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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-year-old women to 55% for 80"border- 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| style="background-year-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:methodology"background-ureteral stentscolor:#4f81bd;padding:0.jpg079cm;"|<center|650px]] ===Prevalence rate in US (women)==><font color="#FFFFFF">'''Title '''</font></center>{|border="2" cellspacingstyle="background-color:#4f81bd;padding:0.079cm;" cellpadding|<center><font color="4" width="100%#FFFFFF">'''Conditions '''</font></center>|align style= "centerbackground-color:#4f81bd;padding:0.079cm;" bgcolor | <center><font color= "#4F81BDFFFFFF" colspan >'''Intervention: Device'''</font></center>| style= "2background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Prevalence of Urinary Incontinence in US (women)Sponsors and Collaborators '''</font></center>
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|align style= "background-color:#dce6f1;padding:0.079cm;"| <center>1</center>| style=" bgcolor background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]| style= "background-color:#D3DFEEdce6f1;padding:0.079cm;"|Age (in yrs)Renal Calculi, Ureteral Obstruction|align style= "centerbackground-color:#dce6f1;padding:0.079cm;" bgcolor | Ureteral Stent| style= "background-color:#D3DFEEdce6f1;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= "centerbackground-color:#dce6f1;padding:0.079cm;" bgcolor | <center>3</center>| style= "background-color:#D3DFEEdce6f1;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;" bgcolor | N\A| style= "background-color:#D3DFEEdce6f1;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= "centerbackground-color:#dce6f1;padding:0.079cm;" bgcolor | <center>5</center>| style= "background-color:#D3DFEEdce6f1;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;" bgcolor |Memokath 051 Ureteral Stent| style= "background-color:#D3DFEEdce6f1;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=" bgcolor background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style= "background-color:#D3DFEEdce6f1;padding:0.079cm;"|80To evaluate the long-90term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|align | style= "centerbackground-color:#dce6f1;padding:0.079cm;" bgcolor |13|| style= "background-color:#D3DFEEdce6f1;padding:0.079cm;"|54%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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{|border="2" cellspacing="0" cellpadding="4" width="100%"|align style= "background-color:#4f81bd;padding:0.079cm;"|<center><font color=" bgcolor #FFFFFF">'''S.No. '''</font></center>| style= "background-color:#4F81BD4f81bd;padding:0.079cm;" colspan |<center><font color= "6#FFFFFF">'''Company '''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Market potential for ureteral stents in US women, 2009Device '''</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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|bgcolor style= "background-color:#D3DFEEdce6f1;padding:0.079cm;"|<center>'''1. Age groups'''<br/center>|bgcolor style= "background-color:#D3DFEEdce6f1;padding:0.079cm;"|2<center>[http://www. Female populationbardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]<br/center>(from US census data)|bgcolor style= "background-color:#D3DFEEdce6f1;padding:0.079cm;"|3<center>[[Image:InLay_Optima. Prevalence rate in female (%)png|thumb|align = "center" bgcolor = "#D3DFEE"|4. Market potential100px|<brcenter>(total prevalence)InLay Optima<br/center>(2|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <nowikicenter>*InLay Optima</nowikicenter>3)]]]|bgcolor style= "background-color:#D3DFEEdce6f1;padding:0.079cm;"|5<center>[http://www. Catherization rate accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(%k)]<br/center>|align style= "background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center>| style=" bgcolor background-color:#dce6f1;padding:0.079cm;"| Silicone| style= "background-color:#D3DFEEdce6f1;padding:0.079cm;"|6Double pigtail with monofilament suture loop| style="background-color:#dce6f1;padding:0. Stent market based on catherization rate079cm;"| <brcenter>(4<nowiki>*365</nowikicenter>5)
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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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|bgcolor style= "background-color:#D3DFEEdce6f1;padding:0.079cm;"|40<center>'''3'''</center>| style="background-49color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center>|bgcolor style= "background-color:#D3DFEEdce6f1;padding:0.079cm;"|22074384[[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]|bgcolor style= "background-color:#D3DFEEdce6f1;padding:0.079cm;"|41%<center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center>|bgcolor style= "background-color:#D3DFEEdce6f1;padding:0.079cm;"|9050497<center>May 2007</center>|bgcolor style= "background-color:#D3DFEEdce6f1;padding:0.079cm;"|Metal| style="background-color:#dce6f1;padding:0.123%079cm;"| Temporary stenting|bgcolor