US FDA advisory panel votes yes for Edwards heart valve

By Dr. Ananya Mandal, MDJul 20 2011

An U.S. Food and Drug Administration advisory panel met Wednesday to discuss the approval of Edwards Lifesciences Corp's heart valve for patients deemed too sick to have open-heart surgery. The panel voted 9-0 with one abstention in favor of valve.

The valve is now set to become the first transcatheter aortic valve sold in the United States. Edwards has sold such a valve in Europe since 2007. Edwards' Sapien transcatheter heart valve is a replacement valve that spares patients, generally elderly, the need for open-heart surgery. It is threaded into place through the arteries via a catheter. 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.

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. The FDA usually follows the recommendations of its advisory panels and will make a final decision at a later date.

About 300,000 U.S. 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.

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 would eventually seek approval for patients who are healthy enough to undergo open heart surgery but favor an alternative treatment. Analysts have pegged the worldwide market for transcatheter aortic valves at more than $2 billion in annual sales.