GAITHERSBURG, Maryland — The Ablatherm PMA by EDAP (Lyon, France) faltered at a July 30 FDA advisory committee despite that the device has been available in Europe for more than a decade, raising questions once again about FDA's higher regulatory standards and the agency's willingness to accept outside-U.S. data for device applications. Enrollment issues associated with the pivotal trial for the Ablatherm device, which boasts more than 20,000 uses in OUS settings, forced the sponsor to make use of a post-hoc analysis assembled prior to completion of the trial, but the panelists largely brushed aside what some said was a reasonable safety record in an 8-0 vote that the benefits do not outweigh the risks. Read More
