N@N

Edwards Lifesciences: Edwards Lifesciences Receives FDA Approval for New Heart Valve

^{Published on 2009-05-08 11:45:40, Last Modified on 2009-11-02 11:35:53 - Market Wire}
 

BOSTON, MA--(Marketwire - May 8, 2009) - Edwards Lifesciences Corporation (NYSE: [ EW ]), the world leader in the science of heart valves, today announced that it has received approval from the U.S. Food and Drug Administration (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.

"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.

"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," said Donald E. Bobo, Jr., Edwards' corporate vice president, heart valve therapy.

Edwards' representatives and information about the Magna Ease aortic valve and the EndoDirect System will be available at Booth #303 at the AATS 2009 meeting, May 10-12 in Boston.

About Edwards Lifesciences

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring, with more than five decades of experience in partnering with clinicians to develop life-saving innovations. Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies, which are sold in approximately 100 countries. The company's global brands include Carpentier-Edwards, Cosgrove-Edwards, Edwards SAPIEN, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz. Additional company information can be found at [ http://www.edwards.com ].

Edwards and Magna Ease are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, Cosgrove-Edwards, Edwards SAPIEN, FloTrac, Fogarty, Magna, PERIMOUNT Magna and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office. EndoDirect and PORT ACCESS are trademarks of Edwards Lifesciences AG.