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* Ureteral stent: resists migration, resists fragmentation, '''''What is kink resistant and radiopaque.* Bacterial colonization: antimicrobial activity for up to two weeks.* Patient Comfort: it?''''' A ureteral stent has is a low coefficient specially designed hollow tube, made of fiiction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comforta flexible plastic material that is placed in the ureter.
{|border "1" style====Obstruction====Obstruction of urine flow and urinary tract sepsis can result in continued growth of the biofilm. Colonization of devices implanted in the urinary tract can lead to dysfunction, tissue intolerance, pain, subclinical or overt infection and even urosepsis. Device related infections are difficult totreat and device removal is usually necessary. The biofilm has been found to impede the diffusion of antibiotics"border-spacing:0; in addition, the bacteria in the biofilm have a decreased metabolic rate , which also protects them against the effects of antibiotics (Wollin et al., 1998). Riedl, et al. (1 999) found 100% ureteral stent colonization rates in permanent and 69.3% in temporary stents. Antibiotic prophylaxis did not prevent bacterial colonization and it was recommended that it not be used.On the other hand, Tieszer, et al. (1 998) believe that fluoroquinolones can prevent infection. They also have found that some stents have denser encrustation than others, however, the stent material did not change the elements of the "conditioning film" adsorbed or alter its receptivity tobacterial biofilms. | style====Infection====The predictive value of urine cultures in the assessment of stent colonization was examined in 65 patients with indwelling ureteral stents. It was found that a sterile urine culture did not rule out the stent itself being colonized (Lifshitz, et al., 1999). Patients with sterile urine culturemay benefit from prophylactic antibiotics; however, the authors contended that the antibiotics must work against gram"background-negative uropathogens and gram-positive bacteria including enterococci.It is obvious that there is controversy in the literature whether prophylactic systemic antibiotics are useful with ureteral stent implant. However, antibiotics do not seem to prevent stent colonization. Denstedt et al. (1998) have found that ciprofloxacin, with a 3 day burst every 2weeks, actually is adsorbed onto the stent which makes longer term treatment possible with reduced risk of bacterial resistance. There has been research targeted at coating or impregnating urinary catheters with antimicrobials and products are on the market, however, there are no antimicrobial ureteral stents approved by the FDA. === The market need ===It is clear that there is a need for a new material that will be able to resist encrustation and infection in the urinary tract. According to Merrill Lynch, ureteral stents represent an $80 MMUS market. Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player. There are a number of other small contenders. The use of ureteral stents is increasingcolor:#4f81bd; the indications for ureteral stenting have broadened from temporary or permanent relief or ureteric obstruction to include temporary urinary diversion following surgical procedures such as endopyelotomy and ureteroscopy and facilitation of stone clearance after ESWL (Tolley, 2000). The use of ureteral stents for patients having ESWL for renal calculi is however controversial and seems to be related to the size of the stones and invasiveness of the procedure. According to survey results reported by Hollowell, et al. (2000), there is a significant difference in opinion concerning the use of stents with ESWL. The number of ureteral stents used in patients with stones 2 cm or less treated with ESWL is significant in spite of the lack scientific evidence in support of this practice. Of 1,029 urologists returning surveys, for patients with renal pelvic stones 10, 15 or 20 rnm treated with ESWL, routine stent placement was preferred by 25.3%, 57.1 % and 87.1 %, respectively. Urologists recommend using ureteroscopy rather than ESWL for distal ureteral calculi 5-1 padding:0 mm. =079cm;"|<center><font color==Market Data===* We determined market data to have an idea about the market potential for ureteral stents"#FFFFFF">'''S.* This data is for women in US in different age groups and having different level of severityNo.'''</font></center>* Prevalence increased with age, from 28% for 30| style="background- to 39-year-old women to 55% for 80- to 90-year-old womencolor:#4f81bd;padding:0.* 18% of respondents reported severe UI.* The prevalence of severe UI also increased notably with age, from 8% for 30- to 39-year-old women to 33% for 80- to 90-year-old women.* Among all, 9% reported slight UI, 15% reported moderate UI, 18% reported severe UI, and 58% reported no UI.079cm;"| <BRcenter><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= "background-color:#4f81bd;padding:0.079cm;"| <center" colspan ><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 || style="background-color:#dce6f1;padding:0.079cm;"|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.|align -| style= "centerpadding:0.079cm;"|54%<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=" colspan #FFFFFF">'''S.No. '''</font></center>| style= "6background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Market potential for ureteral stents in US, 2009 Company '''</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 (Femaledays)'''</font></center>
