'''This is a landscape report on the Ureteral stent market, including key company profiles, products, patents and relevant clinical trailstrials.
'''
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.
=='''Methodology'''==
''' [[Image:Method1.JPG|700px]]'''
=='''Kidney Stones Market'''==
There are four main types of treatments available for curing kidney stones based on type of Kidney Stone, listed as follows
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Sr. No.'''</font>
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Treatment'''</font>
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Indications'''</font>
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Requirement of Ureteral Stent'''</font>
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''% of cases in general'''</font>
|-
|align = "right" bgcolor = "#DBE5F1"|1
|bgcolor = "#DBE5F1"|Lithotripsy
|bgcolor = "#DBE5F1"|Radiolucent calculi, Renal stones <nowiki><</nowiki>2 cm, Ureteral stones <nowiki><</nowiki>1 cm
|bgcolor = "#DBE5F1"|No
|align = "right" bgcolor = "#DBE5F1"|49.07%<nowiki>*</nowiki>
|-
|align = "right"|2
|Ureteroscopy
|Ureteral stones
|Yes
|align = "right"|15.48%<nowiki>*</nowiki>
|-
|align = "right" bgcolor = "#DBE5F1"|3
|bgcolor = "#DBE5F1"|Ureterorenoscopy
|bgcolor = "#DBE5F1"|Renal stones <nowiki><</nowiki>2 cm
|bgcolor = "#DBE5F1"|Yes
|align = "right" bgcolor = "#DBE5F1"|0.47%<nowiki>*</nowiki>
|-
|align = "right"|4
|Percutaneous nephrolithotomy
|Renal stones <nowiki>></nowiki>2 cm, Proximal ureteral stones <nowiki>></nowiki>1 cm
|No
|align = "right"|34.98%<nowiki>*</nowiki>
|-
|}
<nowiki>*</nowiki>Dolcera Estimate 2011
As seen in table ureteral stent is required for Ureteroscopy and Ureterorenoscopy which together constitute for around 16% of Kidney stone cases.
Total Number of Kidney Stone Cases in US in 2006: 166,000
Approximate Stents required in 2006 = 166,000<nowiki>*</nowiki>0.16=26560
=='''Kidney Transplant Market'''==
Every kidney transplant operation required ureteral stent to be placed in Patient<nowiki>’</nowiki>s body for few days till newly placed kidney adapts to Patients<nowiki>’</nowiki> body
Total No. of Kidney Transplants done in United States in 2007 are approx. 17,513
Total Market for Ureteral Stents in 2007 is 17,513
{|border="2" cellspacing="0" cellpadding="4" width="54%"
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Year'''</font>
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''No. of Kidney Transplants'''</font>
|-
|align = "right"|'''2007'''
| 17,513
|-
|align = "right"|'''2006'''
| 18,056
|-
|align = "right"|'''2005'''
| 17,443
|-
|align = "right"|'''2000'''
| 14,611
|-
|align = "right"|'''1995'''
| 12,160
|-
|align = "right"|'''1990'''
| 10,029
|-
|align = "right"|'''1985'''
| 7,504
|-
|align = "right"|'''1980'''
| 3,785
|-
|}
=='''Urinary Incontinence Market'''==
'''Inpatient hospital stays:'''The estimated number of hospital admissions among adults ages 18 or older with urinary incontinence listed as a diagnosis: <br>'''(2000):''' 47,802 hospital stays (1,332 men; 46,470 women)
{|border="2" cellspacing="0" cellpadding="4" width="40%"
|align = "center" bgcolor = "#5CB3FF" colspan = "2"|'''Prevalence of Urinary Incontinece in US (Women)'''
|-
|bgcolor = "#5CB3FF"|'''Age (in years)'''
|'''Population with Urinary Incontinence (in %)'''
|-
|bgcolor = "#5CB3FF"|30-39
|align = "center"|28
|-
|bgcolor = "#5CB3FF"|40-49
|align = "center"|41
|-
|bgcolor = "#5CB3FF"|50-59
|align = "center"|48
|-
|bgcolor = "#5CB3FF"|60-69
|align = "center"|51
|-
|bgcolor = "#5CB3FF"|70-79
|align = "center"|55
|-
|bgcolor = "#5CB3FF"|≥ 80
|align = "center"|54
|-
|}
{|border="2" cellspacing="0" cellpadding="4" width="102%"
|align = "center" colspan = "6"|'''Estimated cases for ureteral stents in US, 2010'''
|-
|bgcolor = "#5CB3FF"|Age groups
|bgcolor = "#5CB3FF"|A) Female population (Million)
|bgcolor = "#5CB3FF"|B) Prevalence rate in female (%)
|bgcolor = "#5CB3FF"|C=A<nowiki>*</nowiki>B Affected population<br>(Million)
|bgcolor = "#5CB3FF"|D) Catherization rate (%)
|bgcolor = "#5CB3FF"|E=C<nowiki>*</nowiki>D<br>Stent market based on catherization
|-
|bgcolor = "#5CB3FF"|30-39
|align = "right"|20.10
|align = "right"|28
|align = "right"|5.62
|align = "right"|0.043
|2420.42
|-
|bgcolor = "#5CB3FF"|40-49
|align = "right"|21.99
|align = "right"|41
|align = "right"|9.01
|align = "right"|0.123
|11092.83
|-
|bgcolor = "#5CB3FF"|50-59
|align = "right"|21.50
|align = "right"|48
|align = "right"|10.32
|align = "right"|0.124
|12800.37
|-
|bgcolor = "#5CB3FF"|60-69
|align = "right"|15.32
|align = "right"|51
|align = "right"|7.81
|align = "right"|0.160
|12503.68
|-
|bgcolor = "#5CB3FF"|70-79
|align = "right"|9.16
|align = "right"|55
|align = "right"|5.04
|align = "right"|0.172
|8674.44
|-
|bgcolor = "#5CB3FF"|≥ 80
|align = "right"|7.15
|align = "right"|54
|align = "right"|3.86
|align = "right"|0.044
|1699.48
|-
|bgcolor = "#5CB3FF"|Total
|align = "right"|95.25
|
|align = "right"|41.69
|
|
|-
|}
* '''Catherization rate''' depicts the actual number of people going in for ureteral stents.
* Prevalence rate in US women is growing at a CAGR of 1.26%
Assuming that each admission in hospital required one ureteral stent, market from Urinary Incontinence is around 47,802 stents per year
'''Total Market for Ureteral Stent'''
Following table displays approximate stent market per year
{|border="2" cellspacing="0" cellpadding="4" width="64%"
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''Category'''</font>
|bgcolor = "#4F81BD"|<font color="#FFFFFF">'''No. of Stents Required'''</font>
|-
|bgcolor = "#DBE5F1"|Stent Market for Kidney Stones
|align = "center" bgcolor = "#DBE5F1"|26560
|-
|Stent Market for Kidney Transplant
|align = "center"|17513
|-
|bgcolor = "#DBE5F1"|Stent Market for Urinary Incontinence
|align = "center" bgcolor = "#DBE5F1"|47802
|-
|bgcolor = "#4F81BD"|<font color="#FFFFFF">Total</font>
|align = "center" bgcolor = "#4F81BD"|<font color="#FFFFFF">91875</font>
|-
|}
* Ureteral stent market is growing at a CAGR of 1.58%
=='''Ureteral stent market forecast in US (women)'''==
'''
[[Image:stent_forcast.jpeg]]
'''
<br/>
<br/>
[[media:4887766.xlsx|Detailed_calculation_workbook]]
'''[[more on market overview...]]'''
=Patents=
==Patent Search Strategy==
[[Image:Patent Search Strategy.jpg|700px]]
==Dolcera Patent Analysis==
{|border "1" style="border-spacing:0;"
| rowspan="2" style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''S.No. '''</font></center>
| rowspan="2" style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Patent/Publication No.'''</font></center>
| rowspan="2" style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Publication Date''' (mm/dd/yyyy)</font></center>
| rowspan="2" style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Assignee/Applicant'''</font></center>
| rowspan="2" style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title'''</font></center>
| colspan="2" style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Dolcera Analysis'''</font></center>
|-
| style="background-color:#4f81bd;padding:0.079cm;"| <center>'''Problem'''</center>
| style="background-color:#4f81bd;padding:0.079cm;"| <center>'''Solution'''</center>
|-
| style="background-color:#dce6f1;padding:0.079cm;"| 1
| style="background-color:#dce6f1;padding:0.079cm;"| [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=%2220090187254%22.PGNR.&OS=DN/20090187254&RS=DN/20090187254 US20090187254A1]
| style="background-color:#dce6f1;padding:0.079cm;"| 07/23/2009
| style="background-color:#dce6f1;padding:0.079cm;"| BOSTON SCIENTIFIC SCIMED, INC.
