Navigation Links
FDA Advisory Committee Recommends Approval of Abbott's XIENCE(TM) V Drug Eluting Stent System
Date:11/29/2007

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 http://www.abbott.com


'/>"/>
SOURCE Abbott
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:
*Name:
*Comment:
*Email:
(Date:2/18/2017)... ... 2017 , ... Park Cities Pet Sitter President, Joette White, has been featured ... network. The episode, which was posted this week, features a 30-minute interview of ... Park Cities Pet Sitter’s being awarded the 2017 National Association of Professional Pet Sitter’s ...
(Date:2/17/2017)... San Diego, CA (PRWEB) , ... February 17, ... ... new initiative—InvestUp—to focus on foundational and sustainable systems change designed to further positively ... Counties. , “The Board of Trustees has long considered it our duty to ...
(Date:2/17/2017)... VA (PRWEB) , ... February 17, 2017 , ... ... the Steps to Prevent a Warning Letter, **An FDAnews Webinar**, Feb. 23, 2017 ... , Do manufacturers distinguish between corrective action (CA) and preventive action (PA)? , ...
(Date:2/17/2017)... ... February 17, 2017 , ... Pharmica Consulting attended CHI's ... facets of clinical trial planning and management. Pharmica discussed the importance of effective ... addition, attendees stopping by Pharmica’s booth were able to demo its cloud-based ...
(Date:2/17/2017)... ... February 17, 2017 , ... ... financial planning assistance to families and business owners in and around the Hampton ... drive to help prevent all forms of domestic violence. , There are multiple ...
Breaking Medicine News(10 mins):
(Date:2/16/2017)... , Feb. 16, 2017 Quest Diagnostics ... of diagnostic information services, today announced that it has ... for 2017 by Fortune. The annual ... companies in the "Health Care: Pharmacy and Other Services" ... diagnostic information services company to attain the designation. This ...
(Date:2/16/2017)... 2017  Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ ... announced that executive management will participate in the RBC ... 22-23, 2017. Adrian Adams , Chief Executive Officer, ... p.m. local time on Wednesday, February 22, 2017. ... event may be accessed from the Investors section of ...
(Date:2/16/2017)... Feb. 16, 2017  Express Scripts (NASDAQ: ESRX ) ... Most Admired Companies within the Health Care: Pharmacy and Other Services ... of the World,s Most Admired Companies," said Tim Wentworth , ... commitment and passion of our 26,000 employees to make medicine more ... ...
Breaking Medicine Technology: