Medtronic to Present DES Trial Results to FDA
October 9, 2007 - Medtronic Inc. will provide a synopsis of clinical data on the Endeavor Drug Eluting Coronary Stent to be presented to an FDA Advisory Panel on October 10, 2007, which will consider whether to recommend approval of the device to the FDA.
Medtronic will submit a pooled data analysis of the major trials encompassing the ENDEAVOR clinical program as well as newly released nine-month results from the ENDEAVOR IV clinical trial. The Panel's recommendation will be subject to FDA approval.
The data from the ENDEAVOR I - IV clinical trials is designed to illustrate the consistent treatment effect of the Endeavor stent on key efficacy, safety and procedural success metrics.
For more information: www.medtronic.com