Boston Scientific Corp. (BSX) announced that FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee voted favorably 13-1, that the benefits of the WATCHMAN Left Atrial Appendage Closure device outweigh the risks.
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.
The vote of the committee followed a review of clinical data from two randomized control trials, PROTECT AF and PREVAIL, as well as from the CAP (Continued Access Protocol) registry.
WATCHMAN is the most studied left atrial appendage closure device and the only one with long-term clinical data from 2,000 patients and with almost 4,900 patient-years of follow-up in clinical trials.
The WATCHMAN device received CE Mark in 2005. In the United States, WATCHMAN is an investigational device, limited to investigational use and not available for sale.
For comments and feedback: editorial@rttnews.com