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|align style= "centerbackground-color:#dce6f1;padding:0.079cm;"|Age groups<center>'''1'''</center>|align style= "centerbackground-color:#dce6f1;padding:0.079cm;"|Female population<center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center>|align 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;"|Market potential<center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center>|align style= "background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center>| style="background-color:#dce6f1;padding:0.079cm;"|Stent market based in catherization rateSilicone|align style= "centerbackground-color:#dce6f1;padding:0.079cm;"|Prevalence rate (moderate and severe) in female (%)Double pigtail with monofilament suture loop|align style= "centerbackground-color:#dce6f1;padding:0.079cm;"|Catherization rate (%)<center>365</center>
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|align style= "centerpadding:0.079cm;"|30-39<center>'''2'''</center>|align style= "centerpadding:0.079cm;"|20128402<center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center>|align style= "centerpadding:0.079cm;"|5635953[[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1() <center>Polaris Loop</center>]]]|align style= "centerpadding:0.079cm;"|2423<center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center>|align style= "padding:0.079cm;"| <center>Mar 2003</center>| style="padding:0.079cm;"|28%Dual Durometer Percuflex with HydroPlus Coating|align style= "centerpadding:0.079cm;"|Bladder loop design| style="padding:0.043%079cm;"| <center>365</center>
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|align style= "centerbackground-color:#dce6f1;padding:0.079cm;"|40-49<center>'''3'''</center>|align style= "centerbackground-color:#dce6f1;padding:0.079cm;"|22074384<center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center>|align style= "centerbackground-color:#dce6f1;padding:0.079cm;"|9050497[[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]|align style= "centerbackground-color:#dce6f1;padding:0.079cm;"|11132<center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center>|align style= "background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center>| style="background-color:#dce6f1;padding:0.079cm;"|41%Metal|align style= "centerbackground-color:#dce6f1;padding:0.079cm;"|Temporary stenting| style="background-color:#dce6f1;padding:0.123%079cm;"| <center>365</center>
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|align style= "centerpadding:0.079cm;" rowspan="2"|50-59<center>'''4'''</center>|align style= "centerpadding:0.079cm;" rowspan="2"|20929761<center>[http://www.fossamedical.com/news.htm Fossa Medical]</center>|align style= "centerpadding:0.079cm;" rowspan="2"|10046285[[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]|align style= "centerpadding:0.079cm;"|12457<center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center>|align style= "padding:0.079cm;"| <center>Aug 2002</center>| style="padding:0.079cm;" rowspan="2"|48%Polyurethane|align style= "centerpadding:0.079cm;" rowspan="2"|Spiral radially expanding stent| style="padding:0.124%079cm;" rowspan="2"| <center>13</center>
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|align style= "center"|60-69|align = "center"|14605565|align = "center"|7448838|align = "center"|11918|align = "center"|51%|align = "center"|padding:0.160%|-|align = "center079cm;"|70-79|align = "<center"|9046207|align = "center"|4975414|align = "center"|8558|align = "center"|55%|align = "center"|0>[http://www.fossamedical.com/news.172%|-|align = "htm CE Mark]</center"|≥ 80>|align style= "center"|7216598|align = "center"|3896963|align = "center"|1715|align = "center"|54%|align = "center"|padding:0.044%|-|align = "center"|'''Total'''|align = "center"| 079cm;|align = "center"|'''41053950'''|align = "<center"|'''48203'''|align = ">Sep 2005</center"| >|align = "center"|
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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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{|border="2" cellspacing="0" cellpadding="4" width= Sample patents =="100%"|align ="center" bgcolor ="#4f81bd"|'''Sr. No.'''{| classalign ="wikitablecenter" stylebgcolor ="font-size:90%#4f81bd" border|'''Company'''|align ="1center" cellpaddingbgcolor ="5#4f81bd" cellspacing|'''Device(s)'''|align ="0center" bgcolor = "#4f81bd"|'''Approval'''|- stylealign ="background:lightgreycenter"bgcolor = "#4f81bd"|'''Approval Date'''!|align = "center" bgcolor = "#00CCFF4f81bd"|Patent'''Material'''!|bgcolor = "#00CCFF4f81bd"|Assignee'''Technology'''!|align = "center" bgcolor = "#00CCFF4f81bd"|Title'''Indwelling Time (days)'''!|align = "center" bgcolor = "#00CCFF4f81bd"|Abstract'''Image'''
