Of additional concern, the panel noted that there was no evidence that the Watchman device was superior to warfarin therapy with regard to the elimination of major bleeding events. During the open portion of the panel meeting, patients and their doctors nearly unanimously indicated their preference for the Watchman technology over warfarin because of their fear of and experience of frequent and significant bleeds while on anticoagulation. The panel suggested that, because of this apparent common misperception, the lack of bleeding benefit should be pointed out in the final indication language.
The panel agreed with FDA’s concern that a postmarketing study should be conducted if the device is approved, and that the study should be large enough to answer some of the concerns brought up in the meeting as to long-term results, including safety and efficacy in a broader population than that studied in the two trials, which was overwhelmingly white, and predominately male.
The FDA usually follows the recommendations of its advisory panels. Members of FDA panels have usually been cleared of conflicts related to the product under review; occasionally, a panelist is given a waiver, but not at this meeting.
The Watchman device has been approved in Europe since 2005.