Monday, December 18, 2017
 
 
News: Page (1) of 1 - 06/13/12 Email this story to a friend. email article Print this page (Article printing at MyDmn.com).print page facebook
FDA panel backs broader use of Edwards heart valve
FDA panel overwhelmingly favors expanding approval of first non-surgical heart valve
By The Associated Press

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.


Page: 1


 
 
 
 
 
 
 
 
 
 
 





Our Privacy Policy --- About The U.S. Daily News - Contact Us - Advertise With Us - Privacy Guidelines