Edwards Lifesciences Receives FDA Approval for New Heart Valve


Edwards Lifesciences Corporation, the world leader in the science of heart valves, announced that it has received approval from the U.S. FDA for the Carpentier-Edwards PERIMOUNT Magna Ease aortic valve, designed for easier implantation in the heart.

The company is introducing this valve, as well as the PORT ACCESS EndoDirect minimally invasive surgery system, at the American Association for Thoracic Surgery's (AATS) 89th Annual Meeting in Boston this week. The new valve includes a low profile and smooth commissure posts to ease insertion through small incisions or small aortic roots.

Cardiac surgeon Michael J. Mack, M.D., founder of CSANT, a cardiology and cardiac surgery practice in Dallas, Texas, and a paid consultant to Edwards Lifesciences said, The Magna Ease valve sets a new standard for tissue valves, by combining enhanced implantability with the unsurpassed hemodynamics and long-term durability of bovine pericardial tissue.

Donald E. Bobo, Jr., Edwards' corporate vice president, heart valve therapy said, Edwards' new offerings are designed to give cardiac surgeons additional choices in tailoring procedures based on their preferred surgical approach and the needs of their patients.