Changes

Ureteral Stent

22,817 bytes added, 13:45, 27 July 2015

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== '''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 comfort~~relevant 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 months~~stent 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 life~~Other uses of Ureteral Stent include Post-~~long necessity. Unfortunately~~surgical swelling/infection of uterus, ~~there are many problems associated with using ureteral stents~~Active kidney infection etc.

~~=== Ureteric stenting difficulties ===~~'''[[~~Image:Ureteral stent~~more 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"|'''Common'''|align = "center" bgcolor = "#00CCFF"|'''Rare~~'''~~~~

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* Trigonal irritation

* Haematuria

* Fever

* Infection

* Tissue inflammation

* Encrustation

* Biofilm formation

* 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>'''S.No. '''</center>| style="background-color:#4f81bd;padding:0.079cm;"| <center>'''Title '''</center>| style="background-color:#4f81bd;padding:0.079cm;"|<center>'''Conditions '''</center>| style="background-color:#4f81bd;padding:0.079cm;"| <center>'''Intervention: Device'''</center>| style="background-color:#4f81bd;padding:0.079cm;"| <center>'''Sponsors and Collaborators '''</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 polymer~~California, ~~the chemical composition of its surface, coatings on the device~~Irvine ~~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 ~~friction~~Obstructed 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. ~~[http~~079cm;"|<center>'''S.No. '''</center>| style="background-color:#4f81bd;padding:0.079cm;"|<center>'''Title'''</~~www~~center>| style="background-color:#4f81bd;padding:0.~~ncbi~~079cm;"|<center>'''Abstract'''</center>| style="background-color:#4f81bd;padding:0.~~nlm~~079cm;"|<center>'''Enrollment'''</center>| style="background-color:#4f81bd;padding:0.~~nih~~079cm;"|<center>'''Disorder'''</center>| style="background-color:#4f81bd;padding:0.~~gov~~079cm;"|<center>'''Conclusion'''</~~pubmed~~font></~~10772512 Koleski et al~~center>|-| 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 ureter~~treatment 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 a~~smooth surface than~~ percutaneous nephrostomy tube (PCN) or a ~~grooved surface, especially when debris is present~~ureteric stent. ~~Stoller~~ Both can cause considerable morbidity and reduce patient's health-related quality of life (~~2000~~QoL) ~~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 stent~~significant 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 used~~for 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 months~~have 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 al~~079cm;"|<center>'''S.~~, 1995 found that 68% of stents forgotten more than 6 months were calcified and 10% were fragmented~~No. ~~Multiple urologic procedures were necessary to remove the stones~~'''</center>| style="background-color:#4f81bd;padding:0. ~~Long~~079cm;"|<center>'''Company '''</center>| style="background-~~term effects~~ color:#4f81bd;padding:0.079cm;"| <center>'''Device '''</center>| style="background-color:#4f81bd;padding:0.079cm;"| <center>'''Approval '''</center>| style="background-color:#4f81bd;padding:0.079cm;"| <center>'''Date of ~~these forgotten stents may lead to voiding dysfunction and renal insufficiency~~Approval '''</center>| style="background-color:#4f81bd;padding:0. ~~Schlick, et al~~079cm;"| <center>'''Material '''</center>| style="background-color:#4f81bd;padding:0.079cm;"| <center>'''Technology '''</center>| style="background-color:#4f81bd;padding:0.079cm;"| <center>'''Indwelling Time (days) '''</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. ~~Long~~079cm;"| <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 device~~history. ~~Encrustation of ureteral stents is a well~~aspx CE Mark]</center>| style="background-~~known problem, which can be treated easily if recognized early~~color:#dce6f1;padding:0. ~~However, severe encrustation leads to renal failure and is difficult to manage (Mohan~~079cm;"| <center>1995</center>| style="background-~~Pillai et al~~color:#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 urine~~079cm;"| 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 been~~reported 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 patients~~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. ~~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 al~~fda.~~, 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~~{|border="2" cellspacing="0" cellpadding="4" width="100%"|align = "center" bgcolor = "#4f81bd"|'''Sr. ~~Calcium oxalate, calcium phosphate, uric acid and cystine stones are metabolic stones because they form as a result of metabolic dysfunction~~No. ~~They usually are excreted from the urinary tract. Struvite~~ '''|align = "center" bgcolor = "#4f81bd"|'''Company'''|align = "center" bgcolor = "#4f81bd"|'''Device(~~magnesium ammonium phosphate~~s) ~~and hydroxyapatite~~ '''|align = "center" bgcolor = "#4f81bd"|'''Approval'''|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''|align = "center" bgcolor = "#4f81bd"|'''Material'''|bgcolor = "#4f81bd"|'''Technology'''|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (~~calcium phosphate~~days) ~~are associated with infection (infection stones). These account for 1520% of urinary calculi. ESWL is used to break up the larger infection stones because they don~~'~~t pass; recurrence of the problem occurs with incomplete removal~~''|align = "center" bgcolor = "#4f81bd"|'''Image'''|-|align = "center" bgcolor = "#dce6f1"|'''1'''|align = "center" bgcolor = "#dce6f1"|[http://www. ~~Infection stones can manifest as poorly mineralized matrix stones~~allium-medical.com/?categoryId=64772 Allium, ~~highly mineralized staghorn calculi or as bladder stones which often form in the presence of ureteral stents~~Israel]|align = "center" bgcolor = "#dce6f1"|[http://www. ~~Urea~~allium-~~splitting bacteria colonize the surface and cause alkalinization of the urine, which lowers the solubility of struvite and hydroxyapatite, and they deposit on the surface~~medical. ~~Bacterial biofilm associated with encrustation is a common clinical occurrence~~com/?categoryId=64772 URS]|align = "center" bgcolor = "#dce6f1"|[http://www. ~~(Gorman and Tunney, 1997)~~highbeam. ~~It has been suggested that prevention of bacterial colonization would prevent encrustation because of their ultimate responsibility for its formation (Bibby et al~~com/doc/1G1-165990208.html CE Mark]|align = "center" bgcolor = "#dce6f1"|Jul, ~~1995)~~2007|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer|bgcolor = "#dce6f1"|Self-expanding stent|align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]

