WASHINGTON (AP) — Federal health officials have approved a first-of-a-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 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, which has been used to replace valves for decades.
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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