Ureteral Stent

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.

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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.

Methodology

Kidney Stones Market

There are four main types of treatments available for curing kidney stones based on type of Kidney Stone, listed as follows

Sr. No.	Treatment	Indications	Requirement of Ureteral Stent	% of cases in general
1	Lithotripsy	Radiolucent calculi, Renal stones <2 cm, Ureteral stones <1 cm	No	49.07%*
2	Ureteroscopy	Ureteral stones	Yes	15.48%*
3	Ureterorenoscopy	Renal stones <2 cm	Yes	0.47%*
4	Percutaneous nephrolithotomy	Renal stones >2 cm, Proximal ureteral stones >1 cm	No	34.98%*

*Dolcera Estimate 2011

As seen in table ureteral stent is required for Ureteroscopy and Ureterorenoscopy which together constitute for around 16% of Kidney stone cases.

Total Number of Kidney Stone Cases in US in 2006: 166,000

Approximate Stents required in 2006 = 166,000*0.16=26560

Kidney Transplant Market

Every kidney transplant operation required ureteral stent to be placed in Patient’s body for few days till newly placed kidney adapts to Patients’ body

Total No. of Kidney Transplants done in United States in 2007 are approx. 17,513

Total Market for Ureteral Stents in 2007 is 17,513

Year	No. of Kidney Transplants
2007	17,513
2006	18,056
2005	17,443
2000	14,611
1995	12,160
1990	10,029
1985	7,504
1980	3,785

Urinary Incontinence Market

Inpatient hospital stays:The estimated number of hospital admissions among adults ages 18 or older with urinary incontinence listed as a diagnosis:
(2000): 47,802 hospital stays (1,332 men; 46,470 women)

Prevalence of Urinary Incontinece in US (Women)
Age (in years)	Population with Urinary Incontinence (in %)
30-39	28
40-49	41
50-59	48
60-69	51
70-79	55
≥ 80	54

Estimated cases for ureteral stents in US, 2010
Age groups	A) Female population (Million)	B) Prevalence rate in female (%)	C=A*B Affected population (Million)	D) Catherization rate (%)	E=C*D Stent market based on catherization
30-39	20.10	28	5.62	0.043	2420.42
40-49	21.99	41	9.01	0.123	11092.83
50-59	21.50	48	10.32	0.124	12800.37
60-69	15.32	51	7.81	0.160	12503.68
70-79	9.16	55	5.04	0.172	8674.44
≥ 80	7.15	54	3.86	0.044	1699.48
Total	95.25		41.69

• Catherization rate depicts the actual number of people going in for ureteral stents.

• Prevalence rate in US women is growing at a CAGR of 1.26%

Assuming that each admission in hospital required one ureteral stent, market from Urinary Incontinence is around 47,802 stents per year

Total Market for Ureteral Stent Following table displays approximate stent market per year

Category	No. of Stents Required
Stent Market for Kidney Stones	26560
Stent Market for Kidney Transplant	17513
Stent Market for Urinary Incontinence	47802
Total	91875

• Ureteral stent market is growing at a CAGR of 1.58%

Ureteral stent market forecast in US (women)

Detailed_calculation_workbook

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Patents

Patent Search Strategy

Dolcera Patent Analysis

S.No.	Patent/Publication No.	Publication Date (mm/dd/yyyy)	Assignee/Applicant	Title	Dolcera Analysis
					Problem	Solution
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

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.

Adverse Events

S.No.	Brand Name	Adverse Event	Date FDA Received
1	Cook Urologicals Cook Urological Stent	Stent broke into pieces while removing it from the patients body.	12/14/2005
2	Boston Scoientific Boston Scientific Ureteral stent System	Fractured stent seen under Fluroscopy	10/17/2007
3	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
4	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
5	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.

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

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)

• Click here to download the excel file.
• Mapped Patent vs Not Mapped Patents

C R Bard

Boston Scientific

Insights

Boston Scientific

Products

• They have 8 ureteral stents in their portfolio
• They are currently into 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)
• 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

• The clinical trials of new medical devices of Class II and Class III can be conducted only after clinical trial approval by the relevant authority in accordance with the rules of the drug regulatory authority under State Council. Currently 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).

• 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

• The mapped patents gives an insight in to patents which were successfully commercialized
• The unmapped patents gives us a vision of the company's future vision in terms of product development strategy.It may also signify those patents which failed to reach towards succesful launch of products.
• The unmapped patents are analysed based on the following parameters

1.Coating on stents: Boston scientific have 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 have patents on various structure 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 have 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
• There are no clinical trials going on for research on new stent
• 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 licesed 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 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

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

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

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.

Results

• 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.

Conclusion

• 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

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

• References

1- http://en.wikipedia.org/wiki/Demographics_of_the_United_States

2- http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink

3- http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf

4- http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html

Trends in stent R&D

• Given that the first bare metal stent entered the market in 1994, the technology is far from mature.

• Whilst drug eluting stents will be improved through the use of what are described as more ‘cell friendly’ (i.e. more hydrophobic) coatings and adapted (by using CFD in stent design) to varying wall sheer conditions, the industry is already well down the road of developing bioresorbable coatings and even bioresorbable stents.

• Such systems are already on limited trial in Europe with FDA trials aimed at 2012 and approval by 2015.

• There are still other areas under study including thinner struts which are important in terms of giving improved stent flexibility, a reduced cross-sectional profile within the vessel and potentially reduced restenosis (due to reduced vascular trauma).

• Silicon carbides, carbon coatings, titanium nitride/oxide and sputtered indium oxide have all been trialled as routes to reducing the incidence of restenosis and/or thrombosis.

• Click here for recent news and developments in Boston Scientific and Cook INC

Source Ceram-newsrelease

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Patent Categorization: Interactive mind map linked to Dolcera Dashboard

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Product-Patent-Clinical Trials 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

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