CoreValve Results Set Path for Panel-Free Approval

Medtronic expects smooth sailing for its CoreValve transcatheter aortic valve PMA, after the FDA took the rare step of saying clinical trial data on extreme-risk patients is so compelling that an advisory panel meeting won’t be needed. The company announced the agency’s decision Tuesday at the Transcatheter Cardiovascular Therapeutics 2013 Conference in San Francisco, where it released results from a 471-patient pivotal trial of CoreValve.
Devices & Diagnostics Letter