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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.


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.

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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.

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Dolcera Patent Analysis

Patent/Publication No.
Publication Date (mm/dd/yyyy)
Dolcera Analysis
1 US20090187254A1 07/23/2009 BOSTON SCIENTIFIC SCIMED, INC. UROLOGICAL MEDICAL DEVICES FOR RELEASE OF UROLOGICALLY BENEFICIAL AGENTS In previous attempts to develope a uerteral stent, encrustation was the problem associated with the stent. Along with this pain and discomfort by stent implantaion was there. This invention provides a ueteral stent which release one or more urologically beneficial agents in effective amounts to reduce the problem of encrustation and pain related to stent.
2 US20090171465A1 07/02/2009 Boston Scientific Scimed, Inc. Polymeric Regions For Implantable Or Insertable Medical Devices In previous attempts to develope a uerteral stent, encrustation was the problem associated with the stent. Along with this pain and discomfort by stent implantaion was there. This invention provides a ureteral stent with a coating of a material(EVA) that reduces the discomfort caused by the stent during implantation.
3 US20080097349A1 04/24/2008 Boston Scientific Scimed, Inc. Partially soluble implantable or insertable medical devices In previous attempts to develope a uerteral stent, encrustation was the problem associated with the stent. Along with this pain and discomfort by stent implantaion was there. Here the device (Stent) is provided with at least one surface that contains one or more depressions, which are at least partially filled with a soluble material. This makes stent more flexible and soft after implantation hence minimizing pain and discomfort after implantation or insertion.
4 US5554147A 09/10/1996 CApHCO, Inc. Compositions and devices for controlled release of active ingredients During implantation of ureteral stent,pain and discomfort are the problem with previous stents. Also microbial or bacterial infection at the site of implantation was the problem. In this invention stent is povided with a pH sensitive coating that includes antimicrobial agent to stop the infection. This coating also has the hydrogel property which Upon swelling, the hydrogel's coefficient of friction is reduced, and the polymer becomes slippery, this mechanism reduces the discomfort.
5 US6468649B1 10/22/2002 Scimed Life Systems, Inc. Antimicrobial adhesion surface In prior art problem was the lack of the device which can remain in vivo for extended periods of time without losing its antimicrobial efficacy and which can provides protection against bacterial and fungal organisms for extended periods of time without leaching substances into a patient. This invention provides a medical device with a hydrophobic coating that inhibits the growth of microbes for extended period of time.
6 US20030153983A1 08/14/2003 Scimed Life Systems, Inc. Implantable or insertable medical device resistant to microbial growth and biofilm formation In previous attempts to develope a ureteral stent with coating the problem was the formation of biofilm and microbial growth. The device of the present invention, therefore, overcomes the disadvantages associated with the use of coatings as discussed above, and provides a reduced risk of biofilm fouling that eventually results in encrustation, occlusion and failure of the device. In this invention medical device comprises at least one biocompatible matrix polymer region and bioactive agents comprising an antimicrobial agent and a microbial attachment/biofilm synthesis inhibitor.
7 US20030139800A1 07/24/2003 None Stent assembly with therapeutic agent exterior banding In earlier attempts for stent with a therapeutic property, the problem was the coating or the sheath (responsible for therapy) may covers side branch arteries, vessels, or other lumens extending from the main lumen in which the stent is installed. The sheath can reduce blood flow to or from the side branch and deliver medication into the side branch where it is unnecessary. This invention provides a stent assembly with exterior banding for delivery of therapeutic agents that would overcome the previous disadvantages. Also this stent assembly which avoids side branch vessel blockage by a sheath, with increased drug storage capacity and allowing delivery of different drugs at different axial and radial locations.
8 US20040117007A1 06/17/2004 STS Biopolymers, Inc. Medicated stent having multi-layer polymer coating The problem associated with previous stent and their implantation was thrombus formation in vicinity of stent. The stent assembly developed in this invention consistently provide therapeutic activity from the surfaces of stents in order to reduce the incidence of restenosis and thrombus formation after coronary stenting procedures in the clinic.
9 WO1990013332A1 11/15/1990 CEDARS-SINAI MEDICAL CENTER STENT WITH SUSTAINED DRUG DELIVERY Problem was to provide an intravascular stent that preserves vessel patency, inhibits luminal narrowing and at the same time stent can deliver a pharmaceutical agent to a specific body site or organ. The stent assembly provided by this invention will release anticoagulants, antiplatelet drugs or drugs that inhibit excessive endothelial cell growth at the placement site, thereby preserving the vessels patency and inhibiting luminal narrowing.
10 WO2001036008A2 05/25/2001 STS BIOPOLYMERS, INC. MEDICAL DEVICES COATED WITH ELASTIC POLYMERIC MATERIAL The lack of flexibility, expandability and lubricity of coating surface was the problem with previous insertable medical device. This invention provides a medical device with a polymeric coating adherent to the covering, such that the coating and covering possess desirable surface characteristics such as lubricity, or lack thereof, as well as flexibility, expandability and elasticity.

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Clinical Trials

New trials

Intervention: Device
Sponsors and Collaborators
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
Memokath® 044TW Stent for Treatment of Urethral Stricture Urethral Stricture Memokath stenting Engineers & Doctors Wallsten Medical Group
Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation Kidney Stones N\A University of California, Irvine
Ureteral Stent Length and Patient Symptoms Kidney Stones Ureteral Stent Emory University
Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent Ureteral Obstruction Memokath 051 Ureteral Stent Mayo Clinic Engineers & Doctors Wallsten Medical Group
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

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.
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.
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.

