Video: FDA's TAVI panel in review with Dr. Michael Gibson

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Video: Justine Cadet speaks with C. Michael Gibson, MD
Interventional Cardiologist
Beth Israel Deaconess Medical Center
Boston, Mass.

BOSTON--Justine Cadet from Cardiovascular Business sat down with C. Michael Gibson, MD, interventional cardiologist at the Beth Israel Deaconess Medical Center in Boston, to discuss the FDA’s Circulatory System Devices Panel, which convened July 20 in Bethesda, Md., and recommended approval of the Sapien transcatheter heart valve (Edwards Lifesciences), based on the results of the Cohort B of the PARTNER trial.

The discussion traversed such topics as the changes to the requested indication, the safety considerations, the final vote and the post-approval studies.