FDA okays Edwards implant to fix defective mitral heart valves

September 3rd, 2008, 6:30 am · Post a Comment · posted by Colin Stewart

FIGHTING HEART DISEASE

Edwards logo Heart-valve maker Edwards Lifesciences of Irvine has won approval from the Food and Drug Administration for a new type of replacement mitral valve made of cow tissue.

The Carpentier-Edwards Perimount Magna mitral valve has been available in Europe since 2005. In the United States, it will compete with mechanical heart valves and pig-tissue valves as treatment for patients with mitral valve disease.

The mitral valve separates two chambers of the heart, the atrium and the ventricle, on the left side of the organ. It closes during contraction of the left ventricle so blood won’t flow back into the atrium.

The new Edwards device is based on an existing Edwards mitral valve, but redesigned to match the asymmetric shape of the human mitral valve, the company said in its announcement.

It’s based on the same technology as the Edwards Perimount Magna replacement for the aortic valve, which is the valve that lets blood flow from the left ventricle out into the aorta.

Mitral valve disease, one of the most common types of heart valve problems, will require an estimated 35,000 to 40,000 surgical mitral valve replacements this year in the United States, Edwards said.

Cardiac surgeon Dr. A. Marc Gillinov at the Cleveland Clinic Heart and Vascular Institute, a consultant to Edwards, said, “This valve provides patients and surgeons with an important option for mitral valve replacement” and is “designed to provide ease of implantation in a difficult valve position.”

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