~~An in vitro model was developed that produces encrustation similar to those seen in vivo (Tunney et al~~|-|align = "center" rowspan = "2"|'''2'''|align = "center" rowspan = "2"|[http://www.~~, 1996a)~~pnnmedical. ~~An experiment was conducted to compare the encrustation potential of various ureteral stent materials. The long~~com/urology/professionals/products/memokath™-~~term struvite and hydroxyapatite encrustation of silicone, polyurethane, hydrogel~~051-~~coated polyurethane, Silitek and Percuflex were compared~~ureter. ~~All of the materials developed encrustation, however, it was found by image analysis that the rates of encrustation varied on the different materials~~aspx Pnn Medical A/S]|align = "center" rowspan = "2"|[http://www. ~~Silicone had less encrustation (69% at 10 weeks) compared to the other materials (1 00%) at the same time point (Tunney et al~~google.~~, 1996b)~~com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www. ~~Continuous flow models have also been developed which are more representative of conditions in the upper urinary tract~~hammer. ~~They are discussed by Gorman and Tunney, (1 997)~~pl/pliki/147_2. ~~Efforts to reduce encrustation using new materials, smoother~~pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]|align = "center"|[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]|align = "center"|1995|rowspan = "2"|Nickel-titanium shape memory alloy|rowspan = "2"|Double fluted ended spiral stent|align = "center" rowspan = "2"|240~~surfaces and hydrogel coatings have been attempted~~|rowspan = "2"|[[Image:Memokath_051. png|thumb|center|100px|<center>Memokath 051</center>]]