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|}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|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 Analytics Services]|align <font color= "center#0000FF"| ><u>[http://www.dolcerafossamedical.com/website_prodnews.htm FDA 510(k)]</servicesu></business-research-services Market Research Services]font>|align = "center" bgcolor = "#dce6f1"| [http://www.dolcera.com/website_prod/tools/patent-dashboard Purchase Patent Dashboard]Aug, 2002
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|align = "center" bgcolor = "#dce6f1" rowspan = "2"| [http://www.dolceraaccessdata.comfda.gov/website_prodscripts/servicescdrh/ip-patent-analytics-servicescfdocs/patent-searchcfPMN/patent-landscapes Patent Landscape ServicesPMNSimple.cfm?db=PMN&ID=K033368 Open lumen 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=K033368 FDA 510(k)]</u></font>|align = "center" bgcolor = "#dce6f1"| [http:Nov, 2003|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</wwwnowiki>|align = "center" bgcolor = "#dce6f1" rowspan = "2"| |align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:Open_Lumen.dolcera.compng|thumb|center|100px|<center>Open_lumen</website_prod/industries Industry Focuscenter>]]
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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 CE Mark]</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]Sep, 2005
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|}<br>align ="center" bgcolor ="#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db= Clinical Trials ==PMN&ID=K021140 Expanding Ureteral 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=K021140 FDA 510(k)]</u></font>|align ="center" bgcolor =={"#dce6f1"| {{table}}Jun, 2002| alignbgcolor ="center#dce6f1"|'''Title'''Polyurethane| alignbgcolor ="center#dce6f1"|'''Conditions'''Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki>| align="center" bgcolor = "#dce6f1"|'''Intervention'''| align="center" bgcolor = "#dce6f1"|'''Sponsors and Collaborators'''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,,/NCT00250406?termmethod/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font>|align =ureteral+stent&rank"center"|<font color=1 Assessment of Drug"#0000FF"><u>Contour</u></font>|align = "center"| |align = "center"| |Percuflex -Eluting Ureteral Stent on Bacterial Adherence proprietary polyolefin copolymer; Hydroplus coating|Fixed and Biofilm Formation]variable length; Tapered tip|align = "center"|Renal Calculi, Ureteral Obstruction365|align = "center" |Device[[Image: Ureteral StentContour.png|thumb|Lawson Health Research Institute, Boston Scientific Corporationcenter|100px|<center>Contour</center>]]
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| [http:align = "center"|<font color="#0000FF"><u>Percuflex</u></clinicaltrials.gov/ct2/show/NCT00270504?termfont>|align =urethral+stent&rank"center"| |align =1 Memokath® 044TW Stent for Treatment of Urethral Stricture]"center"||Urethral Stricturealign = "center"|Percuflex|DevicePigtail|align = "center"|365|align = "center" |[[Image: Memokath stentingPercuflex.png|thumb|Engineers & Doctors Wallsten Medical Groupcenter|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/NCT00581178cfdocs/cfPMN/PMNSimple.cfm?termdb=urologic+stentPMN&rankid=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent EncrustationK010002 FDA 510(k)]</u></font>|align = "center"|Kidney StonesJan, 2001|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.|N\ADouble pigtail|align = "center"|University of California, Irvine365|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|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/NCT00288457cfdocs/cfPMN/pmn.cfm?termID=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms10929 FDA 510(k)]</u></font>|align = "center"|Kidney StonesMar, 2003|Dual Durometer Percuflex with HydroPlus Coating|DeviceBladder loop design|align = "center"|365|align = "center" |[[Image: Ureteral StentPolaris_Loop.png|thumb|Emory Universitycenter|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/NCT00166361?termwww.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=urologic+stentj&rankq=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stentpercuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font>|align = "center"|Ureteral Obstruction|align = "center"|Device|Percuflex material and Hydroplus coating|Endopyelotomy stent|align = "center"|Post-procedure healing|align = "center" |[[Image: Memokath 051 Ureteral StentRetromax_plus.png|thumb|Mayo Clinic Engineers & Doctors Wallsten Medical Groupcenter|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/NCT00739284?termwww.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=urologic+stentj&rankq=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08)percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font>|align = "center"|Kidney Disease|align = "center"|Device: nephrostomy tube |Hydroplus Coating|Variable length coil on distal and ureteral stentproximal ends|align = "center"|Rabin Medical Center90|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]]
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| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergiaalign = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font>|align = "center" bgcolor = "#dce6f1"|13<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font>|align = "center" bgcolor = "#dce6f1"|Detrusor-sphincter dyssynergia<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font>|align = "center" bgcolor = "#dce6f1"|Stenting is an effective alternative to sphincterotomy in the long-termMay, although secondary bladder neck obstruction is a frequent problem2007|bgcolor = "#dce6f1"|Metal|bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|365|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</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 Analysis|align = "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=2055 Sof-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 AQ® Hydrophilic Coating|bgcolor = "#dce6f1"|Radiopaque tip 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 tether for either modality of treatmentrepositioning |align = "center" bgcolor = "#dce6f1"|180|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-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=3627 Endo-Sof]</u></font>{|borderalign ="2center" cellspacingbgcolor ="0" cellpadding="4" width="100%#dce6f1"| |align = "center" bgcolor = "#00CCFFdce6f1"|'''S. No.'''|align bgcolor = "center#dce6f1" |AQ® Hydrophilic Coating|bgcolor = "#00CCFFdce6f1"|'''Brand Name'''Double pigtail|align = "center" bgcolor = "#00CCFFdce6f1"|'''Adverse Event'''365|align = "center" bgcolor = "#00CCFFdce6f1"|'''Date FDA Received'''[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</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 Stent3643 C-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"| |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"|'''2'''|align = "justifydce6f1"|<font color="#0000FF"><u>[http://www.accessdatacookmedical.fda.gov/scripts/cdrh/cfdocscom/cfMAUDEuro/DetaildataSheet.CFMdo?MDRFOI__IDid=930422 Boston Scoientific Boston Scientific Ureteral stent System4692 Smith Universal]</u></font>|align = "justifycenter" bgcolor = "#dce6f1"|Fractured |align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent seen under Fluroscopy|align = "center" bgcolor = "#dce6f1"|1060|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</17/2007center>]]
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|align = "center" bgcolor = "#00CCFFdce6f1"|'''3'''<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/cdrh/cfdocscom/cfMAUDEarticles/Detail90717.CFM?MDRFOI__ID=755260 Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CMphp Launch]</u></font>|align = "justifycenter" bgcolor = "#dce6f1"|During insertion of ureteral stentDec, the 2007|bgcolor = "#dce6f1"|Heparin-bonded stent broke into multiple parts which were retained in the patient.|bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|10/14/2005
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|align = "center" bgcolor = "#00CCFF"|'''46'''|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=564910 Boston Scientific Corp Boston Scientific 8 FR X 28 CM Ureteral Stent System Kit29056 FDA 510(k)]</u></font>|align = "justifycenter"|Breakage of the upper loop of the ureteral stent while trying to insert it.Jan, 2010|Hydrogel|Differentially larger end (no pigtail)|align = "center"|130|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</5/2005center>]]
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|align = "center" bgcolor = "#00CCFFdce6f1"|'''57'''|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=522129 Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stent1&query_string= FDA 510(k) ]</u></font>|align = "justifycenter" bgcolor = "#dce6f1"|Apr, 2010|bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|Broken stent observed during x-ray procedure.|align = "center" bgcolor = "#dce6f1"|1230|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</12/2003center>]]
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|}[[Media: non patent upload.xlsalign = "center" rowspan = "4"|'''Review Articles8''']]|align = "center" rowspan = "4"|<brfont color="#0000FF">[[Mediahttp: non patent upload1//www.xls|'''Non Patent Analysis'''appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Medical Resources, CA, USA]]</font>|align ="center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID= Products 4353 Mesh]</u></font>|align ="center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID={| {{table}}4353 FDA 510(k)]</u></font>| align="center"|'''Boston Scientific ScimedJul, Inc.'''2001|Polyester mesh|Double-pigtail| align="center"|'''Cook Urological Incorporated'''| align="center"|'''OptiMed Global Care'''N/A
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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 Silhouette ]</u></font>| Firlit-Kluge Urethral Stentalign = "center"| | Optialign = "center"| |Coil-J Ureteral Stent System reinforced; SL-6® hydrophilic coating|Patency Device|align = "center"| |align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]]
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| Polaris™ Loop align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral Stent+stents Applied Standard]</u></font>| Koyle Diaper Stent align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font>| Ureteral Stent Setsalign = "center"|Jun, ureterorenoscope 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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| 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 7-10 endopyelotomy]</u></font>| Silicone Universal Drainage Stentalign = "center"| | Extra Strong Stent Sets (align = "center"| |Proprietary thermoplastic elastomer material; SL-Tumor)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'''| Tarkington Urethral Stent Setalign = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font>| Steerable 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, 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"| Zaontz Urethral <font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font>| Multilength align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=8912 FDA 510(k)]</u></font>|align = "center" bgcolor = "#dce6f1"|Jan, 2003|bgcolor = "#dce6f1"|Silicone|bgcolor = "#dce6f1"|Attached with suture for ease of removal|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:Bardex.png|thumb|center|100px|<center>Bardex</center>]]
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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=228 Fluoro-4 Silicone Ureteral Stent]</u></font>|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|Silicone/tantalum|bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:Fluoro_4.png|thumb|center|100px|<center>Fluoro 4</center>]]
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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 implications230 Figure-4 Silicone Ureteral Stent]] === Design History File Review: Review components ===</u></font>{| classalign ="wikitablecenter" stylebgcolor ="font-size:90%" border="1" cellpadding="5" cellspacing="0#dce6f1" | |- style="background:lightgrey"!align = "center" bgcolor = "#00CCFFdce6f1" width| |bgcolor ="15%#dce6f1"|Review Silicone!|bgcolor = "#00CCFFdce6f1" width|Three dimensional design|align ="30%center"|Verification!bgcolor = "#00CCFFdce6f1" width| |align ="40%center"|Tasks!bgcolor = "#00CCFF" width="15%dce6f1"|Expertise[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</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=229 Urinary Diversion Stent]</u></font>|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=86128 FDA 510(k)]</u></font>|align = "center" bgcolor = "# Compare product specifications to design inputsdce6f1"|Apr, 1991|bgcolor = "# Check whether appropriate verifications and validations are performeddce6f1"|Silicone|bgcolor = "# Establish if all specifications are linked to design inputsdce6f1"| |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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| Appropriate design verification and validations align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=248 Biosoft]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(DV&Vk) are performed]</u></font>| align = "center"|Oct, 1998# Show DV&V criteria are based on risk management requirements|Silicone|Extreme flexibility|align = "center"| |align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]
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| Product performance specifications correspond to appropriate design output documentsalign = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font>|align = "center"| # Correlate design drawings with the specifications|align = "center"| # Check whether maximum dimensions, sizes etc|Hard or soft Polyurethane|Designed for short-term use|align = "center"| 90|align = "center"|[[Image:Polyurethane1. (with tolerances) are within the specified rangepng|thumb|center|100px|<center>Polyurethane</center>]]
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| DFMEA links appropriately to the PPSalign = "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 = "# Verify whether DFMEA dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=3&ved=0CCQQFjAC&url=http%3A%2F%2Fwww.myrusch.com%2Fimages%2Frusch%2Fdocs%2FU62C.pdf&rct=j&q=DD%2Bureteral%2Bstent&ei=CcY-TeDWHcrirAfyr4naCA&usg=AFQjCNHSSc9r_DBwotSa_oszWLYMPRuoYg&cad=rja Rüsch Superglide DD]</u></font>|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122381 FDA 510(k)]</u></font>|align = "center" bgcolor = "#dce6f1"|Jul, 1999|bgcolor = "#dce6f1"| WIRUTHAN® (polyurethane) with hydrogel coating|bgcolor = "#dce6f1"| Directable and product specifications are correlateddetachable|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]
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| Appropriate DValign = "center" rowspan = "9"|'''12'''|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEAmaincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font>|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font>|align = "center"|Dec, 1986
