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* Ureteral stent: resists migration, resists fragmentation, '''''What is kink resistant and radiopaque.* Bacterial colonization: antimicrobial activity for up to two weeks.* Patient Comfort: it?''''' A ureteral stent has is a low coefficient specially designed hollow tube, made of fiiction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comforta flexible plastic material that is placed in the ureter.
{|border "1" style====Obstruction====Obstruction of urine flow and urinary tract sepsis can result in continued growth of the biofilm. Colonization of devices implanted in the urinary tract can lead to dysfunction, tissue intolerance, pain, subclinical or overt infection and even urosepsis. Device related infections are difficult totreat and device removal is usually necessary. The biofilm has been found to impede the diffusion of antibiotics"border-spacing:0; in addition, the bacteria in the biofilm have a decreased metabolic rate , which also protects them against the effects of antibiotics (Wollin et al., 1998). 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 "conditioning film" adsorbed or alter its receptivity tobacterial biofilms. | style====Infection====The predictive value of urine cultures in the assessment of stent colonization was examined in 65 patients with indwelling ureteral stents. It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et al., 1999). Patients with sterile urine culturemay benefit from prophylactic antibiotics; however, the authors contended that the antibiotics must work against gram"background-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 al. (1998) have found that ciprofloxacin, with a 3 day burst every 2weeks, actually is adsorbed onto the 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. === The market need ===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, ureteral stents represent an $80 MMUS market. Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player. There are a number of other small contenders. The use of ureteral stents is increasingcolor:#4f81bd; 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). 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 procedure. According to survey results reported by Hollowell, et al. (2000), 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 stent placement was preferred by 25.3%, 57.1 % and 87.1 %, respectively. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5-1 padding:0 mm. 079cm;"|<center><font color==Market Analysis==* We determined market data to have an idea about the market potential for ureteral stents"#FFFFFF">'''S.* This data is for women in US in different age groups and having different level of severityNo.* Prevalence increased with age, from 28% for 30- to 39-year-old women to 55% for 80- to 90-year-old women.* 18% of respondents reported severe UI.* The prevalence of severe UI also increased notably with age, from 8% for 30- to 39-year-old women to 33% for 80- to 90-year-old women.* Among all, 9% reported slight UI, 15% reported moderate UI, 18% reported severe UI, and 58% reported no UI.'''<BR/font></center>| style===Methodology===[[Image:methodology"background-ureteral stentscolor:#4f81bd;padding:0.jpg079cm;"|<center|500px]] ===Prevalence rate==><font color="#FFFFFF">'''Title '''</font></center>{|borderstyle="2background-color:#4f81bd;padding:0.079cm;" cellspacing|<center><font color="0#FFFFFF" cellpadding>'''Conditions '''</font></center>| style="4background-color:#4f81bd;padding:0.079cm;" width| <center><font color="100%#FFFFFF">'''Intervention: Device'''</font></center>|align style= "centerbackground-color:#4f81bd;padding:0.079cm;" colspan | <center><font color= "2#FFFFFF"|>'''Prevalence of Urinary Incontinence in US WomenSponsors and Collaborators '''</font></center>
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|align style= "background-color:#dce6f1;padding:0.079cm;"| <center>1</center>| style="background-color:#dce6f1;padding:0.079cm;"|'''Age (in yrs)'''[http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]|align style= "centerbackground-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;"|'''Population with Urinary incontinence (in %)'''Lawson Health Research Institute, Boston Scientific Corporation
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|align style= "padding:0.079cm;"| <center>2</center>| style="padding:0.079cm;"|30-39[http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]|align style= "centerpadding:0.079cm;"| Urethral Stricture| style="padding:0.079cm;"| Memokath stenting| style="padding:0.079cm;"|28%Engineers & Doctors Wallsten Medical Group
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|align style= "background-color:#dce6f1;padding:0.079cm;"| <center>3</center>| style="background-color:#dce6f1;padding:0.079cm;"|40[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]| style="background-49color:#dce6f1;padding:0.079cm;"| Kidney Stones|align style= "centerbackground-color:#dce6f1;padding:0.079cm;"| N\A| style="background-color:#dce6f1;padding:0.079cm;"|41%University of California, Irvine
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|align style= "padding:0.079cm;"| <center>4</center>| style="padding:0.079cm;"|50-59[http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]|align style= "centerpadding:0.079cm;"| Kidney Stones| style="padding:0.079cm;"| Ureteral Stent| style="padding:0.079cm;"|48%Emory University
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|align style= "background-color:#dce6f1;padding:0.079cm;"| <center>5</center>| style="background-color:#dce6f1;padding:0.079cm;"|60[http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]| style="background-69color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction|align style= "centerbackground-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent| style="background-color:#dce6f1;padding:0.079cm;"|51%Mayo Clinic Engineers & Doctors Wallsten Medical Group
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|align style= "padding:0.079cm;"| <center>6</center>| style="padding:0.079cm;"|70[http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of 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 |} == Concluded trials =={| {{table}}| style="background-79color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center>|align style= "background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center>|55%style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center>
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|align style= "background-color:#dce6f1;padding:0.079cm;"|<center>1</center>| style="background-color:#dce6f1;padding:0.079cm;"|80Long-90term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia |align | style= "centerbackground-color:#dce6f1;padding:0.079cm;"|54%To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| 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 an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.
