== '''This is a landscape report on the Ureteral Stent: Concept ==An antimicrobial ureteral stentmarket, which inhibits encrustation including key company profiles, products, patents and bacterial colonization while maintaining patient comfortrelevant clinical trials.'''
*'''''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.
== 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'''[[more on background. 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 inconjunction 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. ]]'''
The advent of ESWL and the more recent barrage of endourological techniques have increased the indications for ureteral stents (Candela and Bellman 1997). Indications for use include:* Treatment of ureteral or kidney stones* Ureteral trauma or stricture* Genitourinary reconstructive surgery* Hydronephrosis during pregnancy* Obstruction due to malignancy* Retroperitoneal fibrosis=Market Overview=
The need Market for ureteral stents range from a few days to several monthsstent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. For patients with serious urological problems, ureteral stent maintenance may become a lifeOther uses of Ureteral Stent include Post-long necessity. Unfortunatelysurgical swelling/infection of uterus, there are many problems associated with using ureteral stentsActive kidney infection etc.
=== Ureteric stenting difficulties ==='''[[Image:Ureteral stentmore on market overview...jpg|thumb|right|350px|Double-J and Pigtail ureteral stents]]{|border="2" cellspacing="2" cellpadding="4" width="50%"|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Common'''</font>|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Rare'''</font>
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* Trigonal irritation
* Haematuria
* Fever
* Infection
* Tissue inflammation
* Encrustation
* Biofilm formation
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* Obstruction
* Kinking
* Ureteric rupture
* Ureteric perforation
* Stent misplacement
* Stent migration
* Stent misfit
* Stent forgotten
* Tissue hyperplasia
|}
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Today, elastomeric materials, such as silicones, polyurethanes and hydrogel-coated polyolefins are used, with no clear winner, which can withstand the urinary environment. * Although silicone has better long-term stability than other stent materials, its extreme flexibility makes it difficult to pass over guidewires and through narrow or tortuous ureters. * Polyethylene is stiffer and easier to use for patients with strictures; however, it has been known to become brittle with time leading to breakage and is no longer commercially available. * Polyurethane has properties that fall in between polyethylene and silicone; however, stent fracture also has been an issue with polyurethanes.= Clinical Trials =
Attempts have been made to develop polymers with a combination of the best of all properties. The key players are C-Flex (Concept Polymer Technologies), Silitek and Percuflex (Boston Scientific).* C-Flex is proprietary silicone oil and mineral oil interpenetrated into a styrenelolefin block copolymer with the hope of reduced encrustation.* Silitek (Medical Engineering Corporation) is another silicone-based copolymer. * Percuflex is a proprietary olefinic block copolymer. ==New trials ==
Metallic stents have been used recently to treat extrinsic ureteric obstructions{|border "1" style="border-spacing:0;"| 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">'''Title '''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center>|-| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center>| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials. The effect gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of synthetic polymers Drug-Eluting Ureteral Stent on the urothelium Bacterial Adherence and Biofilm Formation]| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation |-| style="padding:0.079cm;"| <center>2</center>| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of the urinary tract seems Urethral Stricture]| style="padding:0.079cm;"| Urethral Stricture| style="padding:0.079cm;"| Memokath stenting| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group |-| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center>| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to be dependent on the bulk chemical composition Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones| style="background-color:#dce6f1;padding:0.079cm;"| N\A| style="background-color:#dce6f1;padding:0.079cm;"| University of the polymerCalifornia, the chemical composition of its surface, coatings on the deviceIrvine surface, smoothness |-| style="padding:0.079cm;"| <center>4</center>| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]| style="padding:0.079cm;"| Kidney Stones| style="padding:0.079cm;"| Ureteral Stent| style="padding:0.079cm;"| Emory University |-| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center>| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the surface Memokath Ureteral Stent]| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group |-| style="padding:0.079cm;"| <center>6</center>| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and coefficient Nephrostomy Tube for an Urgent Drainage of frictionObstructed Kidney (JJVsPCN08)]| style="padding:0.079cm;"| Kidney Disease| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent| style="padding:0.079cm;"| Rabin Medical Center |}
