Navigation Links
Off-Label Stent Use: How Important Are FDA Approvals to Physicians?
Date:4/2/2008

Millennium Research Group survey finds that physicians place importance on

indication-specific FDA approval

WALTHAM, Mass., April 2, 2008 /PRNewswire/ -- Given the recent investigation by the US Department of Justice into the marketing of biliary stents for off-label uses in the peripheral vasculature, obtaining FDA approval for device use in specific arteries could become a key focus for stent manufacturers. A recent study conducted by Millennium Research Group at the Society of Interventional Radiology 33rd Annual Scientific Meeting in Washington, DC found that a significant portion of surveyed physicians would increase their use of biliary stents if the device received FDA approval for use in the peripheral vasculature; some physicians said their use could increase by as much as 50%.

Although stents on the market are only approved for use in the bile ducts, these stents have larger diameters than those used in coronary arteries, making them an attractive choice for physicians to use the peripheral arteries, such as the iliac artery. Once a stent has received pre-market approval from the FDA, physicians are free to use the stent off-label anywhere in the body; however, manufacturers can only promote the device for the specific indication(s) for which FDA approval has been granted.

Millennium Research Group's survey gauged the importance of FDA pre-market approval in physician decisions to use a particular stent brand, and also questioned physicians on whether or not they would be willing to pay a premium for a stent with artery-specific approval.

"The ability of a manufacturer to market FDA approval for a stent in a specific indication would provide physicians with increased confidence in the device's safety and efficacy," says Darren Navarro, Senior Analyst at Millennium Research Group. "Physician attitudes toward off-label use of stents may provoke new manufacturer initiatives to obtain artery-specific FDA
'/>"/>

SOURCE Millennium Research Group
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

Related biology technology :