~~A hydrogel~~|-coated C-flex stent (Hydroplus, Boston Scientific) was shown to have less epithelial cell damage and encrustation than other biomaterials and was recommended by the investigators for long-term use (Cormio, 1995)|align = "center"|[http://www. ~~In addition, a poly(ethy1ene oxide)~~zapconnect.com/~~polyurethane composite hydrogel (Aquavenem, J & J) resisted intraluminal blockage in a urine flow model compared with silicone and polyurethane (Gorman et al~~products/index.~~, 1997a)~~cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561. ~~Another advantage with Aquavene is that it is rigid in the dry state~~html FDA Listing]|align = "center"|Mar, ~~which facilitates insertion past obstructions in the ureter and becomes soft on hydration providing comfort (Gorman and Tunney, 1997)~~2004|-|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''|align = "center" bgcolor = "#dce6f1" rowspan = "5"|[http://www. ~~Gorman et al~~fossamedical. ~~(1997b) concluded that the chance of stent fracture would be reduced if the ureteral stent side holes were eliminated~~com/news. ~~Urinary tract infection is another common major problem with the usage of ureteral stents~~htm Fossa Medical]|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera. ~~Initially, a conditioning film is deposited on the ureteral stent surface~~com/upload/files/stonesweeper_fossa_trial. ~~The film is made up of proteins, electrolyte materials and other unidentified materials that obscure the surface properties of the stent material~~pdf Stone Sweeper]|align = "center" bgcolor = "#dce6f1"|[http://www. ~~Electrostatic interactions, the ionic strength and pH of the urine and differences in fluid surface tensions affect bacterial adhesion to the conditioning film~~fossamedical. ~~Subsequently, a microbial biofilm forms over time~~com/news. ~~The biofilm is composed of bacterial cells embedded in a hydrated~~htm CE Mark]|align = "center" bgcolor = "#dce6f1"|Sep, ~~predominantly anionic mixture of bacterial exopolysaccharides and trapped host extracellular macromolecules~~2005|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]

|-|align ="center" bgcolor ="#dce6f1"|[http://www. ~~Colonization of devices implanted in the urinary tract can lead to dysfunction, tissue intolerance, pain, subclinical or overt infection and even urosepsis~~fossamedical. ~~Device related infections are difficult totreat and device removal is usually necessary~~com/news. The biofilm has been found to impede the diffusion of antibiotics; in addition, the bacteria in the biofilm have a decreased metabolic rate , which also protects them against the effects of antibiotics htm FDA 510(~~Wollin et al., 1998~~k). Riedl, et al. (1 999) found 100% ureteral stent colonization rates in permanent and 69.3% in temporary stents. Antibiotic prophylaxis did not prevent bacterial colonization and it was recommended that it not be used.]On the other hand, Tieszer, et al. (1 998) believe that fluoroquinolones can prevent infection. They also have found that some stents have denser encrustation than others, however, the stent material did not change the elements of the |align = "~~conditioning film~~center" ~~adsorbed or alter its receptivity tobacterial biofilms.~~bgcolor = "#dce6f1"|Aug, 2002