Typically, most ureteral stents are made of relatively smooth catheters== Concluded trials =={| {{table}}| style="background-color:#4f81bd;padding:0. [http079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></wwwcenter>| style="background-color:#4f81bd;padding:0.ncbi079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center>| style="background-color:#4f81bd;padding:0.nlm079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center>| style="background-color:#4f81bd;padding:0.nih079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center>| style="background-color:#4f81bd;padding:0.gov079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</pubmedfont></10772512 Koleski et alcenter>|-| style="background-color:#dce6f1;padding:0., (2000)] tested a longitudinally grooved ureteral stent made by Circon 079cm;"|<center>1</center>| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the pig uretertreatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0. The results indicated that 079cm;"|To evaluate the grooved stent led to better drainage than long-term efficacy of a conventional permanently implanted urethral stentin the treatment of spinally injured patients with detrusor-sphincter dyssynergia. Their opinion || style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is that an effective alternative to sphincterotomy in the ureter wall has long-term, although secondary bladder neck obstruction is a better chance frequent problem.|-| style="padding:0.079cm;"| <center>2</center>| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of collapsing over Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either asmooth surface than percutaneous nephrostomy tube (PCN) or a grooved surface, especially when debris is presentureteric stent. Stoller Both can cause considerable morbidity and reduce patient's health-related quality of life (2000QoL) had . We have compared the same experience QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with the SpiraStent'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (Urosurge Corp.PCN). This helical 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.|-| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center>| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|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.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent was superior at passing stones than renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a conventional smooth stentsignificant increase in urinary tract infections, primarily beyond 30 days after transplantation.Stent removal within 4 weeks of insertion appears advisable.|}
There are a variety of ureteral stent configurations with different anchoring systems. Most stents today have a double [http://linkinghub.elsevier.com/retrieve/pii/S014067360002674X pigtail anchoring system]. (Tolley, 2000), Dunn et al, (2000) conducted a randomized, single-blind study comparing a Tail stent (proximal pigtail with a shaft which tapers to a lumenless straight tail) to a double pigtail stent. The Tail stent was found to be better tolerated than the double-pigtail concerning
lower urinary tract irritative symptoms. A double-J ureteral stent and a flexible ureteropyeloscope are shown in the first diagram. The other two diagrams show a pigtail ureteral stent in place; the end of the pigtail is facing away fiom the ureteral opening in the second of these two diagrams.
Early adverse effects of ureteral stenting include lower abdominal pain, dysuria, fever, urinary frequency, nocturia and hematuria. Patient discomfort and microscopic hematuria happen often. Major late complications include stent migration, stent fragmentation or more serious hydronephrosis with flank pain and infections.
Late complications occurred in one third of the patients in a prospective study using both silicone and polyurethane double pigtail stents (110 stents) in 90 patients. Stent removal was necessary in these patients. Others also have found this percentage of late complications. Device==Pre-related urinary tract infection and encrustation can lead to significant morbidity and even death and are the primary factors limiting long-term use of indwelling devices in the urinary tract. Microbial biofilm and encrustation may lead to stone formation. This is typically not a problem when stents are usedfor short-term indications. Problems of biofilm formation, encrustation and stent fracture occur in patients with long-term indwelling stents.Market Notification==
Typically, manufacturers advise periodic stent evaluation. Cook polyurethane stent removal is recommend at 6 months and 12 months for silicone (Cook product literature). However, Some of the companies active in the field of ureteral stents that are intended for long-term use are usually changed at regular intervals, as frequently as every 3 monthshave been represented in the table below.
Forgotten stents are a problem{| border="2" cellspacing="0" cellpadding="4" width="100%"| style="background-color:#4f81bd;padding:0. Monga et al079cm;"|<center><font color="#FFFFFF">'''S., 1995 found that 68% of stents forgotten more than 6 months were calcified and 10% were fragmentedNo. Multiple urologic procedures were necessary to remove the stones'''</font></center>| style="background-color:#4f81bd;padding:0. Long079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center>| style="background-term effects 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 these forgotten stents may lead to voiding dysfunction and renal insufficiencyApproval '''</font></center>| style="background-color:#4f81bd;padding:0. Schlick, et al079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"| <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:0.079cm;"| <center>'''1'''</center>| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center>| style="background-color:#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-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center>| 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 monofilament suture loop| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center>|-| style="padding:0.079cm;"| <center>'''2'''</center>| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/, 1998 are developing a biodegradable ,/method/DevHome/navRelId/1000.1003/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() <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 