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| style="padding:0.079cm;"| <center>2</center>
| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.
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| 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 at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.
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===Pre-Market potential for ureteral stent=Notification== Some of the companies active in the field of ureteral stents have been represented in the table below.
{|border="2" cellspacing="0" cellpadding="4" width="100%"|align style= "background-color:#4f81bd;padding:0.079cm;"|<center><font color=" colspan #FFFFFF">'''S.No. '''</font></center>| style= "6background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Market potential for ureteral stents in US, 2009Company '''</font></center>| style="background-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 Approval '''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"| <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>
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|Age groupsstyle="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center>|Female populationstyle="background-color:#dce6f1;padding:0.079cm;"| <brcenter>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center>(from US census data)|Prevalence rate in female 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>|Market potentialstyle="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center>|Catherization rate (%)style="background-color:#dce6f1;padding:0.079cm;"| Silicone|Stent market based on catherization ratestyle="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center>
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|30style="padding:0.079cm;"| <center>'''2'''</center>| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/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-39stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]|20128402style="padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center>|28%style="padding:0.079cm;"| <center>Mar 2003</center>|5635953style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating|style="padding:0.043%079cm;"| Bladder loop design|2423style="padding:0.079cm;"| <center>365</center>
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|40style="background-49color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center>|22074384style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center>|41%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>]]]|9050497style="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:0.123%079cm;"| <center>May 2007</center>|11132style="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>
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|50-59style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center>|20929761style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center>|48%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>]]]|10046285style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center>|style="padding:0.124%079cm;"| <center>Aug 2002</center>|12457style="padding:0.079cm;" rowspan="2"| Polyurethane| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent| style="padding:0.079cm;" rowspan="2"| <center>13</center>
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|60-69|14605565|51%|7448838|style="padding:0.160%079cm;"|11918|-|70-79|9046207|55%|4975414|0<center>[http://www.fossamedical.172%|8558|-|≥ 80|7216598|54%|3896963com/news.htm CE Mark]</center>|style="padding:0.044%|1715|-|Total| 079cm;"| <center>Sep 2005</center>|41053950| |48203
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| 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=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>]]]
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center>
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center>
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center>
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The FDA classifies a ureteric stent as follows: * TITLE 21 - FOOD AND DRUGS* CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES* SUBCHAPTER H - MEDICAL DEVICES* PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES* Subpart E - Surgical Devices* Sec. 876.4620 - Ureteral stent. * Classification - class II device [[Mediahttp:Detailed calculation workbook//www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.xls|'''Detailed model workbook''']4620&Term=ureter%20stent Code of Federal Regulations]
