Ureteral Stent

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This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trails.

  • 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

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 friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.

more on background...

Market Overview

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.

more on market overview...

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Patents

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Clinical Trials

New trials

S.No.
Title
Conditions
Intervention: Device
Sponsors and Collaborators
1
Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation Renal Calculi, Ureteral Obstruction Ureteral Stent Lawson Health Research Institute, Boston Scientific Corporation
2
Memokath® 044TW Stent for Treatment of Urethral Stricture Urethral Stricture Memokath stenting Engineers & Doctors Wallsten Medical Group
3
Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation Kidney Stones N\A University of California, Irvine
4
Ureteral Stent Length and Patient Symptoms Kidney Stones Ureteral Stent Emory University
5
Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent Ureteral Obstruction Memokath 051 Ureteral Stent Mayo Clinic Engineers & Doctors Wallsten Medical Group
6
A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08) Kidney Disease Nephrostomy tube and ureteral stent Rabin Medical Center

Concluded trials

S.No.
Title
Abstract
Enrollment
Disorder
Conclusion
1
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.
2
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.
3
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.


Pre-Market Notification

Some of the companies active in the field of ureteral stents have been represented in the table below.

S.No.
Company
Device
Approval
Date of Approval
Material
Technology
Indwelling Time (days)
1
Bard Urological
FDA 510(k)
Dec 2004
Silicone Double pigtail with monofilament suture loop
365
2
Boston Scientific
FDA 510(k)
Mar 2003
Dual Durometer Percuflex with HydroPlus Coating Bladder loop design
365
3
Cook Medical
FDA 510(k)
May 2007
Metal Temporary stenting
365
4
Fossa Medical
FDA 510(k)
Aug 2002
Polyurethane Spiral radially expanding stent
13
CE Mark
Sep 2005
5
Pnn Medical A/S
CE Mark
1995
Nickel-titanium shape memory alloy Double fluted ended spiral stent
240

Timeline Visualization

Timeline.jpg

Ureteral Stent Timeline

Products

The FDA 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. 876.4620 - Ureteral stent.
  • Classification - class II device Code of Federal Regulations
Sr. No. Company Device(s) Approval Approval Date Material Technology Indwelling Time (days) Image
1 Allium, Israel URS CE Mark Jul, 2007 Nickel-titanium shape memory alloy covered by polymer Self-expanding stent
Allium
2 Pnn Medical A/S Memokath 051 CE Mark 1995 Nickel-titanium shape memory alloy Double fluted ended spiral stent 240
Memokath 051
FDA Listing Mar, 2004
3 Fossa Medical Stone Sweeper CE Mark Sep, 2005 Polyurethane Radially expanding stent 13
Stone Sweeper
FDA 510(k) Aug, 2002
Open lumen stent FDA 510(k) Nov, 2003 Polyurethane Pigtail-tipped stent with Pusher
Open_lumen
CE Mark Sep, 2005
Expanding Ureteral Stent FDA 510(k) Jun, 2002 Polyurethane Double pigtail stent with Pusher N/A
4 Boston Scientific Contour Percuflex - proprietary polyolefin copolymer; Hydroplus coating Fixed and variable length; Tapered tip 365
Contour
Percuflex Percuflex Pigtail 365
Percuflex
Polaris Ultra FDA 510(k) Jan, 2001 Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil. Double pigtail 365
Polaris Ultra
Polaris Loop FDA 510(k) Mar, 2003 Dual Durometer Percuflex with HydroPlus Coating Bladder loop design 365
Polaris Loop
Retromax Plus Percuflex material and Hydroplus coating Endopyelotomy stent Post-procedure healing
Retromax Plus
Stretch VL Flexima Hydroplus Coating Variable length coil on distal and proximal ends 90
Stretch VL Flexima
Drug-Eluting Stent Percuflex - proprietary polyolefin copolymer Ketorolac trimethamine loaded stent N/A
5 Cook Medical Resonance FDA 510(k) May, 2007 Metal 365
Resonance
Sof-flex AQ® Hydrophilic Coating Radiopaque tip and tether for repositioning 180
Sof-flex
Endo-Sof AQ® Hydrophilic Coating Double pigtail 365
Endo-Sof
C-Flex Double Pigtail 180
C-Flex
Smith Universal Nephrostomy tube + Ureteral stent 60
Smith Universal
Endo-Sof Radiance Launch Dec, 2007 Heparin-bonded stent
6 Q Urological pAguaMedicina™ Pediatric Ureteral Stent FDA 510(k) Jan, 2010 Hydrogel Differentially larger end (no pigtail) 30
pAguaMedicina
7 Bioteque Corp. Ureteral Stent Set FDA 510(k) Apr, 2010 30
Bioteque
8 Applied Medical Resources, CA, USA Mesh FDA 510(k) Jul, 2001 Polyester mesh Double-pigtail N/A
Silhouette Coil-reinforced; SL-6® hydrophilic coating Patency Device
Silhouette
Applied Standard FDA 510(k) Jun, 1999 Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating Unique wall construction and enlarged drainage holes
Applied Standard
7-10 endopyelotomy Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating Dual Diameter stent
Endopyelotomy Stent
9 Bard Urological InLay Optima FDA 510(k) Dec, 2004 Silicone Double pigtail with monofilament suture loop 365
InLay Optima
Bardex® Double Pigtail Soft Stent FDA 510(k) Jan, 2003 Silicone Attached with suture for ease of removal
Bardex
Fluoro-4 Silicone Ureteral Stent Silicone/tantalum
Fluoro 4
Figure-4 Silicone Ureteral Stent Silicone Three dimensional design
Figure 4
InLay Ureteral Stent FDA 510(k) Dec, 1998 Silicone Tapered tip and lubricious hydrophilic coating
InLay
Urinary Diversion Stent FDA 510(k) Apr, 1991 Silicone
Urinary Diversion Stent
10 Coloplast-Porges Vortek FDA 510(k) Oct, 1998 Silicone Double coating for easy maneuverability as well as flexibility
Vortek
Biosoft FDA 510(k) Oct, 1998 Silicone Extreme flexibility
Biosoft
Polyurethane Hard or soft Polyurethane Designed for short-term use 90
Polyurethane
Silicone FDA 510k) Oct, 2002 Silicone Pyatiprofilnaya technology
Silicone
11 Teleflex Medical Rüsch Superglide DD FDA 510(k) Jul, 1999 WIRUTHAN® (polyurethane) with hydrogel coating Directable and detachable
Superglide DD
12 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek Classic closed-tip FDA 510(k) Dec, 1986 Classic Closed Tip
Classic Closed Tip
Classic Double pigtail FDA 510(k) Mar, 1996 Tecoflex® construction Balanced-curled double pigtail design
Double Pigtail
Double-J FDA 510(k) Apr, 1988 Silicone Double-J closed-tip
Double_J
Lithostent Tecoflex® Grooved design
Lithostent
Lubri-flex FDA 510(k) Nov, 1991 Tecoflex® “Rememberance” of shape with a chemically bonded wettable solution
Lubri-flex
Multi-flex Tecoflex® Two durometers with helical kidney curls
Multi-flex
Quadra-Coil multi-length FDA 510(k) Mar, 1996 Tecoflex® Accomodate ureteral lengths from 22cm to 28cm
Quadra-Coil
Sof-curl Tecoflex® Dual-durometer design and exclusive soft bladder helix
Sof-curl
Uroguide Silicone Classic Double J with open tip
Uroguide
13 Ameco Medical Industries Amecath Nitinol; Available with hydrophilic coating Double loop stent Short-term and long-term
Amecath
14 Angiomed-Movaco (C.R. Bard subsidiary) Ureteral Stent Set FDA 510(k) Jan, 1987 Nitinol Self-expanding stent N/A

