FDA approves innovative heart valve

By The Associated Press

WASHINGTON --
Federal health officials have approved a first-of-its-kind artificial heart valve that can be implanted without major surgery, offering a new treatment option for patients who are too old or frail for the chest-cracking procedure currently used.

The Food and Drug Administration said late Wednesday that it approved Edwards Lifesciences' highly anticipated Sapien heart valve, which can be threaded into place through a major artery that runs from the leg up to the heart.

Cardiologists say the new approach will help old, sickly patients who cannot undergo the more invasive open-heart surgery.

Other companies have won approval for less-invasive heart valves before, but Edwards' implant is the first replacement for the aortic valve, the heart's main doorway.

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