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| 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=9252&catid=122&maincat=Stone%20Management&catname=Stents Classic Double pigtail]</u></font>| align = "center"|<font color="# Validate the process protocol0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font># Validate the inspection procedures used |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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| 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=9254&catid=122&maincat=Stone%20Management&catname=Stents Lithostent]</u></font>|align = "center"| # Obtain First Article Inspection data|align = "center"| # Check if this data correlates with the completeness of drawings|Tecoflex® |Grooved design|align = "center"| |align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</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=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font>|align = "center"| # Identify any missing documentation for inspection procedures|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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|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9255&catid=122&maincat=Stone%20Management&catname=Stents Quadra-Coil multi-length]</u></font>
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=107077 FDA 510(k)]</u></font>
|align = "center"|Mar, 1996
|Tecoflex®
|Accomodate ureteral lengths from 22cm to 28cm
|align = "center"|
|align = "center"|[[Image:Quadra_Coil.png|thumb|center|100px|<center>Quadra-Coil</center>]]
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| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging 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 labeling materialsexclusive soft bladder helix |align = "center"| # Review supplier audit reports for compliance|align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]
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| Calibration records and preventive maintenance records; in-process 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></ incoming inspection test methods and related test method validationsfont>|align = "center"| # Check the entire equipment-related lifecycle|align = "center"| # Check if machine operational qualification was performed|Silicone# Check if the measurement equipment was validated|Classic Double J with open tip|align = "center"| |align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]
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| Design test methods and related test method validationsalign = "center"|'''14'''|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]|align = "center"|Jan, 1987|Nitinol|Self-expanding stent
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=== Sample report ==Product to Clinical Trial Mapping===== Performance/Functional Characteristics ===={| class="wikitable" style="font-size:90%" borderClinical Timeline Visualization ="1" cellpadding="5" cellspacing="0" |- style="background[[Image:lightgrey"Timeline.jpg]]!align = "center" bgcolor = "#00CCFF" colspan = "4" |Design Input!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"[[Media:Ureteral_Stents_Timeline dw.xls|Design OutputUreteral Stent Timeline]]!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Verification Report #!align = "center" bgcolor Product to Patent Mapping = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Validation Report #!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"[[Image:Product_Patent_Mapping_Screen_Shot.png|Status 1000px|centre|thumb|'''Screenshot for the product to patent mapping(P/F/RBard and Boston)''']]* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|-'''Products from Boston Scientific and C R Bard ''']]to download the excel file.!align = "center" bgcolor = "#00CCFF" widthMapped Patent vs Not Mapped Patents =="20%"|User Needs!align = "center" bgcolor = "#00CCFF" width="15%"{|User Need Rationale!align border= "center0" bgcolor cellspacing= "#00CCFF0" widthcellpadding="20%"|Engineering Specification!align = "center" bgcolor = "#00CCFF4" width="20100%"|Engineering Specification Rationale|-[[Image:CRB_Pat.png|Provide antimicrobial resistance for up to 2 weekscenter|Ureteral Stent User Survey (Document #XXXXX)500px|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeksthumb|Document #XXXXX'''C R Bard''']]|Test Document #XXXXX[[Image:BS_pat.png.png|Report 01-005-06-007center|P500px|Report 01-005-06-007thumb|P'''Boston Scientific''']]
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=== Potential DHF Review Outcomes ===Based on a review of the above DHF documents a potential outcome for the uretral stent acquisition project could involve the following:# Better explanation of existing design input documents and also better linkage between the design inputs and product specifications.# Creation of some new test methods for design, incoming and inPatent-process inspections and also include recommendations for the test method validations. Creation of any new DV&V data would be highly unlikely as it could potentially trigger a new submission or a noteProduct-to-file to the regulatory agencies.# Change in raw materials to better grade materials e.g. Switching resin to a USP Class VI biocompatible resin. This would eliminate some on-going testing but require additional upfront one time biocompatibility testing.# Updating drawings based on results from the FAI data.# Converting existing Company Y documents into Company X format and identifying potential gaps and streamlining linkage between raw material specifications and inspection procedures.# Identifying installation, operational and process qualification requirements with the assumption that no additional design verification and validation activities are required based on the fact that the device is currently approved for sale in the US and ROW.