FDA to Review Medtronic's Endeavor Drug Eluting Stent
August 22, 2007 - Medtronic, Inc. announced it has been informed by the FDA that an Advisory Panel will review the Premarket Approval (PMA) application for the Endeavor Drug Eluting Coronary Stent in October 2007.
The FDA will announce the date and the complete agenda four to six weeks prior to the meeting in accordance with their normal communications regarding public panel meetings. Medtronic's PMA submission includes safety and efficacy data on more than 4,100 patients who have been treated with Endeavor in clinical trials that include follow up for as long as four years.
The Endeavor PMA reportedly includes data from the largest, most wide-ranging patient population and for patients with the longest follow-up ever submitted to support the safety and efficacy of a new drug-eluting stent (DES).
For more information: www.medtronic.com