Edwards Lifesciences Receives FDA Approval for First Catheter-Based Aortic Heart Valve in the U.S.

Published
Thursday, February 2, 2012

IRVINE, CA, November 02, 2011 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that it has received approval from the United States Food and Drug Administration (FDA) for the transfemoral delivery of the Edwards SAPIEN transcatheter aortic heart valve for the treatment of inoperable patients with severe symptomatic aortic stenosis. This is the first U.S. commercial approval for a transcatheter device enabling aortic valve replacement without the need for open-heart surgery.

Transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN valve enables multi-disciplinary heart teams to replace a patient's diseased aortic valve without traditional open-heart surgery and while the heart continues to beat -- avoiding the need for cardiopulmonary bypass.

"This day marks an important milestone for inoperable American patients who have long been awaiting a therapeutic option for the often debilitating symptoms associated with severe aortic stenosis," said Michael A. Mussallem, Edwards' chairman and CEO. "We are extremely proud of the dedication of the heart teams and the patients involved in the clinical trial for this therapy, who have paved the way for this therapy to help even more people around the world."

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