Edwards Lifesciences ($EW) won a long-awaited expanded FDA approval to use its Sapien transcatheter aortic heart valve in a larger class of patients. The vote became likely in June, when an FDA panel of experts voted 11-0, with one abstention, that benefits of a broader indication outweighed any risks. (Regulators almost always follow the panel recommendation.)
Sapien is now available to high-risk patients with severe aortic stenosis who could otherwise handle surgery. Surgeons can now deliver Sapien transapically, or through the ribs, as well. Sapien first gained FDA PMA approval on Nov. 2, 2011 as a treatment for patients with the condition who could not handle surgery, and they could only get the treatment transfemorally, or through the leg.
Surgeons deliver Sapien to the location of the diseased valve by crimping it into a catheter-based delivery system. A balloon expands the valve when it reaches the site and it begins to function right away, the company explains.
Edwards Life Sciences won the expanded approval, in part, based on data from the "Cohort B" portion of its pivotal PARTNER trial' "Cohort A" helped obtain the initial PMA approval last year. Researchers tested 699 older patients who had high risk of severe aortic stenosis. Patients randomly had the transcatheter aortic valve implantation or surgery, and both sides reported similar survival rates (though the valve implant patients saw higher stroke rates in the initial 30 days after the procedure).
If only the approval could have come a week earlier. On Oct. 9, Edwards endured a more than 18% drop in its stock price after 2012 third-quarter sales figures came in significantly below expectations. After an initial spike when the expanded Sapien FDA approval came through, the company's stock settled slightly down, at $86.14.
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