style= "background-color:#D3DFEEdce6f1;padding:0.079cm;"|11132<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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|bgcolor style= "#D3DFEE"|60-69|bgcolor = "#D3DFEE"|14605565|bgcolor = "#D3DFEE"|51%|bgcolor = "#D3DFEE"|7448838|bgcolor = "#D3DFEE"|padding:0.160%|bgcolor = "#D3DFEE079cm;"|11918|-|70-79|9046207|55%|4975414|0<center>[http://www.fossamedical.172%com/news.htm CE Mark]</center>|8558|-|bgcolor style= "#D3DFEE"|≥ 80|bgcolor = "#D3DFEE"|7216598|bgcolor = "#D3DFEE"|54%|bgcolor = "#D3DFEE"|3896963|bgcolor = "#D3DFEE"|padding:0.044%|bgcolor = "#D3DFEE079cm;"|1715<center>Sep 2005</center>|-|'''Total'''| | |'''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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=Products=
{|border="2" cellspacing="0" cellpadding=Ureteral stent market forecast in US "4" width="100%"|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''|align = "center" bgcolor = "#4f81bd"|'''Company'''|align = "center" bgcolor = "#4f81bd"|'''Device(womens)'''|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"|[Imagehttp://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 market forecast1|align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|600px100px|<center>Allium</center>]]
|-|align ="center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font>|align =Ureteral "center"|Mar, 2004|-|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font>|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font>|align = "center" bgcolor = "#dce6f1"|Sep, 2005|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane|bgcolor = "#dce6f1" rowspan = "2"|Radially expanding stent companies|align ="center" bgcolor ="#dce6f1" rowspan ="2"|13Various companies offering ureteral stents are|rowspan = "2" bgcolor = "#dce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Stone Sweeper</center>]]
|-|align ="center" bgcolor ="#dce6f1" rowspan ="2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=Ureteral stents of various companiesPMN&ID=K033368 Open lumen stent]|align ="center" bgcolor ="#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font>|align ="center" bgcolor ="#dce6f1"|Nov, 2003|bgcolor =Boston Scientific"#dce6f1" rowspan ="2"|Polyurethane|bgcolor ="#dce6f1" rowspan ="2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki>|align ="center" bgcolor ="#dce6f1" rowspan = "2"| * Contour VL Variable Length Percuflex Stents|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.png|thumb|center|100px|<BRcenter>Inward spiral design of Nautilus Coil minimizes tissue contact for enhanced comfort. Dual variable length coil geometry permits balanced stent positioning to minimize the risk of migration. HydroPlus Coating provides unequalled surface lubricity which reduces friction to minimize risk of buckling during introduction and placement and to reduce risk of trauma and encrustation.Open_lumen</center>]]
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| align = "center" bgcolor = "#dce6f1"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services Patent Analytics Services]|align <font color= "center#0000FF"| ><u>[http://www.dolcerafossamedical.com/website_prodnews.htm CE Mark]</servicesu></business-research-services Market Research Services]font>|align = "center" bgcolor = "#dce6f1"| [http://www.dolcera.com/website_prod/tools/patent-dashboard Purchase Patent Dashboard]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 Landscape ServicesPMNSimple.cfm?db=PMN&ID=K021140 Expanding Ureteral Stent]|align = "center" bgcolor = "#dce6f1"| <font color="#0000FF"><u>[http://www.dolceraaccessdata.comfda.gov/website_prodscripts/research-processes Dolcera Processescdrh/cfdocs/cfPMN/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/industries Industry Focus]A
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|align = "center" rowspan = "7"| '''4'''|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.dolcerabostonscientific.com/website_prodDevice.bsci/services,,/ip-patent-analytics-servicesmethod/patent-searchDevHome/patent-landscapes Patent Search ServicesnavRelId/1000.1003/seo.serve Boston Scientific]</u></font>|align = "center"| [http:<font color="#0000FF"><u>Contour</u></www.dolcera.com/website_prod/services/ip-patent-analytics-services/alertsfont>|align = "center"| |align = "center"| |Percuflex -proprietary polyolefin copolymer; Hydroplus coating|Fixed and-updates Patent Alerting Services]variable length; Tapered tip|align = "center"|365|align = "center"| [http[Image://wwwContour.dolcera.compng|thumb|center|100px|<center>Contour</website_prod/tools Dolcera Toolscenter>]]
