Healthcare Industry News:  Edwards Lifesciences 

Devices Cardiology FDA

 News Release - September 3, 2008

Edwards Lifesciences Receives FDA Approval for PERIMOUNT Magna Mitral Heart Valve

New Valve With Unique Design Approved to Treat Common Heart Valve Disease

IRVINE, CA--(Healthcare Sales & Marketing Network)--Sep 3, 2008 -- Edwards Lifesciences Corporation (EW ), the world leader in the science of heart valves, today 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.

"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.

About Edwards Lifesciences

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies. In 2008, Edwards celebrates 50 years of partnering with clinicians to develop life-saving innovations. The company's global brands, which are sold in approximately 100 countries, include CardioVations, Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz. Additional company information can be found at http://www.edwards.com.

Edwards is a trademark of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, CardioVations, Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, Magna, PERIMOUNT, PERIMOUNT Magna, Swan-Ganz and ThermaFix are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office. CardioVations is a trademark of Edwards Lifesciences AG and is registered in the United States Patent and Trademark Office.


Source: Edwards Lifesciences

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