== Phase 1: Landscape overview ===== '''This is a landscape report on the Ureteral Stent: Concept ===An antimicrobial ureteral stentmarket, which inhibits encrustation including key company profiles, products, patents and bacterial colonization while maintaining patient comfortrelevant clinical trials.'''
*'''''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.
=== Background === Ureteral stents are used in urological surgery to maintain patency of the ureter to allow urine drainage from the renal pelvis to the bladder'''[[more on background. 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 inconjunction 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. ]]'''
The advent of ESWL and the more recent barrage of endourological techniques have increased the indications for ureteral stents (Candela and Bellman 1997). Indications for use include:* Treatment of ureteral or kidney stones* Ureteral trauma or stricture* Genitourinary reconstructive surgery* Hydronephrosis during pregnancy* Obstruction due to malignancy* Retroperitoneal fibrosis=Market Overview=
The need Market for ureteral stents range from a few days to several monthsstent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. For patients with serious urological problems, ureteral stent maintenance may become a lifeOther uses of Ureteral Stent include Post-long necessity. Unfortunatelysurgical swelling/infection of uterus, there are many problems associated with using ureteral stentsActive kidney infection etc.
=== Ureteric stenting difficulties ==='''[[Image:Ureteral stentmore on market overview...jpg|thumb|right|350px|Double-J and Pigtail ureteral stents]]{|border="2" cellspacing="2" cellpadding="4" width="50%"|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Common'''</font>|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Rare'''</font>
|-|=Interactive Mind Map=* Trigonal irritationTo access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']* Haematuria''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''* Fever''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' * Infection* Tissue inflammation* Encrustation* Biofilm formation|* Obstruction* Kinking* Ureteric rupture* Ureteric perforation* Stent misplacement* Stent migration* Stent misfit* Stent forgotten* Tissue hyperplasia''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''{|}border="2" cellspacing="0" cellpadding="4" width="100%"
Today, elastomeric materials, such as silicones, polyurethanes and hydrogel-coated polyolefins are used, with no clear winner, which can withstand the urinary environment. * Although silicone has better long-term stability than other stent materials, its extreme flexibility makes it difficult to pass over guidewires and through narrow or tortuous ureters. * Polyethylene is stiffer and easier to use for patients with strictures; however, it has been known to become brittle with time leading to breakage and is no longer commercially available. * Polyurethane has properties that fall in between polyethylene and silicone; however, stent fracture also has been an issue with polyurethanes|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm>
Attempts have been made to develop polymers with a combination of the best of all properties. The key players are C-Flex (Concept Polymer Technologies), Silitek and Percuflex (Boston Scientific).* C-Flex is proprietary silicone oil and mineral oil interpenetrated into a styrenelolefin block copolymer with the hope of reduced encrustation.* Silitek (Medical Engineering Corporation) is another silicone-based copolymer. * Percuflex is a proprietary olefinic block copolymer. |}
Metallic stents have been used recently to treat extrinsic ureteric obstructions. The effect of synthetic polymers on the urothelium of the urinary tract seems to be dependent on the bulk chemical composition of the polymer, the chemical composition of its surface, coatings on the devicesurface, smoothness of the surface and coefficient of friction.=Patents=
Typically, most ureteral stents are made of relatively smooth catheters. [http://www.ncbi.nlm.nih.gov/pubmed/10772512 Koleski et al., (2000)] tested a longitudinally grooved ureteral stent made by Circon in the pig ureter. The results indicated that the grooved stent led to better drainage than a conventional stent. Their opinion is that the ureter wall has a better chance of collapsing over a
smooth surface than a grooved surface, especially when debris is present. Stoller (2000) had the same experience with the SpiraStent(Urosurge Corp.). This helical stent was superior at passing stones than a conventional smooth stent.
There are a variety of ureteral stent configurations with different anchoring systems. Most stents today have a double ==Patent Search Strategy==[http[Image://linkinghubPatent Search Strategy.elsevier.com/retrieve/pii/S014067360002674X pigtail anchoring systemjpg|700px]]. (Tolley, 2000), Dunn et al, (2000) conducted a randomized, single-blind study comparing a Tail stent (proximal pigtail with a shaft which tapers to a lumenless straight tail) to a double pigtail stent. The Tail stent was found to be better tolerated than the double-pigtail concerninglower urinary tract irritative symptoms. A double-J ureteral stent and a flexible ureteropyeloscope are shown in the first diagram. The other two diagrams show a pigtail ureteral stent in place; the end of the pigtail is facing away fiom the ureteral opening in the second of these two diagrams.
Early adverse effects of ureteral stenting include lower abdominal pain, dysuria, fever, urinary frequency, nocturia and hematuria. Patient discomfort and microscopic hematuria happen often. Major late complications include stent migration, stent fragmentation or more serious hydronephrosis with flank pain and infections.
Late complications occurred in one third of the patients in a prospective study using both silicone and polyurethane double pigtail stents (110 stents) in 90 patients. Stent removal was necessary in these patients. Others also have found this percentage of late complications. Device-related urinary tract infection and encrustation can lead to significant morbidity and even death and are the primary factors limiting long-term use of indwelling devices in the urinary tract. Microbial biofilm and encrustation may lead to stone formation. This is typically not a problem when stents are used
for short-term indications. Problems of biofilm formation, encrustation and stent fracture occur in patients with long-term indwelling stents.
