FDA News

FDA Advisory Panel to Review Medtronic's Endeavor Drug Eluting Stent on October 10

(Sept 11, 2007)-- Medtronic announced that a U.S. Food and Drug Administration (FDA) Advisory Panel will review the Premarket Approval (PMA) application for the company’s Endeavor® Drug Eluting Coronary Stent on October 10.

The FDA’s Circulatory System Devices Panel is scheduled to meet October 10 and 11. Endeavor is the only drug eluting stent on the agenda for review during the October 10 panel meeting.

The Endeavor PMA sets a new standard for clinical data submitted to the FDA, with 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). Medtronic’s PMA submission includes compelling evidence characterizing the long-term safety and efficacy of the Endeavor DES. Medtronic will present data on more than 4,100 patients who have been treated with the Endeavor DES in clinical trials that include follow up for as long as four years; 675 of these patients have been followed for three years and more and 1,287 for two years or more. These data constitute a robust body of evidence for the panel’s review.

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