| style="background-color:#dce6f1;padding:0.079cm;"| UROLOGICAL MEDICAL DEVICES FOR RELEASE OF UROLOGICALLY BENEFICIAL AGENTS
| style="background-color:#dce6f1;padding:0.079cm;"| In previous attempts to develope a uerteral stent, encrustation was the problem associated with the stent. Along with this pain and discomfort by stent implantaion was there.
| style="background-color:#dce6f1;padding:0.079cm;"| This invention provides a ueteral stent which release one or more urologically beneficial agents in effective amounts to reduce the problem of encrustation and pain related to stent.
|-
| style="padding:0.079cm;"| 2
| style="padding:0.079cm;"| [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=%2220090171465%22.PGNR.&OS=DN/20090171465&RS=DN/20090171465 US20090171465A1]
| style="padding:0.079cm;"| 07/02/2009
| style="padding:0.079cm;"| Boston Scientific Scimed, Inc.
| style="padding:0.079cm;"| Polymeric Regions For Implantable Or Insertable Medical Devices
| style="padding:0.079cm;"| In previous attempts to develope a uerteral stent, encrustation was the problem associated with the stent. Along with this pain and discomfort by stent implantaion was there.
| style="padding:0.079cm;"| This invention provides a ureteral stent with a coating of a material(EVA) that reduces the discomfort caused by the stent during implantation.
|-
| style="background-color:#dce6f1;padding:0.079cm;"| 3
| style="background-color:#dce6f1;padding:0.079cm;"| [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=%2220080097349%22.PGNR.&OS=DN/20080097349&RS=DN/20080097349 US20080097349A1]
| style="background-color:#dce6f1;padding:0.079cm;"| 04/24/2008
| style="background-color:#dce6f1;padding:0.079cm;"| Boston Scientific Scimed, Inc.
| style="background-color:#dce6f1;padding:0.079cm;"| Partially soluble implantable or insertable medical devices
| style="background-color:#dce6f1;padding:0.079cm;"| In previous attempts to develope a uerteral stent, encrustation was the problem associated with the stent. Along with this pain and discomfort by stent implantaion was there.
| style="background-color:#dce6f1;padding:0.079cm;"| Here the device (Stent) is provided with at least one surface that contains one or more depressions, which are at least partially filled with a soluble material. This makes stent more flexible and soft after implantation hence minimizing pain and discomfort after implantation or insertion.
|-
| style="padding:0.079cm;"| 4
| style="padding:0.079cm;"| [http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=5554147.PN.&OS=PN/5554147&RS=PN/5554147 US5554147A]
| style="padding:0.079cm;"| 09/10/1996
| style="padding:0.079cm;"| CApHCO, Inc.
| style="padding:0.079cm;"| Compositions and devices for controlled release of active ingredients
| style="padding:0.079cm;"| During implantation of ureteral stent,pain and discomfort are the problem with previous stents. Also microbial or bacterial infection at the site of implantation was the problem.
| style="padding:0.079cm;"| In this invention stent is povided with a pH sensitive coating that includes antimicrobial agent to stop the infection. This coating also has the hydrogel property which Upon swelling, the hydrogel's coefficient of friction is reduced, and the polymer becomes slippery, this mechanism reduces the discomfort.
|-
| style="background-color:#dce6f1;padding:0.079cm;"| 5
| style="background-color:#dce6f1;padding:0.079cm;"| [http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=6468649.PN.&OS=PN/6468649&RS=PN/6468649 US6468649B1]
| style="background-color:#dce6f1;padding:0.079cm;"| 10/22/2002
| style="background-color:#dce6f1;padding:0.079cm;"| Scimed Life Systems, Inc.
| style="background-color:#dce6f1;padding:0.079cm;"| Antimicrobial adhesion surface
| style="background-color:#dce6f1;padding:0.079cm;"| In prior art problem was the lack of the device which can remain in vivo for extended periods of time without losing its antimicrobial efficacy and which can provides protection against bacterial and fungal organisms for extended periods of time without leaching substances into a patient.
| style="background-color:#dce6f1;padding:0.079cm;"| This invention provides a medical device with a hydrophobic coating that inhibits the growth of microbes for extended period of time.
|-
| style="padding:0.079cm;"| 6
| style="padding:0.079cm;"| [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 US20030153983A1]
| style="padding:0.079cm;"| 08/14/2003
| style="padding:0.079cm;"| Scimed Life Systems, Inc.
| style="padding:0.079cm;"| Implantable or insertable medical device resistant to microbial growth and biofilm formation
| style="padding:0.079cm;"| In previous attempts to develope a ureteral stent with coating the problem was the formation of biofilm and microbial growth.
| style="padding:0.079cm;"| The device of the present invention, therefore, overcomes the disadvantages associated with the use of coatings as discussed above, and provides a reduced risk of biofilm fouling that eventually results in encrustation, occlusion and failure of the device. In this invention medical device comprises at least one biocompatible matrix polymer region and bioactive agents comprising an antimicrobial agent and a microbial attachment/biofilm synthesis inhibitor.
|-
| style="background-color:#dce6f1;padding:0.079cm;"| 7
| style="background-color:#dce6f1;padding:0.079cm;"| [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=%2220030139800%22.PGNR.&OS=DN/20030139800&RS=DN/20030139800 US20030139800A1]
| style="background-color:#dce6f1;padding:0.079cm;"| 07/24/2003
| style="background-color:#dce6f1;padding:0.079cm;"| None
| style="background-color:#dce6f1;padding:0.079cm;"| Stent assembly with therapeutic agent exterior banding
| style="background-color:#dce6f1;padding:0.079cm;"| In earlier attempts for stent with a therapeutic property, the problem was the coating or the sheath (responsible for therapy) may covers side branch arteries, vessels, or other lumens extending from the main lumen in which the stent is installed. The sheath can reduce blood flow to or from the side branch and deliver medication into the side branch where it is unnecessary.
| style="background-color:#dce6f1;padding:0.079cm;"| This invention provides a stent assembly with exterior banding for delivery of therapeutic agents that would overcome the previous disadvantages. Also this stent assembly which avoids side branch vessel blockage by a sheath, with increased drug storage capacity and allowing delivery of different drugs at different axial and radial locations.
|-
| style="padding:0.079cm;"| 8
| style="padding:0.079cm;"| [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=%2220040117007%22.PGNR.&OS=DN/20040117007&RS=DN/20040117007 US20040117007A1]
| style="padding:0.079cm;"| 06/17/2004
| style="padding:0.079cm;"| STS Biopolymers, Inc.
| style="padding:0.079cm;"| Medicated stent having multi-layer polymer coating
| style="padding:0.079cm;"| The problem associated with previous stent and their implantation was thrombus formation in vicinity of stent.
| style="padding:0.079cm;"| The stent assembly developed in this invention consistently provide therapeutic activity from the surfaces of stents in order to reduce the incidence of restenosis and thrombus formation after coronary stenting procedures in the clinic.
|-
| style="background-color:#dce6f1;padding:0.079cm;"| 9
| style="background-color:#dce6f1;padding:0.079cm;"| [http://www.wipo.int/pctdb/en/wo.jsp?WO=1990013332 WO1990013332A1]
| style="background-color:#dce6f1;padding:0.079cm;"| 11/15/1990
| style="background-color:#dce6f1;padding:0.079cm;"| CEDARS-SINAI MEDICAL CENTER
| style="background-color:#dce6f1;padding:0.079cm;"| STENT WITH SUSTAINED DRUG DELIVERY
| style="background-color:#dce6f1;padding:0.079cm;"| Problem was to provide an intravascular stent that preserves vessel patency, inhibits luminal narrowing and at the same time stent can deliver a pharmaceutical agent to a specific body site or organ.
| style="background-color:#dce6f1;padding:0.079cm;"| The stent assembly provided by this invention will release anticoagulants, antiplatelet drugs or drugs that inhibit excessive endothelial cell growth at the placement site, thereby preserving the vessels patency and inhibiting luminal narrowing.
|-
| style="padding:0.079cm;"| 10
| style="padding:0.079cm;"| [http://www.wipo.int/pctdb/en/wo.jsp?WO=2001036008 WO2001036008A2]
| style="padding:0.079cm;"| 05/25/2001
| style="padding:0.079cm;"| STS BIOPOLYMERS, INC.
| style="padding:0.079cm;"| MEDICAL DEVICES COATED WITH ELASTIC POLYMERIC MATERIAL
| style="padding:0.079cm;"| The lack of flexibility, expandability and lubricity of coating surface was the problem with previous insertable medical device.
| style="padding:0.079cm;"| This invention provides a medical device with a polymeric coating adherent to the covering, such that the coating and covering possess desirable surface characteristics such as lubricity, or lack thereof, as well as flexibility, expandability and elasticity.
|}
== Dolcera Dashboard ==
[[Image:dashboard_features.png|center|750px|]]
'''Dashboard Link'''<br>
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|'''[httphttps://clientwww.dolcera.com/auth/dashboard/dashboard.htmlphp?workfile_id=1008 Ureteral Stent - Dashboard] '''
|width="100"|[[Image:dashboard_thumb.png|center|100px|]]
|-
* To access the Dashboard you have to signup. You can do so by clicking [https://www.dolcera.com/auth/index.php/login '''here''']
==Patent Heat Map=Clinical Trials =
'''[[more on patent analysis...]]'''
= Clinical Trials =
==New trials ==
| 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.
|}
==Adverse Events==
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center" bgcolor = "#4f81bd"|<center><font color="#FFFFFF">'''S.No. '''</font></center>
|align = "center" bgcolor = "#4f81bd"|<center><font color="#FFFFFF">'''Brand Name'''</font></center>
|align = "center" bgcolor = "#4f81bd"|<center><font color="#FFFFFF">'''Adverse Event'''</font></center>
|align = "center" bgcolor = "#4f81bd"|<center><font color="#FFFFFF">'''Date FDA Received'''</font></center>
|-
| style="background-color:#dce6f1;padding:0.079cm;"|<center>'''1'''</center>
| style="background-color:#dce6f1;padding:0.079cm;"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=660847 Cook Urologicals Cook Urological Stent]</u></font>
| style="background-color:#dce6f1;padding:0.079cm;"|Stent broke into pieces while removing it from the patients body.
| style="background-color:#dce6f1;padding:0.079cm;"|12/14/2005
|-
| style="padding:0.079cm;"|<center>'''2'''</center>
| style="padding:0.079cm;"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=930422 Boston Scoientific Boston Scientific Ureteral stent System]</u></font>
| style="padding:0.079cm;"|Fractured stent seen under Fluroscopy
| style="padding:0.079cm;"|10/17/2007
|-
| style="background-color:#dce6f1;padding:0.079cm;"|<center>'''3'''</center>
| style="background-color:#dce6f1;padding:0.079cm;"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=755260 Boston Scoientific Boston Scientific Ureteral Stent System Kit 8 FR X 24 CM]</u></font>
| style="background-color:#dce6f1;padding:0.079cm;"|During insertion of ureteral stent, the stent broke into multiple parts which were retained in the patient.
| style="background-color:#dce6f1;padding:0.079cm;"|10/14/2005
|-
| style="padding:0.079cm;"|<center>'''4'''</center>
| style="padding:0.079cm;"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=564910 Boston Scientific Corp Boston Scientific 8 FR X 28 CM Ureteral Stent System Kit]</u></font>
| style="padding:0.079cm;"|Breakage of the upper loop of the ureteral stent while trying to insert it.
| style="padding:0.079cm;"|01/05/2005
|-
| style="background-color:#dce6f1;padding:0.079cm;"|<center>'''5'''</center>
| style="background-color:#dce6f1;padding:0.079cm;"|<font color="#0000FF"><u>[http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522129 Boston Scientific Bostoon Scientific Micro Vasive Contour VL Ureteral Stent]</u></font>
| style="background-color:#dce6f1;padding:0.079cm;"|Broken stent observed during x-ray procedure.
| style="background-color:#dce6f1;padding:0.079cm;"|12/12/2003
|-
|}
==Pre-Market Notification==
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance, also known as Premarket Notification. This premarket submission demonstrates to the FDA that the device to be marketed is atleast as safe and effective, that is, ''substantially equivalent'', to a legally marketed device. Parties required to submit a 510(k) to the FDA include domestic or foreign manufacturers introducing a device to the U.S. market, as well as specification developers and repackers/relabelers.
A 510(k) is required when:
* Introducing a device into commercial distribution (marketing) for the first time.
* Proposed different intended use for a device already in commercial distribution.
* Change or modification of a legally marketed device.
[http://dolcera.com/upload/files/510kflowchart.pdf 510(k) “Substantial Equivalence” Decision Making Process]
Some of the companies active in the field of ureteral stents have been represented in the table below.
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Material '''</font></center>
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Technology '''</font></center>
| style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Indwelling time Time (days) '''</font></center>
|-
| style="background-color:#dce6f1;padding:0.079cm;"| <center>'''1'''</center>
|}
=Products=Timeline Visualization ==[[Media:Ureteral_Stents_Timeline dw.xls|Ureteral Stent Timeline]]
=Products=
The FDA classifies a ureteric stent as follows:
* TITLE 21 - FOOD AND DRUGS
|}
=Patent-Product-to 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>==Clinical Timeline Visualization ==[[ureteral_stent_mapping1Image:Timeline.mm|flash|Ureteral Stent mindmap|600ptjpg]]</mm>
[[Media:Ureteral_Stents_Timeline dw.xls|}Ureteral Stent Timeline]]
= Product to Patent Mapping =
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''here 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''']]
|}
=Key FindingsPatent-Product-Clinical Trial Mapping===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 in To access the field are held by Cook Incorporated, Interventional Thermodynamics, Abbott laboratories and Boston Scientific CorpDashboard you have to signup.[You can do so by clicking [Imagehttps:Key patent2//www.png|thumb|center|1100px|Key Patents]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%"
==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|year wise IP activity]] ==Geographical Activity==*USA, Europe and Germany are very active in ureteral stent research. <mm>[[Image:Geodistribution5ureteral_stent_mapping1.pngmm|thumbflash|centerUreteral Stent mindmap|600px|Geographical Activity600pt]] *References 1- [http:<//en.wikipedia.org/wiki/Demographics_of_the_United_States http://en.wikipedia.org/wiki/Demographics_of_the_United_States] 2- [http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink http://www.wrongdiagnosis.com/c/catheter_infection/stats.htm?ktrack=kcplink] 3- [http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM247851.pdf] 4- [http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html http://www.managementparadise.com/forums/principles-management-p-o-m/208329-swot-analysis-boston-scientific-corporation.html] ==Trends in stent R&D== * Given that the first bare metal stent entered the market in 1994, the technology is far from mature. * Whilst drug eluting stents will be improved through the use of what are described as more ‘cell friendly’ (i.e. more hydrophobic) coatings and adapted (by using CFD in stent design) to varying wall sheer conditions, the industry is already well down the road of developing bioresorbable coatings and even bioresorbable stents. * Such systems are already on limited trial in Europe with FDA trials aimed at 2012 and approval by 2015. * There are still other areas under study including thinner struts which are important in terms of giving improved stent flexibility, a reduced cross-sectional profile within the vessel and potentially reduced restenosis (due to reduced vascular trauma). * Silicon carbides, carbon coatings, titanium nitride/oxide and sputtered indium oxide have all been trialled as routes to reducing the incidence of restenosis and/or thrombosis. * Click here for recent news and developments in [[Boston Scientific]] and [[Cook INC]] '''Source''' [http://www.ceram.com/newsroom/news-releases/ceram-examines-the-future-of-stent-materials/ Ceram-newsrelease]mm>
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=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|-|}
===Products===
* They have 8 ureteral stents in their portfolio
* They are currently into 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)
* 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
==Inference =Regulatory data===* Ureteral stents are class II medical devices and hence require a 510(k) approval to launch the product in the market. The time taken for Boston to get their stent approved ranged from 21 days to 9 months
{|border="2" cellspacing="0" cellpadding=Clinical trials"4" width="82%"|bgcolor ="#538ED5"|<font size ="4">'''Boston Scientific'''</font>*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 |bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font>|-|Relatively late entrant with the rules 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 the drug regulatory authority under State Council. Currently Boston scientific is conducting clinical trials for patents yet to be "Truimph Ureteral stentproductized" which is a ureteral stent loaded |Few patents yet to be "productized"|-|Some products undergoing clinical trails|No products undergoing clinical trails|-|Diverse range of products with Triclosan (used as an antimicrobial agent).The trials are currently variation in Phase II in canada(NCT00250406). material <br>and structure|Small product portfolio|-|Seem to be strengthening they market position|Seem to be moving focus away from Ureteral stents market|-|}
