Navigation Links
FDA Advisory Committee Recommends Approval of Abbott's XIENCE(TM) V Drug Eluting Stent System

ABBOTT PARK, Ill., Nov. 29 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT)announced today that the Circulatory System Devices Advisory Panel to the U.S. Food and Drug Administration (FDA) recommended approval for the XIENCE(TM) V Everolimus Eluting Coronary Stent System. XIENCE V is a next-generation drug eluting stent intended for use in the treatment of coronary artery disease.

The FDA advisory committee voted to recommend the XIENCE V stent system for approval with conditions related to post-marketing study requirements and language related to dual antiplatelet therapy. The FDA is not required to, but usually follows the recommendations of its advisory committees.

"The clinical and angiographic benefits of the XIENCE V stent compared to the most widely used drug eluting stent available in the U.S. have been consistent and significant across the SPIRIT trials," said Gregg W. Stone, M.D., of Columbia University Medical Center and the Cardiovascular Research Foundation, New York and principal investigator of the SPIRIT III clinical trial. "The robust body of safety and efficacy data support approval of XIENCE V as an important new technology that will enhance the lives of millions of patients with heart disease."

Abbott filed its Premarket Approval (PMA) submission for XIENCE V with the FDA on June 1, 2007. The PMA for XIENCE V is the first to include data demonstrating superiority of one drug eluting stent over another in the primary endpoint of in-segment late loss in a randomized controlled head-to-head trial with a market leading product.

"The outcome of today's advisory committee meeting is very encouraging," said John M. Capek, Ph.D., executive vice president, Medical Products, Abbott. "We look forward to bringing this important new treatment for coronary artery disease to physicians and patients in the U.S."

XIENCE V was launched in Europe and other international markets in 2006. XIENCE V is currently an investigational device in the United States and Japan.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's Web site at

Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Genaera Announces Formation of Scientific Advisory Board for Obesity Drug Candidate Trodusquemine (MSI-1436)
2. China Holdings Appoints Ronald Shon Chairman of Advisory Board to Its Wholly-Owned Subsidiary China Power, Inc.
3. CryoCor Invited to Participate in FDA Advisory Panel Meeting on Atrial Fibrillation
4. Patient Safety Authority Board of Directors Names Infection Advisory Panel
5. Broker a Suite of Research & Advisory Services to Enhance Human Resources
6. Lynn Clark Callister, National Leader in Maternal-Child Health Nursing, Joins March of Dimes Advisory Council
7. MaxLife Fund Corp. appoints Daniel E. Kahan, to its Advisory Board
8. Delta Dental Plans Association Forms National Scientific Advisory Committee
9. Alter+Care Creates the Advisory Board
10. Patient Safety Authority Releases Advisory Focusing on Common Causes of Medication Errors
11. Susan G. Komen for the Cure Appoints Dr. Amelie G. Ramirez to Scientific Advisory Board
Post Your Comments:
(Date:11/25/2015)... Chicago, IL (PRWEB) , ... November 25, 2015 , ... ... the assets of Tri Lite’s personal heating products business. Cozy Products explains ... low-wattage personal heaters that fit in well with the Cozy Products business model: to ...
(Date:11/25/2015)... ... 25, 2015 , ... SCOTTSDALE, AZ) - Today, Dr. ... both surgical and non-surgical treatments, announced the expansion of his private practice capabilities ... , Highly trained and nationally recognized for his natural approach, Dr. Todd ...
(Date:11/25/2015)... ... November 25, 2015 , ... Brillianteen, McGaw ... and learning in its 65th Anniversary Brillianteen Revue, scheduled for March 4-6, 2016. ... For 65 years, Brillianteen has been a treasured tradition for numerous families in ...
(Date:11/25/2015)... ... November 25, 2015 , ... “While riding the bus, I saw ... N.Y. “I thought there had to be a convenient and comfortable way to protect ... PROTECTOR enables disabled individuals to safely travel during cold or inclement weather. In doing ...
(Date:11/25/2015)... ... November 25, 2015 , ... Castlewood Treatment Center for ... eating disorders as a result of the $20,000 raised at the center’s recent ... Run Golf Club in Eureka, will help individuals who otherwise might not seek ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... ) has ... Future Horizons and Growth Strategies in the ... Shares, Country Segment Forecasts, Competitive Intelligence, Emerging ... --> ) has announced the ... and Growth Strategies in the German Drugs ...
(Date:11/26/2015)... , November 26, 2015 ... the "Self Administration of High Viscosity Drugs" ... ) has announced the addition of the ... report to their offering. --> Research ... addition of the "Self Administration of High ...
(Date:11/25/2015)... global healthcare industry is expected to grow at a rate ... has the highest projected growth at 12.7%, and ... is second with growth projected at 11.5%. ... 2013-2014, total government funded healthcare was nearly 68%. Federal government ... 2013-2014. In real terms, out of pocket expenditure increased by ...
Breaking Medicine Technology: