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:


Published in Brief:

SmartBrief Job Listings for Health Care

Job Title Company Location
Director, Site Quality Management
Minneapolis, MN
Clinical Project Manager
Abiomed, Inc.
Danvers, MA
Sr. Manager, Regulatory Affairs - International
Integra LifeSciences
Plainsboro, NJ
Associate - Food and Drug
Keller and Heckman LLP
Washington, DC
In house Compliance Officer
Pompano Beach, FL