Difference between revisions of "Ureteral Stent"

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== Phase 1: Landscape overview ==
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'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trials.
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=== Ureteral Stent: Concept ===
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'''
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An antimicrobial ureteral stent, which inhibits encrustation and bacterial colonization while maintaining patient comfort.
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*'''''What is it?''''' A ureteral stent is a specially designed hollow tube, made of a flexible plastic material that is placed in the ureter.
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*'''''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.
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==Background==
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[[Image:Ureteral_Stent.png|thumb|200px|<center>[http://www.pnnmedical.com/urology/professionals/products/memokath%E2%84%A2-051-ureter.aspx '''Ureteric Stent''']</center>]]
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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
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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.
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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.
 
* Ureteral stent: resists migration, resists fragmentation, is kink resistant and radiopaque.
 
* Bacterial colonization: antimicrobial activity for up to two weeks.
 
* Bacterial colonization: antimicrobial activity for up to two weeks.
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* Patient Comfort: stent has a low coefficient of fiiction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.
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* Patient Comfort: stent has a low coefficient of friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.
  
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=== Background ===
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'''[[more on background...]]'''
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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
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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.  
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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:
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=Market Overview=
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* Treatment of ureteral or kidney stones
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* Ureteral trauma or stricture
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* Genitourinary reconstructive surgery
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* Hydronephrosis during pregnancy
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* Obstruction due to malignancy
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* Retroperitoneal fibrosis
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The need for ureteral stents range from a few days to several months. For patients with serious urological problems, ureteral stent maintenance may become a life-long necessity. Unfortunately, there are many problems associated with using ureteral stents.
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Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.
  
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=== Ureteric stenting difficulties ===
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'''[[more on market overview...]]'''
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[[Image:Ureteral stent.jpg|thumb|right|350px|Double-J and Pigtail ureteral stents]]
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{|border="2" cellspacing="2" cellpadding="4" width="50%"
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=Interactive Mind Map=
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|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Common'''</font>
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* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']
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|align = "center" bgcolor = "#00CCFF"|<font color="#993366">'''Rare'''</font>
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*''Use the mouse(click and drag/scroll up or down/click on nodes) to explore nodes in the detailed taxonomy''
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*''Click on the red arrow adjacent to the node name to view the content for that particular node in the dashboard''
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*''Click on the "+" sign to zoom the mindmap and "-" sign to shrink the mindmap''
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{|border="2" cellspacing="0" cellpadding="4" width="100%"
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|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm>
  
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* Trigonal irritation
 
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* Haematuria
 
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* Fever
 
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* Infection
 
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* Tissue inflammation
 
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* Encrustation
 
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* Biofilm formation
 
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* Obstruction
 
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* Kinking
 
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* Ureteric rupture
 
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* Ureteric perforation
 
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* Stent misplacement
 
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* Stent migration
 
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* Stent misfit
 
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* Stent forgotten
 
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* Tissue hyperplasia
 
 
|}
 
|}
  
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Today, elastomeric materials, such as silicones, polyurethanes and hydrogel-coated polyolefins are used, with no clear winner, which can withstand the urinary environment.
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=Patents=
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* 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.
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* 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.
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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).
 
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* C-Flex is proprietary silicone oil and mineral oil interpenetrated into a styrenelolefin block copolymer with the hope of reduced encrustation.
 
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* Silitek (Medical Engineering Corporation) is another silicone-based copolymer.
 
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* Percuflex is a proprietary olefinic block copolymer.
 
  
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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 device
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==Patent Search Strategy==
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surface, smoothness of the surface and coefficient of friction.
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[[Image:Patent Search Strategy.jpg|700px]]
  
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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
 
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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.
 
  
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There are a variety of ureteral stent configurations with different anchoring systems. Most stents today have a double [http://linkinghub.elsevier.com/retrieve/pii/S014067360002674X pigtail anchoring system]. (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 concerning
 
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lower 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.
 
  
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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.
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== Dolcera Dashboard ==
  
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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
 
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for short-term indications. Problems of biofilm formation, encrustation and stent fracture occur in patients with long-term indwelling stents.
 
  
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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.
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'''Dashboard Link'''<br>
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{|border="2" cellspacing="0" cellpadding="4" width="100%"
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|'''[https://www.dolcera.com/auth/dashboard/dashboard.php?workfile_id=1008 Ureteral Stent - Dashboard] '''
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|width="100"|[[Image:dashboard_thumb.png|center|100px|]]
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|-
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|}
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*Flash Player is essential to view the Dolcera Dashboard
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* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']
  
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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.
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= Clinical Trials =
  
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==== Encrustation ====
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==New trials ==
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The urinary system presents a challenge because of its chemically unstable environment. Long-term biocompatibility and biodurability of devices have been problems due to the supersaturation of uromucoids and crystalloids at the interface between urine and the device. Encrustation of ureteral stents is a well-known problem, which can be treated easily if recognized early. However, severe encrustation leads to renal failure and is difficult to manage (Mohan-Pillai et al., 1999). All biomaterials currently used become encrusted to some extent when exposed to urine.
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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 been
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{|border "1" style="border-spacing:0;"
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reported to fracture). Stent fragments can migrate to the bladder or renal pelvis with serious repercussions.
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| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center>
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| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title '''</font></center>
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| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conditions '''</font></center>
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| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Intervention: Device'''</font></center>
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| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Sponsors and Collaborators '''</font></center>
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|-
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| style="background-color:#dce6f1;padding:0.079cm;"| <center>1</center>
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| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00250406?term=ureteral+stent&rank=1 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation]
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| style="background-color:#dce6f1;padding:0.079cm;"|Renal Calculi, Ureteral Obstruction
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| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Stent
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| style="background-color:#dce6f1;padding:0.079cm;"| Lawson Health Research Institute, Boston Scientific Corporation
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|-
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| style="padding:0.079cm;"| <center>2</center>
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| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00270504?term=urethral+stent&rank=1 Memokath® 044TW Stent for Treatment of Urethral Stricture]
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| style="padding:0.079cm;"| Urethral Stricture
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| style="padding:0.079cm;"| Memokath stenting
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| style="padding:0.079cm;"| Engineers & Doctors Wallsten Medical Group
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|-
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| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center>
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| style="background-color:#dce6f1;padding:0.079cm;"|[http://clinicaltrials.gov/ct2/show/NCT00581178?term=urologic+stent&rank=3 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation]
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| style="background-color:#dce6f1;padding:0.079cm;"| Kidney Stones
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| style="background-color:#dce6f1;padding:0.079cm;"| N\A
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| style="background-color:#dce6f1;padding:0.079cm;"| University of California, Irvine
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|-
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| style="padding:0.079cm;"| <center>4</center>
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| style="padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00288457?term=urologic+stent&rank=14 Ureteral Stent Length and Patient Symptoms]
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| style="padding:0.079cm;"| Kidney Stones
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| style="padding:0.079cm;"| Ureteral Stent
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| style="padding:0.079cm;"| Emory University
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|-
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| style="background-color:#dce6f1;padding:0.079cm;"| <center>5</center>
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| style="background-color:#dce6f1;padding:0.079cm;"| [http://clinicaltrials.gov/ct2/show/NCT00166361?term=urologic+stent&rank=1 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent]
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| style="background-color:#dce6f1;padding:0.079cm;"| Ureteral Obstruction
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| style="background-color:#dce6f1;padding:0.079cm;"|Memokath 051 Ureteral Stent
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| style="background-color:#dce6f1;padding:0.079cm;"| Mayo Clinic Engineers & Doctors Wallsten Medical Group
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|-
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| style="padding:0.079cm;"| <center>6</center>
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| 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 an Urgent Drainage of Obstructed Kidney (JJVsPCN08)]
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| style="padding:0.079cm;"| Kidney Disease
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| style="padding:0.079cm;"| Nephrostomy tube and ureteral stent
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| style="padding:0.079cm;"| Rabin Medical Center
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|}
  