*The 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 difference in all the ureteral stent of different companies in terms of patient comfort and materials used in the stent =Competitive Landscape ==Patents=Major Players==*The mapped patents gives an insight in to patents which were successfully commercialized *The unmapped patents gives us a vision of the company's future vision in terms of product development strategyBoston Scientific Limited, Abbott, Medtronic and Cook Inc.It may also signify those patents which failed to reach towards succesful launch of products.*The unmapped patents are analysed based on the following parameters'''1.Coating on stents:''' Boston scientific have patents on Therapeutic/ medicinal coatings on stents which releases into the vascular region. Magnetic nanoparticles which helps major players in imaging the ureteral stent using MRIresearch field. Lubricious coatings which help in easy insertion of the stent '''2.Structure of stent[[Image:''' Boston scientific have patents on various structure of stent Major playersnew. 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 have 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)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]]
=Competitor Analysis=Sales ==
Total Sales in 2010 - 4.04 Billion USD
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|bgcolor = "#5CB3FF4f81bd"|'''Company'''|bgcolor = "#5CB3FF4f81bd"|'''Total Sales in 2010'''|bgcolor = "#5CB3FF4f81bd"|'''Urological sales'''|bgcolor = "#5CB3FF4f81bd"|'''Percentage share'''|bgcolor = "#5CB3FF4f81bd"|'''Product portfolio'''
|-
|bgcolor = "#5CB3FF4f81bd"|'''Boston Scientific'''
|7800
|661
|<font color="#0000FF"><u>[http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Boston_portfolio]</u></font>
|-
|bgcolor = "#5CB3FF4f81bd"|'''CR BARD'''
|2700
|702
|<font color="#0000FF"><u>[https://dolcera.net/teamwiki_prod/index.php/BARD_portfolio BARD_portfolio]</u></font>
|-
|bgcolor = "#5CB3FF4f81bd"|'''Cook Medical'''
|1700
|<nowiki>-</nowiki>
|<font color="#0000FF"><u>[http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Cook_portfolio]</u></font>
|-
|bgcolor = "#5CB3FF4f81bd"|'''Medline'''
|4040
|<nowiki>-</nowiki>
|}
All figures in USD million
[[image:stentshare.jpg]] ====Boston Scientific==== [https://dolcera.net/teamwiki_prod/index.php/Boston_Scientific_-_Company_Profile Company profile] [http://www.bostonscientific.com/templatedata/imports/Microsite/Stone/collateral/Percuflex-Brochure.pdf Ureteral Stent portfolio] Net sales |thumb|center|1000px| All figures in 2010 – USD 7.8 Billion Share of Urology- 8.48 % Net sales from Urology- USD 661 Million Source [http://phx.corporate-ir.net/phoenix.zhtml?c=62272&p=irol-reportsother BSsalesdata] ====CR BARD==== [[Urology portfolio]] Net sales in 2010 – USD 2.7 Billion Share of Urology- 26% Net sales from Urology- USD 702 Million Source – CR BARD annual report ====Cook Medical==== [http://www.cookmedical.com/uro/familyListingAction.do?family=Ureteral+Stents Ureteral Stent portfolio] Total Sales - USD 1.7 Billion [http://www.nytimes.com/2011/04/26/business/26cook.html?_r=1 Source] ====Medline==== [http://www.medline.com/irj/catalog/search?initialSearchTerms=ureteral%20stent Ureteral Stent Portfolio] ==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] =Removed Sections=[[Removed Sectionsmillion ]]
=<span style="color:#C41E3A">Like this report?</span>=
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= Addition =
=== Patent Categorization: Interactive mind map linked to Dolcera Dashboard ===
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{|border="2" cellspacing="0" cellpadding="4" width="100%"
|<mm>[[Ureteral_Stent_Patent_Categorization.mm|flash|Patent Categorization|600pt]]</mm>
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=== Product-Patent-Clinical Trials Mapping ===
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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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{|border="2" cellspacing="0" cellpadding="4" width="100%"
|<mm>[[ureteral_stent_mapping1.mm|flash|Ureteral Stent mindmap|600pt]]</mm>
|}
=== Product to Patent Mapping ===
[[Image:Product_Patent_Mapping_Screen_Shot.png|1000px|centre|thumb|'''Screenshot for the product to patent mapping(Bard and Boston)''']]
* Click [[Media:Product_Patent_Mapping_Bard_Boston.xls|'''here ''']]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''']]
|-
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