The U.S. FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted in favour of Boston Scientific Corporation’s WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device. They agreed it’s safe. They agreed benefits outweighed risk. But they didn’t agree that it was especially effective, which begs the question…..
Anyway, despite these misgivings, and while subsequent FDA approval isn’t guaranteed, this vote may well mean WATCHMAN gets is approval soon.
Boston Scientific’s Watchman device is a catheter-delivered heart implant designed to close the left atrial appendage (LAA) in order to prevent the migration of blood clots from the LAA, and thus, reduce the incidence of stroke and systemic embolism for higher risk patients with non-valvular Atrial Fibrillation.
The Watchman last hit our pages in December 2013 when it was looking like the FDA panel’s then-positive vote looked like preceding FDA approval. However the company’s initial PROTECT AF trial had left a few unanswered questions, which have subsequently been addressed by the PREVAIL study. Results of PREVAIL prompted what is to our knowledge an unprecedented third panel review and this time a vote of 6 to 5 (with 1 abstention) the Panel concluded that the benefits of the WATCHMAN Device outweigh the potential risks.
Furthermore, the Panel voted that there is reasonable assurance that the Device is safe (12 yes to 0 no). Despite the otherwise positive votes, on the question of reasonable assurance of effectiveness, the Panel vote was unfavourable (6 yes to 7 no).
There was widespread agreement among the Panel members that the Device provides a much needed alternative to long-term anticoagulation for some patients. The Panel provided substantial input and guidance related to the proposed Indications for Use and target patient population.
While not bound by this vote, the FDA takes Advisory Panel comments and recommendations into account when reviewing the WATCHMAN Device application.
“There is a strong clinical need for a proven device alternative to long-term warfarin therapy for my high stroke risk patients with non-valvular atrial fibrillation,” said Vivek Reddy, M.D., Director of the Cardiac Arrhythmia Service at Mount Sinai Medical Center and co-principal investigator of the PROTECT AF and PREVAIL studies. “I’m encouraged that the Panel recognized the importance of having the WATCHMAN Device as an option for appropriate patients.”
“Today’s recommendation by the Panel is another step toward making this innovative technology available to high risk patients with non-valvular atrial fibrillation who are eligible for warfarin, but who have reasons to seek an alternative to long-term therapy,” said Kenneth Stein, M.D., Chief Medical Officer, Rhythm Management, Boston Scientific. “We continue to believe that the totality of the data for the WATCHMAN Device provide reasonable assurance of its safety and efficacy as a treatment alternative for these patients. We look forward to our ongoing discussions with FDA.”
Source: Boston Scientific Corporation, PR Newswire