U.S. pivotal clinical trial of Medtronic CoreValve begins

Medtronic, Inc. (NYSE: MDT) today announced the beginning of its Medtronic CoreValve® U.S. Pivotal clinical trial in the United States. The first CoreValve transcatheter aortic valve implantation (TAVI) procedure was performed by David H. Adams, M.D., and Samin K. Sharma, M.D., at The Mount Sinai Medical Center in New York City. The Medtronic CoreValve® System, a revolutionary treatment alternative to open-heart surgery for patients with severe aortic stenosis, will be investigated in more than 1,200 patients at up to 40 U.S. clinical trial sites. A second CoreValve case took place this week at El Camino Hospital in Mountain View, Calif.; St. Francis Hospital, The Heart Center in Roslyn, N.Y, also has been activated in the trial and is screening patients.

"Through this trial, we are investigating a minimally invasive, non-surgical alternative to open-heart surgery for valve replacement in patients with severe aortic stenosis," said Dr. Adams, who is chair of the Department of Cardiothoracic Surgery at Mount Sinai and is a national co-principal investigator of the CoreValve U.S. clinical trial. "This study will evaluate the safety and efficacy of the CoreValve system for use in the United States, where many thousands of patients are diagnosed with severe aortic stenosis every year."

The CoreValve System is designed with self-expandable technology to replace a diseased aortic valve percutaneously (through the skin), usually through the femoral artery, without open-heart surgery or surgical removal of the native valve. The CoreValve device is delivered through a controlled deployment delivery system.

"We are very excited with this first step in bringing this important transformational therapy to patients in the United States with life-threatening aortic valve disease, particularly those patients who have limited surgical options," said Jeffrey Popma, M.D., national co-principal investigator of the Medtronic CoreValve U.S. Pivotal Trial and director, Interventional Cardiology at the Beth Israel Deaconess Medical Center in Boston.