Edwards Lifesciences ($EW) wants the FDA to approve its Sapien transcatheter heart valve implant for a broader class of patients.
Company officials plan to make their case before an FDA advisory panel of experts June 13. The panel's positive recommendation would boost Edwards' chances of gaining regulatory approval to use Sapien in patients with severe, symptomatic aortic stenosis who are at high risk for surgery. Right now, Sapien is only allowed commercially in the U.S. for patients with limited classes of stenosis who also can't have surgery.
Edwards will base its application, in large part, on data from the high-risk cohort of the company's PARTNER Trial, which involved 699 patients.
The technology behind Sapien, which is made in part with bovine pericardial tissue, is pretty novel, in that it was the first aortic valve replacement approved in the U.S. to be implanted by way of a catheter rather than open heart surgery. Sapien, in fact, is delivered through an incision in the leg. Once it reaches its targeted location by way of the catheter, the valve is expanded with a balloon and automatically starts working in place of the original valve, the company explains.
Care to bet on how the FDA panel will vote this time? If last July's vote by the FDA's Circulatory System Devices Committee is any indication, then chances are good for an expanded approval. The panel voted with a clear majority that Sapien's benefits outweighed risks, and that it appeared safe and effective. In advance of that review, the FDA issued a report showing that the valve did significantly reduce death rates versus standard therapy for patients with severe aortic stenosis. But the regulators cautioned that there appeared to be a higher number of major strokes and other "major vascular events" in Sapien patients compared with those treated with standard methods.
Meanwhile, companies including Medtronic ($MDT) continue to develop competing products.
(Image of the Sapien transcatheter heart valve courtesy of Edwards Lifesciences)
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