="#0000FF"><u>[http://www. Dolcera provides the following Design History File accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(DHFk) review.]</u></font>|align = "center" bgcolor = "#dce6f1"|Jun, 2002|bgcolor = "#dce6f1"|Polyurethane|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki>|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| N/A
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| Design input documents linked to the product performance specificationsalign = "center"|<font color="#0000FF"><u>Percuflex</u></font>|align = "center"|# Compare product specifications to design inputs|align = "center"|# Check whether appropriate verifications and validations are performed|align = "center"| Percuflex# Establish if all specifications are linked to design inputs|Pigtail|align = "center"|365|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]]
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| Appropriate design verification and validations align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(DV&Vk) are performed]</u></font>| align = "center"|Mar, 2003# Show DV&V criteria are based on risk management requirements|Dual Durometer Percuflex with HydroPlus Coating|Bladder loop design|align = "center"|365|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]]
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| Product performance specifications correspond to appropriate design output documentsalign = "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>|align = "center"| # Correlate design drawings with the specifications|align = "center"| # Check whether maximum dimensions, sizes etc|Percuflex material and Hydroplus coating|Endopyelotomy stent|align = "center"|Post-procedure healing|align = "center" |[[Image:Retromax_plus. (with tolerances) are within the specified rangepng|thumb|center|100px|<center>Retromax Plus</center>]]
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| DFMEA links appropriately to the PPSalign = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]|align = "center"| # Verify |align = "center"| |Percuflex - proprietary polyolefin copolymer|Ketorolac trimethamine loaded stent|align = "center"||align = "center"| N/A
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| Appropriate DV&V reports and design output documents are reference correctly as risk mitigation activities in the DFMEAalign = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''| align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font>|align = "center" bgcolor = "# Validate the process and correlate with design inputsdce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font>|align = "center" bgcolor = "# Validate the ranges used are within range of risk mitigation criteriadce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font>|align = "center" bgcolor = "#dce6f1"|May, 2007|bgcolor = "#dce6f1"|Metal|bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|365|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]]
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| PFMEA links appropriately to the process validation protocol acceptance criteria; Inalign = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-process inspection procedures andflex]</or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEAu></font>| align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|AQ® Hydrophilic Coating|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning |align = "center" bgcolor = "#dce6f1"|180|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]]
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| Correlate First Article Inspection data to the dimensions on the drawingsalign = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font>|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "# Obtain First Article Inspection datadce6f1"| |bgcolor = "# Check if this data correlates with the completeness of drawingsdce6f1"| |bgcolor = "#dce6f1"|Double Pigtail|align = "center" bgcolor = "#dce6f1"|180|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]]
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| Linkage between component and raw material specifications and appropriate incoming inspection proceduresalign = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font>| align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font>|align = "center" bgcolor = "# dce6f1"|Dec, 2007|bgcolor = "#dce6f1"|Heparin-bonded stent|bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|
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|align = "center"|'''6'''
|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font>
|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font>
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font>
|align = "center"|Jan, 2010
|Hydrogel
|Differentially larger end (no pigtail)
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|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]]
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| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materialsalign = "center" bgcolor = "#dce6f1"|'''7'''| align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font>|align = "center" bgcolor = "# Review supplier audit reports for compliancedce6f1"|Ureteral Stent Set|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>|align = "center" bgcolor = "#dce6f1"|Apr, 2010|bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|30|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]]
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| Calibration records align = "center" rowspan = "4"|'''8'''|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>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font>|align = "center"|Jul, 2001|Polyester mesh|Double-pigtail|align = "center"| |align = "center"| N/A|-|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>|align = "center"| |align = "center"| |Coil-reinforced; SL-6® hydrophilic coating|Patency Device|align = "center"| |align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] |-|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>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font>|align = "center"|Jun, 1999|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating|Unique wall construction and preventive maintenance recordsenlarged drainage holes |align = "center"| |align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] |-|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>|align = "center"| |align = "center"| |Proprietary thermoplastic elastomer material; inSL-process 6® hydrophilic coating|Dual Diameter stent|align = "center"| |align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</ incoming inspection test methods