Jefferson City, MO 53° View Live Radar Wed H 70° L 50° Thu H 68° L 50° Fri H 80° L 63° Weather Sponsored By:

FDA panel backs broader use of Edwards heart valve

FDA panel backs broader use of Edwards heart valve

June 14th, 2012 in News

WASHINGTON (AP) - A panel of heart experts is recommending the government expand approval of the first artificial heart valve designed to be implanted without major surgery, despite limited information about some long-term side effects.

The Food and Drug Administration's panel of cardiologists voted 11-0 in favor of broadening approval of Edwards Life Sciences' Sapien valve.

The valve is currently available for patients who aren't healthy enough to undergo the more invasive open-heart surgery.

If the FDA follows the group's advice, the implant will be approved for patients who are healthier, but still face serious risks from chest-opening surgery. Many such patients are in their 80s and have complicating medical conditions.

The FDA is not required to follow the panel's advice, though it often does. A decision is expected later this year.