The Food and Drug Administration’s advisory panel voted 9 to 0, with one abstention, that the benefits of the Sapien aortic heart valve outweigh its risks for patients who can’t undergo traditional valve replacement surgery, according to an agency spokeswoman.
On a separate question, the panel voted 7-3 that the valve was reasonably safe.
The endorsement came despite concerns about increased stroke and heart complications among patients. The vote is only a recommendation to the FDA, which will make a final approval decision in coming months.
If approved, the implant would be the first artificial aortic valve that can be threaded into place through one of the body’s major arteries. Cardiologists hope this approach could offer a new option for patients who aren’t healthy enough to undergo the more invasive open-heart surgery, which has been used for decades to replace valves.
The aortic valve is the heart’s main doorway. About 300,000 US patients suffer from deterioration of the valve, which forces the heart to work harder to pump blood. Eventually the condition can lead to heart failure, blood clots and sudden death.
More than 50,000 people a year undergo open-heart surgery to replace the valve, and thousands more are turned away, deemed too old or ill to survive the operation. The surgery involves sawing the patient’s breastbone in half, stopping the heart, cutting out the old valve and sewing a new one into place.
Edwards’ Sapien transcatheter valve, which is already available in Europe, is threaded through a leg artery up to the heart and then propped open and wedged into the aortic opening, replacing the natural heart valve.
One-year data from Edwards showed that nearly 70 percent of patients with the valve survived at least a year, compared with only 50 percent of those who received basic comfort care.
Edwards plans to eventually seek approval for patients who are healthy enough to undergo open heart surgery but favor an alternative treatment.
