Medtronic CoreValve System IDE for transcatheter aortic valve implantation receives FDA approval

Medtronic, Inc. (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) conditional approval for its Investigational Device Exemption (IDE) application and pivotal clinical trial protocol to begin evaluating the Medtronic CoreValve System for transcatheter aortic valve implantation (TAVI). The CoreValve System is designed to provide a minimally invasive, non-surgical treatment option for patients with symptomatic, severe aortic stenosis who are at high risk, or are ineligible, for open-heart surgery. Worldwide, approximately 300,000 people have been diagnosed with this condition, and approximately one-third of these patients are deemed at too high a risk for open-heart surgery, the only therapy with significant clinical effect that is currently available in the United States. The Medtronic CoreValve System will soon be under investigational use and is not yet commercially available in the U.S.

“This study represents a significant opportunity to fundamentally change the way we treat Americans with severe aortic stenosis”

"There is a distinct need for a new treatment option for many older patients with a severely diseased aortic heart valve and, as the population ages, this need continues to grow," said Jeffrey Popma, M.D., Medtronic CoreValve U.S. Pivotal Trial co-principal investigator based at Beth Israel Deaconess Medical Center in Boston.

The CoreValve System is designed with self-expandable technology to replace a diseased aortic valve percutaneously, usually through the femoral artery, without open-heart surgery or surgical removal of the native valve. Since receipt of CE (Conformité Européenne) Mark in March 2007, the system has been implanted in more than 12,000 patients worldwide in more than 34 countries outside the U.S.

"This study represents a significant opportunity to fundamentally change the way we treat Americans with severe aortic stenosis," said David H. Adams, M.D., professor and chairman of the Department of Cardiothoracic Surgery at The Mount Sinai Medical Center in New York City and co-principal investigator of the CoreValve trial. "Cardiologists and cardiac surgeons will collaborate more closely than ever before to carefully select and deliver this innovative therapy."