The FDA has approved Sapien transcatheter heart valve (THV), an artificial aortic heart valve that can be placed without open-heart surgery.
Edward Lifescience’s device is the first artificial copy of an aortic heart valve to replace valves that have been damaged by senile aortic valve stenosis without open-heart surgery.
Dr Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health, said that the artificial valve “is an example of an innovative new device that will provide some people with this condition who can’t undergo open heart surgery with the option of valve replacement”.
The approval was based on a study of 365 patients who were not eligible for open-heart surgery, half of which received the Sapien valve, the rest were given an alternative therapy that did not require open-heart surgery.
The study showed that patients receiving the Sapien valve experienced two and a half times more strokes and eight times as many vascular and bleeding complications than patients who did not receive the implant.
However, Sapien patients were more likely to survive one year after surgery, with 69% alive compared with 50% of those who received an alternative treatment.
Patients with severe aortic valve stenosis would usually have to undergo open-heart surgery to replace the valve, but some patients are unable to do so.
According to the FDA, more than half of all patients will die within two years of the onset of senile aortic stenosis.
Senile aortic valve stenosis is a progressive disease that can affect elderly patients. The condition incurs an accumulation of calcium deposits on the aortic valve, causing the valve to become narrower.