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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.
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=Clinical Trials =Urinary Problems in men and women==* Both men and women have an increased risk for urinary incontinence as they get older, with men's rates rising steadily and women's rates peaking during menopause. * The prevalence of incontinence in men of all ages is certainly lower than that for women. * Women over 70, however, are twice as likely to have urinary incontinence as men of the same age.
{|border "1" style==Market Analysis==* We determined market data to have an idea about the market potential for ureteral stents.* We have done this modeling for female population in US as women has the higher prevalence rate for urinary incontinence than men in all age groups.* Prevalence increased with age, from 28% for 30- to 39"border-year-old women to 55% for 80- to 90-year-old women.spacing:0;"* 18% of respondents reported severe UI.* The prevalence of severe UI also increased notably with age, from 8% for 30- to 39-year| style="background-old women to 33% for 80- to 90-year-old womencolor:#4f81bd;padding:0.* Among all, 9% reported slight UI, 15% reported moderate UI, 18% reported severe UI, and 58% reported no UI079cm;"|<center><font color="#FFFFFF">'''S.No. '''<BR/font></center>| style===Methodology===[[Image"background-color:methodology-ureteral stents#4f81bd;padding:0.jpg079cm;"|<center|650px]] ===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=Ureteral stent companies"4" width="100%"|align ="center" bgcolor ="#4f81bd"|'''Sr. No.'''Various companies offering ureteral stents are|align = "center" bgcolor = "#4f81bd"|'''Company'''|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''|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 (days)'''|align = "center" bgcolor = "#4f81bd"|'''Image'''|-|align = "center" bgcolor = "#dce6f1"|'''1'''|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font>|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font>|align = "center" bgcolor = "#dce6f1"|Jul, 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>]]
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| align = "center"| <font color="#0000FF"><u>[http://www.dolcerazapconnect.com/website_prodproducts/servicesindex.cfm/ip-patent-analytics-services Patent Analytics Services]|align = "center"| [http:fuseaction/products_display_detail/www.dolcera.comeregnum/8021561/owner_operator_number/website_prod8021561/servicesproduct_code/business-research-services Market Research ServicesFAD/8021561.html FDA Listing]</u></font>|align = "center"| [http://www.dolcera.com/website_prod/tools/patent-dashboard Purchase Patent Dashboard]Mar, 2004
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|align = "center" bgcolor = "#dce6f1" rowspan = "5"| '''3'''|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.dolcerafossamedical.com/website_prod/servicesnews.htm Fossa Medical]</ip-patent-analytics-servicesu></patent-search/patent-landscapes Patent Landscape Services]font>|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [http://www.dolcera.com/website_produpload/research-processes Dolcera Processesfiles/stonesweeper_fossa_trial.pdf Stone Sweeper]|align = "center" bgcolor = "#dce6f1"| <font color="#0000FF"><u>[http://www.dolcerafossamedical.com/website_prodnews.htm CE Mark]</industries Industry Focusu></font>|align = "center" bgcolor = "#dce6f1"|Sep, 2005|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent|align = "center" bgcolor = "#dce6f1" rowspan = "2"|13|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]
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|align = "center" bgcolor = "#dce6f1"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/patent-search/patent-landscapes Patent Search Services]|align <font color= "center#0000FF"| ><u>[http://www.dolcerafossamedical.com/website_prodnews.htm FDA 510(k)]</servicesu></ip-patent-analytics-services/alerts-and-updates Patent Alerting Services]font>|align = "center" bgcolor = "#dce6f1"| [http://www.dolcera.com/website_prod/tools Dolcera Tools]Aug, 2002
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|}<br>align ="center" bgcolor ="#dce6f1" rowspan = Clinical Trials ="2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]|align ="center" bgcolor ="#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=New trials PMN&ID=K033368 FDA 510(k)]</u></font>|align ="center" bgcolor =={"#dce6f1"| {{table}}Nov, 2003| alignbgcolor ="center#dce6f1" rowspan = "2"|'''Title'''Polyurethane| alignbgcolor ="center#dce6f1" rowspan = "2"|'''Conditions'''Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki>| align="center" bgcolor = "#dce6f1" rowspan = "2"|'''Intervention'''| align="center" bgcolor = "#dce6f1" rowspan = "2"|'''Sponsors and Collaborators'''[[Image:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]
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| align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://clinicaltrialswww.govfossamedical.com/ct2news.htm CE Mark]</showu></NCT00250406?termfont>|align =ureteral+stent&rank"center" bgcolor =1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]||Renal Calculi, Ureteral Obstruction||Device: Ureteral Stent|"#dce6f1"|Lawson Health Research InstituteSep, Boston Scientific Corporation2005