Adverse Events

Brand Name
Adverse Event
Date FDA Received
Cook Urologicals Cook Urological Stent Stent broke into pieces while removing it from the patients body. 12/14/2005
Boston Scoientific Boston Scientific Ureteral stent System Fractured stent seen under Fluroscopy 10/17/2007
Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CM During insertion of ureteral stent, the stent broke into multiple parts which were retained in the patient. 10/14/2005
Boston Scientific Corp Boston Scientific 8 FR X 28 CM Ureteral Stent System Kit Breakage of the upper loop of the ureteral stent while trying to insert it. 01/05/2005
Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stent Broken stent observed during x-ray procedure. 12/12/2003

Pre-Market Notification

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.

A 510(k) is required when:

  • Introducing a device into commercial distribution (marketing) for the first time.
  • Proposed different intended use for a device already in commercial distribution.
  • Change or modification of a legally marketed device.

510(k) “Substantial Equivalence” Decision Making Process

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

Date of Approval
Indwelling Time (days)
Bard Urological
FDA 510(k)
Dec 2004
Silicone Double pigtail with monofilament suture loop
Boston Scientific
FDA 510(k)
Mar 2003
Dual Durometer Percuflex with HydroPlus Coating Bladder loop design
Cook Medical
FDA 510(k)
May 2007
Metal Temporary stenting
Fossa Medical
FDA 510(k)
Aug 2002
Polyurethane Spiral radially expanding stent
CE Mark
Sep 2005
Pnn Medical A/S
CE Mark
Nickel-titanium shape memory alloy Double fluted ended spiral stent

Timeline Visualization


Ureteral Stent Timeline


The FDA classifies a ureteric stent as follows:

  • 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
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
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
Percuflex Percuflex Pigtail 365
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
Sof-flex AQ® Hydrophilic Coating Radiopaque tip and tether for repositioning 180
Endo-Sof AQ® Hydrophilic Coating Double pigtail 365
C-Flex Double Pigtail 180
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
7 Bioteque Corp. Ureteral Stent Set FDA 510(k) Apr, 2010 30
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
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
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
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
Biosoft FDA 510(k) Oct, 1998 Silicone Extreme flexibility
Polyurethane Hard or soft Polyurethane Designed for short-term use 90
Silicone FDA 510k) Oct, 2002 Silicone Pyatiprofilnaya technology
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
Lithostent Tecoflex® Grooved design
Lubri-flex FDA 510(k) Nov, 1991 Tecoflex® “Rememberance” of shape with a chemically bonded wettable solution
Multi-flex Tecoflex® Two durometers with helical kidney curls
Quadra-Coil multi-length FDA 510(k) Mar, 1996 Tecoflex® Accomodate ureteral lengths from 22cm to 28cm
Sof-curl Tecoflex® Dual-durometer design and exclusive soft bladder helix
Uroguide Silicone Classic Double J with open tip
13 Ameco Medical Industries Amecath Nitinol; Available with hydrophilic coating Double loop stent Short-term and long-term
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)
  • Click here to download the excel file.
  • Mapped Patent vs Not Mapped Patents
C R Bard
Boston Scientific

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Concordance Dashboard


Boston Scientific C R BARD
Products Portfolio 8 Products 6 Products
Material Percuflex - Biocompatible Polymer Silicone
Coating Hydroplus Licensed from pHreecoat
Shape Pigtailed and More Figure 4 and more
Current Trials Truimph Ureteral stent - Loaded with Triclosan
Currently in Phase II (Canada)
Patents Coating Therapeutic / Medicinal coatings
Magnetic nano particles for MRI Imaging
Lubricious coatings helping easy insertion
Therapeutic coatings
Structure Multiple channels filled with therapeutic agent
Multiple collapsible segments preventing fluid passing
Renal coil with wick to prevent reflux
Stent with beads on its surface
Stent with reservoir indicating its release
with change in color of urine
Expandable and collapsible stent
Stents with degradable barbs
Expandable stents for reducing discomfort
Material Elastically deformable stents
Biodegradable polymer based stents
Porous polymer for long term implantation
Stent with variable hardness
Biodegradable polymers
Shape memory alloys
General polymer based


Boston Scientific C R BARD
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
and structure
Small product portfolio
Seem to be strengthening they market position Seem to be moving focus away from Ureteral stents market

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


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


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



Ureteral Stent Portfolio

Academic Research

Research at University of Minnesota about symptoms and pain associated with ureteral stent

Research Team

Background and Purpose

  • Ureteral stents are associated with significant pain and urinary symptoms.
  • Manufacturers have altered stent designs and materials in an attempt to minimize this morbidity.
  • This study evaluated the impact of these modifications.

Patients and Methods

  • Stent manufacturers were asked to provide the 6F ureteral stent they believed would be associated with the least patient discomfort.
  • Patients undergoing uncomplicated ureteroscopy were randomized to the Bard Inlay, Cook Endo-Sof, Microvasive Contour, Applied Medical Vertex, or Surgitek Classic Double-Pigtail stent.
  • The Ureteric Stent Symptom Questionnaire (USSQ) was administered on days 1, 3, and 5, and the patients maintained a narcotic diary. The data were analyzed using ANOVA and nonparametric methods.


  • A total of 44 patients (73%) completed all USSQ questionnaires.
  • Urinary symptom scores were significantly lower for the Inlay stent on day 3 than for the Vertex (P = 0.01), Contour (P = 0.05), Endo-Sof (P = 0.03), and Classic (P = 0.02) stents. No significant differences were noted in pain and general symptom scores or narcotic use.


  • The Bard Inlay stent is associated with less-severe urinary symptoms than other ureteral stents.
  • The USSQ is a sensitive tool to measure differences between stents.

The complete USSQ form is available at BUI and endourology.

Source University of Minnesota

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