Edwards Lifesciences Receives FDA Clearance for New Heart Valve


May 11, 2009

May 10, 2009 - Edwards Lifesciences Corp. Friday said it received clearance from the FDA for the Carpentier-Edwards PERIMOUNT Magna Ease aortic valve, designed for easier implantation in the heart.

The company is introduced the 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 last week.

The new valve includes a low profile and smooth commissure posts to ease insertion through small incisions or small aortic roots.

"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," said 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.

Also at the AATS annual meeting, Edwards is introducing the PORT ACCESS EndoDirect System, which allows cardiac surgeons to stop a patient's heart and keep it at rest for the duration of the heart valve procedure without an incision down the middle of the chest. In procedures such as mitral valve repair and replacement, the EndoDirect System provides a minimally invasive alternative for direct aortic cannulation when femoral access (groin cannulation) is not an option.

For more information: www.edwards.com