|-|align ="center" bgcolor ="#dce6f1" rowspan ="2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=~~Infection~~PMN&ID=K033368 Open lumen stent]|align ="center" bgcolor ="#dce6f1"|[http://www. ~~It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et al~~accessdata.~~, 1999)~~fda. ~~Patients with sterile urine culturemay benefit from prophylactic antibiotics; however, the authors contended that the antibiotics must work against gram-negative uropathogens and gram-positive bacteria including enterococci.~~It is obvious that there is controversy in the literature whether prophylactic systemic antibiotics are useful with ureteral stent implant. However, antibiotics do not seem to prevent stent colonization. Denstedt et algov/scripts/cdrh/cfdocs/cfPMN/PMNSimple. cfm?db=PMN&ID=K033368 FDA 510(~~1998~~k) ~~have found that ciprofloxacin~~]|align = "center" bgcolor = "#dce6f1"|Nov, ~~with a 3 day burst every~~ 2003|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane~~weeks, actually is adsorbed onto the~~ |bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent ~~which makes longer term treatment possible~~ with reduced risk of bacterial resistance. There has been research targeted at coating or impregnating urinary catheters with antimicrobials and products are on the market, however, there are no antimicrobial ureteral stents approved by the FDA<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"|[http://www.fossamedical.com/news.htm CE Mark]|align ="center" bgcolor ==~~It is clear that there is a need for a new material that will be able to resist encrustation and infection in the urinary tract. According to Merrill Lynch~~"#dce6f1"|Sep, ~~ureteral stents represent an $80 MM~~2005~~US market~~|-|align = "center" bgcolor = "#dce6f1"|[http://www. ~~Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player~~accessdata. ~~There are a number of other small contenders~~fda. The use of ureteral stents is increasing; the indications for ureteral stenting have broadened from temporary or permanent relief or ureteric obstruction to include temporary urinary diversion following surgical~~procedures such as endopyelotomy and ureteroscopy and facilitation of stone clearance after ESWL (Tolley, 2000)~~gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple. ~~The use of ureteral stents for patients having ESWL for renal calculi is however controversial and seems to be related to the size of the stones and invasiveness of the~~cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]~~procedure~~|align = "center" bgcolor = "#dce6f1"|[http://www. ~~According to survey results reported by Hollowell, et al~~accessdata. fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(~~2000~~k)]|align = "center" bgcolor = "#dce6f1"|Jun, there is a significant difference in opinion concerning the use of stents with ESWL. The number of ureteral stents used in patients with stones 2 cm or less treated with ESWL is significant in spite of the lack scientific evidence in support of this practice. Of 1,029 urologists returning surveys, for patients with renal pelvic stones 10, 15 or 20 rnm treated with ESWL, routine 2002|bgcolor = "#dce6f1"|Polyurethane|bgcolor = "#dce6f1"|Double pigtail stent ~~placement was preferred by 25.3%,~~with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki>~~57.1 % and 87.1 %, respectively. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5-1 0 mm.~~ |align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| N/A

|align = "center" rowspan = "7"|'''4'''

|align = "center" rowspan = "7"|[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]

|align = "center"|Contour

|align = "center"|

|Percuflex - proprietary polyolefin copolymer; Hydroplus coating

|Fixed and variable length; Tapered tip

|align = "center"|365

|align = "center"|Percuflex

|align = "center"|

|align = "center"| Percuflex

|Pigtail

|align = "center"|365

|align = "center"|Polaris Ultra

|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]

|align = "center"|Jan, 2001

|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.

|Double pigtail

|align = "center"|365

|align = "center"|Polaris Loop

|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]

|align = "center"|Mar, 2003

|Dual Durometer Percuflex with HydroPlus Coating

|Bladder loop design

|align = "center"|365

|align = "center"|[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]

|align = "center"|

|Percuflex material and Hydroplus coating

|Endopyelotomy stent

|align = "center"|Post-procedure healing

|align = "center"|

|Hydroplus Coating

|Variable length coil on distal and proximal ends

|align = "center"|90

|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]

|align = "center"|

|Percuflex - proprietary polyolefin copolymer

|Ketorolac trimethamine loaded stent

|align = "center"|

|align = "center"| N/A

|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''

|align = "center" bgcolor = "#dce6f1" rowspan = "6"|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]

|align = "center" bgcolor = "#dce6f1"|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]

|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]

|align = "center" bgcolor = "#dce6f1"|May, 2007

|bgcolor = "#dce6f1"|Metal

|bgcolor = "#dce6f1"|

|align = "center" bgcolor = "#dce6f1"|365

|align = "center" bgcolor = "#dce6f1"|[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]

|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"|[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]

|align = "center" bgcolor = "#dce6f1"|

|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating

|bgcolor = "#dce6f1"|Double pigtail

|align = "center" bgcolor = "#dce6f1"|365

|align = "center" bgcolor = "#dce6f1"|[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]

|align = "center" bgcolor = "#dce6f1"|

|bgcolor = "#dce6f1"|

|bgcolor = "#dce6f1"|Double Pigtail

|align = "center" bgcolor = "#dce6f1"|180

|align = "center" bgcolor = "#dce6f1"|[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]

|align = "center" bgcolor = "#dce6f1"|

|bgcolor = "#dce6f1"|

|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent

|align = "center" bgcolor = "#dce6f1"|60

|align = "center" bgcolor = "#dce6f1"|[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]

|align = "center" bgcolor = "#dce6f1"|[http://www.medicalnewstoday.com/articles/90717.php Launch]

