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FDA broadens options for using Edwards heart valve
First Published Sep 23 2013 03:56 pm • Last Updated Sep 23 2013 03:56 pm

WASHINGTON • The Food and Drug Administration said Monday that it has approved broader use of an innovative artificial heart valve that can be implanted without major surgery, allowing surgeons to insert the implant through multiple pathways.

The agency approved revised labeling for Edwards Lifesciences’ Sapien heart valve, which is approved for patients who face major risks from open-heart surgery or who are too sick to have that procedure done.

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The device’s original labeling instructed surgeons to thread the valve into place through a major artery that runs from the leg up to the heart. The new labeling approved by the FDA removes that language, allowing surgeons to choose from multiple methods of implantation.

About 300,000 U.S. patients suffer from deterioration of the aortic heart valve, which forces the heart to work harder to pump blood, often leading to heart failure, blood clots and sudden death. About 30 percent of patients are considered inoperable or at high risk of surgical complications and are not referred for open-heart surgery. That procedure involves sawing the breastbone in half, stopping the heart, cutting out the old valve and sewing a new one into place.

Analysts estimate as many as 70,000 to 100,000 patients per year could eventually receive the Sapien replacement valve.

Edwards Lifesciences Corp. reported $182 million in sales of the heart valve in the last quarter, or 35 percent of the company’s total sales.

Shares of the Irvine, Calif.-based company fell 76 cents, or 1.1 percent, to close at $69.27 Monday. That is near the low end of their 52-week range of $62.34 to $110.79.




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