Changes

=== '''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.'''

* 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 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>

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.|}

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>|}

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{|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 dysfunctionNo. They usually are excreted from the urinary tract. Struvite '''|align = "center" bgcolor = "#4f81bd"|'''Company'''|align = "center" bgcolor = "#4f81bd"|'''Device(magnesium ammonium phosphates) 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 phosphatedays) 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"|<font color="#0000FF"><u>[http://www. Infection stones can manifest as poorly mineralized matrix stonesallium-medical.com/?categoryId=64772 Allium, highly mineralized staghorn calculi or as bladder stones which often form in the presence of ureteral stentsIsrael]</u></font>|align = "center" bgcolor = "#dce6f1"|[http://www. Ureaallium-splitting bacteria colonize the surface and cause alkalinization of the urine, which lowers the solubility of struvite and hydroxyapatite, and they deposit on the surfacemedical. Bacterial biofilm associated with encrustation is a common clinical occurrencecom/?categoryId=64772 URS]|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[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 alcom/doc/1G1-165990208.html CE Mark]</font>|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"|<font color="#0000FF">[http://www., 1996a)pnnmedical. An experiment was conducted to compare the encrustation potential of various ureteral stent materials. The longcom/urology/professionals/products/memokath™-term struvite and hydroxyapatite encrustation of silicone, polyurethane, hydrogel051-coated polyurethane, Silitek and Percuflex were comparedureter. All of the materials developed encrustation, however, it was found by image analysis that the rates of encrustation varied on the different materialsaspx Pnn Medical A/S]</font>|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 algoogle., 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 tracthammer. They are discussed by Gorman and Tunney, (1 997)pl/pliki/147_2. Efforts to reduce encrustation using new materials, smootherpdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja Memokath 051]|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font>|align = "center"|1995|rowspan = "2"|Nickel-titanium shape memory alloy|rowspan = "2"|Double fluted ended spiral stent|align = "center" rowspan = "2"|240surfaces 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"|<font color="#0000FF"><u>[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 alproducts/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 statehtml FDA Listing]</u></font>|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"|<font color="#0000FF"><u>[http://www. Gorman et alfossamedical. (1997b) concluded that the chance of stent fracture would be reduced if the ureteral stent side holes were eliminatedcom/news. Urinary tract infection is another common major problem with the usage of ureteral stentshtm Fossa Medical]</u></font>|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera. Initially, a conditioning film is deposited on the ureteral stent surfacecom/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 materialpdf Stone Sweeper]|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www. Electrostatic interactions, the ionic strength and pH of the urine and differences in fluid surface tensions affect bacterial adhesion to the conditioning filmfossamedical. Subsequently, a microbial biofilm forms over timecom/news. The biofilm is composed of bacterial cells embedded in a hydratedhtm CE Mark]</u></font>|align = "center" bgcolor = "#dce6f1"|Sep, predominantly anionic mixture of bacterial exopolysaccharides and trapped host extracellular macromolecules2005|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"|<font color==Obstruction====Obstruction of urine flow and urinary tract sepsis can result in continued growth of the biofilm"#0000FF"><u>[http://www. Colonization of devices implanted in the urinary tract can lead to dysfunction, tissue intolerance, pain, subclinical or overt infection and even urosepsisfossamedical. Device related infections are difficult totreat and device removal is usually necessarycom/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., 1998k). 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.]</u></font>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 filmcenter" 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=InfectionPMN&ID=K033368 Open lumen stent]|align ="center" bgcolor ="#dce6f1"|<font color=The predictive value of urine cultures in the assessment of stent colonization was examined in 65 patients with indwelling ureteral stents"#0000FF"><u>[http://www. It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et alaccessdata., 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(1998k) have found that ciprofloxacin]</u></font>|align = "center" bgcolor = "#dce6f1"|Nov, with a 3 day burst every 2003|bgcolor = "#dce6f1" rowspan = "2"|Polyurethaneweeks, 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"|<font color= The market need "#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]It is clear that there is a need |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]</u></font>|align = "center"|<font color="#0000FF"><u>Contour</u></font>|align = "center"| |align = "center"| |Percuflex - proprietary polyolefin copolymer; Hydroplus coating|Fixed and variable length; Tapered tip|align = "center"|365|align = "center" |[[Image:Contour.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.png|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 proximal ends|align = "center"|90|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]] |-|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]|align = "center"| |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"|<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, 2007|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 a new 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, 2007|bgcolor = "#dce6f1"|Heparin-bonded stent|bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"||-|align = "center"|'''6'''|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]</font>|align = "center"|<font color="#0000FF"><u>[http://qurological.com/product/ pAguaMedicina™ Pediatric Ureteral Stent]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font>|align = "center"|Jan, 2010|Hydrogel|Differentially larger end (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=4 Bioteque Corp.]</font>|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 = "#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'''|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, 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 ]</u></font>|align = "center"| |align = "center"| |Coil-reinforced; SL-6® hydrophilic coating|Patency Device|align = "center"| |align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</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 Applied Standard]</u></font>|align = "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 that will be able ; SL-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'''|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font>|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, 2004|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, 2003|bgcolor = "#dce6f1"|Silicone|bgcolor = "#dce6f1"|Attached with suture for ease of removal|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]|-|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font>|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.png|thumb|center|100px|<center>Fluoro 4</center>]]|-|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.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 lubricious 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.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-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 easy maneuverability as well as flexibility|align = "center"| |align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]|-|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 short-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 detachable|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]|-|align = "center" rowspan = "9"|'''12'''|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font>|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.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(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>]]|-|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)]</u></font>|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 chemically bonded wettable solution |align = "center"| |align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]|-|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 lengths from 22cm to resist encrustation 28cm|align = "center"| |align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]|-|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 infection in exclusive soft bladder helix |align = "center"| |align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]|-|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>|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 (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 = [[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the urinary tractproduct to patent mapping(Bard and Boston)''']]* Click [[Media:Product_Patent_Mapping_Bard_Boston. According xls|'''Products from Boston Scientific and C R Bard ''']]to Merrill Lynch, ureteral stents represent an $80 MMdownload the excel file.US market== 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 is ''']]|-|} =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 lead detailed taxonomy''*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' *''Click on the "+" 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 with ~50Triclosan <br>Currently in Phase II (Canada)|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 color 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 the 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 followed by Maxxim (Circon)position|Seem to be moving focus away from Ureteral stents market|-|} = Competitive Landscape ===Major Players==*Boston Scientific Limited, Cook Abbott, Medtronic and Bard is a smaller playerCook Inc. There are the major players in ureteral stent research field. [[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 number peak no. of other small contenderspatents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area. [[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]] ==Sales == Total Sales in 2010 - 4.04 Billion USD {|border="2" cellspacing="0" cellpadding="4" width="100%"|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 is only a sample report with brief analysis''' <br>'''Dolcera can provide a comprehensive report customized to your needs'''</p>{|border="2" cellspacing="0" cellpadding="4" align="center" "|style="background:lightgrey" align = "center" colspan = "3"|'''[mailto:info@dolcera.com <span style="color:#0047AB">Buy the customized report from Dolcera</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>