{|border="2" cellspacing="0" cellpadding= Intellectual property "4" width="100%"|align ="center" bgcolor ="#4f81bd"|'''Sr. No.'''|align ="center" bgcolor ="#4f81bd"|'''Company'''|align ="center" bgcolor = Search strategy "#4f81bd"|'''Device(s)'''|align ="center" bgcolor ="#4f81bd"|'''Approval'''|align ="center" bgcolor ="#4f81bd"|'''Approval Date'''* Databases searched|align = "center" bgcolor = "#4f81bd"|'''Material'''|bgcolor = "#4f81bd"|'''Technology'''|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''|align = "center" bgcolor = "#4f81bd"|'''Image'''|-|align = "center" bgcolor = "#dce6f1"|'''1'''|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http: US//www.allium-Gmedical.com/?categoryId=64772 Allium, USIsrael]</u></font>|align = "center" bgcolor = "#dce6f1"|[http://www.allium-A, EP-A, EP-B, WO, JP, DE, GB, FRmedical.com/?categoryId=64772 URS]* Search scope|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http: Title//www.highbeam.com/doc/1G1-165990208.html CE Mark]</font>|align = "center" bgcolor = "#dce6f1"|Jul, Abstract or Claims2007* Years: 1981|bgcolor = "#dce6f1"|Nickel-July 2008titanium shape memory alloy covered by polymer* Search query: (ureter* OR urether* OR ureth* OR uretr*) AND (|bgcolor = "#dce6f1"|Self-expanding stent*) AND (*microb* OR *bacter*)* Results|align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|[[Image: '''177 patents (82 unique patent families)'''656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]
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|}align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font>|align = "center" bgcolor = "#dce6f1"|Aug, 2002
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| align = "center" bgcolor = "#dce6f1" rowspan = "2"| [http://www.dolceraaccessdata.comfda.gov/website_prodscripts/servicescdrh/ip-patent-analytics-services Patent Analytics Servicescfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]|align = "center" bgcolor = "#dce6f1"| <font color="#0000FF"><u>[http://www.dolceraaccessdata.comfda.gov/website_prodscripts/servicescdrh/business-research-services Market Research Servicescfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font>|align = "center" bgcolor = "#dce6f1"| [http:Nov, 2003|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</wwwnowiki>|align = "center" bgcolor = "#dce6f1" rowspan = "2"| |align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.dolcera.compng|thumb|center|100px|<center>Open_lumen</website_prod/tools/patent-dashboard Purchase Patent Dashboardcenter>]]
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|align = "center" bgcolor = "#dce6f1"| <font color="#0000FF"><u>[http://www.dolcerafossamedical.com/website_prodnews.htm CE Mark]</servicesu></ip-patent-analytics-services/patent-search/patent-landscapes Patent Landscape Services]font>|align = "center"| [http://www.dolcera.com/website_prod/research-processes Dolcera Processes]|align bgcolor = "center#dce6f1"| [http://www.dolcera.com/website_prod/industries Industry Focus]Sep, 2005
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|align = "center" bgcolor = "#dce6f1"| [http://www.dolceraaccessdata.comfda.gov/website_prodscripts/servicescdrh/ip-patent-analytics-servicescfdocs/patent-searchcfPMN/patent-landscapes Patent Search ServicesPMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]|align = "center" bgcolor = "#dce6f1"| <font color="#0000FF"><u>[http://www.dolceraaccessdata.comfda.gov/website_prodscripts/servicescdrh/ip-patent-analytics-servicescfdocs/alerts-and-updates Patent Alerting ServicescfPMN/PMNSimple.cfm?db=PMN&ID=K021140 FDA 510(k)]</u></font>|align = "center" bgcolor = "#dce6f1"| [http:Jun, 2002|bgcolor = "#dce6f1"|Polyurethane|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</www.dolcera.comnowiki>|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| N/website_prod/tools Dolcera Tools]A
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|}<br>align ="center" rowspan ="7"|'''4'''|align = Clinical Trials ="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===New trials ===={| {{table}}"#0000FF"><u>Contour</u></font>| align="center"|'''Title'''| align="center"|'''Conditions'''|Percuflex - proprietary polyolefin copolymer; Hydroplus coating|Fixed and variable length; Tapered tip| align="center"|'''Intervention'''365| align="center"|'''Sponsors and Collaborators'''[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]]
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| [http:align = "center"|<font color="#0000FF"><u>Percuflex</u></clinicaltrials.gov/ct2/show/NCT00250406?termfont>|align =ureteral+stent&rank"center"| |align =1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]"center"||Renal Calculi, Ureteral Obstructionalign = "center"|Percuflex|DevicePigtail|align = "center"|365|align = "center" |[[Image: Ureteral StentPercuflex.png|thumb|Lawson Health Research Institute, Boston Scientific Corporationcenter|100px|<center>Percuflex</center>]]
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| align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font>|align = "center"|<font color="#0000FF"><u>[http://clinicaltrialswww.accessdata.fda.gov/ct2scripts/showcdrh/NCT00270504cfdocs/cfPMN/PMNSimple.cfm?termdb=urethral+stentPMN&rankid=1 Memokath® 044TW Stent for Treatment of Urethral StrictureK010002 FDA 510(k)]</u></font>|align = "center"|Urethral StrictureJan, 2001|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.|DeviceDouble pigtail|align = "center"|365|align = "center" |[[Image: Memokath stentingPolaris_Ultra.png|thumb|Engineers & Doctors Wallsten Medical Groupcenter|100px|<center>Polaris Ultra</center>]]
