Medtronic, Inc., (NYSE:MDT) today announced that a review of data from the ENDEAVOR IV Clinical Trial indicates that the trial has met its primary, non-inferiority endpoint.
The ENDEAVOR IV Clinical Trial is a randomized, single-blind trial evaluating the safety and efficacy of the Endeavor™ Drug Eluting Coronary Stent as compared to the TAXUS Paclitaxel-Eluting Coronary Stent System from Boston Scientific Corporation (NYSE:BSX). ENDEAVOR IV is evaluating 1,548 patients at 80 clinical centers in the United States, with a primary endpoint of Target Vessel Failure (TVF - a composite of cardiac death, myocardial infarction and target vessel revascularization) at nine months. Medtronic will submit these data to the U.S. Food and Drug Administration (FDA) in support of the Endeavor Pre-Market Approval (PMA) application and intends to present the final ENDEAVOR IV clinical trial data at the Transcatheter Cardiovascular Therapeutics (TCT) annual conference in Washington, DC, in October 2007.
“The Endeavor stent continues to demonstrate positive results for patients around the world,” said Scott Ward, president of the CardioVascular business at Medtronic. “The Endeavor stent has produced excellent results across an extensive clinical program, with long-term clinical follow up extending to three and four years. We have the most comprehensive dossier of clinical data ever produced for a drug eluting stent application in the U.S., with more than 4,100 patients. The Endeavor stent will be reviewed by FDA at a panel this fall, and we continue to anticipate FDA approval later this calendar year.”
About Medtronic
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™ Drug Eluting Coronary Stent is an investigational device. The device is limited by federal (or United States) law to investigational use only.
Any statements made about anticipated regulatory review or approval are forward-looking statements 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.