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|}align = "center"|<brfont color="#0000FF"><u>Percuflex</u></font>|align === Clinical Trials =======New trials ===={"center"| {{table}}| align="center"|'''Title'''| align="center"|'''Conditions'''Percuflex|Pigtail| align="center"|'''Intervention'''365| align="center"|'''Sponsors and Collaborators'''[[Image:Percuflex.png|thumb|center|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/NCT00250406cfdocs/cfPMN/PMNSimple.cfm?termdb=ureteral+stentPMN&rankid=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm FormationK010002 FDA 510(k)]</u></font>|align = "center"|Renal CalculiJan, Ureteral Obstruction2001|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.|DeviceDouble pigtail|align = "center"|365|align = "center" |[[Image: Ureteral StentPolaris_Ultra.png|thumb|Lawson Health Research Institute, Boston Scientific Corporationcenter|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/NCT00270504cfdocs/cfPMN/pmn.cfm?termID=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture10929 FDA 510(k)]</u></font>|align = "center"|Urethral StrictureMar, 2003|Dual Durometer Percuflex with HydroPlus Coating|DeviceBladder loop design|align = "center"|365|align = "center" |[[Image: Memokath stentingPolaris_Loop.png|thumb|Engineers & Doctors Wallsten Medical Groupcenter|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/NCT00581178?termwww.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=urologic+stentj&rankq=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustationpercuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font>|align = "center"|Kidney Stones|align = "center"|N\A|Percuflex material and Hydroplus coating|University of California, IrvineEndopyelotomy stent|align = "center"|Post-procedure healing|align = "center" |[[Image:Retromax_plus.png|thumb|center|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/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 Stretch VL Flexima]</u></font>|align = "center"|Kidney Stones|align = "center"|Device|Hydroplus Coating|Variable length coil on distal and proximal ends|align = "center"|90|align = "center" |[[Image: Ureteral StentStretch_VL_Flexima.png|thumb|Emory Universitycenter|100px|<center>Stretch VL Flexima</center>]]
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|align = "center"| [http://clinicaltrialsdolcera.govcom/ct2upload/showfiles/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]|align = "center"|Ureteral Obstruction|align = "center"|Device: Memokath 051 Ureteral Stent|Percuflex - proprietary polyolefin copolymer|Mayo Clinic Engineers & Doctors Wallsten Medical GroupKetorolac trimethamine loaded stent|align = "center"||align = "center"| N/A
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| align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://clinicaltrialswww.gov/ct2cookmedical.com/showuro/NCT00739284familyListingAction.do?termfamily=urologicUreteral+stent&rankStents Cook Medical]</font>|align =15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font>|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(JJVsPCN08k)]</u></font>|align = "center" bgcolor = "#dce6f1"|Kidney DiseaseMay, 2007|bgcolor = "#dce6f1"|DeviceMetal|bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|365|align = "center" bgcolor = "#dce6f1"|[[Image: nephrostomy tube and ureteral stentResonance.png|thumb|Rabin Medical Centercenter|100px|<center>Resonance</center>]]
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|}align ="center" bgcolor ="#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id= Concluded trials 2055 Sof-flex]</u></font>|align ="center" bgcolor ==={"#dce6f1"| {{table}}| align="center" bgcolor = "#dce6f1" |'''Title'''| alignbgcolor ="center#dce6f1" |'''Abstract'''AQ® Hydrophilic Coating| alignbgcolor ="center#dce6f1" |'''Enrollment'''Radiopaque tip and tether for repositioning | align="center" bgcolor = "#dce6f1" |'''Disorder'''180| align="center" bgcolor = "#dce6f1" |'''Conclusion'''[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</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=3627 Endo-sphincter dyssynergia Sof]</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 problemDouble pigtail|align = "center" bgcolor = "#dce6f1"|365|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</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=3643 C-Flex]</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)|bgcolor = "#dce6f1"|Double Pigtail|align = "center" bgcolor = "#dce6f1"|180|align = "center" bgcolor = "#dce6f1"|[[Image:C_Flex. However, based on the EuroQol analysis, there is no significant difference in the gross impact on the healthpng|thumb|center|100px|<center>C-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.Flex</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=4692 Smith Universal]</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'''Nephrostomy tube <nowiki>+</nowiki> Ureteral stent|align = "center" bgcolor = "#00CCFFdce6f1"|'''Adverse Event'''60|align = "center" bgcolor = "#00CCFFdce6f1"|'''Date FDA Received'''[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]]
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|align = "center" bgcolor = "#00CCFFdce6f1"|'''1'''<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/scriptscom/cdrharticles/cfdocs/cfMAUDE/Detail90717.cfm?MDRFOI__ID=660847 Cook Urologicals Cook Urological Stentphp Launch]</u></font>|align = "justifycenter" bgcolor = "#dce6f1"|Dec, 2007|bgcolor = "#dce6f1"|Heparin-bonded stent|bgcolor = "#dce6f1"|Stent broke into pieces while removing it from the patients body.|align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|12/14/2005
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|align = "center" bgcolor = "#00CCFF"|'''26'''|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=930422 Boston Scoientific Boston Scientific Ureteral stent System29056 FDA 510(k)]</u></font>|align = "justifycenter"|Fractured stent seen under FluroscopyJan, 2010|Hydrogel|Differentially larger end (no pigtail)|align = "center"|1030|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</17/2007center>]]
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|align = "center" bgcolor = "#00CCFFdce6f1"|'''37'''|align = "justifycenter" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdatabioteq.fdacom.govtw/scriptsen/cdrhproducts.php?kind=2&series=4 Bioteque Corp.]</cfdocsfont>|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/cfMAUDEen/Detailnews_detail.CFMphp?MDRFOI__IDid=755260 Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CM1&query_string= FDA 510(k) ]</u></font>|align = "justifycenter" bgcolor = "#dce6f1"|During insertion of ureteral stentApr, the stent broke into multiple parts which were retained in the patient.2010|bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|1030|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</14/2005center>]]
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|align = "center" bgcolor rowspan = "#00CCFF4"|'''48'''|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=564910 Boston Scientific Corp Boston Scientific 8 FR X 28 CM Ureteral Stent System Kit4353 Mesh]</u></font>|align = "justifycenter"|Breakage of the upper loop of the ureteral stent while trying to insert it<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font>|align = "center"|1/5Jul, 2001|Polyester mesh|Double-pigtail|align = "center"| |align = "center"| N/2005A
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|align = "center" bgcolor = "#00CCFF"|'''5'''|align = "justify"|<font color="#0000FF"><u>[http://www.accessdataappliedmed.fda.govcom/scriptsproducts/cdrh/cfdocs/cfMAUDE/Detailproduct_card.CFMaspx?MDRFOI__IDsection=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=522129 Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stent+stents Silhouette ]</u></font>|align = "justifycenter"|Broken stent observed during x|align = "center"| |Coil-ray procedure.reinforced; SL-6® hydrophilic coating|Patency Device|align = "center"|12|align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</12/2003center>]]
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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 Applied Standard]</u></font>{| {{table}}align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font>| align="center"|'''Boston Scientific ScimedJun, Inc.'''1999|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating|Unique wall construction and enlarged drainage holes | align="center"|'''Cook Urological Incorporated'''| align="center"|'''OptiMed Global Care'''[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</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 7-10 endopyelotomy]</u></font>| Firlit-Kluge Urethral Stentalign = "center"| | Optialign = "center"| |Proprietary thermoplastic elastomer material; SL-J Ureteral 6® hydrophilic coating|Dual Diameter stent|align = "center"| |align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent System </center>]]
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| Polaris™ Loop Ureteral Stentalign = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''| Koyle Diaper Stent align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font>| Ureteral Stent Setsalign = "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, ureterorenoscope 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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| Stretch™ VL Variable Length Flexima® Stents align = "center" bgcolor = "#dce6f1"| Silicone Universal Drainage <font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font>| Extra Strong Stent Sets align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(-Tumork)]</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"| Tarkington Urethral <font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=228 Fluoro-4 Silicone Ureteral Stent Set]</u></font>| Steerable Ureteral Stent Setsalign = "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"| Zaontz Urethral <font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font>| Multilength 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"| Pediatric Urethral C-<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font>|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font>|align = "center" bgcolor = "#dce6f1"|Dec, 1998|bgcolor = "#dce6f1"|Silicone|bgcolor = "#dce6f1"|Tapered tip and lubricious hydrophilic coating |align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]
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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]229 Urinary Diversion 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" 86128 FDA 510(k)]</u></font>|- style="background:lightgrey"!align = "center" bgcolor = "#00CCFFdce6f1" width|Apr, 1991|bgcolor ="15%#dce6f1"|Review Silicone!|bgcolor = "#00CCFFdce6f1" width| |align ="30%center"|Verification!bgcolor = "#00CCFFdce6f1" width| |align ="40%center"|Tasks!bgcolor = "#00CCFF" width="15%dce6f1"|Expertise[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]
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| Design input documents linked to the product performance specificationsalign = "center"|<font color="# Compare product specifications to design inputs0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font>|align = "center"|<font color="# Check whether appropriate verifications and validations are performed0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font># Establish if all specifications are linked to design inputs|align = "center"|Oct, 1998|Silicone|Extreme flexibility|align = "center"| |align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]
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| Appropriate design verification and validations (DV&Valign = "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) are performed]</u></font>| align = "center"|Oct, 2002# Show DV&V criteria are based on risk management requirements|Silicone|''Pyatiprofilnaya'' technology |align = "center"| |align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]
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| Product performance specifications correspond to appropriate design output documentsalign = "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 = "# Correlate design drawings with the specificationsdce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font>|align = "center" bgcolor = "# Check whether maximum dimensions, sizes etcdce6f1"|<font color="#0000FF"><u>[http://www. accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(with tolerancesk) are within the specified range]</u></font>|align = "center" bgcolor = "#dce6f1"|Jul, 1999|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating|bgcolor = "#dce6f1"| Directable and detachable|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]
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| DFMEA links appropriately to the PPSalign = "center"| <font color="# Verify whether DFMEA and 0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product specifications are correlated&pid=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font>|align = "center"|Mar, 1996|Tecoflex® construction|Balanced-curled double pigtail design|align = "center"| |align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]
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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=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font>| align = "center"|<font color="# Validate the process and correlate with design inputs0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font># Validate that sizes used are within range of risk mitigation criteria|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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| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures andalign = "center"|<font color="#0000FF"><u>[http:/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA/www.gyrusacmi.com/user/display.cfm?display=product&pid=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font>|align = "center"| # Validate the process protocol|align = "center"| # Validate the inspection procedures used |Tecoflex® |Grooved design|align = "center"| |align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]
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| Correlate First Article Inspection data to the dimensions on the drawingsalign = "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"| # Obtain First Article Inspection data|align = "center"| # Check if this data correlates |Tecoflex®|Two durometers with the completeness of drawingshelical kidney curls|align = "center"| |align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]
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| Linkage between component 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 raw material specifications and appropriate incoming inspection proceduresexclusive soft bladder helix |align = "center"| # Identify any missing documentation for inspection procedures|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]
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|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font>
|align = "center"|
|align = "center"|
|Silicone
|Classic Double J with open tip
|align = "center"|
|align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]
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| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materialsalign = "center" bgcolor = "#dce6f1"|'''13'''| align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]|align = "center" bgcolor = "# Review supplier audit reports for compliancedce6f1"|[http://www.amecath.com/ Amecath]|bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating|bgcolor = "#dce6f1"|Double loop stent|align = "center" bgcolor = "#dce6f1"|Short-term and long-term|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]
