A replacement heart valve that doesn’t require open-heart surgery received nearly full support from an FDA advisory panel Wednesday.
The panel voted 9 to 0, with one abstention, that the benefits of the Edwards Sapien heart valve, which can be placed in patients deemed too frail for surgery, outweigh its risks.
The panel still expressed concern about a major side effect of the device — an increased risk of stroke — and voted 7-3 that data show the valve is reasonably safe for its intended patients.
If approved, and the Food and Drug Administration usually follows the recommendation of advisory panels, the replacement valve would be the first transcatheter aortic valve in the U.S. (it was approved in Europe in 2007).
Patients who have severe aortic stenosis, in which the aortic heart valve has become narrowed or obstructed, have to undergo open-heart surgery to get a replacement. Not all patients are healthy enough for the surgery; in particular, elderly patients might be too frail. But the Edwards device can be threaded via catheter through a leg artery to the heart — a video animation from the device maker shows how.