Medtronic Resolute®Drug-Eluting Stent Delivers Compelling Clinical Outcomes in Major Studies

Results of two major clinical studies presented at ACC.11 – the 60th Annual Scientific Session & Expo of the American College of Cardiology – demonstrate that the Resolute drug-eluting stent from Medtronic, Inc. MDT, provides a positive and persistent treatment effect for a wide variety of patients with coronary artery disease. One-year results of RESOLUTE US were presented today in the late-breaking clinical trials session for interventional cardiology and published by the Journal of the American College of Cardiology. Two-year results of RESOLUTE All Comers were presented yesterday as a featured interventional clinical study and published by The Lancet. These studies are key components of the comprehensive RESOLUTE clinical program, which has enrolled more than 5,000 patients across a combination of randomized controlled and single-arm trials conducted around the world. These new data from RESOLUTE US complete Medtronic's submission to the U.S. Food and Drug Administration for pre-market approval of the Resolute DES, which remains an investigational device in the United States, where its use is limited to this FDA-approved clinical trial. The FDA's decision is expected in the first half of 2012. “The latest findings from the uniquely designed RESOLUTE clinical program, with the broad spectrum of patients enrolled, support this novel drug-eluting stent as a new alternative in the treatment of coronary artery disease,” said Martin B. Leon, M.D., director of the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center and a RESOLUTE US principal investigator. “Based on the growing body of clinical evidence on the device, the Resolute DES has distinguished itself as a viable choice for a wide variety of patients.”