Patent-Product-Clinical Trial Mapping

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Product to Patent Mapping

Screenshot for the product to patent mapping(Bard and Boston)
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  • Mapped Patent vs Not Mapped Patents
C R Bard
Boston Scientific



Insights

Boston Scientific

Products

  • They have 8 ureteral stents in their portfolio
  • Boston's ureteral stent portfolio have some common features such as:
  1. Stent material consisting of Percuflex- a Biocompatible Polymer Material
  2. The coating on the stent may be a Hydroplus coating
  3. Most of the stents are designed to have an indwelling time of 365 days
  4. Pigtailed shaped ureteral stent

Regulatory data

  • Ureteral stents are class II medical devices and hence require a 510(k) approval to launch the product in the market. The time taken for Boston to get their stent approved ranged from 21 days to 9 months

Clinical trials

  • 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).

Patents

  • The unmapped patents are analysed based on the following parameters

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

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

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)

C.R.Bard

Products

  • They have 6 products in their ureteral stent portfolio
  • C.R Bard ureteral stent portfolio have some common features such as:
  1. Most of the stent has Silicone as their main material
  2. They have stent with various designs and shapes eg Figure 4 ureteral stent
  3. Some of the stent have coatings which is liscensed from third party eg."pHreecoat"


Clinical trials

There are no trials currently conducted by C.R.Bard.

Patents

C R Bard is not very active in filing patents with very few patents filed after 2000.

  • The unmapped patents are analysed based on the following parameters

1.Coating on stent:They have a couple of patents related to therapeutic coatigs on stent surface

2.Structure of stent:C R. Bard patents are related to expandable stents for reducing patent discomfort

3.Material used on stent: Recent patents focuses on Biodegrable polymers, Shape memory alloys or general polymer based stent

Key Findings

Major Players

  • Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field.
Major Players

Key Patents

  • The key patents in the field are held by Cook Incorporated, Interventional Thermodynamics, Abbott laboratories and Boston Scientific Corp.
Key Patents

IP Activity

  • 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.
year wise IP activity

Geographical Activity

  • USA, Europe and Germany are very active in ureteral stent research.
Geographical Activity


Competitor Analysis

Total Sales in 2010 - 4.04 Billion USD

Company Total Sales in 2010 Urological sales Percentage share Product portfolio
Boston Scientific 7800 661 8.48 Boston_portfolio
CR BARD 2700 702 26.00 BARD_portfolio
Cook Medical 1700 - - Cook_portfolio
Medline 4040 - - Medline_portfolio


All figures in USD million

Stentshare.jpg


Boston Scientific

Company profile

Ureteral Stent portfolio

Net sales in 2010 – USD 7.8 Billion

Share of Urology- 8.48 %

Net sales from Urology- USD 661 Million

Source BSsalesdata

CR BARD

Urology portfolio


Net sales in 2010 – USD 2.7 Billion

Share of Urology- 26%

Net sales from Urology- USD 702 Million

Source – CR BARD annual report

Cook Medical

Ureteral Stent portfolio

Total Sales - USD 1.7 Billion

Source

Medline

Ureteral Stent Portfolio



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