|align = "center" bgcolor = "#dce6f1"|Dec, 2007

|bgcolor = "#dce6f1"|Heparin-bonded stent

|bgcolor = "#dce6f1"|

|align = "center" bgcolor = "#dce6f1"|

|bgcolor = "#dce6f1"|

|align = "center"|'''6'''

|align = "center"|[http://qurological.com/product/ Q Urological]

|align = "center"|[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]

|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]

|align = "center"|Jan, 2010

|Hydrogel

|Differentially larger end (no pigtail)

|align = "center"|30

|align = "center" bgcolor = "#dce6f1"|'''7'''

|align = "center" bgcolor = "#dce6f1"|[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]

|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set

|align = "center" bgcolor = "#dce6f1"|[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]

|align = "center" bgcolor = "#dce6f1"|Apr, 2010

|bgcolor = "#dce6f1"|

|align = "center" bgcolor = "#dce6f1"|30

|align = "center" rowspan = "4"|'''8'''

|align = "center" rowspan = "4"|[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]

|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]

|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]

|align = "center"|Jul, 2001

|Polyester mesh

|Double-pigtail

|align = "center"|

|align = "center"| N/A

|align = "center"|[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]

|align = "center"|

|Coil-reinforced; SL-6® hydrophilic coating

|Patency Device

|align = "center"|

|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]

|align = "center"|Jun, 1999

|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating

|Unique wall construction and enlarged drainage holes

|align = "center"|

|align = "center"|

|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating

|Dual Diameter stent

|align = "center"|

|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''

|align = "center" bgcolor = "#dce6f1" rowspan = "6"|[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]

|align = "center" bgcolor = "#dce6f1"|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]

|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]

|align = "center" bgcolor = "#dce6f1"|Dec, 2004

|bgcolor = "#dce6f1"|Silicone

|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop

|align = "center" bgcolor = "#dce6f1"|365

|align = "center" bgcolor = "#dce6f1"|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]

|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]

|align = "center" bgcolor = "#dce6f1"|Jan, 2003

|bgcolor = "#dce6f1"|Silicone

|bgcolor = "#dce6f1"|Attached with suture for ease of removal

|align = "center" bgcolor = "#dce6f1"|

|align = "center" bgcolor = "#dce6f1"|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]

|align = "center" bgcolor = "#dce6f1"|

|bgcolor = "#dce6f1"|Silicone/tantalum

|bgcolor = "#dce6f1"|

|align = "center" bgcolor = "#dce6f1"|

|align = "center" bgcolor = "#dce6f1"|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]

|align = "center" bgcolor = "#dce6f1"|

|bgcolor = "#dce6f1"|Silicone

|bgcolor = "#dce6f1"|Three dimensional design

|align = "center" bgcolor = "#dce6f1"|

|align = "center" bgcolor = "#dce6f1"|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]

|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]

|align = "center" bgcolor = "#dce6f1"|Dec, 1998

|bgcolor = "#dce6f1"|Silicone

|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating

|align = "center" bgcolor = "#dce6f1"|

|align = "center" bgcolor = "#dce6f1"|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=229 Urinary Diversion Stent]

|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]

|align = "center" bgcolor = "#dce6f1"|Apr, 1991

|bgcolor = "#dce6f1"|Silicone

|bgcolor = "#dce6f1"|

|align = "center" bgcolor = "#dce6f1"|

|align = "center" rowspan = "4"|'''10'''

|align = "center" rowspan = "4"|[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]

|align = "center"|[http://www.porges.ru/catalog.html?cid=251 Vortek]

|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]

|align = "center"|Oct, 1998

|Silicone

|Double coating for easy maneuverability as well as flexibility

|align = "center"|

|align = "center"|[http://www.porges.ru/catalog.html?cid=248 Biosoft]

|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]

|align = "center"|Oct, 1998

|Silicone

|Extreme flexibility

|align = "center"|

|align = "center"|[http://www.porges.ru/catalog.html?cid=249 Polyurethane]

