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/* Dolcera Dashboard */
*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.
*'''''Need for a ureteral stent:''''' In patients who have, or might have, an obstruction (blockage) of the kidney, an internal drainage tube called a ‘stent’ is commonly placed in the ureter, the tube between the kidney and the bladder. This is placed there in order to prevent or temporarily relieve the obstruction.
==Background==
[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]
Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder. These devices can be placed by a number of different endourological techniques. They are typically inserted through a cystoscope and may also be inserted intraoperatively. Indwelling ureteral stents help to reduce complications and morbidity subsequent to urological and surgical procedures. Frequently, ureteral stents are used
to facilitate drainage in conjunction with Extracorporeal Shock Wave Lithotripsy (ESWL) and after endoscopic procedures. They are also used to internally support anastomoses and prevent urine leakage after surgery. Ureteral stenting may almost eliminate the urological complications of renal transplantation.
An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.
* Bacterial colonization: antimicrobial activity for up to two weeks.
* Patient Comfort: stent has a low coefficient of fiiction friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.
'''Dashboard Link'''<br>{|border="2" cellspacing="0" cellpadding="4" width= Encrustation ==="100%"|'''[https://www.dolcera.com/auth/dashboard/dashboard.php?workfile_id=1008 Ureteral Stent - Dashboard] '''The urinary system presents a challenge because of its chemically unstable environment|width="100"|[[Image:dashboard_thumb. Longpng|center|100px|]]|-term biocompatibility and biodurability of devices have been problems due |}*Flash Player is essential to view the supersaturation of uromucoids and crystalloids at Dolcera Dashboard* To access the interface between urine and the deviceDashboard you have to signup. Encrustation of ureteral stents is a well-known problem, which You can be treated easily if recognized earlydo so by clicking [https://www. However, severe encrustation leads to renal failure and is difficult to manage (Mohan-Pillai et aldolcera., 1999). All biomaterials currently used become encrusted to some extent when exposed to urinecom/auth/index.php/login '''here''']
==Pre-Market Notification==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-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.
{|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 =<span style"#dce6f1" rowspan ="5"|<font color:="#C41E3A0000FF">Like this report?<u>[http:/span/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]<p |align="center" bgcolor = "#dce6f1"|<font color="#0000FF"> '''This is only a sample report with brief analysis''' <bru>'''Dolcera can provide a comprehensive report customized to your needs'''[http://www.fossamedical.com/news.htm CE Mark]</pu></font>{|borderalign ="2center" cellspacingbgcolor ="0#dce6f1" cellpadding|Sep, 2005|bgcolor ="4#dce6f1" alignrowspan ="center" 2"|Polyurethane|stylebgcolor ="background:lightgrey#dce6f1" rowspan = "2"|Radially expanding stent|align = "center" colspan bgcolor = "3#dce6f1" rowspan = "2"|'''[mailto:info@dolcera.com <span style13|rowspan = "2" bgcolor ="color:#0047ABdce6f1"|[[Image:Stone_Sweeper.png|thumb|center|100px|<center>Buy the customized report from DolceraStone Sweeper</spancenter>]''' ]
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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'''
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|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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[[image:stentshare.jpg |thumb|center|1000px| All figures in USD million ]]
<p align="center"> '''This is only a sample report with brief analysis''' <br>
'''Dolcera can provide a comprehensive report customized to your needs'''</p>
<br>