News | September 02, 2008

Edwards Lifesciences Receives FDA Approval for PERIMOUNT Magna Mitral Heart Valve

September 3, 2008 - Edwards Lifesciences Corp. today said it received FDA approval for the Carpentier-Edwards PERIMOUNT Magna mitral heart valve, which the company plans to immediately launch for sale in the U.S.

Designed for the treatment of mitral valve disease, one of the most common forms of heart valve disease in the world, the PERIMOUNT Magna mitral valve is a pericardial tissue-based bioprosthetic device that replaces a patient’s diseased mitral valve. Industry estimates indicate that there will be 35,000-40,000 surgical mitral valve replacements in the U.S. in 2008.

The PERIMOUNT Magna mitral valve is the first mitral tissue valve to feature an asymmetric shape that mimics the native mitral anatomy. The company said this design provides the lowest effective profile and lowest ventricular projection for any tissue mitral valve in the industry.

“This valve provides patients and surgeons with an important option for mitral valve replacement,” said A. Marc Gillinov, M.D., staff cardiac surgeon at the Cleveland Clinic Heart and Vascular Institute, and a paid consultant to Edwards Lifesciences. “The features of the valve, including its asymmetric shape, low profile and expansive sewing cuff, are designed to provide ease of implantation in a difficult valve position, low ventricular projection and strong hemodynamic performance.”

The PERIMOUNT Magna mitral valve was launched in Europe in September 2005. It incorporates features of the Carpentier-Edwards PERIMOUNT mitral valve, which has demonstrated 16 years of durability, including the treatment of the bovine pericardial tissue leaflets with the Carpentier-Edwards ThermaFix process. This anti-calcification technology was developed to help mitigate tissue heart valve leaflet calcification, which is one of the primary causes of tissue valve deterioration.

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