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|align = "center" bgcolor = "#dce6f1"| [http://clinicaltrialswww.accessdata.fda.gov/ct2scripts/showcdrh/NCT00270504cfdocs/cfPMN/PMNSimple.cfm?termdb=urethral+stentPMN&rankID=1 Memokath® 044TW K021140 Expanding Ureteral Stent for Treatment of Urethral Stricture]|align = "center" bgcolor = "#dce6f1"|Urethral Stricture<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"|Device: Memokath stentingJun, 2002|bgcolor = "#dce6f1"|Engineers & Doctors Wallsten Medical GroupPolyurethane|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki>|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| N/A
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| align = "center" rowspan = "7"|'''4'''|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://clinicaltrialswww.govbostonscientific.com/ct2Device.bsci/show,,/NCT00581178?termmethod/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font>|align =urologic+stent&rank"center"|<font color=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]"#0000FF"><u>Contour</u></font>|align = "center"|Kidney Stones|align = "center"|N\A|Percuflex - proprietary polyolefin copolymer; Hydroplus coating|University of California, IrvineFixed and variable length; Tapered tip|align = "center"|365|align = "center" |[[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/NCT00288457?termfont>|align =urologic+stent&rank"center"| |align =14 Ureteral Stent Length and Patient Symptoms]"center"||Kidney Stonesalign = "center"|Percuflex|DevicePigtail|align = "center"|365|align = "center" |[[Image: Ureteral StentPercuflex.png|thumb|Emory Universitycenter|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/NCT00166361cfdocs/cfPMN/PMNSimple.cfm?termdb=urologic+stentPMN&rankid=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral StentK010002 FDA 510(k)]</u></font>|align = "center"|Ureteral ObstructionJan, 2001|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.|DeviceDouble pigtail|align = "center"|365|align = "center" |[[Image: Memokath 051 Ureteral StentPolaris_Ultra.png|thumb|Mayo Clinic 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/NCT00739284cfdocs/cfPMN/pmn.cfm?termID=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney 10929 FDA 510(JJVsPCN08k)]</u></font>|align = "center"|Kidney DiseaseMar, 2003|Dual Durometer Percuflex with HydroPlus Coating|DeviceBladder loop design|align = "center"|365|align = "center" |[[Image: nephrostomy tube and ureteral stentPolaris_Loop.png|thumb|Rabin Medical Centercenter|100px|<center>Polaris Loop</center>]]
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|}align ="center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source= Concluded trials web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct={| {{table}}j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font>| align="center" |'''Title'''| align="center" |'''Abstract'''| align="center" Percuflex material and Hydroplus coating|'''Enrollment'''Endopyelotomy stent| align="center" |'''Disorder'''Post-procedure healing| align="center" |'''Conclusion'''[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]]
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| Longalign = "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-term outcome of permanent urethral stents in the treatment of detrusorEU/collateral/stone-sphincter dyssynergia ||To evaluate the longeu-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusorpercuflex-sphincter dyssynergiabrochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font>|align = "center"|13|align = "center"|Detrusor-sphincter dyssynergia|Hydroplus Coating|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problemVariable 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>]]
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| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstructionalign = "center"|[http: Assessment of Patient Perspectives Using Quality//dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-of-Life Survey and Utility AnalysisEluting Stent]|align = "center"|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|align = "center"| |Percuflex -related quality of life (QoL). We have compared the QoL in these 2 groups.proprietary polyolefin copolymer|Ketorolac trimethamine loaded stent|34align = "center"||Upper urinary tract obstructionalign = "center"||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.N/A
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| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.align = "center" bgcolor = "#dce6f1" rowspan = "6"||A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.||201||Renal transplant recipient||Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.'''5'''|}align ="center" bgcolor ="#dce6f1" rowspan ="6"|<font color=Adverse Events==="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font>{|borderalign ="2center" cellspacingbgcolor ="0#dce6f1" cellpadding|<font color="4#0000FF" width><u>[http://www.cookmedical.com/uro/dataSheet.do?id="100%"4418 Resonance]</u></font>|align = "center" bgcolor = "#00CCFFdce6f1"|'''S<font color="#0000FF"><u>[http://www. Noaccessdata.'''fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font>|align = "center" bgcolor = "#00CCFFdce6f1"|May, 2007|bgcolor = "#dce6f1"|Metal|bgcolor = "#dce6f1"|'''Brand Name'''|align = "center" bgcolor = "#00CCFFdce6f1"|'''Adverse Event'''365|align = "center" bgcolor = "#00CCFFdce6f1"|'''Date FDA Received'''[[Image:Resonance.png|thumb|center|100px|<center>Resonance</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 Stent2055 Sof-flex]</u></font>|align = "justifycenter" bgcolor = "#dce6f1"|Stent broke into pieces while removing it from the patients body.|align = "center" bgcolor = "#dce6f1"|12|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning |align = "center" bgcolor = "#dce6f1"|180|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</14/2005center>]]
