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Edwards Lifesciences wins FDA approval for new mitral heart valve

Edwards Lifesciences, a developer of products and technologies designed to treat cardiovascular disease, has received approval from the FDA for the Carpentier-Edwards Perimount Magna mitral heart valve. Edwards is planning to launch the Perimount Magna mitral valve in the US 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.

The Perimount Magna mitral valve is said to be 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, the company said.

Donald Bobo, Jr, Edwards’s corporate vice president for heart valve therapy, said: “The Perimount Magna mitral valve represents a significant advancement for patients needing mitral valve replacement. It extends the exceptional hemodynamic performance and durability of the Magna valve platform to a design that is unique and specific to the mitral valve.”