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
Now the Food and Drug Administration is considering expanding
the device to patients who are healthier, but still face risks from
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.
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