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'''</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>| style="padding:0.079cm;" 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 FDA 510(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 that will preclude the need for stent removal| 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="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa= Encrustation 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>]]]The urinary system presents a challenge because of its chemically unstable environment| style="background-color:#dce6f1;padding:0. Long079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-term biocompatibility and biodurability of devices have been problems due to the supersaturation of uromucoids and crystalloids at the interface between urine and the devicehistory. Encrustation of ureteral stents is a wellaspx CE Mark]</center>| style="background-known problem, which can be treated easily if recognized earlycolor:#dce6f1;padding:0. However, severe encrustation leads to renal failure and is difficult to manage (Mohan079cm;"| <center>1995</center>| style="background-Pillai et alcolor:#dce6f1;padding:0., 1999)079cm;"| Nickel-titanium shape memory alloy| style="background-color:#dce6f1;padding:0. All biomaterials currently used become encrusted to some extent when exposed to urine079cm;"| Double fluted ended spiral stent| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center>|}
The encrusted deposits can harbor bacterial biofilms. In addition, they can render the biomaterial brittle which causes fracture in-situ, a serious problem especially associated with the use of polyethylene and polyurethane ureteral stents (although silicone stents have also beenreported to fracture). Stent fragments can migrate to the bladder or renal pelvis with serious repercussions.=Products=
Surface science techniques were used to study three The FDA classifies a ureteric stent types after use in patientsas 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. The 876.4620 - Ureteral stent type, duration of insertion and age or sex of the patient did not correlate significantly with the amount of encrustation (Wollin et al., 1998)* Classification - class II device [http://www. However, it has been suggested that factors which affect the amount of encrustation include the composition or the urine, the type of invading and colonizing bacteria and the structure and surface properties of the biomaterial used (Gorman 1995)accessdata. A low surface energy surface seems to resist encrustation compared with a high surface energy surface (Denstedt et alfda., 1998)gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]
Many different types of stone can form in the urinary tract. Calcium oxalate, calcium phosphate, uric acid and cystine stones are metabolic stones because they form as a result of metabolic dysfunction. They usually are excreted from the urinary tract. Struvite (magnesium ammonium phosphate) and hydroxyapatite (calcium phosphate) are associated with infection (infection stones). These account for 1520{|border="2" cellspacing="0" cellpadding="4" width="100% of urinary calculi. ESWL is used to break up the larger infection stones because they don"|align = "center" bgcolor = "#4f81bd"|'t pass; recurrence of the problem occurs with incomplete removal''Sr. Infection stones can manifest as poorly mineralized matrix stones, highly mineralized staghorn calculi or as bladder stones which often form in the presence of ureteral stentsNo. Urea-splitting bacteria colonize the surface and cause alkalinization of the urine, which lowers'''the solubility of struvite and hydroxyapatite, and they deposit on the|align = "center" bgcolor = "#4f81bd"|'''Company'''surface. Bacterial biofilm associated with encrustation is a commonclinical occurrence. |align = "center" bgcolor = "#4f81bd"|'''Device(Gorman and Tunney, 1997s). It has been suggested'''that prevention of bacterial colonization would prevent encrustation|align = "center" bgcolor = "#4f81bd"|'''Approval'''because of their ultimate responsibility for its formation (Bibby et al.,|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''1995).|align = "center" bgcolor = "#4f81bd"|'''Material'''An in vitro model was developed that produces encrustation|bgcolor = "#4f81bd"|'''Technology'''similar to those seen in vivo |align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (Tunney et al., 1996adays). An experiment was'''conducted to compare the encrustation potential of various ureteral stent|align = "center" bgcolor = "#4f81bd"|'''Image'''materials. The long|-term struvite and hydroxyapatite encrustation ofsilicone, polyurethane, hydrogel-coated polyurethane, Silitek and|align = "center" bgcolor = "#dce6f1"|'''1'''Percuflex were compared|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www. All of the materials developed encrustationallium-medical.com/?categoryId=64772 Allium,Israel]</u></font>however, it was found by image analysis that the rates of encrustationvaried on the different materials|align = "center" bgcolor = "#dce6f1"|[http://www. Silicone had less encrustation (69% at10 weeks) compared to the other materials (1 00%) at the same time pointallium-medical.com/?categoryId=64772 URS](Tunney et al|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www., 1996b)highbeam. Continuous flow models have also been developedwhich are more representative of conditions in the upper urinary tractcom/doc/1G1-165990208.html CE Mark]</font>They are discussed by Gorman and Tunney|align = "center" bgcolor = "#dce6f1"|Jul, (1 997).2007Efforts to reduce encrustation using new materials, smoothersurfaces and hydrogel coatings have been attempted. A hydrogel|bgcolor = "#dce6f1"|Nickel-coatedtitanium shape memory alloy covered by polymerC|bgcolor = "#dce6f1"|Self-flex expanding stent (Hydroplus, Boston Scientific) was shown to have lessepithelial cell damage and encrustation than other biomaterials and was|align = "center" bgcolor = "#dce6f1"| recommended by the investigators for long|bgcolor = "#dce6f1"|[[Image:656px-term use (Cormio, 1995)Allium. Inaddition, a poly(ethy1ene oxide)jpg|thumb|center|100px|<center>Allium</polyurethane composite hydrogel(Aquavenem, J & J) resisted intraluminal blockage in a urine flow modelcenter>]]
