FDA reviewers say Edwards' heart valve "demonstrated superiority"

07/18/2011 | Reuters

FDA reviewers said Edwards Lifesciences' Sapien transcatheter aortic valve "demonstrated superiority" in a clinical trial involving patients with severe aortic stenosis who are too weak to undergo open-heart surgery. However, the trial also found the device increased the risk of stroke and neurological harm. An FDA advisory panel is set to assess clinical trial data on Edwards' device.

View Full Article in:

Reuters

Published in Brief:

SmartBrief Job Listings for Health Care

Job Title Company Location
Vice President, Science and Regulatory Affairs
American Beverage Association
Washington, DC
Senior Manager of Medical Management
Network Health
Medford, MA
MEDICAL SCIENCE LIAISON - 14000002RO
Abbott
Columbus, OH
Manager, Medical Management
Network Health
Medford, MA
Executive Medical Director
Aspirus Network Inc
Wausau, WI