Edwards Sapien 3 Prosthetic Aortic Heart Valve Gets FDA Approval In U.S, Europe

by Julia Samuel on  June 19, 2015 at 6:04 PM Medical Gadgets
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Edwards has announced the release of its latest transcatheter aortic heart valve, the SAPIEN 3, including the Commander Delivery System, to the U.S. market as the FDA has issued approval.
Edwards Sapien 3 Prosthetic Aortic Heart Valve Gets FDA Approval In U.S, Europe
Edwards Sapien 3 Prosthetic Aortic Heart Valve Gets FDA Approval In U.S, Europe

The device was designed to lower the chances of leakage around the valve, which should reduce various side effects, including the potential for stroke.

The SAPIEN 3 now has an outer layer of polyethylene terephthalate over the frame of the device that more consistently plugs blood flow from having a chance to pass through outside of the valve.

The SAPIEN 3 valve is the only commercial transcatheter heart valve, which has shown a low rate of complication. The valve can be implanted through multiple approaches: transfemoral, transapical or transaortic.

"Edwards SAPIEN 3 valve has a unique design intended to provide a simpler procedure, along with fewer post-procedural complications and a faster recovery for patients," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves.

"Based on our clinical leadership in transcatheter heart valves, we believe the SAPIEN 3 valve's characteristics and procedural refinements have the potential to transform TAVI for both physicians and patients."

Source: Medindia

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