Typically, manufacturers advise periodic stent evaluation. Cook polyurethane stent removal is recommend at 6 months and 12 months for silicone (Cook product literature). However, stents that are intended for long-term use are usually changed at regular intervals, as frequently as every 3 months.== Dolcera Dashboard ==
Forgotten stents are a problem. Monga et al., 1995 found that 68% of stents forgotten more than 6 months were calcified and 10% were fragmented. Multiple urologic procedures were necessary to remove the stones. Long-term effects of these forgotten stents may lead to voiding dysfunction and renal insufficiency. Schlick, et al., 1998 are developing a biodegradable stent that will preclude the need for stent removal.
'''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''']
The encrusted deposits can harbor bacterial biofilms. In addition, they can render the biomaterial brittle which causes fracture in-situ, a serious problem especially associated with the use of polyethylene and polyurethane ureteral stents (although silicone stents have also beenreported to fracture). Stent fragments can migrate to the bladder or renal pelvis with serious repercussions.= Clinical Trials =
Surface science techniques were used to study three stent types after use in patients. The stent type, duration of insertion and age or sex of the patient did not correlate significantly with the amount of encrustation (Wollin et al., 1998). However, it has been suggested that factors which affect the amount of encrustation include the composition or the urine, the type of invading and colonizing bacteria and the structure and surface properties of the biomaterial used (Gorman 1995). A low surface energy surface seems to resist encrustation compared with a high surface energy surface (Denstedt et al., 1998).==New trials ==
Many different types {|border "1" style="border-spacing:0;"| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center>|-| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center>| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of stone can form in the urinary tractDrug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]| style="background-color:#dce6f1;padding:0. Calcium oxalate079cm;"|Renal Calculi, calcium phosphateUreteral Obstruction| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, uric acid and cystine stones are metabolic stones because they form as a result of metabolic dysfunctionBoston Scientific Corporation |-| style="padding:0. They usually are excreted from the urinary tract079cm;"| <center>2</center>| style="padding:0. Struvite (magnesium ammonium phosphate) and hydroxyapatite (calcium phosphate) are associated with infection (infection stones)079cm;"| [http://clinicaltrials. These account gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for 1520% Treatment of urinary calculiUrethral Stricture]| style="padding:0. ESWL is used 079cm;"| Urethral Stricture| style="padding:0.079cm;"| Memokath stenting| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group |-| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center>| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to break up the larger infection stones because they don't passDetermine if There Are Specific Clinical Factors to Determine Stent Encrustation]| style="background-color:#dce6f1; recurrence of the problem occurs with incomplete removalpadding:0. Infection stones can manifest as poorly mineralized matrix stones, highly mineralized staghorn calculi or as bladder stones which often form in the presence of ureteral stents079cm;"| Kidney Stones| style="background-color:#dce6f1;padding:0. Urea079cm;"| N\A| style="background-splitting bacteria colonize the surface and cause alkalinization color:#dce6f1;padding:0.079cm;"| University of the urineCalifornia, which lowers the solubility of struvite and hydroxyapatite, and they deposit on the surfaceIrvine |-| style="padding:0. Bacterial biofilm associated with encrustation is a common clinical occurrence079cm;"| <center>4</center>| style="padding:0. (Gorman 079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Tunney, 1997)Patient Symptoms]| style="padding:0.079cm;"| Kidney Stones| style="padding:0.079cm;"| Ureteral Stent| style="padding:0.079cm;"| Emory University |-| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center>| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials. It has been suggested that prevention gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of bacterial colonization would prevent encrustation because of their ultimate responsibility Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group |-| style="padding:0.079cm;"| <center>6</center>| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00739284?term=urologic+stent&rank=15 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for its formation an Urgent Drainage of Obstructed Kidney (Bibby et al., 1995JJVsPCN08)]| style="padding:0.079cm;"| Kidney Disease| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent| style="padding:0.079cm;"| Rabin Medical Center |}
An in vitro model was developed that produces encrustation similar to those seen in vivo (Tunney et al== Concluded trials =={| {{table}}| style="background-color:#4f81bd;padding:0., 1996a)079cm;"|<center><font color="#FFFFFF">'''S. An experiment was conducted to compare No. '''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center>| 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>|-| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center>| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the encrustation potential treatment of various ureteral stent materialsdetrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0. The 079cm;"|To evaluate the long-term struvite and hydroxyapatite encrustation efficacy of silicone, polyurethane, hydrogela permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-coated polyurethane, Silitek and Percuflex were comparedsphincter dyssynergia. All of || 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 materials developed encrustation, howeverlong-term, it was found by image analysis that the rates although secondary bladder neck obstruction is a frequent problem.|-| style="padding:0.079cm;"| <center>2</center>| Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of encrustation varied on the different materialsPatient 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. Silicone had less encrustation Both can cause considerable morbidity and reduce patient's health-related quality of life (69% at 10 weeksQoL) . We have compared to the other materials 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 (1 00%PCN) at . However, based on the same time point (Tunney et alEuroQol 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.|-| 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, 1996b)randomized clinical trial. Continuous flow models have also been developed which are more representative || style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of conditions 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 upper early urinary tract. They are discussed by Gorman complications of urine leakage and Tunney, (1 997)obstruction. Efforts to reduce encrustation using new materialsHowever, smoothersurfaces and hydrogel coatings have been attemptedthere is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.|}
A hydrogel-coated C-flex stent (Hydroplus, Boston Scientific) was shown to have less epithelial cell damage and encrustation than other biomaterials and was recommended by the investigators for long-term use (Cormio, 1995). In addition, a poly(ethy1ene oxide)/polyurethane composite hydrogel (Aquavenem, J & J) resisted intraluminal blockage in a urine flow model compared with silicone and polyurethane (Gorman et al., 1997a). Another advantage with Aquavene is that it is rigid in the dry state, which facilitates insertion past obstructions in the ureter and becomes soft on hydration providing comfort (Gorman and Tunney, 1997). Gorman et al. (1997b) concluded that the chance of stent fracture would be reduced if the ureteral stent side holes were eliminated. Urinary tract infection is another common major problem with the usage of ureteral stents. Initially, a conditioning film is deposited on the ureteral stent surface. The film is made up of proteins, electrolyte materials and other unidentified materials that obscure the surface properties of the stent material. Electrostatic interactions, the ionic strength and pH of the urine and differences in fluid surface tensions affect bacterial adhesion to the conditioning film. Subsequently, a microbial biofilm forms over time. The biofilm is composed of bacterial cells embedded in a hydrated, predominantly anionic mixture of bacterial exopolysaccharides and trapped host extracellular macromolecules.