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| align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font>|align = "center"|<font color="#0000FF"><u>[http://clinicaltrialswww.accessdata.fda.gov/ct2scripts/showcdrh/NCT00581178cfdocs/cfPMN/pmn.cfm?termID=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation10929 FDA 510(k)]</u></font>|align = "center"|Kidney StonesMar, 2003|Dual Durometer Percuflex with HydroPlus Coating|N\ABladder loop design|align = "center"|University of California, Irvine365|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]]
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| align = "center"|<font color="#0000FF"><u>[http://clinicaltrialswww.govgoogle.com/ct2url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http:/show/NCT00288457?termwww.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=urologic+stentj&rankq=14 Ureteral Stent Length and Patient Symptomspercuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font>|align = "center"|Kidney Stones|align = "center"|Device|Percuflex material and Hydroplus coating|Endopyelotomy stent|align = "center"|Post-procedure healing|align = "center" |[[Image: Ureteral StentRetromax_plus.png|thumb|Emory Universitycenter|100px|<center>Retromax Plus</center>]]
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| align = "center"|<font color="#0000FF"><u>[http://clinicaltrialswww.govgoogle.com/ct2url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http:/show/NCT00166361?termwww.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=urologic+stentj&rankq=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stentpercuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font>|align = "center"|Ureteral Obstruction|align = "center"|Device|Hydroplus Coating|Variable length coil on distal and proximal ends|align = "center"|90|align = "center" |[[Image: Memokath 051 Ureteral StentStretch_VL_Flexima.png|thumb|Mayo Clinic Engineers & Doctors Wallsten Medical Groupcenter|100px|<center>Stretch VL Flexima</center>]]
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|align = "center"| [http://clinicaltrialsdolcera.govcom/ct2upload/showfiles/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral drug_eluting_ureteral_stent.pdf Drug-Eluting Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]|align = "center"|Kidney Disease|align = "center"|Device: nephrostomy tube and ureteral |Percuflex - proprietary polyolefin copolymer|Ketorolac trimethamine loaded stent|align = "center"|Rabin Medical Center|align = "center"| N/A
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|}align ="center" bgcolor ="#dce6f1" rowspan ="6"|'''5'''|align = Concluded trials "center" bgcolor ="#dce6f1" rowspan ="6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family={| {{table}}Ureteral+Stents Cook Medical]</font>| align="center" bgcolor = "#dce6f1" |'''Title'''<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font>| align="center" bgcolor = "#dce6f1" |'''Abstract'''<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" |'''Enrollment'''| align="center" bgcolor = "#dce6f1" |'''Disorder'''365| align="center" bgcolor = "#dce6f1" |'''Conclusion'''[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]]
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| Long-term outcome of permanent urethral stents in the treatment of detrusoralign = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-sphincter dyssynergia flex]</u></font>|align = "center" bgcolor = "#dce6f1"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|align = "center" bgcolor = "#dce6f1"|13|bgcolor = "#dce6f1"|Detrusor-sphincter dyssynergiaAQ® Hydrophilic Coating|bgcolor = "#dce6f1"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problemRadiopaque tip and tether for repositioning |align = "center" bgcolor = "#dce6f1"|180|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]]
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| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysisalign = "center" bgcolor = "#dce6f1"||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent<font color="#0000FF"><u>[http://www. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL)cookmedical. We have compared the QoL in these 2 groupscom/uro/dataSheet.do?id=3627 Endo-Sof]</u></font>|align = "center" bgcolor = "#dce6f1"|34|align = "center" bgcolor = "#dce6f1"|Upper urinary tract obstruction|bgcolor = "#dce6f1"|Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN)AQ® Hydrophilic Coating|bgcolor = "#dce6f1"|Double pigtail|align = "center" bgcolor = "#dce6f1"|365|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof. However, based on the EuroQol analysis, there is no significant difference in the gross impact on the healthpng|thumb|center|100px|<center>Endo-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.Sof</center>]]
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| Impact of stents on urological complications and health care expenditure in renal transplant recipientsalign = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http: results of a prospective, randomized clinical trial//www.||A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stentingcookmedical.||201||Renal transplant recipient||Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstructioncom/uro/dataSheet. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.|}====Adverse Events===do?id=3643 C-Flex]</u></font>{|borderalign ="2center" cellspacingbgcolor ="0" cellpadding="4" width="100%#dce6f1"| |align = "center" bgcolor = "#00CCFFdce6f1"|'''S. No.'''|align bgcolor = "center#dce6f1" | |bgcolor = "#00CCFFdce6f1"|'''Brand Name'''Double Pigtail|align = "center" bgcolor = "#00CCFFdce6f1"|'''Adverse Event'''180|align = "center" bgcolor = "#00CCFFdce6f1"|'''Date FDA Received'''[[Image:C_Flex.png|thumb|center|100px|<center>C-Flex</center>]]
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|align = "center" bgcolor = "#00CCFF"|'''1'''|align = "justifydce6f1"|<font color="#0000FF"><u>[http://www.accessdatacookmedical.fda.gov/scripts/cdrhcom/cfdocsuro/cfMAUDE/DetaildataSheet.cfmdo?MDRFOI__IDid=660847 Cook Urologicals Cook Urological Stent4692 Smith Universal]</u></font>|align = "justifycenter" bgcolor = "#dce6f1"|Stent broke into pieces while removing it from the patients body.|align = "center" bgcolor = "#dce6f1"|12|bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</14nowiki> Ureteral stent|align = "center" bgcolor = "#dce6f1"|60|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</2005center>]]
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|align = "center" bgcolor = "#00CCFFdce6f1"|'''2'''<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font>|align = "justifycenter" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdatamedicalnewstoday.fda.gov/scripts/cdrhcom/cfdocsarticles/cfMAUDE/Detail90717.CFM?MDRFOI__ID=930422 Boston Scoientific Boston Scientific Ureteral stent Systemphp Launch]</u></font>|align = "justifycenter" bgcolor = "#dce6f1"|Fractured Dec, 2007|bgcolor = "#dce6f1"|Heparin-bonded stent seen under Fluroscopy|bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|10/17/2007
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|align = "center" bgcolor = "#00CCFF"|'''36'''|align = "justifycenter"|<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/cfMAUDEcfPMN/Detailpmn.CFMcfm?MDRFOI__IDID=755260 Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CM29056 FDA 510(k)]</u></font>|align = "justifycenter"|During insertion of ureteral stentJan, the stent broke into multiple parts which were retained in the patient.2010|Hydrogel|Differentially larger end (no pigtail)|align = "center"|1030|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</14/2005center>]]
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|align = "center" bgcolor = "#00CCFFdce6f1"|'''47'''|align = "justifycenter" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdatabioteq.fdacom.govtw/scriptsen/cdrh/cfdocs/cfMAUDE/Detailproducts.CFMphp?MDRFOI__IDkind=564910 Boston Scientific 2&series=4 Bioteque Corp Boston Scientific 8 FR X 28 CM .]</font>|align = "center" bgcolor = "#dce6f1"|Ureteral Stent System KitSet|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 = "justifycenter" bgcolor = "#dce6f1"|Apr, 2010|bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|Breakage of the upper loop of the ureteral stent while trying to insert it.|align = "center" bgcolor = "#dce6f1"|130|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</5/2005center>]]
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|align = "center" bgcolor rowspan = "#00CCFF4"|'''58'''|align = "justifycenter" 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/cfMAUDEcfPMN/Detailpmn.CFMcfm?MDRFOI__IDID=522129 Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stent4353 Mesh]</u></font>|align = "justifycenter"|Broken stent observed during x-ray procedure<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font>|align = "center"|12/12Jul, 2001|Polyester mesh|Double-pigtail|align = "center"| |align = "center"| N/2003A
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|}[[Media: non patent upload.xlsalign = "center"|'''Review Articles''']]<brfont color="#0000FF"><u>[[Mediahttp: non patent upload1//www.xls|'''Non Patent Analysis''']] appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName= Products =Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font>{| {{table}}align = "center"| | align="center"|'''Boston Scientific Scimed, Inc.'''|Coil-reinforced; SL-6® hydrophilic coating|Patency Device| align="center"|'''Cook Urological Incorporated'''| align="center"|'''OptiMed Global Care'''[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]]
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| Polaris™ Ultra align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral Stent +stents Applied Standard]</u></font>| Firlit-Kluge Urethral Stentalign = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font>| Optialign = "center"|Jun, 1999|Proprietary thermoplastic elastomer material; SL-J Ureteral Stent System 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>]]
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| Polaris™ Loop align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral Stent+stents 7-10 endopyelotomy]</u></font>| Koyle Diaper Stent align = "center"| | Ureteral 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 Sets, ureterorenoscope </center>]]
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| Stretch™ VL Variable Length Flexima® Stents align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''| Silicone Universal Drainage Stentalign = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font>| Extra Strong Stent Sets 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(-Tumork)]</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>]]
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|align = "center" bgcolor = "#dce6f1"| Tarkington Urethral <font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent Set]</u></font>| Steerable Ureteral Stent Setsalign = "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>]]
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|align = "center" bgcolor = "#dce6f1"| Zaontz Urethral <font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent]</u></font>| Multilength 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>]]
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|align = "center" bgcolor = "#dce6f1"| Pediatric Urethral C<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>]]
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|} align ="center" bgcolor ="#dce6f1"|<font color= Startup activity ===* "#0000FF"><u>[http://twincitieswww.bizjournalsbardurological.com/twincitiesproducts/stories/2008/07/28/story8loadProduct.html AbbeyMoor Medical Inc.], a med-tech firm that’s developed devices for treating urological disorders, has raised $2.7 million in bridge financing. aspx?bUnitID=3&prodID= Phase 2: Deeper Dive ===== Scenario ===Client wishes to acquire a ureteral stent company. === Deal analysis for a target company ===[[Image:DealImplications.jpg|thumb|center|700px|Deal implications]226 InLay Ureteral Stent]</u></font> === Design History File Review: Review components ==={| classalign ="wikitablecenter" stylebgcolor ="font-size:90%#dce6f1" border|<font color="1#0000FF" cellpadding><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID="5" cellspacing="0" 122796 FDA 510(k)]</u></font>|- style="background:lightgrey"!align = "center" bgcolor = "#00CCFFdce6f1" width|Dec, 1998|bgcolor ="15%#dce6f1"|Review Silicone!|bgcolor = "#00CCFFdce6f1" width|Tapered tip and lubricious hydrophilic coating |align ="30%center"|Verification!bgcolor = "#00CCFFdce6f1" width| |align ="40%center"|Tasks!bgcolor = "#00CCFF" width="15%dce6f1"|Expertise[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]
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| Design input documents linked to the product performance specificationsalign = "center" rowspan = "4"|'''10'''|align = "center" rowspan = "4"|<font color="# Compare product specifications to design inputs0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font>|align = "center"|<font color="# Check whether appropriate verifications and validations are performed0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font>|align = "center"|<font color="# Establish if all specifications are linked to design inputs0000FF"><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>]]
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| Appropriate design verification and validations (DV&V) are performedalign = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font>|align = "center"| # Show DV&V criteria are based on risk management requirements|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>]]
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| Product performance specifications correspond to appropriate design output documentsalign = "center"| <font color="# Correlate design drawings with the specifications0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font>|align = "center"|<font color="# Check whether maximum dimensions, sizes etc0000FF"><u>[http://www. (with tolerancesaccessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k) are within the specified range]</u></font>|align = "center"|Oct, 2002|Silicone|''Pyatiprofilnaya'' technology |align = "center"| |align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]
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| DFMEA links appropriately to the PPSalign = "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
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| Appropriate DValign = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEApid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font>| align = "center"|<font color="# Validate the process and correlate with 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 inputs# Validate that sizes used are within range of risk mitigation criteria|align = "center"| |align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]
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| PFMEA links appropriately to the process validation protocol acceptance criteria; Inalign = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-process inspection procedures andJ]</or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEAu></font>| align = "center"|<font color="# Validate the process protocol0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font># Validate the inspection procedures used |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>]]
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| Correlate First Article Inspection data to the dimensions on the drawingsalign = "center"| <font color="# Obtain First Article Inspection data0000FF"><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="# Check if this data correlates with the completeness 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 drawingsshape with a chemically bonded wettable solution |align = "center"| |align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]
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| Linkage between component and raw material specifications and appropriate incoming inspection proceduresalign = "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="# Identify any missing documentation for inspection procedures0000FF"><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 28cm|align = "center"| |align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]
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|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 exclusive soft bladder helix
|align = "center"|
|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]
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| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materialsalign = "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"| # Review supplier audit reports for compliance|align = "center"| |Silicone|Classic Double J with open tip|align = "center"| |align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]
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| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validationsalign = "center" bgcolor = "#dce6f1"| '''13'''|align = "center" bgcolor = "# Check the entire equipment-related lifecycledce6f1"|[http://www.amecath.com/ Ameco Medical Industries]|align = "center" bgcolor = "# Check if machine operational qualification was performeddce6f1"|[http://www.amecath.com/ Amecath]|bgcolor = "# Check if the measurement equipment was validateddce6f1"|-!rowspan|bgcolor ="2#dce6f1"|Validation Report| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reportsbgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating|bgcolor = "#dce6f1"|Double loop stent|align = "center" bgcolor = "# Ensure all reports are available dce6f1"|Short-term and linked together appropriately# Identify all inconsistencies across different reportslong-term| rowspanalign ="2center" bgcolor = "#dce6f1"| Quality systems[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]
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| Design test methods and related test method validationsalign = "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
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=== Sample report ==Product to Clinical Trial Mapping===== Performance/Functional Characteristics ===={| class="wikitable" style="font-size:90%" borderClinical Timeline Visualization ="1" cellpadding="5" cellspacing="0" |- style="background[[Image:lightgrey"Timeline.jpg]]!align = "center" bgcolor = "#00CCFF" colspan = "4" |Design Input!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"[[Media:Ureteral_Stents_Timeline dw.xls|Design OutputUreteral Stent Timeline]]!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Verification Report #!align = "center" bgcolor Product to Patent Mapping = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Validation Report #!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"[[Image:Product_Patent_Mapping_Screen_Shot.png|Status 1000px|centre|thumb|'''Screenshot for the product to patent mapping(P/F/RBard and Boston)''']]* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|-'''Products from Boston Scientific and C R Bard ''']]to download the excel file.!align = "center" bgcolor = "#00CCFF" widthMapped Patent vs Not Mapped Patents =="20%"|User Needs!align = "center" bgcolor = "#00CCFF" width="15%"{|User Need Rationale!align border= "center0" bgcolor cellspacing= "#00CCFF0" widthcellpadding="20%"|Engineering Specification!align = "center" bgcolor = "#00CCFF4" width="20100%"|Engineering Specification Rationale|-[[Image:CRB_Pat.png|Provide antimicrobial resistance for up to 2 weekscenter|Ureteral Stent User Survey (Document #XXXXX)500px|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeksthumb|Document #XXXXX'''C R Bard''']]|Test Document #XXXXX[[Image:BS_pat.png.png|Report 01-005-06-007center|P500px|Report 01-005-06-007thumb|P'''Boston Scientific''']]
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=== Potential DHF Review Outcomes ===Based on a review of the above DHF documents a potential outcome for the uretral stent acquisition project could involve the following:# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.# Creation of some new test methods for design, incoming and inPatent-process inspections and also include recommendations for the test method validations. Creation of any new DV&V data would be highly unlikely as it could potentially trigger a new submission or a noteProduct-to-file to the regulatory agencies.# Change in raw materials to better grade materials e.g. Switching resin to a USP Class VI biocompatible resin. This would eliminate some on-going testing but require additional upfront one time biocompatibility testing.# Updating drawings based on results from the FAI data.# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw material specifications and inspection procedures.# Identifying installation, operational and process qualification requirements with the assumption that no additional design verification and validation activities are required based on the fact that the device is currently approved for sale in the US and ROW.# Recommend activities necessary for completing packaging, labeling, ship testing and shelf-life testing. Stress should be on being able to leverage existing data for shelf-life without changing the regulatory status of the device. # Company X may want to perform additional biocompatibility testing to create an internal baseline and also update their biocompatibility files.# Help streamline suppliers for components when switching over from Company Y to Company X. Search for existing Company X suppliers that can supply off the shelf items that Company Y may be sourcing from other vendors / suppliers.# Identify process improvements that can be rolled into the manufacturing transfer without changing the design and impacting the existing regulatory status for the device e.g. instead of hand mixing pigment to resin use a pre-mixer to control quality of mixing and resulting extrusion or perform the molding and over-molding steps in 1 machine instead of 2 separate molding machines.Clinical Trial Mapping=
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|Design align = "center integration plan" bgcolor = "#538ED5" rowspan = "4"|'''Products'''|* Gap analysis completion (acquiree)* Gap analysis completion (acquirer)'''Portfolio'''|8 Products|September 15, 20086 Products
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|Design to manufacturing transfer'''Material'''|Percuflex - Biocompatible Polymer||December 15, 2008Silicone
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|Equipment transfer'''Coating'''|Hydroplus|Milestone I payment|Jan 7, 2009Licensed from pHreecoat
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|Shut production at acquiree facility'''Shape'''|Negotiation for contract extensionPigtailed and More|Milestone II payment|Feb 15, 2009Figure 4 and more
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|Start production in acquirer facilityalign = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''|'''Current Trials'''|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)|Feb 7, 2009None
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|Switch to new SKUalign = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''|'''Coating'''|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion|Feb 15, 2009Therapeutic coatings
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|End development of new generation product/s in old facility|'''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|Feb 7, 2009Expandable stents for reducing discomfort
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|Restart development of new generation product/s post-acquisition'''Material'''|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness|Final milestone payment|Mar 1, 2009Biodegradable polymers<br>Shape memory alloys<br>General polymer based
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=== Documents and Ownership =Inference == {| classborder="wikitable2" stylecellspacing="font-size:90%" border="10" cellpadding="54" cellspacingwidth="082%" |- style="background:lightgrey"!align = "center" bgcolor = "#00CCFF538ED5" |Document!align <font size = "center4" >'''Boston Scientific'''</font>|bgcolor = "#00CCFF538ED5" |Owner!align <font size = "center4" bgcolor = "#00CCFF" |Last update date>'''C R BARD'''</font>
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|Product performance specificationsRelatively late entrant with patents filed post mid 90s|Paul Swain|07/27/2008 08:15:35 PSTEarly mover with patents filed in mid 80s
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|Component specificationsIncreased patent activity since 2000|Kevin Teller|06/12/2008 12:22:07 PSTPatent activity never gained traction
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|Preclinical test resultsLarge number of patents yet to be "productized"|Joanne Krannert|07/03/2008 14:17:00 PSTFew patents yet to be "productized"
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|Clinical testsSome products undergoing clinical trails|Joanne KrannertNo products undergoing clinical trails|08/01/2008 08:00:55 PST-|Diverse range of products with variation in material <br>and structure|Small product portfolio|-|Seem to be strengthening they market position|Seem to be moving focus away from Ureteral stents market
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= Competitive Landscape =
==Major Players==
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. 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 peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.
[[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>
|-
|}
<p align="center"> '''This is only a sample report with brief analysis''' <br>
'''Dolcera can provide a comprehensive report customized to your needs'''</p>
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