# Recommend activities necessary for completing packaging, labeling, ship testing and shelf-life testing. Stress should be on being able to leverage existing data for shelf-life without changing the regulatory status of the device. # Company X may want to perform additional biocompatibility testing to create an internal baseline and also update their biocompatibility files.# Help streamline suppliers for components when switching over from Company Y to Company X. Search for existing Company X suppliers that can supply off the shelf items that Company Y may be sourcing from other vendors / suppliers.# Identify process improvements that can be rolled into the manufacturing transfer without changing the design and impacting the existing regulatory status for the device e.g. instead of hand mixing pigment to resin use a pre-mixer to control quality of mixing and resulting extrusion or perform the molding and over-molding steps in 1 machine instead of 2 separate molding machines.Clinical Trial Mapping=
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|Design align = "center integration plan" bgcolor = "#538ED5" rowspan = "4"|'''Products'''|* Gap analysis completion (acquiree)* Gap analysis completion (acquirer)'''Portfolio'''|8 Products|September 15, 20086 Products
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|Design to manufacturing transfer'''Material'''|Percuflex - Biocompatible Polymer||December 15, 2008Silicone
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|Equipment transfer'''Coating'''|Hydroplus|Milestone I payment|Jan 7, 2009Licensed from pHreecoat
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|Shut production at acquiree facility'''Shape'''|Negotiation for contract extensionPigtailed and More|Milestone II payment|Feb 15, 2009Figure 4 and more
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|Start production in acquirer facilityalign = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''|'''Current Trials'''|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)|Feb 7, 2009None
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|Switch to new SKUalign = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''|'''Coating'''|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion|Feb 15, 2009Therapeutic coatings
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|End development of new generation product/s in old facility|'''Structure'''|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs|Feb 7, 2009Expandable stents for reducing discomfort
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|Restart development of new generation product/s post-acquisition'''Material'''|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness|Final milestone payment|Mar 1, 2009Biodegradable polymers<br>Shape memory alloys<br>General polymer based
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=== Documents and Ownership =Inference == {| classborder="wikitable2" stylecellspacing="font-size:90%" border="10" cellpadding="54" cellspacingwidth="082%" |- style="background:lightgrey"!align = "center" bgcolor = "#00CCFF538ED5" |Document!align <font size = "center4" >'''Boston Scientific'''</font>|bgcolor = "#00CCFF538ED5" |Owner!align <font size = "center4" bgcolor = "#00CCFF" |Last update date>'''C R BARD'''</font>
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|Product performance specificationsRelatively late entrant with patents filed post mid 90s|Paul Swain|07/27/2008 08:15:35 PSTEarly mover with patents filed in mid 80s
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|Component specificationsIncreased patent activity since 2000|Kevin Teller|06/12/2008 12:22:07 PSTPatent activity never gained traction
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|Preclinical test resultsLarge number of patents yet to be "productized"|Joanne Krannert|07/03/2008 14:17:00 PSTFew patents yet to be "productized"
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|Clinical testsSome products undergoing clinical trails|Joanne KrannertNo products undergoing clinical trails|08/01/2008 08:00:55 PST-|Diverse range of products with variation in material <br>and structure|Small product portfolio|-|Seem to be strengthening they market position|Seem to be moving focus away from Ureteral stents market
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= Competitive Landscape =
==Major Players==
*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field.
[[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]]
==IP Activity==
*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.
[[Image:IPactivity3.png|thumb|center|1000px| IP activity over the years]]
==Sales ==
Total Sales in 2010 - 4.04 Billion USD
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|bgcolor = "#4f81bd"|'''Company'''
|bgcolor = "#4f81bd"|'''Total Sales in 2010'''
|bgcolor = "#4f81bd"|'''Urological sales'''
|bgcolor = "#4f81bd"|'''Percentage share'''
|bgcolor = "#4f81bd"|'''Product portfolio'''
|-
|bgcolor = "#4f81bd"|'''Boston Scientific'''
|7800
|661
|8.48
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font>
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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>
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