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| Calibration records and preventive maintenance records; inalign = "center"|'''14'''|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-process Movaco (C.R. Bard subsidiary)]|align = "center"|[http:/ incoming inspection test methods and related test method validations/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 ==
{|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'''
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| stylebgcolor ="background-color:#ffcc99;padding:0.079cm;4f81bd"| <center>'''1Boston Scientific'''</center>| style="background-color:#ccffff;padding:0.079cm;"7800| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center>661| style="background-color:#ccffff;padding:08.079cm;"48| <center>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 InLay Optima]</center>| stylefont color="background-color:#ccffff;padding:0.079cm;0000FF"| ><centeru>[http://www.accessdatabostonscientific.fda.govcom/scriptstemplatedata/cdrhimports/cfdocsMicrosite/cfPMNStone/pmn.cfm?ID=16869 FDA 510(k)]<collateral/center>| style="backgroundPercuflex-color:#ccffff;padding:0Brochure.079cm;"| <center>Dec 2004pdf Boston_portfolio]</centeru>| style="background-color:#ccffff;padding:0.079cm;"| Silicone| style="background-color:#ccffff;padding:0.079cm;"| Double pigtail with monofilament suture loop| style="background-color:#ccffff;padding:0.079cm;"| <center>365</centerfont>| style="background-color:#ccffff;padding:0.079cm;"| [[Image:InLay_Optima.png|thumb|center|200px|<center>InLay Optima</center>]]
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| stylebgcolor ="background-color:#ffcc99;padding:0.079cm;4f81bd"| <center>'''2CR BARD'''</center>| style="padding:0.079cm;"2700| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center>702| style="padding:026.079cm;"00| <center>[http://www.bostonscientific.com/urology-stone/product.html?methodfont color=product_detail∏uct_id=10122561"#initialLoad1() Polaris Loop]</center0000FF">| style="padding:0.079cm;"| <centeru>[httphttps://wwwdolcera.accessdata.fda.govnet/scriptsteamwiki_prod/cdrhindex.php/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)BARD_portfolio BARD_portfolio]</centeru>| style="padding:0.079cm;"| <center>Mar 2003</centerfont>| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating| style="padding:0.079cm;"| Bladder loop design| style="padding:0.079cm;"| <center>365</center>| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|200px|<center>Polaris Loop</center>]]
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| stylebgcolor ="background-color:#ffcc99;padding:0.079cm;4f81bd"| <center>'''3Cook Medical'''</center>| style="background-color:#ccffff;padding:0.079cm;"1700| <centernowiki>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]-</centernowiki>| style="background-color:#ccffff;padding:0.079cm;"| <centernowiki>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]-</centernowiki>| style<font color="background-color:#ccffff;padding:0.079cm;0000FF"| ><centeru>[http://www.accessdatacookmedical.fda.govcom/scriptsuro/cdrh/cfdocs/cfPMN/pmnfamilyListingAction.cfmdo?IDfamily=23620 FDA 510(k)Ureteral+Stents Cook_portfolio]</centeru>| style="background-color:#ccffff;padding:0.079cm;"| <center>May 2007</centerfont>| style="background-color:#ccffff;padding:0.079cm;"| Metal| style="background-color:#ccffff;padding:0.079cm;"| Temporary stenting| style="background-color:#ccffff;padding:0.079cm;"| <center>365</center>| style="background-color:#ccffff;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|200px|<center>Resonance</center>]]
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| stylebgcolor ="background-color:#ffcc99;padding:0.079cm;" rowspan="24f81bd"| <center>'''4Medline'''</center>| style="padding:0.079cm;" rowspan="2"4040| <centernowiki>[http://www.fossamedical.com/news.htm Fossa Medical]-</centernowiki>| style="padding:0.079cm;" rowspan="2"| <centernowiki>[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]-</centernowiki>| style<font color="padding:0.079cm;#0000FF"| ><centeru>[http://www.fossamedicalmedline.com/news.htm FDA 510(k)]<irj/center>| style="padding:0.079cm;"| <center>Aug 2002<catalog/center>| stylesearch?initialSearchTerms="padding:0.079cm;" rowspan="2"| Polyurethane| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent| style="padding:0.079cm;" rowspan="2"| <center>13ureteral%20stent Medline_portfolio]</centeru>| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|200px|<center>Stone Sweeper</centerfont>]]
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| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center>| style="padding:0.079cm;"| <center>Sep 2005</center>}
<p align="center"> '''This is only a sample report with brief analysis''' <br>
'''Dolcera can provide a comprehensive report customized to your needs'''</p>
=== Product to Patent Mapping ===Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''here '''Backup]]to download the excel file.=