compared with silicone and polyurethane (Gorman et al., 1997a). Another|-advantage with Aquavene is that it is rigid in the dry state, which|align = "center" rowspan = "2"|'''2'''facilitates insertion past obstructions in the ureter and becomes soft onhydration providing comfort (Gorman and Tunney, 1997)|align = "center" rowspan = "2"|<font color="#0000FF">[http://www. Gorman et alpnnmedical.(1 997b) concluded that the chance of stent fracture would be reduced ifthe ureteral stent side holes were eliminatedcom/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font>Urinary tract infection is another common major problem with theusage of ureteral stents|align = "center" rowspan = "2"|[http://www. Initially, a conditioning film is deposited on theureteral stent surfacegoogle. The film is made up of proteins, electrolytematerials and other unidentified materials that obscure the surfaceproperties of the stent materialcom/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www. Electrostatic interactions, the ionicstrength and pH of the urine and differences in fluid surface tensions affectbacterial adhesion to the conditioning filmhammer. Subsequently, a microbialbiofilm forms over timepl/pliki/147_2. The biofilm is composed of bacterial cellsembedded in a hydrated, predominantly anionic mixture of bacterialexopolysaccharides and trapped host extracellular macromolecules.Obstruction of urine flow and urinary tract sepsis can result in continuedgrowth of the biofilm. Colonization of devices implanted in the urinarytract can lead to dysfunction, tissue intolerance, pain, subclinical or overtinfection and even urosepsis. Device related infections are difficult totreat and device removal is usually necessary. The biofilm has been foundto impede the diffusion of antibiotics; in addition, the bacteria in thebiofilm have a decreased metabolic rate , which also protects them againstthe effects of antibiotics (Wollin et al., 1998).Riedl, et al. (1 999) found 100pdf&rct=j&q=memokath% ureteral stent colonization rates in20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]permanent and 69.3% in temporary stents. Antibiotic prophylaxis did notprevent bacterial colonization and it was recommended that it not be used.On the other hand, Tieszer, et al. (1 998) believe that fluoroquinolones canprevent infection. They also have found that some stents have denserencrustation than others, however, the stent material did not change theelements of the |align = "conditioning filmcenter" adsorbed or alter its receptivity tobacterial biofilms|<font color="#0000FF">[http://www.The predictive value of urine cultures in the assessment of stentcolonization was examined in 65 patients with indwelling ureteral stentspnnmedical.It was found that a sterile urine culture did not rule out the stent itselfbeing colonized (Lifshitz, et al., 1999). Patients with sterile urine culturemay benefit from prophylactic antibiotics; however, the authors contendedthat the antibiotics must work against gramcom/about-negative uropathogens andgrampnn-positive bacteria including enterococcimedical/company-history.aspx CE Mark]</font>It is obvious that there is controversy in the literature whether|align = "center"|1995prophylactic systemic antibiotics are useful with ureteral stent implant.|rowspan = "2"|Nickel-titanium shape memory alloyHowever, antibiotics do not seem to prevent |rowspan = "2"|Double fluted ended spiral stent colonization. Denstedtet al. (1998) have found that ciprofloxacin, with a 3 day burst every |align = "center" rowspan = "2"|240weeks, actually is adsorbed onto the stent which makes longer termtreatment possible with reduced risk of bacterial resistance|rowspan = "2"|[[Image:Memokath_051. There hasbeen research targeted at coating or impregnating urinary catheters withpng|thumb|center|100px|<center>Memokath 051</center>]]
antimicrobials and products are on the market, however, there are no|-antimicrobial ureteral stents approved by the FDA|align = "center"|<font color="#0000FF"><u>[http://www.It is clear that there is a need for a new material that will be able toresist encrustation and infection in the urinary tractzapconnect.According to Merrill Lynch, ureteral stents represent an $80 MMUS marketcom/products/index. Boston Scientific is in the lead with -50% of the marketfollowed by Maxxim (Circon), Cook and Bard is a smaller playercfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561. Therehtml FDA Listing]</u></font>are a number of other small contenders.The use of ureteral stents is increasing; the indications for ureteralstenting have broadened from temporary or permanent relief or uretericobstruction to include temporary urinary diversion following surgicalprocedures such as endopyelotomy and ureteroscopy and facilitation ofstone clearance after ESWL (Tolley|align = "center"|Mar, 2000). The use of ureteral stents for2004patients having ESWL for renal calculi is however controversial and|-seems to be related to the size of the stones and invasiveness of the|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''procedure|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www. According to survey results reported by Hollowell, et alfossamedical.