On 11 December, the FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee voted favourably by a majority, Yes: 13, No: 1, that the benefits of the Watchman left atrial appendage closure device outweigh the risks.
The FDA panel was further asked if there is reasonable assurance that the device is safe, for what it voted Yes: 13, No: 1. On the question of reasonable assurance of efficacy, the panel voted Yes: 13, No: 1. The FDA will take into account the panel’s vote in its decision on approval of the Watchman device. The company expects a decision from the FDA in the first half of 2014.
“We are pleased with the outcome of today’s panel, which represents an important milestone toward making this innovative technology available to patients with atrial fibrillation at higher risk for stroke who need an alternative to long-term warfarin therapy,” said Kenneth Stein, chief medical officer, Cardiac Rhythm Management, Boston Scientific.
The vote of the committee followed a review of clinical data from two randomised control trials, PROTECT AF and PREVAIL, as well as from the CAP (Continued access protocol) registry. The Watchman device received CE Mark in 2005.