August 28, 2007 – The FDA Advisory Panel will review the Premarket Approval (PMA) application for Endeavor Drug Eluting Coronary Stent by Medtronic Inc. in October, which would mark the introduction of a drug-eluting stent with a polymer-drug combination specifically designed to reduce restenosis to the market.
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.
For more information: www.medtronic.com