1. Real-World Data from ARRIVE Registries Show Favorable Outcomes for TAXUS(R) Express(TM) Stent
2. The Lancet Publishes Results From Worlds First Clinical Trial of a Fully Bioabsorbable Drug Eluting Coronary Stent
3. OrbusNeichs Genous(TM) Bio-Engineered R Stent(TM) is Feasible in Acute Myocardial Infarction Patients, American Heart Journal Paper Reports
4. Boston Scientific Announces Start of Major European Registry Assessing Different Olimus-Eluting Stents
5. Tryton Medical Receives CE Mark Approval for its Side-Branch Stent
6. CV Therapeutics and Medlogics Device Corporation Sign Licensing Agreement for CVTs Innovative Stent Coating Technology
7. Biosensors Receives CE Mark Approval for Its BioMatrix(R) Drug-Eluting Coronary Stent System
8. PCI Guideline Update Stresses Long-Term Anticoagulant Therapy After Treatment With Drug-Eluting Stents
9. ARRIVE Registry Analysis Demonstrates Continued Safety and Efficacy of TAXUS(R) Stent in Complex Real-World Patients
10. Preclinical Research on Coronary Stent with CeloNova BioSciences Polyzene(R)- F Nanocoating Receives Award at CIRSE 2007
11. Safety Profile of TAXUS(R) Liberte(TM) Stent System Highlighted in Worlds Largest Stent Registry
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/10/2014)... Senior supply chain management executives from over ... challenges of “Reducing Cost, Lead Time, & Defects in ... Describing the partnership of the Bio Supply Management Alliance ... ( SCMI) of the University of San Diego ... Kroc Institute of Peace and Justice in San Diego, ...
(Date:7/10/2014)... , July 10, 2014  Kainos Capital, a firm ... today announced that it has acquired the Slim-Fast brand ... the business. Terms of the transaction were not disclosed. ... meal replacement business that markets ready-to-drink shakes, powders, bars ... America and in the United ...
(Date:7/10/2014)... July 10, 2014   Ceres, Inc . (Nasdaq: ... company, announced today financial results for the three months ... its business. Ceres reported that the company ... performance this growing season in Brazil, which concluded in ... company,s sorghum evaluation areas for part of the growing ...
(Date:7/10/2014)... microscopic polymer light resonators that expand in the ... Photonics Laboratory have developed new optical sensors with ... sensors are ideal for detecting trace gas concentrations ... nature, and immunity to electromagnetic interference. , Although ... the MIT team conceived an extremely sensitive, compact ...
Breaking Biology Technology:Biotech & Biopharm Supply Chain Management Executives Launch BSMA in San Diego 2Biotech & Biopharm Supply Chain Management Executives Launch BSMA in San Diego 3Biotech & Biopharm Supply Chain Management Executives Launch BSMA in San Diego 4Kainos Capital Acquires Slim-Fast From Unilever 2Ceres Announces Fiscal Third Quarter 2014 Financial Results 2Ceres Announces Fiscal Third Quarter 2014 Financial Results 3Ceres Announces Fiscal Third Quarter 2014 Financial Results 4Ceres Announces Fiscal Third Quarter 2014 Financial Results 5Ceres Announces Fiscal Third Quarter 2014 Financial Results 6Ceres Announces Fiscal Third Quarter 2014 Financial Results 7Ceres Announces Fiscal Third Quarter 2014 Financial Results 8Ceres Announces Fiscal Third Quarter 2014 Financial Results 9Swell new sensors 2
... ILI ), announced today that it will host ... at 4:30 p.m. ET to review the Company,s,first quarter ... developments., To access the live call, dial 877-627-6555 ... on the Investors,section of the Company,s website, http://www.ilgenetics.com ...
... Pharmaceuticals, Inc.,(Nasdaq: AMLN ) will be presenting at ... 2008 at 10:00 a.m. PT in Las Vegas. Michael,York, ... providing a corporate overview., The live presentation and ... made available following the event. The webcast and,recording will ...
... to augment Quintiles Consulting offerings, RESEARCH ... Corp. today announced that it has signed ... decision-analytics and market research,consulting firm located in ... business., The acquisition of Eidetics will ...
Cached Biology Technology:Interleukin Genetics Announces Conference Call and Webcast to Discuss First Quarter 2008 Business Results 2Quintiles Signs Agreement to Acquire Eidetics 2
(Date:7/10/2014)... overfishing in the English Channel has resulted in the ... left fishermen ,scraping the barrel, for increasing amounts of ... haddock and many other species at the head of ... removed from the area completely., These are some of ... at Plymouth University, in association with international non-profit research ...
(Date:7/10/2014)... at NJIT,s business incubator, received a $1.4 million federal ... use to staunch bleeding during brain surgery. , Surgeons ... the natural bio-polymer solutions in the gel will cohere ... , The gel can shorten an intracranial surgery ... time for the patient,s skull to be open and ...
(Date:7/10/2014)... that Courtney Aldrich, Ph.D., will head the brand-new, ... editor-in-chief. With the first issue slated for publication ... a growing demand for a place to publish ... is to develop a journal focused on diseases ... that advances the field and lays the foundation ...
Breaking Biology News(10 mins):Overfishing in the English Channel leaves fisherman scraping the bottom of the barrel 2Overfishing in the English Channel leaves fisherman scraping the bottom of the barrel 3A start-up at NJIT develops bleeding-control gel for brain surgery 2ACS Infectious Diseases: Unique chemistry journal names editor 2
... from a puddle or a pond to a vast ocean, ... animals. These so-called sessile suspension feeders are critical to aquatic ... contaminants by consuming bacteria. A study published by Cell Press ... that by actively changing the angle of their bodies relative ...
... time, it was thought impossible to isolate a pearl,s ... this elusive goal. Scientists Joana Meyer, from the ETH ... McDonald, and Laurent Cartier of the Swiss Gemmological Institute ... the first time in extracting trace amounts of DNA ...
... Oct. 7, 2013 ValidSoft, a global supplier of ... and a wholly owned subsidiary of Elephant Talk Communications ... commerce technology with Spindle,s new "MeNetwork360" mobile commerce ecosystem, ... ) conference being held from October 6 to October ...
Cached Biology News:How tiny organisms make a big impact on clean water 2A bad break for fake pearls 2ValidSoft and Spindle to Demo New Mobile Commerce Ecosystem at Money2020 2ValidSoft and Spindle to Demo New Mobile Commerce Ecosystem at Money2020 3ValidSoft and Spindle to Demo New Mobile Commerce Ecosystem at Money2020 4ValidSoft and Spindle to Demo New Mobile Commerce Ecosystem at Money2020 5
... TOPO Cloning is ... available for cloning PCR ... and Zero Blunt TOPO ... and activated with topoisomerase ...
ready-to-use solution...
... analysis & visualization software. ... multiple samples. Combine Sequest ... increased confidence. Get more ... from your MS/MS experiments.14 ...
... Immunogen: Synthetic peptide derived from ... rat mouse dog and orangutang occludin ... human occludin protein. Reactivity: Human ... Reactivity with rat mouse dog and ...
Biology Products: