Medtronic reports positive results of the latest study involving its Endeavor™ drug eluting stent, as presented at the American College of Cardiology meeting in Orlando, Florida:
“Overall the clinical results are impressive and show that more than 95 percent of the patients who received an Endeavor stent in the trial required no further treatment or revascularization at the original treatment site at the nine month assessment period,” said Dr. Wijns. “The Endeavor stent’s performance in this trial provides substantial evidence that the Endeavor drug eluting stent is safe and that it substantially reduces clinical restenosis compared to a bare metal stent. These clinical results, taken together with the ease of use of the Driver stent platform, establish the Endeavor stent as a valuable treatment option for patients undergoing angioplasty with drug eluting stents.”
The ENDEAVOR II Clinical Trial, sponsored by Medtronic, Inc. (NYSE: MDT), was a randomized, double-blind pivotal trial designed to evaluate the safety and efficacy of Medtronic’s Endeavor™ Drug Eluting Coronary Stent compared to Medtronic’s Driver™ Cobalt Alloy Coronary Stent in patients with coronary artery disease.
The trial enrolled 1,197 patients at 72 facilities in 17 countries, making it the first and largest drug eluting stent trial comparing a drug eluting stent to a bare metal stent ever performed outside the U.S. The primary endpoint of the trial was TVF at nine months. TVF is a composite endpoint, which includes death, myocardial infarction and Target Vessel Revascularization (TVR). The results from the trial will be used to support Endeavor product approvals globally.