Medtronic: FDA to review Endeavor stent |
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Wed, 12 Sep 2007 16:06
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MINNEAPOLIS (AP) - Medical device maker Medtronic Inc. said Wednesday a Food and Drug Administration panel will review its premarket approval application for the Endeavor drug-eluting coronary stent on Oct. 10.Medtronic will present data on more than 4,100 patients who have been treated with the Endeavor stent in clinical trials that include follow-up for as long as four years.Coronary stents are miniature mesh tubes that are implanted in arteries to keep blocked parts open after angioplasty.Endeavor, which is already being sold in Europe, showed positive results in a late-stage study comparing it with the Taxus stent made by rival Boston Scientific, Medtronic claims.In August, Chief Financial Officer Gary Ellis projected potential Endeavor sales in the U.S. at $30 million a month.Shares of Medtronic added 18 cents to $54.67 in morning trading.Copyright 2007 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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