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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).
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== Concluded trials ==
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{| {{table}}
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| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center>
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| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Title'''</font></center>
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| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Abstract'''</font></center>
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| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Enrollment'''</font></center>
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| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Disorder'''</font></center>
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| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Conclusion'''</font></center>
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|-
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| style="background-color:#dce6f1;padding:0.079cm;"|<center>1</center>
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| style="background-color:#dce6f1;padding:0.079cm;"| Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia || style="background-color:#dce6f1;padding:0.079cm;"|To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia.|| style="background-color:#dce6f1;padding:0.079cm;"|13|| style="background-color:#dce6f1;padding:0.079cm;"|Detrusor-sphincter dyssynergia|| style="background-color:#dce6f1;padding:0.079cm;"|Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.
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|-
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| style="padding:0.079cm;"| <center>2</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||Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups.||34||Upper urinary tract obstruction||Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.
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|-
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| style="background-color:#dce6f1;padding:0.079cm;"| <center>3</center>
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| style="background-color:#dce6f1;padding:0.079cm;"| Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial.|| style="background-color:#dce6f1;padding:0.079cm;"|A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting.|| style="background-color:#dce6f1;padding:0.079cm;"|201|| style="background-color:#dce6f1;padding:0.079cm;"|Renal transplant recipient|| style="background-color:#dce6f1;padding:0.079cm;"|Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.
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|}
  
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Many different types of stone can form in the urinary tract. Calcium oxalate, calcium phosphate, uric acid and cystine stones are metabolic stones because they form as a result of metabolic dysfunction. They usually are excreted from the urinary tract. Struvite (magnesium ammonium phosphate) and hydroxyapatite (calcium phosphate) are associated with infection (infection stones). These account for 1520% of urinary calculi. ESWL is used to break up the larger infection stones because they don't pass; recurrence of the problem occurs with incomplete removal. 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 stents. Urea-splitting bacteria colonize the surface and cause alkalinization of the urine, which lowers the solubility of struvite and hydroxyapatite, and they deposit on the surface. Bacterial biofilm associated with encrustation is a common clinical occurrence. (Gorman and Tunney, 1997). It has been suggested that prevention of bacterial colonization would prevent encrustation because of their ultimate responsibility for its formation (Bibby et al., 1995).
 
  
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An in vitro model was developed that produces encrustation similar to those seen in vivo (Tunney et al., 1996a). An experiment was conducted to compare the encrustation potential of various ureteral stent materials. The long-term struvite and hydroxyapatite encrustation of silicone, polyurethane, hydrogel-coated polyurethane, Silitek and Percuflex were compared. All of the materials developed encrustation, however, it was found by image analysis that the rates of encrustation varied on the different materials. Silicone had less encrustation (69% at 10 weeks) compared to the other materials (1 00%) at the same time point (Tunney et al., 1996b). Continuous flow models have also been developed which are more representative of conditions in the upper urinary tract. They are discussed by Gorman and Tunney, (1 997). Efforts to reduce encrustation using new materials, smoother
 
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surfaces and hydrogel coatings have been attempted.
 
  
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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.
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==Pre-Market Notification==
  
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====Obstruction====
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Some of the companies active in the field of ureteral stents have been represented in the table below.  
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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
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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.
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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
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bacterial biofilms.
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====Infection====
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{| border="2" cellspacing="0" cellpadding="4" width="100%"
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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 culture
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| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''S.No. '''</font></center>
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may benefit from prophylactic antibiotics; however, the authors contended that the antibiotics must work against gram-negative uropathogens and gram-positive bacteria including enterococci.
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| style="background-color:#4f81bd;padding:0.079cm;"|<center><font color="#FFFFFF">'''Company '''</font></center>
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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 2
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| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Device '''</font></center>
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weeks, 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.
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| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Approval '''</font></center>
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| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Date of Approval '''</font></center>
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| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center>
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| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center>
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| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling Time (days) '''</font></center>
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|-
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| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center>
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| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.bardurological.com/products/categoryTwo.aspx?bUnitID=3&catOneID=71 Bard Urological]</center>
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| 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>]]]
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| 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>
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| style="background-color:#dce6f1;padding:0.079cm;"| <center>Dec 2004</center>
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| style="background-color:#dce6f1;padding:0.079cm;"| Silicone
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| style="background-color:#dce6f1;padding:0.079cm;"| Double pigtail with monofilament suture loop
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| style="background-color:#dce6f1;padding:0.079cm;"| <center>365</center>
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|-
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| style="padding:0.079cm;"| <center>'''2'''</center>
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| style="padding:0.079cm;"| <center>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</center>
 +
| style="padding:0.079cm;"| [[Image:Polaris_Loop.png|thumb|center|100px|[http://www.bostonscientific.com/urology-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 market need ===
+
|-
−
It is clear that there is a need for a new material that will be able to resist encrustation and infection in the urinary tract. According to Merrill Lynch, ureteral stents represent an $80 MM
+
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''5'''</center>
−
US market. Boston Scientific is in the lead with ~50% of the market followed by Maxxim (Circon), Cook and Bard is a smaller player. There are a number of other small contenders.  
+
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</center>
 +
| style="background-color:#dce6f1;padding:0.079cm;"| [[Image:Memokath_051.png|thumb|center|100px|[http://www.google.com/url?sa=t&source=web&cd=4&ved=0CC4QFjAD&url=http://www.hammer.pl/pliki/147_2.pdf&rct=j&q=memokath%20051&ei=MfhATezNIoaqvQP-_ZGtAw&usg=AFQjCNFR-ZFsu33rk6B9Flq1tCsYBZyXMw&cad=rja <center>Memokath 051</center>]]]
 +
| style="background-color:#dce6f1;padding:0.079cm;"| <center>[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</center>
 +
| style="background-color:#dce6f1;padding:0.079cm;"| <center>1995</center>
 +
| style="background-color:#dce6f1;padding:0.079cm;"| Nickel-titanium shape memory alloy
 +
| style="background-color:#dce6f1;padding:0.079cm;"| Double fluted ended spiral stent
 +
| style="background-color:#dce6f1;padding:0.079cm;"| <center>240</center>
 +
|}
  
−
The use of ureteral stents is increasing; the indications for ureteral stenting have broadened from temporary or permanent relief or ureteric obstruction to include temporary urinary diversion following surgical procedures such as endopyelotomy and ureteroscopy and facilitation of stone clearance after ESWL (Tolley, 2000).
+
=Products=
  
−
The use of ureteral stents for patients having ESWL for renal calculi is however controversial and seems to be related to the size of the stones and invasiveness of the procedure. According to survey results reported by Hollowell, et al. (2000), there is a significant difference in opinion concerning the use of stents with ESWL.  
+
The FDA classifies a ureteric stent as follows:
 +
* TITLE 21      - FOOD AND DRUGS
 +
* CHAPTER I      - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
 +
* SUBCHAPTER H  - MEDICAL DEVICES
 +
* PART 876      - GASTROENTEROLOGY-UROLOGY DEVICES
 +
* Subpart E      - Surgical Devices
 +
* Sec. 876.4620  - Ureteral stent.  
 +
* Classification - class II device [http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfCFR/CFR.cfm?fr=876.4620&Term=ureter%20stent Code of Federal Regulations]
  
−
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.
+
{|border="2" cellspacing="0" cellpadding="4" width="100%"
 +
|align = "center" bgcolor = "#4f81bd"|'''Sr. No.'''
 +
|align = "center" bgcolor = "#4f81bd"|'''Company'''
 +
|align = "center" bgcolor = "#4f81bd"|'''Device(s)'''
 +
|align = "center" bgcolor = "#4f81bd"|'''Approval'''
 +
|align = "center" bgcolor = "#4f81bd"|'''Approval Date'''
 +
|align = "center" bgcolor = "#4f81bd"|'''Material'''
 +
|bgcolor = "#4f81bd"|'''Technology'''
 +
|align = "center" bgcolor = "#4f81bd"|'''Indwelling Time (days)'''
 +
|align = "center" bgcolor = "#4f81bd"|'''Image'''
 +
|-
 +
|align = "center" bgcolor = "#dce6f1"|'''1'''
 +
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.allium-medical.com/?categoryId=64772 Allium, Israel]</u></font>
 +
|align = "center" bgcolor = "#dce6f1"|[http://www.allium-medical.com/?categoryId=64772 URS]
 +
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF">[http://www.highbeam.com/doc/1G1-165990208.html CE Mark]</font>
 +
|align = "center" bgcolor = "#dce6f1"|Jul, 2007
 +
|bgcolor = "#dce6f1"|Nickel-titanium shape memory alloy covered by polymer
 +
|bgcolor = "#dce6f1"|Self-expanding stent
 +
|align = "center" bgcolor = "#dce6f1"|
 +
|bgcolor = "#dce6f1"|[[Image:656px-Allium.jpg|thumb|center|100px|<center>Allium</center>]]
  
−
=== Intellectual property ===
+
|-
−
==== Search strategy ====
+
|align = "center" rowspan = "2"|'''2'''
−
* Databases searched: US-G, US-A, EP-A, EP-B, WO, JP, DE, GB, FR
+
|align = "center" rowspan = "2"|<font color="#0000FF">[http://www.pnnmedical.com/urology/professionals/products/memokath™-051-ureter.aspx Pnn Medical A/S]</font>
−
* Search scope: Title, Abstract or Claims
+
|align = "center" rowspan = "2"|[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 Memokath 051]
−
* Years: 1981-July 2008
+
|align = "center"|<font color="#0000FF">[http://www.pnnmedical.com/about-pnn-medical/company-history.aspx CE Mark]</font>
−
* Search query: (ureter* OR urether* OR ureth* OR uretr*) AND (stent*) AND (*microb* OR *bacter*)
+
|align = "center"|1995
−
* Results: '''177 patents (82 unique patent families)'''
+
|rowspan = "2"|Nickel-titanium 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>]]
  
−
==== Sample patents ====
 
−
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0"
 
−
|- style="background:lightgrey"
 
−
!align = "center" bgcolor = "#00CCFF"|Patent
 
−
!bgcolor = "#00CCFF"|Assignee
 
−
!bgcolor = "#00CCFF"|Title
 
−
!bgcolor = "#00CCFF"|Abstract
 
 
|-
 
|-
−
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=6468649.PN.&OS=PN/6468649&RS=PN/6468649 US6468649 B1]
+
|align = "center"|<font color="#0000FF"><u>[http://www.zapconnect.com/products/index.cfm/fuseaction/products_display_detail/eregnum/8021561/owner_operator_number/8021561/product_code/FAD/8021561.html FDA Listing]</u></font>
−
| SCIMED LIFE SYSTEMS INC
+
|align = "center"|Mar, 2004
−
| Antimicrobial adhesion surface
+
−
| 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 thereof.
+
 
|-
 
|-
−
![http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2Fsrchnum.htm&r=1&f=G&l=50&s1=5554147.PN.&OS=PN/5554147&RS=PN/5554147 US5554147 A]
+
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|'''3'''
−
| CApHCO, Inc.
+
|align = "center" bgcolor = "#dce6f1" rowspan = "5"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm Fossa Medical]</u></font>
−
| Compositions and devices for controlled release of active ingredients
+
|align = "center" bgcolor = "#dce6f1" rowspan = "2"|[http://dolcera.com/upload/files/stonesweeper_fossa_trial.pdf Stone Sweeper]
−
| 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. The polymer matrix swells when the environment reaches pH 8.5, 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 pH-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 urease-producing bacteria. 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 pH-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 time.  
+
|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>]]
 +
 
 
|-
 
|-
−
![http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220030153983%22.PGNR.&OS=DN/20030153983&RS=DN/20030153983 US20030153983 A1]
+
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm FDA 510(k)]</u></font>
−
| SCIMED LIFE SYSTEMS INC
+
|align = "center" bgcolor = "#dce6f1"|Aug, 2002
−
|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 particular, 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
+
 
|-
 
|-
−
|}
+
|align = "center" bgcolor = "#dce6f1" rowspan = "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:Open_Lumen.png|thumb|center|100px|<center>Open_lumen</center>]]
  
−
== Phase 2: Deeper Dive ==
+
|-
−
=== Scenario ===
+
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.fossamedical.com/news.htm CE Mark]</u></font>
−
Client wishes to acquire a ureteral stent company.
+
|align = "center" bgcolor = "#dce6f1"|Sep, 2005
 +
|-
 +
|align = "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 = "#dce6f1"|Jun, 2002
 +
|bgcolor = "#dce6f1"|Polyurethane
 +
|bgcolor = "#dce6f1"|Double pigtail stent with <nowiki>’</nowiki>Pusher<nowiki>’</nowiki>
 +
|align = "center" bgcolor = "#dce6f1"|
 +
|align = "center" bgcolor = "#dce6f1"| N/A
  
−
=== 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
 
 
|-
 
|-
−
!rowspan="2"|Design Input
+
|align = "center" rowspan = "7"|'''4'''
−
| Design input documents for sufficiency
+
|align = "center" rowspan = "7"|<font color="#0000FF"><u>[http://www.bostonscientific.com/Device.bsci/,,/method/DevHome/navRelId/1000.1003/seo.serve Boston Scientific]</u></font>
−
|  
+
|align = "center"|<font color="#0000FF"><u>Contour</u></font>
−
# Access electronic data room.
+
|align = "center"|  
−
# Check what documents are provided.
+
|align = "center"|
−
# Compare document list with standard client document list.
+
|Percuflex - proprietary polyolefin copolymer; Hydroplus coating
−
# Check whether each specified document has appropriate content.
+
|Fixed and variable length; Tapered tip
−
| rowspan="2"|Quality systems
+
|align = "center"|365
 +
|align = "center" |[[Image:Contour.png|thumb|center|100px|<center>Contour</center>]]
 
|-
 
|-
−
| Design input documents linked to the product performance specifications
+
|align = "center"|<font color="#0000FF"><u>Percuflex</u></font>
−
|
+
|align = "center"|  
−
# Compare product specifications to design inputs
+
|align = "center"|
−
# Check whether appropriate verifications and validations are performed
+
|align = "center"| Percuflex
−
# Establish if all specifications are linked to design inputs
+
|Pigtail
 +
|align = "center"|365
 +
|align = "center" |[[Image:Percuflex.png|thumb|center|100px|<center>Percuflex</center>]]
 
|-
 
|-
−
!rowspan="3"|Product Performance Specifications (PPS)
+
|align = "center"|<font color="#0000FF"><u>Polaris Ultra</u></font>
−
| 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 plans
+
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/PMNSimple.cfm?db=PMN&id=K010002 FDA 510(k)]</u></font>
−
|  
+
|align = "center"|Jan, 2001
−
# Compare product specifications to design inputs
+
|Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil.
−
# Check whether appropriate verifications and validations are performed
+
|Double pigtail
−
# Establish if all specifications are linked to design inputs
+
|align = "center"|365
−
| rowspan="3"|Quality systems, CAD
+
|align = "center" |[[Image:Polaris_Ultra.png|thumb|center|100px|<center>Polaris Ultra</center>]]
 
|-
 
|-
−
| Appropriate design verification and validations (DV&V) are performed
+
|align = "center"|<font color="#0000FF"><u>Polaris Loop</u></font>
−
|  
+
|align = "center"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10929 FDA 510(k)]</u></font>
−
# Show DV&V criteria are based on risk management requirements
+
|align = "center"|Mar, 2003
 +
|Dual Durometer Percuflex with HydroPlus Coating
 +
|Bladder loop design
 +
|align = "center"|365
 +
|align = "center" |[[Image:Polaris_Loop.png|thumb|center|100px|<center>Polaris Loop</center>]]
 
|-
 
|-
−
| Product performance specifications correspond to appropriate design output documents
+
|align = "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"|  
−
# Correlate design drawings with the specifications
+
|align = "center"|
−
# Check whether maximum dimensions, sizes etc. (with tolerances) are within the specified range
+
|Percuflex material and Hydroplus coating
 +
|Endopyelotomy stent
 +
|align = "center"|Post-procedure healing
 +
|align = "center" |[[Image:Retromax_plus.png|thumb|center|100px|<center>Retromax Plus</center>]]
 
|-
 
|-
−
!rowspan="4"|Risk Management Documents
+
|align = "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 Stretch VL Flexima]</u></font>
−
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation
+
|align = "center"|  
−
|  
+
|align = "center"|
−
# Check whether documentation is available
+
|Hydroplus Coating
−
# Check whether it adheres to appropriate ISO 14971 standards
+
|Variable length coil on distal and proximal ends
−
# Check whether it adheres to appropriate client standards
+
|align = "center"|90
−
|rowspan="4"| Quality systems
+
|align = "center" |[[Image:Stretch_VL_Flexima.png|thumb|center|100px|<center>Stretch VL Flexima</center>]]
 
|-
 
|-
−
| DFMEA links appropriately to the PPS
+
|align = "center"|[http://dolcera.com/upload/files/drug_eluting_ureteral_stent.pdf Drug-Eluting Stent]
−
|  
+
|align = "center"|  
−
# Verify whether DFMEA and product specifications are correlated
+
|align = "center"|
 +
|Percuflex - proprietary polyolefin copolymer
 +
|Ketorolac trimethamine loaded stent
 +
|align = "center"|
 +
|align = "center"| N/A
 
|-
 
|-
−
| Appropriate DV&V reports and design output documents are referenced correctly as risk mitigation activities in the DFMEA
+
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|'''5'''
−
|  
+
|align = "center" bgcolor = "#dce6f1" rowspan = "6"|<font color="#0000FF">[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook Medical]</font>
−
# Validate the process and correlate with design inputs
+
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4418 Resonance]</u></font>
−
# Validate that sizes used are within range of risk mitigation criteria
+
|align = "center" bgcolor = "#dce6f1"|<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"|May, 2007
 +
|bgcolor = "#dce6f1"|Metal
 +
|bgcolor = "#dce6f1"|
 +
|align = "center" bgcolor = "#dce6f1"|365
 +
|align = "center" bgcolor = "#dce6f1"|[[Image:Resonance.png|thumb|center|100px|<center>Resonance</center>]]
 
|-
 
|-
−
| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA
+
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=2055 Sof-flex]</u></font>
−
|  
+
|align = "center" bgcolor = "#dce6f1"|  
−
# Validate the process protocol
+
|align = "center" bgcolor = "#dce6f1"|
−
# Validate the inspection procedures used
+
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating
 +
|bgcolor = "#dce6f1"|Radiopaque tip and tether for repositioning
 +
|align = "center" bgcolor = "#dce6f1"|180
 +
|align = "center" bgcolor = "#dce6f1"|[[Image:Sof_flex.png|thumb|center|100px|<center>Sof-flex</center>]]
 
|-
 
|-
−
!rowspan="2"|Design Output Documents
+
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3627 Endo-Sof]</u></font>
−
| Completeness of drawings
+
|align = "center" bgcolor = "#dce6f1"|
−
|
+
|align = "center" bgcolor = "#dce6f1"|  
−
# Check if the CAD diagrams overlay and "fit" perfectly
+
|bgcolor = "#dce6f1"|AQ® Hydrophilic Coating
−
# Check tolerance stackups
+
|bgcolor = "#dce6f1"|Double pigtail
−
|rowspan="2"| Quality systems, CAD
+
|align = "center" bgcolor = "#dce6f1"|365
 +
|align = "center" bgcolor = "#dce6f1"|[[Image:Endo_Sof.png|thumb|center|100px|<center>Endo-Sof</center>]]
 
|-
 
|-
−
| Correlate First Article Inspection data to the dimensions on the drawings
+
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=3643 C-Flex]</u></font>
−
|  
+
|align = "center" bgcolor = "#dce6f1"|  
−
# Obtain First Article Inspection data
+
|align = "center" bgcolor = "#dce6f1"|
−
# Check if this data correlates with the completeness of drawings
+
|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>]]
 
|-
 
|-
−
!rowspan="4"|Manufacturing Documents
+
|align = "center" bgcolor = "#dce6f1"|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/dataSheet.do?id=4692 Smith Universal]</u></font>
−
| Manufacturing procedures, component specifications, raw material specifications, incoming and in-process inspection procedures for completeness
+
|align = "center" bgcolor = "#dce6f1"|
−
|  
+
|align = "center" bgcolor = "#dce6f1"|  
−
# Verify the Bill of Materials corresponds to raw materials and manufacturing procedures
+
|bgcolor = "#dce6f1"|
−
# Correlate incoming and in-process inspection procedures with the process specifications
+
|bgcolor = "#dce6f1"|Nephrostomy tube <nowiki>+</nowiki> Ureteral stent
−
| rowspan="4"|Material science, manufacturing engineering, quality systems
+
|align = "center" bgcolor = "#dce6f1"|60
 +
|align = "center" bgcolor = "#dce6f1"|[[Image:Smith_Universal.png|thumb|center|100px|<center>Smith Universal</center>]]
 
|-
 
|-
−
| Linkage between component and raw material specifications and appropriate incoming inspection procedures
+
|align = "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>
−
# Identify any missing documentation for inspection procedures
+
|align = "center" bgcolor = "#dce6f1"|Dec, 2007
 +
|bgcolor = "#dce6f1"|Heparin-bonded stent
 +
|bgcolor = "#dce6f1"|
 +
|align = "center" bgcolor = "#dce6f1"|
 +
|bgcolor = "#dce6f1"|
 
|-
 
|-
 +
|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>]]
 
|-
 
|-
−
| Inspection procedures have adequate sampling plans based on PFMEA risk mitigation levels – this includes packaging and labeling materials
+
|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>
−
# Review supplier audit reports for compliance
+
|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>]]
 
|-
 
|-
−
| Calibration records and preventive maintenance records; in-process / incoming inspection test methods and related test method validations
+
|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 enlarged 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; SL-6® hydrophilic coating
 +
|Dual Diameter stent
 +
|align = "center"|
 +
|align = "center" |[[Image:Applied_7_10.png|thumb|center|100px|<center>Endopyelotomy Stent</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 lubricious 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
 
|  
 
|  
−
# Check the entire equipment-related lifecycle
+
|Classic Closed Tip
−
# Check if machine operational qualification was performed
+
|align = "center"|
−
# Check if the measurement equipment was validated
+
|align = "center"|[[Image:Gyrus_Closed_Tip.png|thumb|center|100px|<center>Classic Closed Tip</center>]]
 +
|-
 +
|align = "center"|<font color="#0000FF"><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-curled double pigtail design
 +
|align = "center"|
 +
|align = "center"|[[Image:Gyrus_Pigtail.png|thumb|center|100px|<center>Double Pigtail</center>]]
 +
|-
 +
|align = "center"|<font color="#0000FF"><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="#0000FF"><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>]]
 
|-
 
|-
−
!rowspan="2"|Validation Report
+
|align = "center" bgcolor = "#dce6f1"|'''13'''
−
| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports
+
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Ameco Medical Industries]
−
|
+
|align = "center" bgcolor = "#dce6f1"|[http://www.amecath.com/ Amecath]
−
# Ensure all reports are available and linked together appropriately
+
|bgcolor = "#dce6f1"|
−
# Identify all inconsistencies across different reports
+
|bgcolor = "#dce6f1"|
−
| rowspan="2"| Quality systems
+
|bgcolor = "#dce6f1"|Nitinol; Available with hydrophilic coating
 +
|bgcolor = "#dce6f1"|Double loop stent
 +
|align = "center" bgcolor = "#dce6f1"|Short-term and long-term
 +
|align = "center" bgcolor = "#dce6f1"|[[Image:Amecath.png|thumb|center|100px|<center>Amecath</center>]]
 
|-
 
|-
−
| Design test methods and related test method validations
+
|align = "center"|'''14'''
 +
|align = "center"|[http://www.zapconnect.com/companies/index.cfm/fuseaction/companies_detail/eregnum/9681442.html Angiomed-Movaco (C.R. Bard subsidiary)]
 +
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 Ureteral Stent Set]
 +
|align = "center"|[http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K864225 FDA 510(k)]
 +
|align = "center"|Jan, 1987
 +
|Nitinol
 +
|Self-expanding stent
 
|  
 
|  
−
# Compare test methods used to those in client and ISO standards
+
|align = "center"|N/A
−
# Identify inconsistencies across test methods
+
 
|-
 
|-
 
|}
 
|}
  
−
=== Sample report ===
+
= Product to Clinical Trial Mapping=
−
==== Performance/Functional Characteristics ====
+
 
−
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0"  
+
==Clinical Timeline Visualization ==
−
|- style="background:lightgrey"
+
[[Image:Timeline.jpg]]
−
!align = "center" bgcolor = "#00CCFF" colspan = "4" |Design Input
+
 
−
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Output
+
[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]
−
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Verification Report #
+
 
−
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)
+
= Product to Patent Mapping =
−
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Design Validation Report #
+
 
−
!align = "center" bgcolor = "#00CCFF" width="5%" rowspan="2"|Status (P/F/R)
+
[[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.
 +
== Mapped Patent vs Not Mapped Patents ==
 +
{|border="0" cellspacing="0" cellpadding="4" width="100%"
 +
|[[Image:CRB_Pat.png|center|500px|thumb|'''C R Bard''']]
 +
|[[Image:BS_pat.png.png|center|500px|thumb|'''Boston Scientific''']]
 +
|-
 +
|}
 +
 
 +
=Patent-Product-Clinical Trial Mapping=
 +
 
 +
* To access the Dashboard you have to signup. You can do so by clicking [https://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''
 +
{|border="2" cellspacing="0" cellpadding="4" width="100%"
 +
 
 +
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm>
 +
 
 +
|}
 +
 
 +
=Insights=
 +
 
 +
{|border="2" cellspacing="0" cellpadding="4" width="100%"
 +
|bgcolor = "#538ED5"|<font size = "4">''' '''</font>
 +
|bgcolor = "#538ED5"|<font size = "4">''' '''</font>
 +
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font>
 +
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font>
 +
|-
 +
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''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 = "#538ED5"|'''Clinical <br>Trials'''
 +
|'''Current Trials'''
 +
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)
 +
|None
 +
|-
 +
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''
 +
|'''Coating'''
 +
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion
 +
|Therapeutic coatings
 
|-
 
|-
−
!align = "center" bgcolor = "#00CCFF" width="20%"|User Needs
+
|'''Structure'''
−
!align = "center" bgcolor = "#00CCFF" width="15%"|User Need Rationale
+
|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
−
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification
+
|Expandable stents for reducing  discomfort
−
!align = "center" bgcolor = "#00CCFF" width="20%"|Engineering Specification Rationale
+
 
|-
 
|-
−
|Provide antimicrobial resistance for up to 2 weeks
+
|'''Material'''
−
|Ureteral Stent User Survey (Document #XXXXX)
+
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness
−
|Stent must have chlorohexadine surface concentration of 10-20 mg/cm2 for 3 weeks
+
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based
−
|Document #XXXXX
+
−
|Test Document #XXXXX
+
−
|Report 01-005-06-007
+
−
|P
+
−
|Report 01-005-06-007
+
−
|P
+
 
|-
 
|-
 
|}
 
|}
  
−
=== 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
+
  
−
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0"  
+
{|border="2" cellspacing="0" cellpadding="4" width="82%"
−
|- style="background:lightgrey"
+
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font>
−
!align = "center" bgcolor = "#00CCFF" |Stage
+
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font>
−
!align = "center" bgcolor = "#00CCFF" |Tasks
+
−
!align = "center" bgcolor = "#00CCFF" |Milestone payment
+
−
!align = "center" bgcolor = "#00CCFF" |Date
+
 
|-
 
|-
−
|Design center integration plan
+
|Relatively late entrant with patents filed post mid 90s
−
|
+
|Early mover with patents filed in mid 80s
−
* Gap analysis completion (acquiree)
+
−
* Gap analysis completion (acquirer)
+
−
|
+
−
|September 15, 2008
+
 
|-
 
|-
−
|Design to manufacturing transfer
+
|Increased patent activity since 2000
−
|
+
|Patent activity never gained traction
−
|
+
−
|December 15, 2008
+
 
|-
 
|-
−
|Equipment transfer
+
|Large number of patents yet to be "productized"
−
|
+
|Few patents yet to be "productized"
−
|Milestone I payment
+
−
|Jan 7, 2009
+
 
|-
 
|-
−
|Shut production at acquiree facility
+
|Some products undergoing clinical trails
−
|Negotiation for contract extension
+
|No products undergoing clinical trails
−
|Milestone II payment
+
−
|Feb 15, 2009
+
 
|-
 
|-
−
|Start production in acquirer facility
+
|Diverse range of products with variation in material <br>and structure
−
|
+
|Small product portfolio
−
|
+
−
|Feb 7, 2009
+
 
|-
 
|-
−
|Switch to new SKU
+
|Seem to be strengthening they market position
−
|
+
|Seem to be moving focus away from Ureteral stents market
−
|
+
−
|Feb 15, 2009
+
 
|-
 
|-
−
|End development of new generation product/s in old facility
+
|}
−
|
+
 
−
|
+
= Competitive Landscape =
−
|Feb 7, 2009
+
==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'''
 
|-
 
|-
−
|Restart development of new generation product/s post-acquisition
+
|bgcolor = "#4f81bd"|'''Boston Scientific'''
−
|
+
|7800
−
|Final milestone payment
+
|661
−
|Mar 1, 2009
+
|8.48
 +
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font>
 +
|-
 +
|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>
 +
|-
 +
|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>
 
|-
 
|-
 
|}
 
|}
  
−
=== Documents and Ownership ===
+
 
−
{| class="wikitable" style="font-size:90%" border="1" cellpadding="5" cellspacing="0"  
+
[[image:stentshare.jpg |thumb|center|1000px| All figures in USD million ]]
−
|- style="background:lightgrey"
+
 
−
!align = "center" bgcolor = "#00CCFF" |Document
+
=<span style="color:#C41E3A">Like this report?</span>=
−
!align = "center" bgcolor = "#00CCFF" |Owner
+
<p align="center"> '''This is only a sample report with brief analysis''' <br>
−
!align = "center" bgcolor = "#00CCFF" |Last update date
+
'''Dolcera can provide a comprehensive report customized to your needs'''</p>
 +
{|border="2" cellspacing="0" cellpadding="4" align="center" "
 +
|style="background:lightgrey" align = "center" colspan = "3"|'''[mailto:info@dolcera.com <span style="color:#0047AB">Buy the customized report from Dolcera</span>]'''
 
|-
 
|-
−
|Product performance specifications
+
| align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services Patent Analytics Services]
−
|Paul Swain
+
|align = "center"| [http://www.dolcera.com/website_prod/services/business-research-services Market Research Services]
−
|07/27/2008 08:15:35 PST
+
|align = "center"| [http://www.dolcera.com/website_prod/tools/patent-dashboard Purchase Patent Dashboard]
 
|-
 
|-
−
|Component specifications
+
|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/patent-search/patent-landscapes Patent Landscape Services]
−
|Kevin Teller
+
|align = "center"| [http://www.dolcera.com/website_prod/research-processes Dolcera Processes]
−
|06/12/2008 12:22:07 PST
+
|align = "center"| [http://www.dolcera.com/website_prod/industries Industry Focus]
 
|-
 
|-
−
|Preclinical test results
+
|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/patent-search/patent-landscapes Patent Search Services]
−
|Joanne Krannert
+
|align = "center"| [http://www.dolcera.com/website_prod/services/ip-patent-analytics-services/alerts-and-updates Patent Alerting Services]
−
|07/03/2008 14:17:00 PST
+
|align = "center"| [http://www.dolcera.com/website_prod/tools Dolcera Tools]
−
|-
+
−
|Clinical tests
+
−
|Joanne Krannert
+
−
|08/01/2008 08:00:55 PST
+
 
|-
 
|-
 
|}
 
|}
 +
<br>
 +
 +
 +
 +
=[[Backup]]=

Latest revision as of 05:45, 27 July 2015

This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant 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

Ureteric Stent

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 friction (value) for ease of insertion and will soften on implant at body temperature to maintain patient comfort.

more on background...

Market Overview

Market for ureteral stent can be analyzed by estimating market for each of Ureteral Stent’s fundamental use. Other uses of Ureteral Stent include Post-surgical swelling/infection of uterus, Active kidney infection etc.

more on market overview...

Interactive Mind Map

  • To access the Dashboard you have to signup. You can do so by clicking 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

Patents

Patent Search Strategy

Patent Search Strategy.jpg


Dolcera Dashboard

Dashboard Link

Ureteral Stent - Dashboard
Dashboard thumb.png
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  • To access the Dashboard you have to signup. You can do so by clicking here

Clinical Trials

New trials

S.No.
Title
Conditions
Intervention: Device
Sponsors and Collaborators
1
 Assessment of Drug-Eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation Renal Calculi, Ureteral Obstruction Ureteral Stent Lawson Health Research Institute, Boston Scientific Corporation
2
 Memokath® 044TW Stent for Treatment of Urethral Stricture Urethral Stricture Memokath stenting Engineers & Doctors Wallsten Medical Group
3
 Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation Kidney Stones N\A University of California, Irvine
4
 Ureteral Stent Length and Patient Symptoms Kidney Stones Ureteral Stent Emory University
5
 Drainage of Malignant Extrinsic Ureteral Obstruction Using the Memokath Ureteral Stent Ureteral Obstruction Memokath 051 Ureteral Stent Mayo Clinic Engineers & Doctors Wallsten Medical Group
6
 A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney (JJVsPCN08) Kidney Disease Nephrostomy tube and ureteral stent Rabin Medical Center

Concluded trials

S.No.
Title
Abstract
Enrollment
Disorder
Conclusion
1
 Long-term outcome of permanent urethral stents in the treatment of detrusor-sphincter dyssynergia To evaluate the long-term efficacy of a permanently implanted urethral stent in the treatment of spinally injured patients with detrusor-sphincter dyssynergia. 13 Detrusor-sphincter dyssynergia Stenting is an effective alternative to sphincterotomy in the long-term, although secondary bladder neck obstruction is a frequent problem.
2
 Nephrostomy Tube or 'JJ' Ureteric Stent in Ureteric Obstruction: Assessment of Patient Perspectives Using Quality-of-Life Survey and Utility Analysis Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups. 34 Upper urinary tract obstruction Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.
3
 Impact of stents on urological complications and health care expenditure in renal transplant recipients: results of a prospective, randomized clinical trial. A randomized, prospective trial to compare the incidence of early urological complications and health care expenditures in renal transplant recipients with or without ureteral stenting. 201 Renal transplant recipient Using a ureteral stent at renal transplantation significantly decreases the early urinary complications of urine leakage and obstruction. However, there is a significant increase in urinary tract infections, primarily beyond 30 days after transplantation. Stent removal within 4 weeks of insertion appears advisable.


Pre-Market Notification

Some of the companies active in the field of ureteral stents have been represented in the table below.

S.No.
Company
Device
Approval
Date of Approval
Material
Technology
Indwelling Time (days)
1
Bard Urological
InLay Optima
FDA 510(k)
Dec 2004
 Silicone Double pigtail with monofilament suture loop
365
2
Boston Scientific
Polaris Loop
FDA 510(k)
Mar 2003
 Dual Durometer Percuflex with HydroPlus Coating Bladder loop design
365
3
Cook Medical
Resonance
FDA 510(k)
May 2007
 Metal Temporary stenting
365
4
Fossa Medical
Stone Sweeper
FDA 510(k)
Aug 2002
 Polyurethane Spiral radially expanding stent
13
CE Mark
Sep 2005
5
Pnn Medical A/S
Memokath 051
CE Mark
1995
 Nickel-titanium shape memory alloy Double fluted ended spiral stent
240

Products

The FDA classifies a ureteric stent as follows:

  • TITLE 21 - FOOD AND DRUGS
  • CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
  • SUBCHAPTER H - MEDICAL DEVICES
  • PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES
  • Subpart E - Surgical Devices
  • Sec. 876.4620 - Ureteral stent.
  • Classification - class II device Code of Federal Regulations
Sr. No. Company Device(s) Approval Approval Date Material Technology Indwelling Time (days) Image
1 Allium, Israel URS CE Mark Jul, 2007 Nickel-titanium shape memory alloy covered by polymer Self-expanding stent
Allium
2 Pnn Medical A/S Memokath 051 CE Mark 1995 Nickel-titanium shape memory alloy Double fluted ended spiral stent 240
Memokath 051
FDA Listing Mar, 2004
3 Fossa Medical Stone Sweeper CE Mark Sep, 2005 Polyurethane Radially expanding stent 13
Stone Sweeper
FDA 510(k) Aug, 2002
Open lumen stent FDA 510(k) Nov, 2003 Polyurethane Pigtail-tipped stent with ’Pusher’
Open_lumen
CE Mark Sep, 2005
Expanding Ureteral Stent FDA 510(k) Jun, 2002 Polyurethane Double pigtail stent with ’Pusher’ N/A
4 Boston Scientific Contour Percuflex - proprietary polyolefin copolymer; Hydroplus coating Fixed and variable length; Tapered tip 365
Contour
Percuflex Percuflex Pigtail 365
Percuflex
Polaris Ultra FDA 510(k) Jan, 2001 Dual Durometer Percuflex with HydroPlus Coating; soft Nautilus Bladder Coil. Double pigtail 365
Polaris Ultra
Polaris Loop FDA 510(k) Mar, 2003 Dual Durometer Percuflex with HydroPlus Coating Bladder loop design 365
Polaris Loop
Retromax Plus Percuflex material and Hydroplus coating Endopyelotomy stent Post-procedure healing
Retromax Plus
Stretch VL Flexima Hydroplus Coating Variable length coil on distal and proximal ends 90
Stretch VL Flexima
Drug-Eluting Stent Percuflex - proprietary polyolefin copolymer Ketorolac trimethamine loaded stent N/A
5 Cook Medical Resonance FDA 510(k) May, 2007 Metal 365
Resonance
Sof-flex AQ® Hydrophilic Coating Radiopaque tip and tether for repositioning 180
Sof-flex
Endo-Sof AQ® Hydrophilic Coating Double pigtail 365
Endo-Sof
C-Flex Double Pigtail 180
C-Flex
Smith Universal Nephrostomy tube + Ureteral stent 60
Smith Universal
Endo-Sof Radiance Launch Dec, 2007 Heparin-bonded stent
6 Q Urological pAguaMedicina™ Pediatric Ureteral Stent FDA 510(k) Jan, 2010 Hydrogel Differentially larger end (no pigtail) 30
pAguaMedicina
7 Bioteque Corp. Ureteral Stent Set FDA 510(k) Apr, 2010 30
Bioteque
8 Applied Medical Resources, CA, USA Mesh FDA 510(k) Jul, 2001 Polyester mesh Double-pigtail N/A
Silhouette Coil-reinforced; SL-6® hydrophilic coating Patency Device
Silhouette
Applied Standard FDA 510(k) Jun, 1999 Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating Unique wall construction and enlarged drainage holes
Applied Standard
7-10 endopyelotomy Proprietary thermoplastic elastomer material; SL-6® hydrophilic coating Dual Diameter stent
Endopyelotomy Stent
9 Bard Urological InLay Optima FDA 510(k) Dec, 2004 Silicone Double pigtail with monofilament suture loop 365
InLay Optima
Bardex® Double Pigtail Soft Stent FDA 510(k) Jan, 2003 Silicone Attached with suture for ease of removal
Bardex
Fluoro-4 Silicone Ureteral Stent Silicone/tantalum
Fluoro 4
Figure-4 Silicone Ureteral Stent Silicone Three dimensional design
Figure 4
InLay Ureteral Stent FDA 510(k) Dec, 1998 Silicone Tapered tip and lubricious hydrophilic coating
InLay
Urinary Diversion Stent FDA 510(k) Apr, 1991 Silicone
Urinary Diversion Stent
10 Coloplast-Porges Vortek FDA 510(k) Oct, 1998 Silicone Double coating for easy maneuverability as well as flexibility
Vortek
Biosoft FDA 510(k) Oct, 1998 Silicone Extreme flexibility
Biosoft
Polyurethane Hard or soft Polyurethane Designed for short-term use 90
Polyurethane
Silicone FDA 510k) Oct, 2002 Silicone Pyatiprofilnaya technology
Silicone
11 Teleflex Medical Rüsch Superglide DD FDA 510(k) Jul, 1999 WIRUTHAN® (polyurethane) with hydrogel coating Directable and detachable
Superglide DD
12 Gyrus ACMI/Cabot/Acromed/Circon/Surgitek Classic closed-tip FDA 510(k) Dec, 1986 Classic Closed Tip
Classic Closed Tip
Classic Double pigtail FDA 510(k) Mar, 1996 Tecoflex® construction Balanced-curled double pigtail design
Double Pigtail
Double-J FDA 510(k) Apr, 1988 Silicone Double-J closed-tip
Double_J
Lithostent Tecoflex® Grooved design
Lithostent
Lubri-flex FDA 510(k) Nov, 1991 Tecoflex® “Rememberance” of shape with a chemically bonded wettable solution
Lubri-flex
Multi-flex Tecoflex® Two durometers with helical kidney curls
Multi-flex
Quadra-Coil multi-length FDA 510(k) Mar, 1996 Tecoflex® Accomodate ureteral lengths from 22cm to 28cm
Quadra-Coil
Sof-curl Tecoflex® Dual-durometer design and exclusive soft bladder helix
Sof-curl
Uroguide Silicone Classic Double J with open tip
Uroguide
13 Ameco Medical Industries Amecath Nitinol; Available with hydrophilic coating Double loop stent Short-term and long-term
Amecath
14 Angiomed-Movaco (C.R. Bard subsidiary) Ureteral Stent Set FDA 510(k) Jan, 1987 Nitinol Self-expanding stent N/A

Product to Clinical Trial Mapping

Clinical Timeline Visualization

Timeline.jpg

Ureteral Stent Timeline

Product to Patent Mapping

Screenshot for the product to patent mapping(Bard and Boston)

Mapped Patent vs Not Mapped Patents

C R Bard
Boston Scientific

Patent-Product-Clinical Trial Mapping

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Insights

Boston Scientific C R BARD
Products Portfolio 8 Products 6 Products
Material Percuflex - Biocompatible Polymer Silicone
Coating Hydroplus Licensed from pHreecoat
Shape Pigtailed and More Figure 4 and more
Clinical
Trials 		Current Trials Truimph Ureteral stent - Loaded with Triclosan
Currently in Phase II (Canada) 		None
Patents Coating Therapeutic / Medicinal coatings
Magnetic nano particles for MRI Imaging
Lubricious coatings helping easy insertion 		Therapeutic coatings
Structure Multiple channels filled with therapeutic agent
Multiple collapsible segments preventing fluid passing
Renal coil with wick to prevent reflux
Stent with beads on its surface
Stent with reservoir indicating its release
with change in color of urine
Expandable and collapsible stent
Stents with degradable barbs 		Expandable stents for reducing discomfort
Material Elastically deformable stents
Biodegradable polymer based stents
Porous polymer for long term implantation
Stent with variable hardness 		Biodegradable polymers
Shape memory alloys
General polymer based


Inference

Boston Scientific C R BARD
Relatively late entrant with patents filed post mid 90s Early mover with patents filed in mid 80s
Increased patent activity since 2000 Patent activity never gained traction
Large number of patents yet to be "productized" Few patents yet to be "productized"
Some products undergoing clinical trails No products undergoing clinical trails
Diverse range of products with variation in material
and structure 		Small product portfolio
Seem to be strengthening they market position Seem to be moving focus away from Ureteral stents market

Competitive Landscape

Major Players

  • Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field.
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.
IP activity over the years

Sales

Total Sales in 2010 - 4.04 Billion USD

Company Total Sales in 2010 Urological sales Percentage share Product portfolio
Boston Scientific 7800 661 8.48 Boston_portfolio
CR BARD 2700 702 26.00 BARD_portfolio
Cook Medical 1700 - - Cook_portfolio
Medline 4040 - - Medline_portfolio


All figures in USD million

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