Edwards Lifesciences (EW) Receives FDA Approval for PERIMOUNT Magna Mitral Heart Valve

September 3, 2008 9:20 AM EDT

Edwards Lifesciences Corporation (NYSE: EW) announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the Carpentier-Edwards PERIMOUNT Magna mitral heart valve. Edwards will launch the PERIMOUNT Magna mitral valve in the United States immediately.

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 United States this year.

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

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring.

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