FDA panel backs broader use of Edwards Lifesciences heart valve
Wednesday, June 13, 2012 - 18:30
in Health & Medicine
Edwards Lifesciences' Sapien device is the first artificial heart valve that can be implanted without major surgery. A final FDA decision on the Irvine firm's valve is expected later this year.WASHINGTON — A panel of heart experts is recommending that 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.