|align = "center"|

|Hard or soft Polyurethane

|Designed for short-term use

|align = "center"| 90

|align = "center"|[http://www.porges.ru/catalog.html?cid=250 Silicone]

|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]

|align = "center"|Oct, 2002

|Silicone

|''Pyatiprofilnaya'' technology

|align = "center"|

|align = "center" bgcolor = "#dce6f1"|'''11'''

|align = "center" bgcolor = "#dce6f1"|[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]

|align = "center" bgcolor = "#dce6f1"|[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]

|align = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]

|align = "center" bgcolor = "#dce6f1"|Jul, 1999

|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating

|bgcolor = "#dce6f1"| Directable and detachable

|align = "center" bgcolor = "#dce6f1"|

|align = "center" rowspan = "9"|'''12'''

|align = "center" rowspan = "9"|[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]

|align = "center"|[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]

|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]

|align = "center"|Dec, 1986

|Classic Closed Tip

|align = "center"|

|align = "center"|[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]

|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]

|align = "center"|Mar, 1996

|Tecoflex® construction

|Balanced-curled double pigtail design

|align = "center"|

|align = "center"|[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]

|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]

|align = "center"|Apr, 1988

|Silicone

|Double-J closed-tip

|align = "center"|

|align = "center"|[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]

|align = "center"|

|Tecoflex®

|Grooved design

|align = "center"|

|align = "center"|[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]

|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]

|align = "center"|Nov, 1991

|Tecoflex®

|“Rememberance” of shape with a chemically bonded wettable solution

|align = "center"|

|align = "center"|[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]

|align = "center"|

|Tecoflex®

|Two durometers with helical kidney curls

|align = "center"|

|align = "center"|[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]

|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]

|align = "center"|Mar, 1996

|Tecoflex®

|Accomodate ureteral lengths from 22cm to 28cm

|align = "center"|

|align = "center"|[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]

|align = "center"|

|Tecoflex®

|Dual-durometer design and exclusive soft bladder helix

|align = "center"|

|align = "center"|[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]

|align = "center"|

|Silicone

|Classic Double J with open tip

|align = "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"|Nitinol; Available with hydrophilic coating

|bgcolor = "#dce6f1"|Double loop stent

|align = "center" bgcolor = "#dce6f1"|Short-term and long-term

|align = "center"|'''14'''

|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]

|align = "center"|[http://www.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 =

1[[Image:Product_Patent_Mapping_Screen_Shot.~~2 Fit with Gore Corporate Strategy+ This product fits into Gore~~png|1000px|centre|thumb|'~~s DSP market segment+ A family of products is needed~~ ''Screenshot for the product to ~~market through a distributor+ A possible family of products includes ureteral stents, urethralslings, urologic suture, urethral stents and urethral catheters(Foley), renal artery stent?+ It is preferable that a stand alone product be of high value+ 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~~ patent mapping(Bard) and ~~Percuflex (~~Boston)''']]* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific~~) catheters after being subjected to in vitro static~~ and ~~dynamicflowsynthetic urine models~~C R Bard ''']]to download the excel file.~~Static Model~~== Mapped Patent vs Not Mapped Patents ==~~Dried tube pieces were suspended in stirring synthetic urine for up~~{|border="0" cellspacing="0" cellpadding="4" width="100%"~~to 3 months~~|[[Image:CRB_Pat. ~~Samples were taken at 1,2 and 3 months at which time they~~png|center|500px|thumb|'''C R Bard''']]~~were dried and weighed~~|[[Image:BS_pat. ~~The results of this experiment can be found in agraph of Absolute Weight Change vs Time in the Appendix~~png. ~~There are no~~png|center|500px|thumb|'''Boston Scientific''']]|-|}