center>]] |-|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''|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>|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font>|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>|align = "center" bgcolor = "#dce6f1"|Dec, 2004|bgcolor = "#dce6f1"|Silicone|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop|align = "center" bgcolor = "#dce6f1"|365|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] |-|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>|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>|align = "center" bgcolor = "#dce6f1"|Jan, 2003|bgcolor = "#dce6f1"|Silicone|bgcolor = "#dce6f1"|Attached with suture for ease of removal|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]|-|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>|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|Silicone/tantalum|bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]|-|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>|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|Silicone|bgcolor = "#dce6f1"|Three dimensional design|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]|-|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font>|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>|align = "center" bgcolor = "#dce6f1"|Dec, 1998|bgcolor = "#dce6f1"|Silicone|bgcolor = "#dce6f1"|Tapered tip and related test method validationslubricious hydrophilic coating |align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]|-|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]</u></font>|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>|align = "center" bgcolor = "#dce6f1"|Apr, 1991|bgcolor = "#dce6f1"|Silicone|bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]|-|align = "center" rowspan = "4"|'''10'''|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font>|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font>|align = "center"|Oct, 1998|Silicone|Double coating for easy maneuverability as well as flexibility|align = "center"| |align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]|-|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font>|align = "center"|Oct, 1998|Silicone|Extreme flexibility|align = "center"| |align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]|-|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font>|align = "center"| |align = "center"| |Hard or soft Polyurethane|Designed for short-term use|align = "center"| 90|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]|-|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font>|align = "center"|Oct, 2002|Silicone|''Pyatiprofilnaya'' technology |align = "center"| |align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]|-|align = "center" bgcolor = "#dce6f1"|'''11'''|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font>|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>|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>|align = "center" bgcolor = "#dce6f1"|Jul, 1999|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating|bgcolor = "#dce6f1"| Directable and detachable|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]|-|align = "center" rowspan = "9"|'''12'''|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>|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>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font>|align = "center"|Dec, 1986
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| Design test methods 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>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font>|align = "center"|Apr, 1988|Silicone|Double-J closed-tip |align = "center"| |align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]|-|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>|align = "center"| |align = "center"| |Tecoflex® |Grooved design|align = "center"| |align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]|-|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>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font>|align = "center"|Nov, 1991|Tecoflex®|“Rememberance” of shape with a chemically bonded wettable solution |align = "center"| |align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]|-|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>|align = "center"| |align = "center"| |Tecoflex®|Two durometers with helical kidney curls|align = "center"| |align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]|-|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>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font>|align = "center"|Mar, 1996|Tecoflex®|Accomodate ureteral lengths from 22cm to 28cm|align = "center"| |align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]|-|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>|align = "center"| |align = "center"| |Tecoflex®|Dual-durometer design and related test method validationsexclusive soft bladder helix |align = "center"| |align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]|-|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>|align = "center"| |align = "center"| |Silicone|Classic Double J with open tip|align = "center"| |align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]|-|align = "center" bgcolor = "#dce6f1"|'''13'''|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]|bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating|bgcolor = "#dce6f1"|Double loop stent|align = "center" bgcolor = "#dce6f1"|Short-term and long-term|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]|-|align = "center"|'''14'''|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]|align = "center"|Jan, 1987|Nitinol|Self-expanding stent
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=Product to Clinical Trial Mapping= = Potential DHF Review Outcomes =Clinical Timeline Visualization ==Based on a review of the above DHF documents a potential outcome [[Image:Timeline.jpg]] [[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]] = Product to Patent Mapping = [[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the uretral stent acquisition project could involve product to patent mapping(Bard and Boston)''']]* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the followingexcel file.