Edwards Lifesciences, a heart valves company, has received approval from the FDA for the Carpentier-Edwards Perimount Magna mitral heart valve.
The Irvine, Calif.-based Edwards said that its 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 features an asymmetric shape that mimics the native mitral anatomy, according to the company.
Edwards said it will launch the Perimount Magna mitral valve in the U.S. immediately.