FDA Advisory Panel to Review Medtronic's Endeavor Drug Eluting Stent on October 10MINNEAPOLIS--(BUSINESS WIRE)--Sep 12, 2007 - Medtronic, Inc. (NYSE:MDT), announced today that a U.S. Food and Drug Administration (FDA) Advisory Panel will review the Premarket Approval (PMA) application for the company's Endeavor(R) 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.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
Caution: The Endeavor(R) Drug Eluting Coronary Stent is an investigational device. The device is limited by federal (or United States) law to investigational use only.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 27, 2007. Actual results may differ materially from anticipated results.
Rob Clark, 763-505-2635
Martha Goldberg Aronson, 763-505-2694
Posted: September 2007
Recommended for you