====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 to
treat and device removal is usually necessary. The biofilm has been found to impede the diffusion of antibiotics; 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 to
bacterial biofilms.
==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.
=== The market need ===It is clear that there is a need for a new material that will be able to resist encrustation and infection Some of the companies active in the urinary tract. According to Merrill Lynch, field of ureteral stents represent an $80 MMUS market. Boston Scientific is have been represented 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 contenderstable below.
The use of ureteral stents is increasing{| border="2" cellspacing="0" cellpadding="4" width="100%"| style="background-color:#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 padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center>| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''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 stone clearance after ESWL 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 (Tolleydays) '''</font></center>|-| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center>| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center>| style="background-color:#dce6f1;padding:0.079cm;"| <center>[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>|[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3∏ID=225 <center>InLay Optima</center>]]]| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</center>| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center>| style="background-color:#dce6f1;padding:0.079cm;"| Silicone| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center>|-| style="padding:0.079cm;"| <center>'''2'''</center>| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/, 2000,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center>| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-stone/product.html?method=product_detail∏uct_id=10122561#initialLoad1()<center>Polaris Loop</center>]]]| style="padding:0. 079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</center>| style="padding:0.079cm;"| <center>Mar 2003</center>| style="padding:0.079cm;"| Dual Durometer Percuflex with HydroPlus Coating| style="padding:0.079cm;"| Bladder loop design| style="padding:0.079cm;"| <center>365</center>|-| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''3'''</center>| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</center>| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Resonance.png|thumb|center|100px|[http://www.cookmedical.com/uro/dataSheet.do?id=4418 <center>Resonance</center>]]]| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</center>| style="background-color:#dce6f1;padding:0.079cm;"| <center>May 2007</center>| style="background-color:#dce6f1;padding:0.079cm;"| Metal| style="background-color:#dce6f1;padding:0.079cm;"| Temporary stenting| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center>|-| style="padding:0.079cm;" rowspan="2"| <center>'''4'''</center>| style="padding:0.079cm;" rowspan="2"| <center>[http://www.fossamedical.com/news.htm Fossa Medical]</center>| style="padding:0.079cm;" rowspan="2"| [[Image:Stone_Sweeper.png|thumb|center|100px|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf <center>Stone Sweeper</center>]]]| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm FDA 510(k)]</center>| style="padding:0.079cm;"| <center>Aug 2002</center>| style="padding:0.079cm;" rowspan="2"| Polyurethane| style="padding:0.079cm;" rowspan="2"| Spiral radially expanding stent| style="padding:0.079cm;" rowspan="2"| <center>13</center>|-| style="padding:0.079cm;"| <center>[http://www.fossamedical.com/news.htm CE Mark]</center>| style="padding:0.079cm;"| <center>Sep 2005</center>
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|-| style="background-color:#dce6f1;padding:0. According to survey results reported by Hollowell, et al079cm;"| <center>'''5'''</center>| style="background-color:#dce6f1;padding:0. (2000), there is a significant difference in opinion concerning the use of stents with ESWL079cm;"| <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>|}
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 0 mm.=Products=
=== Intellectual property ===The FDA classifies a ureteric stent as follows: ==== Search strategy ====* TITLE 21 - FOOD AND DRUGS* Databases searched: USCHAPTER I -G, USFOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES* SUBCHAPTER H -A, EPMEDICAL DEVICES* PART 876 -A, EPGASTROENTEROLOGY-B, WO, JP, DE, GB, FRUROLOGY DEVICES* Search scope: Title, Abstract or ClaimsSubpart E - Surgical Devices* Years: 1981Sec. 876.4620 -July 2008Ureteral stent. * Search queryClassification - class II device [http: (//www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter* OR urether* OR ureth* OR uretr*) AND (stent*) AND (*microb* OR *bacter*)* Results: '''177 patents (82 unique patent families)'''%20stent Code of Federal Regulations]
{|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"|'''1'''|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://patftwww.usptoallium-medical.govcom/netacgi/nph-Parser?Sect1categoryId=PTO1&Sect2=HITOFF&d=PALL&p=1&64772 Allium, Israel]</u></font>|align =%2Fnetahtml%2Fsrchnum"center" bgcolor = "#dce6f1"|[http://www.htm&rallium-medical.com/?categoryId=1&f64772 URS]|align =G&l"center" bgcolor =50&s1"#dce6f1"|<font color=6468649"#0000FF">[http://www.PNhighbeam.&OS=PNcom/6468649&RS=PNdoc/6468649 US6468649 B11G1-165990208.html CE Mark]</font>| SCIMED LIFE SYSTEMS INCalign = "center" bgcolor = "#dce6f1"|Jul, 2007| Antimicrobial adhesion surfacebgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer| The present invention provides an implantable medical device having a substrate with a hydrophilic coating composition to limit in vivo colonization of bacteria and fungi. The hydrophilic coating composition includes a hydrophilic polymer with a molecular weight in the range from about 100, 000 to about 15 million selected from copolymers acrylic acid, methacrylic acid, isocrotonic acid and combinations thereofbgcolor = "#dce6f1"|Self-expanding stent|align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]
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!|align = "center" rowspan = "2"|'''2'''|align = "center" rowspan = "2"|<font color="#0000FF">[http://patftwww.usptopnnmedical.govcom/netacgiurology/nphprofessionals/products/memokath™-Parser051-ureter.aspx Pnn Medical A/S]</font>|align = "center" rowspan = "2"|[http://www.google.com/url?Sect1sa=PTO1t&Sect2source=HITOFFweb&dcd=PALL4&pved=10CC4QFjAD&uurl=%2Fnetahtml%2Fsrchnumhttp://www.hammer.pl/pliki/147_2.htmpdf&rrct=1j&fq=Gmemokath%20051&lei=50MfhATezNIoaqvQP-_ZGtAw&s1usg=5554147.PN.AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&OScad=PN/5554147&RS=PN/5554147 US5554147 Arja Memokath 051]| CApHCO, Inc. align = "center"| Compositions and devices for controlled release of active ingredients | A method for the controlled release of a biologically active agent wherein the agent is released from a hydrophobic, pH-sensitive polymer matrix is disclosed and claimed<font color="#0000FF">[http://www. The polymer matrix swells when the environment reaches pH 8pnnmedical.5, releasing the active agent. A polymer of hydrophobic and weakly acidic comonomers is disclosed for use in the controlled release system. Further disclosed is a specific embodiment in which the controlled release system may be used. The pHcom/about-sensitive polymer is coated onto a latex catheter used in ureteral catheterization. A common problem with catheterized patients is the infection of the urinary tract with ureasepnn-producing bacteriamedical/company-history. In addition to the irritation caused by the presence of the bacteria, urease produced by these bacteria degrade urea in the urine, forming carbon dioxide and ammonia. The ammonia causes an increase in the pH of the urine. Minerals in the urine begin to precipitate at this high pH, forming encrustations which complicate the functioning of the catheter. A ureteral catheter coated with a pHaspx CE Mark]</font>|align = "center"|1995|rowspan = "2"|Nickel-sensitive polymer having an antibiotic or urease inhibitor trapped within its matrix will release the active agent when exposed to the high pH urine as the polymer gel swells. Such release can be made slow enough so that the drug remains at significant levels for a clinically useful period of timetitanium shape memory alloy|rowspan = "2"|Double fluted ended spiral stent|align = "center" rowspan = "2"|240|rowspan = "2"|[[Image:Memokath_051. png|thumb|center|100px|<center>Memokath 051</center>]]
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!|align = "center"|<font color="#0000FF"><u>[http://appft1www.usptozapconnect.govcom/netacgiproducts/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnumindex.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html&r=1&f=G&l=50&s1=%2220030153983%22.PGNR.&OS=DNFDA Listing]</20030153983&RS=DNu></20030153983 US20030153983 A1]font>| SCIMED LIFE SYSTEMS INCalign = "center"|Implantable or insertable medical device resistant to microbial growth and biofilm formation | Disclosed are implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particularMar, the invention discloses implantable or insertable medical devices that comprise at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device. Also disclosed are methods of manufacturing such devices under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of the biocompatible matrix polymer and substantially prevent chemical modification of said bioactive agents 2004
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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>]]
|-|align ="center" bgcolor = Phase 2"#dce6f1"|<font color="#0000FF"><u>[http: Deeper Dive ==//www.fossamedical.com/news.htm FDA 510(k)]</u></font>|align ="center" bgcolor == Scenario ===Client wishes to acquire a ureteral stent company."#dce6f1"|Aug, 2002
|-|align ="center" bgcolor ="#dce6f1" rowspan = Deal analysis for a target company "2"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 Open lumen stent]|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&ID=K033368 FDA 510(k)]</u></font>|align = "center" bgcolor = "#dce6f1"|Nov, 2003|bgcolor = "#dce6f1" rowspan = "2"|Polyurethane|bgcolor = "#dce6f1" rowspan = "2"|Pigtail-tipped stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki>|align = "center" bgcolor = "#dce6f1" rowspan = "2"| |align = "center" bgcolor = "#dce6f1" rowspan = "2"| [[Image:DealImplicationsOpen_Lumen.jpgpng|thumb|center|700px100px|Deal implications<center>Open_lumen</center>]]
=== Design History File Review: Review components ===
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0"
|- style="background:lightgrey"
!align = "center" bgcolor = "#00CCFF" width="15%"|Review
!bgcolor = "#00CCFF" width="30%"|Verification
!bgcolor = "#00CCFF" width="40%"|Tasks
!bgcolor = "#00CCFF" width="15%"|Expertise
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!rowspan|align ="2center" bgcolor = "#dce6f1"|Design Input| Design input documents for sufficiency| <font color="# Access electronic data room0000FF"><u>[http://www.# Check what documents are providedfossamedical.# Compare document list with standard client document list.# Check whether each specified document has appropriate contentcom/news.htm CE Mark]</u></font>| rowspanalign ="2center" bgcolor = "#dce6f1"|Quality systemsSep, 2005
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| Design input documents linked to the product performance specificationsalign = "center" bgcolor = "#dce6f1"|[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=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=PMN&ID=K021140 FDA 510(k)]</u></font>|align = "center" bgcolor = "# Compare product specifications to design inputsdce6f1"|Jun, 2002|bgcolor = "# Check whether appropriate verifications and validations are performeddce6f1"|Polyurethane|bgcolor = "# Establish if all specifications are linked to design inputsdce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki>|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| N/A
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!|align = "center" rowspan="37"|Product Performance Specifications (PPS) '''4'''| Design inputs correlate adequately to the specifications; DV&V (design verification and validation) criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plansalign = "center" rowspan = "7"| <font color="# Compare product specifications to design inputs0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font>|align = "center"|<font color="# Check whether appropriate verifications 0000FF"><u>Contour</u></font>|align = "center"| |align = "center"| |Percuflex - proprietary polyolefin copolymer; Hydroplus coating|Fixed and validations are performedvariable length; Tapered tip# Establish if all specifications are linked to design inputs|align = "center"|365| rowspanalign ="3center"|Quality systems, CAD[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]]
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| Appropriate design verification and validations (DV&V) are performedalign = "center"|<font color="#0000FF"><u>Percuflex</u></font>|align = "center"| # Show DV&V criteria are based on risk management requirements|align = "center"||align = "center"| Percuflex|Pigtail|align = "center"|365|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]]
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| Product performance specifications correspond to appropriate design output documentsalign = "center"| <font color="# Correlate design drawings with the specifications0000FF"><u>Polaris Ultra</u></font>|align = "center"|<font color="# Check whether maximum dimensions, sizes etc0000FF"><u>[http://www. accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(with tolerancesk) are within the specified range]</u></font>|align = "center"|Jan, 2001|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.|Double pigtail|align = "center"|365|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]]
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!rowspan|align ="4center"|Risk Management Documents <font color="#0000FF"><u>Polaris Loop</u></font>| Risk Analysis, Design Failure Modes and Effects Analysis align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(DFMEAk)]</u></font>|align = "center"|Mar, Process FMEA, other risk management documentation2003| Dual Durometer Percuflex with HydroPlus Coating# Check whether documentation is available|Bladder loop design# Check whether it adheres to appropriate ISO 14971 standards# Check whether it adheres to appropriate client standards|align = "center"|365|rowspanalign ="4center"| Quality systems[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]]
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| DFMEA links appropriately to the PPSalign = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Retromax Plus]</u></font>|align = "center"| # Verify whether DFMEA |align = "center"| |Percuflex material and product specifications are correlatedHydroplus coating|Endopyelotomy stent|align = "center"|Post-procedure healing|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]]
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| Appropriate DValign = "center"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEAsource=web&cd=4&ved=0CCkQFjAD&url=http://www.bostonscientific.com/templatedata/imports/Microsite/Stone-EU/collateral/stone-eu-percuflex-brochure-eng.pdf&rct=j&q=percuflex%20brochure&ei=bIE-Tb79HMnqrAf5-_HRCA&usg=AFQjCNEJ-JOc Stretch VL Flexima]</u></font>|align = "center"| # Validate the process |align = "center"| |Hydroplus Coating|Variable length coil on distal and correlate with design inputsproximal ends# Validate that sizes used are within range of risk mitigation criteria|align = "center"|90|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]]
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| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures andalign = "center"|[http:/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA/dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]|align = "center"| # Validate the process protocol|align = "center"| # Validate the inspection procedures used |Percuflex - proprietary polyolefin copolymer|Ketorolac trimethamine loaded stent|align = "center"||align = "center"| N/A
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!|align = "center" bgcolor = "#dce6f1" rowspan="26"|Design Output Documents '''5'''| Completeness of drawingsalign = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font>|align = "center" bgcolor = "# Check if the CAD diagrams overlay and dce6f1"fit|<font color=" perfectly#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font>|align = "center" bgcolor = "# Check tolerance stackupsdce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=23620 FDA 510(k)]</u></font>|rowspanalign ="2center" bgcolor = "#dce6f1"| Quality systemsMay, CAD2007|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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| Correlate First Article Inspection data to the dimensions on the drawingsalign = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font>|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "# Obtain First Article Inspection datadce6f1"| |bgcolor = "# Check if this data correlates with the completeness of drawingsdce6f1"|AQ® Hydrophilic Coating|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning |align = "center" bgcolor = "#dce6f1"|180|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]]
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!rowspan|align ="4center" bgcolor = "#dce6f1"|Manufacturing Documents <font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font>| Manufacturing procedures, component specifications, raw material specifications, incoming and in-process inspection procedures for completenessalign = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |bgcolor = "# Verify the Bill of Materials corresponds to raw materials and manufacturing proceduresdce6f1"|AQ® Hydrophilic Coating|bgcolor = "# Correlate incoming and in-process inspection procedures with the process specificationsdce6f1"|Double pigtail| rowspanalign ="4center" bgcolor = "#dce6f1"|Material science, manufacturing engineering, quality systems365|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]]
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| Linkage between component and raw material specifications and appropriate incoming inspection proceduresalign = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font>|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "# Identify any missing documentation for inspection proceduresdce6f1"| |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</center>]]
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|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font>
|align = "center" bgcolor = "#dce6f1"|
|align = "center" bgcolor = "#dce6f1"|
|bgcolor = "#dce6f1"|
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent
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|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]]
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| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materialsalign = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Endo-Sof Radiance]</u></font>| align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/90717.php Launch]</u></font>|align = "center" bgcolor = "# Review supplier audit reports for compliancedce6f1"|Dec, 2007|bgcolor = "#dce6f1"|Heparin-bonded stent|bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|
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| Calibration records align = "center"|'''6'''|align = "center"|<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/cfPMN/pmn.cfm?ID=29056 FDA 510(k)]</u></font>|align = "center"|Jan, 2010|Hydrogel|Differentially larger end (no pigtail)|align = "center"|30|align = "center" |[[Image:pAguaMedicina.png|thumb|center|100px|<center>pAguaMedicina</center>]] |-|align = "center" bgcolor = "#dce6f1"|'''7'''|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.bioteq.com.tw/en/products.php?kind=2&series=4 Bioteque Corp.]</font>|align = "center" bgcolor = "#dce6f1"|Ureteral Stent Set|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bioteq.com.tw/en/news_detail.php?id=1&query_string= FDA 510(k) ]</u></font>|align = "center" bgcolor = "#dce6f1"|Apr, 2010|bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|30|align = "center" bgcolor = "#dce6f1"|[[Image:bioteque.png|thumb|center|100px|<center>Bioteque</center>]] |-|align = "center" rowspan = "4"|'''8'''|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+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=4353 Mesh]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=4353 FDA 510(k)]</u></font>|align = "center"|Jul, 2001|Polyester mesh|Double-pigtail|align = "center"| |align = "center"| N/A|-|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Silhouette ]</u></font>|align = "center"| |align = "center"| |Coil-reinforced; SL-6® hydrophilic coating|Patency Device|align = "center"| |align = "center" |[[Image:silhouette.png|thumb|center|100px|<center>Silhouette</center>]] |-|align = "center"|<font color="#0000FF"><u>[http://www.appliedmed.com/products/product_card.aspx?section=professionals&proceGroupID=4&groupName=Urology&catID=37&Name=Ureteral+stents Applied Standard]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=124645 FDA 510(k)]</u></font>|align = "center"|Jun, 1999|Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating|Unique wall construction and preventive maintenance recordsenlarged drainage holes |align = "center"| |align = "center" |[[Image:Applied_Std1.png|thumb|center|100px|<center>Applied Standard</center>]] |-|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>|align = "center"| |align = "center"| |Proprietary thermoplastic elastomer material; inSL-process 6® hydrophilic coating|Dual Diameter stent|align = "center"| |align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</ incoming inspection test methods center>]] |-|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''9'''|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF"><u>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</u></font>|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=225 InLay Optima]</u></font>|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=16869 FDA 510(k)]</u></font>|align = "center" bgcolor = "#dce6f1"|Dec, 2004|bgcolor = "#dce6f1"|Silicone|bgcolor = "#dce6f1"|Double pigtail with monofilament suture loop|align = "center" bgcolor = "#dce6f1"|365|align = "center" bgcolor = "#dce6f1"|[[Image:InLay_Optima.png|thumb|center|100px|<center>InLay Optima</center>]] |-|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=227 Bardex® Double Pigtail Soft Stent]</u></font>|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>]]|-|align = "center" bgcolor = "#dce6f1"|<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>]]|-|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=230 Figure-4 Silicone Ureteral Stent]</u></font>|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |bgcolor = "#dce6f1"|Silicone|bgcolor = "#dce6f1"|Three dimensional design|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:Figure_4.png|thumb|center|100px|<center>Figure 4</center>]]|-|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.bardurological.com/products/loadProduct.aspx?bUnitID=3&prodID=226 InLay Ureteral Stent]</u></font>|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=122796 FDA 510(k)]</u></font>|align = "center" bgcolor = "#dce6f1"|Dec, 1998|bgcolor = "#dce6f1"|Silicone|bgcolor = "#dce6f1"|Tapered tip and related test method validationslubricious hydrophilic coating |align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:InLay.png|thumb|center|100px|<center>InLay</center>]]|-|align = "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 = "#dce6f1"|Apr, 1991|bgcolor = "#dce6f1"|Silicone|bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:Urinary_Diversion_Stent.png|thumb|center|100px|<center>Urinary Diversion Stent</center>]]|-|align = "center" rowspan = "4"|'''10'''|align = "center" rowspan = "4"|<font color="#0000FF">[http://www.coloplast.com/Pages/home.aspx Coloplast-Porges]</font>|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=251 Vortek]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=121312 FDA 510(k)]</u></font>|align = "center"|Oct, 1998|Silicone|Double coating for easy maneuverability as well as flexibility|align = "center"| |align = "center"|[[Image:Vortek.png|thumb|center|100px|<center>Vortek</center>]]|-|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(k)]</u></font>|align = "center"|Oct, 1998|Silicone|Extreme flexibility|align = "center"| |align = "center"|[[Image:Biosoft.png|thumb|center|100px|<center>Biosoft</center>]]|-|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=249 Polyurethane]</u></font>|align = "center"| |align = "center"| |Hard or soft Polyurethane|Designed for short-term use|align = "center"| 90|align = "center"|[[Image:Polyurethane1.png|thumb|center|100px|<center>Polyurethane</center>]]|-|align = "center"|<font color="#0000FF"><u>[http://www.porges.ru/catalog.html?cid=250 Silicone]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=6586 FDA 510k)]</u></font>|align = "center"|Oct, 2002|Silicone|''Pyatiprofilnaya'' technology |align = "center"| |align = "center"|[[Image:Silicone1.png|thumb|center|100px|<center>Silicone</center>]]|-|align = "center" bgcolor = "#dce6f1"|'''11'''|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.teleflex.com/en/emea/productAreas/urology/index.html Teleflex Medical]</font>|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.google.com/url?sa=t&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 detachable|align = "center" bgcolor = "#dce6f1"| |align = "center" bgcolor = "#dce6f1"|[[Image:Superglide_DD.png|thumb|center|100px|<center>Superglide DD</center>]]|-|align = "center" rowspan = "9"|'''12'''|align = "center" rowspan = "9"|<font color="#0000FF">[http://www.gyrusacmi.com/user/display.cfm?display=cat_menu&maincat=Stone%20Management&catid=122 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek]</font>|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9257&catid=122&maincat=Stone%20Management&catname=Stents Classic closed-tip]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=68160 FDA 510(k)]</u></font>|align = "center"|Dec, 1986
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|Classic Closed Tip|align = "center"| |align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]|-|align = "center"|<font color="# Check the entire equipment0000FF"><u>[http://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="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=111987 FDA 510(k)]</u></font>|align = "center"|Mar, 1996|Tecoflex® construction|Balanced-related lifecyclecurled double pigtail design|align = "center"| |align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]|-|align = "center"|<font color="# Check if machine operational qualification was performed0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9256&catid=122&maincat=Stone%20Management&catname=Stents Double-J]</u></font>|align = "center"|<font color="# Check if the measurement equipment was validated0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=74392 FDA 510(k)]</u></font>|align = "center"|Apr, 1988|Silicone|Double-J closed-tip |align = "center"| |align = "center"|[[Image:Gyrus_Double_J.png|thumb|center|100px|<center>Double_J</center>]]|-|align = "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"| |align = "center"| |Tecoflex® |Grooved design|align = "center"| |align = "center"|[[Image:Lithostent.png|thumb|center|100px|<center>Lithostent</center>]]|-|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9253&catid=122&maincat=Stone%20Management&catname=Stents Lubri-flex]</u></font>|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=91169 FDA 510(k)]</u></font>|align = "center"|Nov, 1991|Tecoflex®|“Rememberance” of shape with a chemically bonded wettable solution |align = "center"| |align = "center"|[[Image:Lubri_Flex.png|thumb|center|100px|<center>Lubri-flex</center>]]|-|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9250&catid=122&maincat=Stone%20Management&catname=Stents Multi-flex]</u></font>|align = "center"| |align = "center"| |Tecoflex®|Two durometers with helical kidney curls|align = "center"| |align = "center"|[[Image:Multi_Flex.png|thumb|center|100px|<center>Multi-flex</center>]]|-|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>]]|-|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9249&catid=122&maincat=Stone%20Management&catname=Stents Sof-curl]</u></font>|align = "center"| |align = "center"| |Tecoflex®|Dual-durometer design and exclusive soft bladder helix |align = "center"| |align = "center"|[[Image:Sof_curl.png|thumb|center|100px|<center>Sof-curl</center>]]|-|align = "center"|<font color="#0000FF"><u>[http://www.gyrusacmi.com/user/display.cfm?display=product&pid=9258&catid=122&maincat=Stone%20Management&catname=Stents Uroguide]</u></font>|align = "center"| |align = "center"| |Silicone|Classic Double J with open tip|align = "center"| |align = "center"|[[Image:Uroguide.png|thumb|center|100px|<center>Uroguide</center>]]
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!rowspan|align ="2center" bgcolor = "#dce6f1"|Validation Report'''13'''| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reportsalign = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]|bgcolor = "# Ensure all reports are available and linked together appropriatelydce6f1"| |bgcolor = "# Identify all inconsistencies across different reportsdce6f1"| | rowspanbgcolor ="2#dce6f1"| Quality systemsNitinol; Available with hydrophilic coating|bgcolor = "#dce6f1"|Double loop stent|align = "center" bgcolor = "#dce6f1"|Short-term and long-term|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]
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| 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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# Compare test methods used to those in client and ISO standards# Identify inconsistencies across test methods|align = "center"|N/A
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=Product to Clinical Trial Mapping= = Sample report =Clinical Timeline Visualization ==[[Image:Timeline.jpg]] [[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]] =Product to Patent Mapping = [[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''Products from Boston Scientific and C R Bard ''']]to download the excel file.== Performance/Functional Characteristics ==Mapped Patent vs Not Mapped Patents =={| classborder="wikitable0" stylecellspacing="font-size:90%" border="10" cellpadding="54" cellspacingwidth="0100%" |[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]|- style|} ="backgroundPatent-Product-Clinical Trial Mapping= * To access the Dashboard you have to signup. You can do so by clicking [https:lightgrey//www.dolcera.com/auth/index.php/login '''here''']*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard'' *''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''!align {|border= "center2" bgcolor cellspacing= "#00CCFF0" colspan cellpadding= "4" width="100%" |Design Input<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm> |} !align =Insights= {|border= "center2" bgcolor cellspacing= "#00CCFF0" cellpadding="4" width="5100%" rowspan|bgcolor ="2#538ED5"|Design Output!align <font size = "center4" >''' '''</font>|bgcolor = "#00CCFF538ED5" width|<font size ="5%4" rowspan>''' '''</font>|bgcolor ="2#538ED5"|Design Verification Report #!align <font size = "center4" >'''Boston Scientific'''</font>|bgcolor = "#00CCFF538ED5" width|<font size ="5%4" rowspan="2"|Status (P>'''C R BARD'''</F/R)font>!|-|align = "center" bgcolor = "#00CCFF" width="5%538ED5" rowspan="24"|Design Validation Report #'''Products'''!|'''Portfolio'''|8 Products|6 Products|-|'''Material'''|Percuflex - Biocompatible Polymer|Silicone|-|'''Coating'''|Hydroplus|Licensed from pHreecoat|-|'''Shape'''|Pigtailed and More|Figure 4 and more|-|align = "center" bgcolor = "#00CCFF538ED5" width|'''Clinical <br>Trials'''|'''Current Trials'''|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)|None|-|align ="5%center" bgcolor = "#538ED5" rowspan="23"|Status (P/F'''Patents'''|'''Coating'''|Therapeutic /R)Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion|Therapeutic coatings
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!align = "center" bgcolor = "#00CCFF" width="20%"|User Needs'''Structure'''!align = "center" bgcolor = "#00CCFF" width="15%"|User Need RationaleMultiple 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!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification RationaleExpandable stents for reducing discomfort
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|Provide antimicrobial resistance for up to 2 weeks'''Material'''|Ureteral Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent User Survey (Document #XXXXX)|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeks|Document #XXXXX|Test Document #XXXXX|Report 01-005-06-007|P|Report 01-005-06-007with variable hardness|PBiodegradable polymers<br>Shape memory alloys<br>General polymer based
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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 in-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 note-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.
