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FDA says survival with Edwards heart valve similar to surgery, but with more strokes
WASHINGTON (AP) ' Federal health officials are asking safety questions about the first artificial heart valve designed to be implanted without major surgery, ahead of a meeting to consider broadening its use.
Last summer Edwards Lifesciences won approval for the first-of-a-kind heart valve that can be threaded into place through one of the body's major arteries. The valve is currently available for patients who aren't healthy enough to undergo the more invasive open-heart surgery.
Now the Food and Drug Administration is considering expanding the device to patients who are healthier, but still face risks from chest-opening surgery.
In an online review, the FDA says the heart valve compared favorably to surgery after one year, with patients living about the same amount of time. However, it says heart valve patients had higher rates of stroke.