(2000), there is a significant difference in opinion concerning the use ofstents with ESWLcom/news. The number of ureteral stents used in patients withhtm Fossa Medical]</u></font>stones |align = "center" bgcolor = "#dce6f1" rowspan = "2 cm or less treated with ESWL is significant in spite of the lackscientific evidence in support of this practice"|[http://dolcera. Of 1,029 urologistsreturning surveys, for patients with renal pelvic stones 10, 15 or 20 rnmtreated with ESWL, routine stent placement was preferred by 25com/upload/files/stonesweeper_fossa_trial.3%,pdf Stone Sweeper]57|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.1 % and 87fossamedical.1 %, respectivelycom/news. Urologists recommend usinghtm CE Mark]</u></font>ureteroscopy rather than ESWL for distal ureteral calculi 5-1 0 mm.|align = "center" bgcolor = "#dce6f1"|Sep, 20051.|bgcolor = "#dce6f1" rowspan = "2 Fit with Gore Corporate Strategy"|Polyurethane+ This product fits into Gore's DSP market segment+ A family of products is needed to market through a distributor+ A possible family of products includes ureteral stents, urethralslings, urologic suture, urethral stents and urethral catheters(Foley), renal artery |bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent?+ It is preferable that a stand alone product be of high value|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13+ Gore is interested in exploiting PATT technology in products wheresilicone and polyurethanes have not met expectations and where PATThas potential product performance benefit1.3 PrototypesThe amount of encrustation on PATT tubes (measured by weightgain) was compared with that on silicone (Bard) and Percuflex (BostonScientific) catheters after being subjected to in vitro static and dynamicflowsynthetic urine models.Static ModelDried tube pieces were suspended in stirring synthetic urine for upto 3 months. Samples were taken at 1,|rowspan = "2 and 3 months at which time theywere dried and weighed. The results of this experiment can be found in agraph of Absolute Weight Change vs Time in the Appendix" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper. There are nopng|thumb|center|100px|<center>Stone Sweeper</center>]]
error bars because this was a destructive test and there was only one|-sample in each group|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www. The PATT catheter was found to encrust to a lesserfossamedical.com/news.htm FDA 510(k)]</u></font>extent than the other catheters|align = "center" bgcolor = "#dce6f1"|Aug, 2002 |-|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http: 6 times less than the //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="#0000FF"><u>[http://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=PMN&ID=K021140 Expanding Ureteral Stent]|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</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 |-|align = "center" rowspan = "7"|'''4'''|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific stent]</u></font>|align = "center"|<font color="#0000FF"><u>Contour</u></font>|align = "center"| |align = "center"| |Percuflex - proprietary polyolefin copolymer; Hydroplus coating|Fixed and almost half as much as the Bard stent at two monthsvariable length; Tapered tip|align = "center"|365|align = "center" |[[Image:Contour. Note that the 1 png|thumb|center|100px|<center>Contour</center>]] |-|align = "center"|<font color="#0000FF"><u>Percuflex</u></font>|align = "center"| |align = "center"||align = "center"| Percuflex|Pigtail|align = "center"|365|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]] |-|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font>|align = "center"|Jan, 2001|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.|Double pigtail|align = "center"|365|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]] |-|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(k)]</u></font>|align = "center"|Mar, 2003|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>]] |-|align = "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"| |align = "center"| |Percuflex material and Hydroplus coating|Endopyelotomy stent|align = "center"|Post-procedure healing|align = "center" |[[Image:Retromax_plus.L month Bard data is in error because the sample broke during preparationpng|thumb|center|100px|<center>Retromax Plus</center>]] |-|align = "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 Stretch VL Flexima]</u></font>|align = "center"| |align = "center"| |Hydroplus Coating|Variable length coil on distal and the lost segment was not recoveredproximal ends|align = "center"|90|align = "center" |[[Image:Stretch_VL_Flexima. The 3png|thumb|center|100px|<center>Stretch VL Flexima</center>]] |-month data is pending|align = "center"|[http://dolcera. Incom/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]dA|align = "center"| |align = "center"| |Percuflex - proprietary polyolefin copolymer|Ketorolac trimethamine loaded stent|align = "center"||align = "center"| N/A|-|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'eadndcrituiostna''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 = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font>|align = "center" bgcolor = "#dce6f1"|<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,t iSoEnM ons tahree cinacthluedteerd l uinm tihnea lA apnpde anbdliuxm2007|bgcolor = "#dce6f1"|Metal|bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|365|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]] |-|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></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>]] |-|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font>|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|AQ® Hydrophilic Coating|bgcolor = "#dce6f1"|Double pigtail|align = "center" bgcolor = "#dce6f1"|365|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]] |-|align = "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 = "#dce6f1"| |bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|Double Pigtail|align = "center" bgcolor = "#dce6f1"|180|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]] |-|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font>|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent|align = "center" bgcolor = "#dce6f1"|60|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]] |-|align = "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, winhailc shu vrfisaucaelsi2007|bgcolor = "#dce6f1"|Heparin-bonded stent|bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"||-|align = "center"|'''6'''|align = "center"|<font color="#0000FF">[http://qurological.z eT thhee SEMscom/product/ Q Urological]</font>suggest that PATT has a clean surface relative to the other two materials|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font>Dynamic Model|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font>Straight pieces cut from the stents |align = "center"|Jan, 2010|Hydrogel|Differentially larger end (approximately no pigtail)|align = "center"|30|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] |-|align = "center" bgcolor = "#dce6f1"|'''7'''|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4Bioteque Corp.5 cm) were]</font>attached to nozzles through which artificial urine passed from a reservoir|align = "center" bgcolor = "#dce6f1"|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 = " @ The artificial urine was recirculated from the collecting tank to the P #dce6f1" | |bgcolor = " #dce6f1"| |align = "center" bgcolor = "#dce6f1"|30|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] $|-|align = "center" rowspan = "4"|'''8'''reservoir|align = "center" rowspan = "4"|<font color="#0000FF">[http://www. The experiment was run for two monthsappliedmed. Unfortunatelycom/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, theCA, 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 ]</J' data from this experiment proved inconclusiveu></font>|align = "center"| |align = "center"| |Coil-reinforced; SL-6® hydrophilic coating|Patency Device|align = "center"| |align = "center" |[[Image:silhouette. It appears that the nozzles were the weak link in this experiment as they were found to encrust whichpng|thumb|center|100px|<center>Silhouette</center>]] |-|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.rpcom/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font>|align = "e 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;pSL-6® hydrophilic coating|Unique wall construction and enlarged 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; SL-6® hydrophilic coating|Dual Diameter stent|align = "center"| |align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</center>]] |-|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''led to the decreased flow rates through the test articles downstream|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www. Inbardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font>addition|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, the test articles were found to weigh less after the experiment2004than they did before|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, an artifact that is probably a result 2003|bgcolor = "#dce6f1"|Silicone|bgcolor = "#dce6f1"|Attached with suture for ease of the scale beingremovalmoved and recalibrated while the experiment was ongoing|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]\L |-Ndm 2|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.0 Intellectual Property Assessmentbardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font>Z3|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.Lpng|thumb|center|100px|<center>Fluoro 4</center>]]+ Will be verbally communicated at the meeting|-|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_4.0 Sales 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 Marketing Assessmentlubricious 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.1 Market Opportunities 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- + Urological surgeons are the potential customers 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 the Gore ureteraleasy maneuverability as well as flexibilitystent|align = "center"| |align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]+ Merrill Lynch estimates the US market |-|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 ureteral stents is $80 MMshort-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 that Boston Scientific has detachable|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]|-50|align = "center" rowspan = "9"|'''12'''|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone% of the market20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font>|align = "center"|<font color="#0000FF"><u>[http://www. Steve Nordstromgyrusacmi.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(worked at Boston Scientific for k)]</u></font>|align = "center"|Dec, 1986| |Classic Closed Tip|align = "center"| |align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]|-10 years|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k) believes that the Boston]</u></font>Scientific US revenues are $38 MM with 70|align = "center"|Mar, 1996|Tecoflex® construction|Balanced-curled double pigtail design|align = "center"| |align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]|-|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 $50 MM marketchemically bonded wettable solution |align = "center"| |align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]+ It is very difficult to obtain an accurate estimate of the number of|-procedures using a |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 stentlengths from 22cm to 28cm|align = "center"| |align = "center"|[[Image:Quadra_Coil. This is because temporary stents arepng|thumb|center|100px|<center>Quadra-Coil</center>]]not coded |-|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 therefore their use in a given procedure is not recordedexclusive soft bladder helix |align = "center"| |align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]In 1998, MDI estimated that there were 212,000 procedures in the U|-|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>S|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 (corresponding revenue $26C.5 MMR. Bard subsidiary)]|align = "center"|[http://www. MDI would have had 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| |align = "center"|N/A|-|} = Product to Clinical Trial Mapping= ==Clinical Timeline Visualization ==[[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 sameproduct to patent mapping(Bard and Boston)''']]problem we encounter* Click [[Media:Product_Patent_Mapping_Bard_Boston. The only hard data that Helene Johns is able xls|'''Products from Boston Scientific and C R Bard ''']]todownload the excel file.obtain in which a stent definitely was used == Mapped Patent vs Not Mapped Patents =={|border="0" cellspacing="0" cellpadding="4" width="100%"|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]|-|} =Patent-Product-Clinical Trial Mapping= * To access the Dashboard you have to signup. You can do so by clicking [https://www.