Monday, September 8, 2008

Edwards PERIMOUNT Magna Mitral Valve Gets FDA's Green Light

Filed under: Cardiac Surgery

The FDA has given Edwards Lifesciences approval to market the company's new bovine pericardial mitral valve, that features more native asymmetric mitral morphology, and an easy implantation design.

Edwards explains:

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.

“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 expands Edwards’ Magna platform, utilizing the company’s proprietary bovine pericardial tissue and incorporating 50 years of clinical experience and design technology.

“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,” said Donald E. Bobo, Jr., Edwards' corporate vice president, heart valve therapy. “When surgeons see the new PERIMOUNT Magna mitral valve, they immediately appreciate that its design offers an advanced and easily implantable option.”

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.

Press release: Edwards Lifesciences Receives FDA Approval for PERIMOUNT Magna Mitral Heart Valve...

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