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

Ureteric Stent

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 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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New trials

Concluded trials

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	InLay Optima	FDA 510(k)	Dec 2004	Silicone	Double pigtail with monofilament suture loop	365
2	Boston Scientific	Polaris Loop	FDA 510(k)	Mar 2003	Dual Durometer Percuflex with HydroPlus Coating	Bladder loop design	365
3	Cook Medical	Resonance	FDA 510(k)	May 2007	Metal	Temporary stenting	365
4	Fossa Medical	Stone Sweeper	FDA 510(k)	Aug 2002	Polyurethane	Spiral radially expanding stent	13
			CE Mark	Sep 2005
5	Pnn Medical A/S	Memokath 051	CE Mark	1995	Nickel-titanium shape memory alloy	Double fluted ended spiral stent	240

Timeline Visualization

Ureteral Stent Timeline

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

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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

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"

Regulatory data

The time taken for C.R. Bard to get their stent approved ranged from 21 days to 9 months

Clinical trials

There are no trials currently conducted by C.R.Bard. The other trials are related to comparison of various ureteral stent of different companies in terms of patient comfort and materials used in the stent. The result of trials is that there is not much difference in all the ureteral stent of different companies in terms of patient comfort and materials used in the stent

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

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

Total Sales in 2010 - 4.04 Billion USD

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

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

This is only a sample report with brief analysis
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