Federal health officials are asking safety questions about the first artificial heart valve designed to be implanted without major surgery to consider broadening its use.
Last November, Edwards Lifesciences Corp. won approval for its Sapien heart valve, which is threaded into place through one of the body’s major arteries. The valve is available for patients who aren’t healthy enough to undergo open-heart surgery. Now the FDA is considering expanding the device to patients who are healthier, but still face serious risks from surgery.
News Tribune news services
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