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 procedure is 147,000detailed taxonomy''inpatient ureteral catheterization procedures *''Click on the red arrow adjacent to the node name to view the content for that particular node in 1999 from NIPS data.the dashboard'' In *''Click on the 1998 Outpatient Handbook, there were 7,003 cystoscopies "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''{|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 = "#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 withTriclosan <br>Currently in Phase II (Canada)stone removal |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 prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in which 30color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs|Expandable stents for reducing discomfort|-|'''Material'''|Elastically deformable stents<br>Biodegradable polymer based 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 = "#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 <br>and structure|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, Abbott, Medtronic and Cook Inc. are the time a major players in ureteral stent placementresearch field. occurred; there were 30[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]] ==IP Activity==*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005,5 19 cystoscopies followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral catheterizationsstent research area.[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]] ==Sales == Total Sales in which there were ureteral stents placed 62010 - 4.304 Billion USD {|border="2" cellspacing="0" cellpadding="4" width="100% of the time"|bgcolor = "#4f81bd"|'''Company'''|bgcolor = "#4f81bd"|'''Total Sales in 2010'''|bgcolor = "#4f81bd"|'''Urological sales'''|bgcolor = "#4f81bd"|'''Percentage share'''|bgcolor = "#4f81bd"|'''Product portfolio'''|-|bgcolor = "#4f81bd"|'''Boston Scientific'''|7800|661|8. 48|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font>|-|bgcolor = "#4f81bd"|'''CR BARD'''|2700|702|26.00|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font>|-|bgcolor = "#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 givesis only a sample report with brief analysis''' <br>'''Dolcera can provide a total of 15 1,033 procedurescomprehensive report customized to your needs'''</p>{|border="2" cellspacing="0" cellpadding="4" align="center" "|style="background:lightgrey" align = "center" colspan = "3"|'''[mailto:info@dolcera. Based on information obtained com <span style="color:#0047AB">Buy the customized report fromDolcera</span>]''' |-| align = "center"| [http://www.dolcera.com/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-and-updates Patent Alerting Services]|align = "center"| [http://www.dolcera.com/website_prod/tools Dolcera Tools]|-|}<br>
Merrill Lynch and Steve Nordstrom, this number must be substantially
higher.
+ Ureteral stents are the standard of care even though the available stents
have issues of encrustation, fracturing and infection and need to be
replaced frequently.
3.2 Competitive Assessment
+ There are different types of ureteral stents on the market. Merrill
Lynch (May 2000) estimates that Boston Scientific is the leader with
-50% of the market followed by Maxxim (Circon), Cook and Bard
with the smallest share. There are other smaller players. Steve
Nordstrom estimates that Boston Scientific has 70% of the market.
+ There are various ureteral stent designs: Double J, Double Pig Tail,
Multi Coil, etc., some with hydrophilic coatings. Ureteral stents are
typically silicone, polyolefin or polyurethane. There are no FDA
approved antimicrobial ureteral stents. Europe?
+ We do not foresee alternative technologies that will replace the need
for ureteral stenting because it has various intraoperative and
postoperative indications. It was predicted that the number of stenting
procedures would decrease with ESWL, however, this does not seem
to be the case. The indications have actually broadened.
+ In general, encrustation and infection are the main problems
associated with all available ureteral stents.
+ See Appendix for a comparison of existing products (living document)
3.3 Value Price
+ In 1998, MDI estimated the current average selling price of ureteral
stents to be a p p r o x i m a t e l m Gore purchased stents from various
3 5 u ' t *r companies through the Science Center for approximately $1 50 each.
+.p QOaJ '. 4- Steve Nordstrom stated that the average sellin rices for the Boston
Scientific, Bard and Cook ureteral stents ar& $90 and $70,
3 1 6 respectively, with discounts.
7 ? - + + Bard increased the price of their Foley Catheters from- to ,with a
silver coating. We estimate that if the Gore ureteral stent were to add
value by improved encrustation and biofilm resistance, a- small increase could be commanded. s di A .-.L ? e-k LA&v 3+ &
+ According to estimates by Steve Nordstrom and John Brinkman, a ~ ;;+ s
corporate partner such as Boston Scientific, who makes ureteral stents
at approximatel&- would only pay more if our stent were
clearly superior to theirs.