~~error bars because this was a destructive test and there was only one~~=Patent-Product-Clinical Trial Mapping=~~sample in each group. The PATT catheter was found to encrust to a lesserextent than~~ * To access the ~~other catheters~~Dashboard you have to signup. You can do so by clicking [https: ~~6 times less than the Boston Scientific stent~~//www.dolcera.com/auth/index.php/login '''here''']*''Use the mouse(click and ~~almost half as much as~~ drag/scroll up or down/click on nodes) to explore nodes in the ~~Bard stent at two months. Note that the 1 -~~detailed taxonomy''~~%-.L month Bard data is~~ *''Click on the red arrow adjacent to the node name to view the content for that particular node in ~~error because~~ the ~~sample broke during preparation~~dashboard'' ~~& &~~ *''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the ~~lost segment was not recovered~~mindmap''{|border="2" cellspacing="0" cellpadding="4" width="100%" |<mm>[[ureteral_stent_mapping1. ~~The 3~~mm|flash|Ureteral Stent mindmap|600pt]]</mm> |} =Insights= {|border="2" cellspacing="0" cellpadding="4" width="100%"|bgcolor = "#538ED5"|''' '''|bgcolor = "#538ED5"|''' '''|bgcolor = "#538ED5"|'''Boston Scientific'''|bgcolor = "#538ED5"|'''C R BARD'''|-~~month data is pending. In~~dA|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''~~eadndcrituiostna,t iSoEnM ons tahree cinacthluedteerd l uinm tihnea lA apnpde anbdliuxm, winhailc shu vrfisaucaelsi.z eT thhee SEMssuggest that PATT has a clean surface relative to the other two materials.~~|'''Portfolio'''~~Dynamic Model~~|8 Products~~Straight pieces cut~~ |6 Products|-|'''Material'''|Percuflex - Biocompatible Polymer|Silicone|-|'''Coating'''|Hydroplus|Licensed from ~~the stents (approximately~~ pHreecoat|-|'''Shape'''|Pigtailed and More|Figure 4~~.5 cm~~and more|-|align = "center" bgcolor = "#538ED5"|'''Clinical Trials'''|'''Current Trials'''|Truimph Ureteral stent - Loaded with Triclosan Currently in Phase II (Canada) ~~wereattached to nozzles through which artificial urine passed from a reservoir.~~|None|-|align = ",center" ~~@ The artificial urine was recirculated from the collecting tank to the P~~ bgcolor = " #538ED5" rowspan = "3"|'''Patents'''|'''Coating'''|Therapeutic / Medicinal coatings Magnetic nano particles for MRI Imaging Lubricious coatings helping easy insertion$4|Therapeutic coatings|-|'''Structure'''|Multiple channels filled with therapeutic agent Multiple collapsible segments preventing fluid passing Renal coil with wick to prevent reflux Stent with beads on its surface Stent with reservoir~~. The experiment was run~~ indicating its release with change in color of urine Expandable and collapsible stent Stents with degradable barbs|Expandable stents for ~~two months. Unfortunately, the~~reducing discomfort&|-|'''Material'''|Elastically deformable stents Biodegradable polymer based stents Porous polymer for long term implantation Stent with variable hardness|Biodegradable polymers Shape memory alloys General polymer based|-|} == Inference == {|border="2" cellspacing="0" cellpadding="4" width="82%"|bgcolor = "#538ED5"|'''Boston Scientific'''</Jfont>|bgcolor = "#538ED5"|' ~~data from this experiment proved inconclusive. It appears that the nozzles were the weak link~~ ''C R BARD'''|-|Relatively late entrant with patents filed post mid 90s|Early mover with patents filed in ~~this experiment as they were found~~ mid 80s|-|Increased patent activity since 2000|Patent activity never gained traction|-|Large number of patents yet to ~~encrust which~~be "productized"~~..rp.~~|Few patents yet to be "~~e ;p~~productized"'|-~~led~~ |Some products undergoing clinical trails|No products undergoing clinical trails|-|Diverse range of products with variation in material and structure|Small product portfolio|-|Seem to be strengthening they market position|Seem to be moving focus away from Ureteral stents market|-|} = Competitive Landscape ===Major Players==*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the ~~decreased flow rates through the test articles downstream~~major players in ureteral stent research field. In~~addition~~[[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, followed by saturation during the ~~test articles were found~~ period 2006 to ~~weigh less~~ 2008 and after ~~the experimentthan they did before, an artifact~~ that ~~is probably~~ a ~~result of~~ gradual declination upto year 2010 in the ~~scale being~~ureteral stent research area.