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.