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|align = "center" bgcolor = "#00CCFF"|'''2'''|align = "justifydce6f1"|<font color="#0000FF"><u>[http://www.accessdatacookmedical.fda.gov/scriptscom/cdrhuro/cfdocs/cfMAUDE/DetaildataSheet.CFMdo?MDRFOI__IDid=930422 Boston Scoientific Boston Scientific Ureteral stent System3627 Endo-Sof]</u></font>|align = "justifycenter" bgcolor = "#dce6f1"|Fractured stent seen under Fluroscopy|align = "center" bgcolor = "#dce6f1"|10|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</17/2007center>]]
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|align = "center" bgcolor = "#00CCFF"|'''3'''|align = "justifydce6f1"|<font color="#0000FF"><u>[http://www.accessdatacookmedical.fda.gov/scripts/cdrhcom/cfdocsuro/cfMAUDE/DetaildataSheet.CFMdo?MDRFOI__IDid=755260 Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CM3643 C-Flex]</u></font>|align = "justifycenter" bgcolor = "#dce6f1"|During insertion of ureteral stent, the stent broke into multiple parts which were retained in the patient.|align = "center" bgcolor = "#dce6f1"|10|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</14/2005center>]]
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|align = "center" bgcolor = "#00CCFF"|'''4'''|align = "justifydce6f1"|<font color="#0000FF"><u>[http://www.accessdatacookmedical.fda.gov/scripts/cdrh/cfdocscom/cfMAUDEuro/DetaildataSheet.CFMdo?MDRFOI__IDid=564910 Boston Scientific Corp Boston Scientific 8 FR X 28 CM Ureteral Stent System Kit4692 Smith Universal]</u></font>|align = "justifycenter" bgcolor = "#dce6f1"|Breakage of the upper loop of the ureteral |align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent while trying to insert it.|align = "center" bgcolor = "#dce6f1"|160|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</5/2005center>]]
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|align = "center" bgcolor = "#00CCFFdce6f1"|'''5'''<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=522129 Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stentphp Launch]</u></font>|align = "justifycenter" bgcolor = "#dce6f1"|Broken stent observed during xDec, 2007|bgcolor = "#dce6f1"|Heparin-ray procedure.bonded stent|bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|12/12/2003
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|}[[Media: non patent upload.xlsalign = "center"|'''Review Articles6''']|align = "center"|<font color="#0000FF">[http://qurological.com/product/ Q Urological]<br/font>|align = "center"|<font color="#0000FF"><u>[[Mediahttp: non patent upload1//qurological.xls|'''Non Patent Analysis'''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= Products ==={| {{table}}29056 FDA 510(k)]</u></font>| align="center"|'''Boston Scientific ScimedJan, Inc.'''2010|Hydrogel|Differentially larger end (no pigtail)| align="center"|'''Cook Urological Incorporated'''30| align="center"|'''OptiMed Global Care'''[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]]
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| Polaris™ Ultra Ureteral Stent align = "center" bgcolor = "#dce6f1"|'''7'''| Firlit-Kluge Urethral Stentalign = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font>| Opti-J align = "center" bgcolor = "#dce6f1"|Ureteral Stent System 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>]]
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| Polaris™ Loop 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 Stent+stents Applied Medical Resources, CA, USA]</font>| Koyle Diaper Stent align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 Mesh]</u></font>| Ureteral Stent Setsalign = "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, ureterorenoscope 2001|Polyester mesh|Double-pigtail|align = "center"| |align = "center"| N/A
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| Stretch™ VL Variable Length Flexima® Stents 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>| Silicone Universal Drainage Stentalign = "center"| | Extra Strong Stent Sets (align = "center"| |Coil-Tumor)reinforced; SL-6® hydrophilic coating|Patency Device|align = "center"| |align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]]
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|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>| Tarkington Urethral Stent Setalign = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font>| Steerable Ureteral Stent Setsalign = "center"|Jun, 1999|Proprietary thermoplastic elastomer material; 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>]]
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|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>| Zaontz Urethral Stentalign = "center"| | Multilength 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>]]
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|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''| Pediatric Urethral C-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>|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>]]
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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]227 Bardex® Double Pigtail Soft 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" 8912 FDA 510(k)]</u></font>|- style="background:lightgrey"!align = "center" bgcolor = "#00CCFFdce6f1" width|Jan, 2003|bgcolor ="15%#dce6f1"|Review Silicone!|bgcolor = "#00CCFFdce6f1" width|Attached with suture for ease of removal|align ="30%center"|Verification!bgcolor = "#00CCFFdce6f1" width| |align ="40%center"|Tasks!bgcolor = "#00CCFF" width="15%dce6f1"|Expertise[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]
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| Design input documents linked to the product performance specificationsalign = "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 = "# Compare product specifications to design inputsdce6f1"| |bgcolor = "# Check whether appropriate verifications and validations are performeddce6f1"|Silicone|bgcolor = "# Establish if all specifications are linked to dce6f1"|Three dimensional design inputs|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]
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| Appropriate design verification and validations (DValign = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&VprodID=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) are performed]</u></font>| align = "center" bgcolor = "#dce6f1"|Apr, 1991|bgcolor = "# Show DV&V criteria are based on risk management requirementsdce6f1"|Silicone|bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]
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| Product performance specifications correspond to appropriate design output documentsalign = "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="# Correlate design drawings with the specifications0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font>|align = "center"|<font color="# Check whether maximum dimensions, sizes etc0000FF"><u>[http://www. accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(with tolerancesk) are within the specified range]</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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| DFMEA links appropriately to the PPSalign = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font>|align = "center"| # Verify whether DFMEA and product specifications are correlated|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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| Appropriate DValign = "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&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEAsource=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 = "# Validate the process and correlate dce6f1"|Jul, 1999|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with design inputshydrogel coating|bgcolor = "# Validate that sizes used are within range of risk mitigation criteriadce6f1"| Directable and detachable|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]
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| PFMEA links appropriately to the process validation protocol acceptance criteria; Inalign = "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-process inspection procedures andtip]</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></or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEAfont>|align = "center"|Dec, 1986
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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=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font>|align = "center"|<font color="# Check if this data correlates with the completeness of drawings0000FF"><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>]]
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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=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</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=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>]]
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|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>]]
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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=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font>|align = "center"|<font color="# Review supplier audit reports for compliance0000FF"><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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| Calibration records and preventive maintenance records; inalign = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-process curl]</ incoming inspection test methods and related test method validationsu></font>|align = "center"| # Check the entire equipment|align = "center"| |Tecoflex®|Dual-related lifecycledurometer design and exclusive soft bladder helix # Check if machine operational qualification was performed|align = "center"| # Check if the measurement equipment was validated|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]
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| Design test methods 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 related test method validationslong-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
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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>
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|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>
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|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>
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|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>
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<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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