THURSDAY, Nov. 3 (HealthDay News) -- The first artificial heart
valve that can replace a diseased aortic valve without requiring
open-heart surgery has been approved by the U.S. Food and Drug
A patient's aortic valve can be damaged by stenosis, a narrowing
of the valve caused by the buildup of calcium deposits. The heart
must then work harder to pump blood through the diseased valve,
which could lead to symptoms including fainting, chest pain, heart
failure, irregular heartbeat or cardiac arrest. More than half of
the people with these symptoms die within two years, the FDA said
in a news release.
Traditionally, replacement of this valve has required open-heart
surgery. But the newly approved Sapien Transcatheter Heart Valve
(THV) allows doctors to implant it using a tube-shaped device
called a delivery catheter, via a small incision in the leg. The
catheter is slightly wider than a pencil.
This can benefit patients for whom open-heart surgery is too
risky, the FDA said.
The agency said patients in whom the new device was implanted
had 2 1/2 times more strokes, and eight times as many vascular or
bleeding complications than those who didn't get the implant. At
the same time, clinical testing found that 69 percent of patients
who received the new device were alive a year after the implant,
compared with 50 percent who were treated by a different
Maker Edwards Lifescience will continue to monitor patients who
receive the implant, the agency said. The device is not recommended
for people who can be treated with open-heart surgery.
Edwards Lifescience is based in Irvine, Calif.
The U.S. National Heart Lung and Blood Institute has more about
heart valve disease.