FDA panel recommends Edwards’ heart valves for high-risk patients

Late Wednesday, a U.S. Food and Drug Administration panel recommended that Edwards Lifesciences (NYSE:EV) transcatheter aortic valve replacement procedure be approved for patients with high risk to the alternative open-heart surgery.

Late last year, Edwards became the first company in the U.S. to win FDA approval for using the so-called TAVR procedure on patients with severe artery blockage who were too sick to undergo surgery.

Although it isn’t a guarantee, but the agency typically follows the recommendation of the panel in approving or rejecting applications.

This time around Edwards is seeking an approval for both a transfemoral — through the femoral artery in the leg or groin area — and a transapical — through the ribs — approach, explained Edwards spokeswoman Janet Kim, prior to the vote that recommended the product.

“We are very encouraged by the Advisory Panel’s strong recommendation for approval to expand the current indication for the Edwards SAPIEN valve to patients at high risk for surgery. A broader indication for high-risk patients would enable multidisciplinary Heart Teams to choose the approach best suited to their patients’ needs, including for the first time a transapical delivery option,” said Michael A. Mussallem, Edwards’ chairman and CEO, in a news release.

Edwards is ahead in the race to commercialize TAVR technology, with Medtronic following closely with its CoreValve product, which is currently being tested. Both have invested millions into the technology and have a lot riding on it. A Medtronic executive has even said that he wants Edwards, a company with which it has had legal wrangling over the technology in Europe, to succeed because that would bode well for Medtronic in the U.S.

CoreValve is already approved in Europe.

 

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