== Phase 3: Post-acquisition integration Inference ===== Deadlines ==='''Goal''': Switch production transparently to new facilities transparently to the distribution system
{| classborder="wikitable2" stylecellspacing="font-size:90%" border="10" cellpadding="54" cellspacingwidth="082%" |- style="background:lightgrey"!align = "center" bgcolor = "#00CCFF538ED5" |Stage!align <font size = "center" bgcolor = "#00CCFF4" >'''Boston Scientific'''</font>|Tasks!align = "center" bgcolor = "#00CCFF538ED5" |Milestone payment!align <font size = "center4" bgcolor = "#00CCFF" |Date>'''C R BARD'''</font>
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|Design center integration planRelatively late entrant with patents filed post mid 90s|* Gap analysis completion (acquiree)* Gap analysis completion (acquirer)||September 15, 2008Early mover with patents filed in mid 80s
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|Design to manufacturing transferIncreased patent activity since 2000|||December 15, 2008Patent activity never gained traction
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|Equipment transferLarge number of patents yet to be "productized"||Milestone I payment|Jan 7, 2009Few patents yet to be "productized"
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|Shut production at acquiree facilitySome products undergoing clinical trails|Negotiation for contract extension|Milestone II payment|Feb 15, 2009No products undergoing clinical trails
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|Start production Diverse range of products with variation in acquirer facilitymaterial <br>and structure|||Feb 7, 2009Small product portfolio
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|Switch Seem to new SKUbe strengthening they market position|||Feb 15, 2009Seem to be moving focus away from Ureteral stents market
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|End development } = 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 new generation product/s patents in old facilityyear 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%"|Feb 7, 2009bgcolor = "#4f81bd"|'''Company'''|bgcolor = "#4f81bd"|'''Total Sales in 2010'''|bgcolor = "#4f81bd"|'''Urological sales'''|bgcolor = "#4f81bd"|'''Percentage share'''|bgcolor = "#4f81bd"|'''Product portfolio'''
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|Restart development of new generation productbgcolor = "#4f81bd"|'''Boston Scientific'''|7800|661|8.48|<font color="#0000FF"><u>[http:/s post/www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-acquisitionBrochure.pdf Boston_portfolio]</u></font>|-|Final milestone paymentbgcolor = "#4f81bd"|'''CR BARD'''|Mar 1, 20092700|702|26.00|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font>|-|bgcolor = "#4f81bd"|'''Cook Medical'''|1700|<nowiki>-</nowiki>|<nowiki>-</nowiki>|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font>|-|bgcolor = "#4f81bd"|'''Medline'''|4040|<nowiki>-</nowiki>|<nowiki>-</nowiki>|<font color="#0000FF"><u>[http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Medline_portfolio]</u></font>
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=== Documents and Ownership ==={[[image:stentshare.jpg | classthumb|center|1000px| All figures in USD million ]] ="wikitable" <span style="font-sizecolor:90%#C41E3A" border>Like this report?</span>=<p align="1center" cellpadding> '''This is only a sample report with brief analysis''' <br>'''Dolcera can provide a comprehensive report customized to your needs'''</p>{|border="52" cellspacing="0" |- stylecellpadding="background:lightgrey4"!align = "center" bgcolor "|style= "#00CCFFbackground:lightgrey" |Document!align = "center" bgcolor colspan = "#00CCFF3" |Owner!align = "center" bgcolor '''[mailto:info@dolcera.com <span style= "color:#00CCFF0047AB" |Last update date>Buy the customized report from Dolcera</span>]'''
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|Product performance specificationsalign = "center"|Paul Swain[http://www.dolcera.com/website_prod/services/ip-patent-analytics-services Patent Analytics Services]|07align = "center"| [http:/27/2008 08www.dolcera.com/website_prod/services/business-research-services Market Research Services]|align = "center"| [http:15:35 PST//www.dolcera.com/website_prod/tools/patent-dashboard Purchase Patent Dashboard]
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|Component specificationsalign = "center"|Kevin Teller[http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/patent-search/patent-landscapes Patent Landscape Services]|06align = "center"| [http:/12/2008 12www.dolcera.com/website_prod/research-processes Dolcera Processes]|align = "center"| [http:22:07 PST//www.dolcera.com/website_prod/industries Industry Focus]
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|Preclinical test resultsalign = "center"|Joanne Krannert|07[http:/03/2008 14:17:00 PST|www.dolcera.com/website_prod/services/ip-patent-analytics-services/patent-search/patent-landscapes Patent Search Services]|Clinical testsalign = "center"|Joanne Krannert[http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/alerts-and-updates Patent Alerting Services]|08align = "center"| [http:/01/2008 08:00:55 PSTwww.dolcera.com/website_prod/tools Dolcera Tools]
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