Watchman gets tepid support from FDA panel
Watchman’s future became even murkier with the latest vote from an FDA advisory panel. Panelists voted unanimously in favor of the device for safety but split on efficacy.
The Circulatory System Devices Panel met Oct. 8 to review data on the Watchman Left Atrial Appendage Closure device, which has been proposed for use in patients with nonvalvular atrial fibrillation who are eligible for warfarin therapy to reduce the risk of stroke and systemic embolism. The committee voted thumbs up for the device in December 2013, based on data from PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) and PREVAIL (Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy).
PREVAIL in particular has been controversial. The sponsor, Boston Scientific, broke an embargo at the American College of Cardiology meeting in 2013 when it announced the study met two of its three primary endpoints. There was a reduction in hemorrhagic stroke compared with warfarin but an increase in perioperative events.
The FDA requested the panel seek “review and recommendations regarding new clinical data and associated additional adverse events including stroke that have become available since the previous advisory committee meeting.”
In this round, panelists voted unanimously in favor the Watchman’s safety. But they split 6-6 on efficacy, with panel chair Richard Page, MD, voting no to break the tie. On a vote of risk vs. benefit, six panelists voted in favor, five against and one abstained.
The FDA, which has wrestled with issues related to the Watchman trial designs and findings in the past, is tasked with determining the proper indication for the device, if it is approved. The trials and proposed indication targeted patients who are eligible for warfarin but the final indication may limit the patient population to those who can’t tolerate warfarin.
The FDA often but not always follows the advice of its panels.