Thursday, November 3, 2011
The Food and Drug Administration has given the green light to an artificial heart valve that can be inserted into the body through a small incision in the leg.
SAN DIEGO Federal regulators have approved the nation's first artificial heart valve replacement that can be applied without the need for open heart surgery.
The device is designed primarily for elderly patients whose aortic valve is diseased, but who are too sick for open heart surgery. The artificial valve is inserted into an artery in the leg. Once it reaches the heart, the valve is expanded with a balloon.
Dr. Paul Tierstein is the director of cardiology at Scripps Clinic; he said the implant makes a big difference.
"The patients feel like their time clock's been set back about 10 years," Dr. Tierstein said. "They can breathe better, they're much more active. I mean, it's really transformative."
The average age of the patients involved in the clinical trial was 83.
Patients receiving the new valve suffered more strokes and other complications than those who had a different treatment - but they were more likely to survive one year after surgery.