~~moved and recalibrated while the experiment was ongoing~~[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]]~~\L -Ndm 2.0 Intellectual Property Assessment~~==Sales ==Z3Total Sales in 2010 - 4.L04 Billion USD~~+ Will be verbally communicated at the meeting~~3.{|border="2" cellspacing="0 " cellpadding="4" width="100%"|bgcolor = "#4f81bd"|'''Company'''|bgcolor = "#4f81bd"|'''Total Sales ~~and Marketing Assessment~~in 2010'''~~3.1 Market Opportunities - - +~~ |bgcolor = "#4f81bd"|'''Urological ~~surgeons are the potential customers for the Gore ureteral~~sales'''~~stent.~~|bgcolor = "#4f81bd"|'''Percentage share'''~~+ Merrill Lynch estimates the US market for ureteral stents is $80 MM~~|bgcolor = "#4f81bd"|'''Product portfolio'''~~and that~~ |-|bgcolor = "#4f81bd"|'''Boston Scientific ~~has~~ '''|7800|661|8.48|[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-~~50% of the market~~Brochure. ~~Steve Nordstrom~~pdf Boston_portfolio]~~(worked at Boston Scientific for~~ |-~~10 years) believes that the BostonScientific US revenues are $38 MM with 70% of a $50 MM market~~|bgcolor = "#4f81bd"|'''CR BARD'''|2700|702|26.00|[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]|-|bgcolor = "#4f81bd"|'''Cook Medical'''|1700|<nowiki>-</nowiki>|<nowiki>-</nowiki>|[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+ ~~It is very difficult to obtain an accurate estimate of the number of~~Stents Cook_portfolio]~~procedures using a~~ |-|bgcolor = "#4f81bd"|'''Medline'''|4040|<nowiki>-</nowiki>|<nowiki>-</nowiki>|[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral ~~stent~~%20stent Medline_portfolio]|-|} [[image:stentshare. jpg |thumb|center|1000px| All figures in USD million ]] =Like this report?= '''This is ~~because temporary stents are~~only a sample report with brief analysis''' ~~not coded and therefore their use in~~ '''Dolcera can provide a ~~given procedure is not recorded.~~comprehensive report customized to your needs'''~~In 1998, MDI estimated that there were 212,000 procedures in~~ {|border="2" cellspacing="0" cellpadding="4" align="center" "|style="background:lightgrey" align = "center" colspan = "3"|'''[mailto:info@dolcera.com Buy the Ucustomized report from Dolcera]''' |-| align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services Patent Analytics Services]S|align = "center"| [http://www. ~~(corresponding revenue $26~~dolcera.~~5 MM)~~com/website_prod/services/business-research-services Market Research Services]|align = "center"| [http://www. ~~MDI would have had the same~~dolcera.com/website_prod/tools/patent-dashboard Purchase Patent Dashboard]~~problem we encounter~~|-|align = "center"| [http://www. ~~The only hard data that Helene Johns is able to~~dolcera.com/website_prod/services/ip-patent-analytics-services/patent-search/patent-landscapes Patent Landscape Services]~~obtain in which a stent definitely was used in the procedure is 147,000~~|align = "center"| [http://www.dolcera.com/website_prod/research-processes Dolcera Processes]~~inpatient ureteral catheterization procedures in 1999 from NIPS data~~|align = "center"| [http://www.dolcera.com/website_prod/industries Industry Focus]~~In the 1998 Outpatient Handbook, there were 7,003 cystoscopies with~~|-~~stone removal in which 30% of the time a ureteral stent placement~~|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/patent-search/patent-landscapes Patent Search Services]~~occurred; there were 30,5 19 cystoscopies~~ |align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/alerts-and ~~ureteral catheterizations~~-updates Patent Alerting Services]~~in which there were ureteral stents placed 6~~|align = "center"| [http://www.~~3% of the time~~dolcera. ~~This gives~~com/website_prod/tools Dolcera Tools]~~a total of 15 1,033 procedures. Based on information obtained from~~|-|}

~~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]]=

Thungana.praveen

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