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 this week to consider broadening its use.
Last November Edwards Lifesciences Corp. won approval for its first-of-a-kind Sapien heart valve, which 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 which has been used to replace the valve for decades.
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