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/* Dolcera Patent Analysis */
=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
|-
|'''Structure'''
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs
|Expandable stents for reducing discomfort
|-
|'''Material'''
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based
|-
|}
==Boston ScientificInferences == {|border="2" cellspacing="0" cellpadding=Products"4" width="82%"|bgcolor ==* They have '''8 ureteral stents''' in their portfolio* Boston's ureteral stent portfolio have some common features such as:"#Stent '''material''' consisting of '''Percuflex'''- a Biocompatible Polymer Material#The '''coating''' on the stent may be a '''Hydroplus''' coating#Most of the stents are designed to have an '''indwelling time''' of '''365 days'''#Pigtailed shaped ureteral stent 538ED5"|<font size ===Regulatory data===* Ureteral stents are class II medical devices and hence require a 510(k) approval to launch the product in the market. The "4">'''time''' taken for Boston to get their stent Scientific'''approved''' ranged from '''21 days to 9 months''' ===Clinical trials===*The clinical trials of new medical devices of Class II and Class III can be conducted only after clinical trial approval by the relevant authority in accordance with the rules of the drug regulatory authority under State Council. '''Currently''' Boston scientific is conducting clinical '''trials''' for '''Truimph Ureteral stent''' which is a ureteral '''stent''' loaded with '''Triclosan''' (used as an antimicrobial agent).The trials are currently in '''Phase II''' in '''canada'''(NCT00250406).  *Other trials are related to comparison of various ureteral stent of different companies in terms of patient comfort and materials used in the stent.*The result of trials is that there is '''not much differenc'''e among the ureteral stents of different companies in terms of '''patient comfort''' and '''materials''' used in the stent ===Patents===*The '''mapped patents''' gives an insight in to patents which were '''successfully commercialized''' *The '''unmapped patents''' gives us a glimpse of '''future moves''' in terms of product development strategy.It may also '''signify''' those patents which '''failed to productize'''.*The unmapped patents are analysed based on the following parameters'''1.Coating on stents:''' Boston scientific has patents on Therapeutic</ medicinal coatings on stents which releases into the vascular region. Magnetic nanoparticles which helps in imaging the ureteral stent using MRI. Lubricious coatings which help in easy insertion of the stent '''2.Structure of stent:''' Boston scientific has patents on various structures of stent . For eg: Multiple channels(Depressions) along the length of stent filled with therapeutic agent,Multiple segments on the distal side of stent which is collapsible to prevent fluid from passing from the bladder to the kidney, Stent with a renal coil with wick portion to prevent reflux of urine,Stent with beads on its surface which is of figure 8 shape having therapeutic agents, Stent with reservoir indicating its release with change in color of urine,Stents with degradable barbs,Expandable and collapsible stent to reduce patient discomfort '''3.Materials used for stent:'''Boston scientific has patents on various materials used for stent. For eg.Elastically deformable stents(polysaccharide-based hydrogels), Biodegradable polymer based stents, Porous polymer for long term implantation( poly(styrene) blocks and polyisobutylene blocks),Stent with variable hardness (ethylene vinyl acetate and hydroxypropylcellulose)font>|bgcolor ="#538ED5"|<font size =C.R.Bard== ===Products===* They have '''6 products''' in their ureteral stent portfolio* C.R Bard ureteral stent portfolio have some common features such as:#Most of the stent has '''Silicone''' as their '''main material'''#They have stent with '''various''' '''designs''' and shapes eg Figure "4 ureteral stent#Some of the stent have '''coatings''' which is '''liscensed''' from third party eg.">'''pHreecoat'''" ===Regulatory data===The time taken for C.R. Bard to get their '''stent approved''' ranged from '''21 days to 9 monthsBARD'''</font>|-===Clinical trials===|Relatively late entrant with patents filed post mid 90sThere are '''no trials currently''' conducted by C.R.Bard. The other trials are related to comparison of various ureteral stent of different companies |Early mover with patents filed in terms of patient comfort and materials used in the stent. The result of trials is that there is not much difference in all the ureteral stent of different companies in terms of patient comfort and materials used in the stentmid 80s|- ===Patents===C R Bard is '''not very active''' in filing patents with very '''few''' patents '''filed after |Increased patent activity since 2000'''.|Patent activity never gained traction*The unmapped patents are analysed based on the following parameters|- '''1.Coating on stent:'''They have a couple |Large number of patents related yet to therapeutic coatigs on stent surfacebe "productized" '''2.Structure of stent:'''C R. Bard |Few patents are related yet to expandable stents for reducing patent discomfortbe "productized"|-'''3.Material used on stent:''' Recent patents focuses on Biodegrable polymers, Shape memory alloys or general polymer based stent|Some products undergoing clinical trails|No products undergoing clinical trails=Key Findings===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]] ==Key Patents==*The key patents Diverse range of products with variation in the field are held by Cook Incorporated, Interventional Thermodynamics, Abbott laboratories material <br>and Boston Scientific Corp.structure[[Image:Key patent2.png|thumbSmall product portfolio|center-|1100pxSeem to be strengthening they market position|Key Patents]] ==IP Activity==*Patenting activity has been high growth rate during the period 2001 Seem 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.be moving focus away from Ureteral stents market[[Image:IPactivity3.png|thumb|center|1000px|year wise IP activity]]- ==Geographical Activity==*USA, Europe and Germany are very active in ureteral stent research. [[Image:Geodistribution5.png|thumb|center|600px|Geographical Activity]]}
=Competitor AnalysisCompetitive landscape=
Total Sales in 2010 - 4.04 Billion USD
==Academic Research ==
 
Research at University of Minnesota about symptoms and pain associated with ureteral stent
 
[[Research Team]]
 
'''Background and Purpose'''
 
*Ureteral stents are associated with significant pain and urinary symptoms.
 
*Manufacturers have altered stent designs and materials in an attempt to minimize this morbidity.
 
*This study evaluated the impact of these modifications.
 
'''Patients and Methods'''
 
*Stent manufacturers were asked to provide the 6F ureteral stent they believed would be associated with the least patient discomfort.
 
*Patients undergoing uncomplicated ureteroscopy were randomized to the Bard Inlay, Cook Endo-Sof, Microvasive Contour, Applied Medical Vertex, or Surgitek Classic Double-Pigtail stent.
 
*The Ureteric Stent Symptom Questionnaire (USSQ) was administered on days 1, 3, and 5, and the patients maintained a narcotic diary. The data were analyzed using ANOVA and nonparametric methods.
 
'''Results'''
 
*A total of 44 patients (73%) completed all USSQ questionnaires.
 
*Urinary symptom scores were significantly lower for the Inlay stent on day 3 than for the Vertex (P = 0.01), Contour (P = 0.05), Endo-Sof (P = 0.03), and Classic (P = 0.02) stents. No significant differences were noted in pain and general symptom scores or narcotic use.
 
'''Conclusion'''
 
*'''The Bard Inlay stent is associated with less-severe urinary symptoms than other ureteral stents.'''
 
*The USSQ is a sensitive tool to measure differences between stents.
 
The complete USSQ form is available at [http://www.bui.ac.uk/ BUI] and [http://www.endourology.org/ endourology].
Source [http://www.liebertonline.com/doi/abs/10.1089/end.2005.19.990?journalCode=end University of Minnesota]
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