== Mapped Patent vs Not Mapped Patents =={|border="0" cellspacing="0" cellpadding="4" width="100%"|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]# Better explanation of existing design input documents and also better linkage between |[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]|-|} =Patent-Product-Clinical Trial Mapping= * To access the design inputs and product specificationsDashboard you have to signup.You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']# Creation of some new test methods for design, incoming *''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in-process inspections and also include recommendations the detailed taxonomy''*''Click on the red arrow adjacent to the node name to view the content for that particular node in 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-dashboard'' *''Click on the "+" sign tozoom the mindmap and "-file " sign to shrink the regulatory agenciesmindmap''{|border="2" cellspacing="0" cellpadding="4" width="100%" |<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm> |} =Insights= {|border="2" cellspacing="0" cellpadding="4" width="100%"|bgcolor = "# Change 538ED5"|<font size = "4">''' '''</font>|bgcolor = "#538ED5"|<font size = "4">''' '''</font>|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font>|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font>|-|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''|'''Portfolio'''|8 Products|6 Products|-|'''Material'''|Percuflex - Biocompatible Polymer|Silicone|-|'''Coating'''|Hydroplus|Licensed from pHreecoat|-|'''Shape'''|Pigtailed and More|Figure 4 and more|-|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''|'''Current Trials'''|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in raw materials Phase II (Canada)|None|-|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''|'''Coating'''|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion|Therapeutic coatings|-|'''Structure'''|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to better grade materials e.g. Switching resin to a USP Class VI biocompatible resin. This would eliminate some prevent reflux <br>Stent with beads onits 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|Expandable stents for reducing discomfort|-going testing but require additional upfront one time biocompatibility testing.# Updating drawings |'''Material'''|Elastically deformable stents<br>Biodegradable polymer based on results from the FAI data.stents<br>Porous polymer for long term implantation<br>Stent with variable hardness|Biodegradable polymers<br>Shape memory alloys<br>General polymer based|-|} == Inference == {|border="2" cellspacing="0" cellpadding="4" width="82%"|bgcolor = "# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw 538ED5"|<font size = "4">'''Boston Scientific'''</font>|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font>|-|Relatively late entrant with patents filed post mid 90s|Early mover with patents filed in mid 80s|-|Increased patent activity since 2000|Patent activity never gained traction|-|Large number of patents yet to be "productized"|Few patents yet to be "productized"|-|Some products undergoing clinical trails|No products undergoing clinical trails|-|Diverse range of products with variation in material specifications <br>and inspection procedures.structure# Identifying installation|Small product portfolio|-|Seem to be strengthening they market position|Seem to be moving focus away from Ureteral stents market|-|} = Competitive Landscape ===Major Players==*Boston Scientific Limited, operational and process qualification requirements with the assumption that no additional design verification Abbott, Medtronic and validation activities Cook Inc. are required based on the fact that major players in ureteral stent research field. [[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]] ==IP Activity==*Patenting activity has been high growth rate during the device is currently approved for sale period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the US period 2006 to 2008 and ROWafter that a gradual declination upto year 2010 in the ureteral stent research area.[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]] ==Sales == Total Sales in 2010 - 4.04 Billion USD {|border="2" cellspacing="0" cellpadding="4" width="100%"|bgcolor = "# Recommend activities necessary for completing packaging, labeling, ship testing and shelf4f81bd"|'''Company'''|bgcolor = "#4f81bd"|'''Total Sales in 2010'''|bgcolor = "#4f81bd"|'''Urological sales'''|bgcolor = "#4f81bd"|'''Percentage share'''|bgcolor = "#4f81bd"|'''Product portfolio'''|-life testing|bgcolor = "#4f81bd"|'''Boston Scientific'''|7800|661|8. Stress should be on being able to leverage existing data for shelf48|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-life without changing the regulatory status of the deviceBrochure. pdf Boston_portfolio]</u></font>|-|bgcolor = "# Company X may want to perform additional biocompatibility testing to create an internal baseline and also update their biocompatibility files4f81bd"|'''CR BARD'''|2700|702|26.00|<font color="# Help streamline suppliers for components when switching over from Company Y to Company X0000FF"><u>[https://dolcera. Search for existing Company X suppliers that can supply off the shelf items that Company Y may be sourcing from other vendors net/teamwiki_prod/ suppliersindex.php/BARD_portfolio BARD_portfolio]</u></font>|-|bgcolor = "# Identify process improvements that 4f81bd"|'''Cook Medical'''|1700|<nowiki>-</nowiki>|<nowiki>-</nowiki>|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font>|-|bgcolor = "#4f81bd"|'''Medline'''|4040|<nowiki>-</nowiki>|<nowiki>-</nowiki>|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font>|-|} [[image:stentshare.jpg |thumb|center|1000px| All figures in USD million ]] =<span style="color:#C41E3A">Like this report?</span>=<p align="center"> '''This is only a sample report with brief analysis''' <br>'''Dolcera can be rolled into provide a comprehensive report customized to your needs'''</p>{|border="2" cellspacing="0" cellpadding="4" align="center" "|style="background:lightgrey" align = "center" colspan = "3"|'''[mailto:info@dolcera.com <span style="color:#0047AB">Buy the manufacturing transfer without changing the design and impacting the existing regulatory status for the device ecustomized report from Dolcera</span>]''' |-| align = "center"| [http://www.gdolcera. instead of hand mixing pigment to resin use a precom/website_prod/services/ip-patent-analytics-services Patent Analytics Services]|align = "center"| [http://www.dolcera.com/website_prod/services/business-research-services Market Research Services]|align = "center"| [http://www.dolcera.com/website_prod/tools/patent-dashboard Purchase Patent Dashboard]|-|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/patent-search/patent-landscapes Patent Landscape Services]|align = "center"| [http://www.dolcera.com/website_prod/research-processes Dolcera Processes]|align = "center"| [http://www.dolcera.com/website_prod/industries Industry Focus]|-|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/patent-search/patent-landscapes Patent Search Services]|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/alerts-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 machinesupdates Patent Alerting Services]|align = "center"| [http://www.dolcera.com/website_prod/tools Dolcera Tools]|-|}<br> =[[Backup]]=