+ At this time, it is premature to estimate the cost of a GORE stent due
to potential changes in process equipment and raw material cost.
4.0 Regulatory and Clinical Assessment
+ A new ureteral stent requires a 5 1 OK
+ We will propose a 5 1 OK with no clinical trial to FDA based on:
+ Safety and efficacy data in a pig model with histology of the
urothelium
+ Extensive PATT biocompatibility in PATT Master File
+ Antimicrobial performance to claim inhibition of bacterial
colonization of the devices for up to 2 weeks after implantation.
Sequential zone-of-inhibition assays will be conducted to show
substantial preservative activity against the following clinical isolates
of gram-positive and grarn-negative organisms: Candida sp.,
rb Citrobacter diversus, Enterobacter cloacae, Enterococcus, Escherichia
coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas
aeruginosa, Staphylococcus saprophyticus and Streptococcus fecalis.
+ It is possible FDA will require a clinical trial because of the antimicrobial
substances andlor because PATT is a new material for a ureteral stent
application.
+ If FDA requires a clinical trial, we believe it will be relatively short-term (3-6
months) and will require a relatively low number of patients (under 100).
5.0 Manufacturing Assessment
5.1 Process Technology- PATT-EXT (extrusion grade)
+ Tube extrusion-screw extrusion of PATT into catheter size tubes
+ Possible co-extrusion if filled material becomes necessary
+ Antimicrobial coating and filled technologies
5.2 Manufacturing Approach
+ The ureteral stent can be manufactured at Elk Hill
+ Capital requirements: existing equipment, possible scale-up and
additional equipment for antimicrobial incorporation
+ Greatest uncertainty to success in manufacturing: cost of final device,
$uy-c-timicrobial incorporation without affecting the mechanical
&J...bGs roperties of the overall device
5.3 Materials Strategy
+ Greatest uncertainty for success with materials: measurable difference
in efficacy in-vivo demonstrating that PATT + antimicrobial
technology meets performance criteria. -r iuhrd & ~ e ~ s + & r ?
oatarc+- -K-buh?
6.0 Risk Assessment M<~-A+ cld9XPU4+3yr
6.1 Probability of Project success exiting Phase 4: 80% s Ce-0 q
-
6.2 Critical assumptions
+ Key criteria that would trigger an interim review: toxicity in the - -
urinary tract, encrustation performance inferior to competition.
+ Technology (technology feasibility; IP protection; scale-up): safe and
efficacious in vivo; we can practice and are protected; we can scale-up
+ Market and competitive: we will partner with a major player
+ Manufacturing (costs; ramp-up; yields; sourcing): TBD
s i t e of
s+aK;C, + Project commitments (objectives; targets; resources): evaluation of
prototypes with antimicrobial, in vitro antimicrobial activity studies,
pig implant data, encrustation testing of comparative catheters, surfacelubricity tests (coefficient of friction); resources will include three fulltimeassociates for engineering, NPD, project management and sales &marketing.6.3 Death Blow+ In vitro tests show no difference in encrustation compared withcompetitors+ Toxicity in the urinary tract in pig model+ Surgeons do not see value in a perfluoroelastomeric device and itsattributes+ Lack of distribution partner (Phase 11)+ Cost to manufacture is more than we could sell for6.4 Plan to test Critical Assumptions and Death Blow+ Prototypes with antimicrobial+ ASTM encrustation model+ In vivo safetyltoxicity study in pig+ Understand surgical techniques+ Survey surgeons+ Develop strategy for alliance+ Estimate costs to make device from synthesis to final device6.5 Risks to Gore+ A business partner is needed+ It needs to be decided what our product offering will be: the catheteronly or the entire package (or something in between). Depending onwhat is decided, this may have impact on our profitability.+ No potential legal conflicts foreseen7.0 Project Plan7.1 Phase I Plan+ Objectives and deliverables:+ Detailed Plan+ Understand surgical procedures+ Survey surgeons+ + Prototypes with antimicrobials+ Antimicrobial elution study-b *4 + In vitro antimicrobial testing (zones of inhibition)-it&-pe++de"". + Mechanical and surface testing (tensile, elongation, etc. accordingto Draft Guidance; coefficient of friction, surface energy, etc.)+ In vitro encrustation further testing A S~L+S&.?+ Animal experiment (pig) toxicity in urinary tract; toxicity tourinary mucosa+ Critical Path: same as above+ Milestones: same as above7.2 Core Team+ Cindy Eaton, Thane Kranzler, Ruth Cutright?, Norman Pih=[[Backup]]=
