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FDA okays Edwards PERIMOUNT Magna Mitral Heart Valve

Edwards Lifesciences Corp.confirmed that the Food and Drug Administration (FDA) has given approval for its heart valve to fix defective mitral heart valves.
 
This new device is based on an existing Edwards mitral valve, but it is designed in an all-together different manner, in order to match the asymmetric shape of the human mitral valve. According to the Irvine-based Edwards, the Perimount Magna mitral valve will be launched very soon.
 
"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." he further said.

This device is basically a cow-tissue device. It will be used to replace a patient’s diseased mitral valve, that is located between the left atrium and ventricle in the heart.
 
"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, who is a  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." he further said.
 
Dr. A. Marc Gillinov, who is a Cardiac surgeon 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.”

One Response to “FDA okays Edwards PERIMOUNT Magna Mitral Heart Valve”

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