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.
