A U.S. Food and Drug Administration (FDA) panel recommended approval of the WATCHMAN Left Atrial Appendage Closure (LAAC) device after determining that the benefits of the device outweigh the associated risks.
The panel under the Medical Devices Advisory Committee voted favoring the approval of the device, with six voting yes, five voting no and one abstaining. Twelve attendees voted that the device is safe to use, but only half believe that it is effective.
LAAC is a treatment that prevents the formation of blood clot in patients diagnosed with atrial fibrillation (AF) which affects up to 20 percent of those with heart rhythm disorder. The Watchman device was developed to serve as a heart surgery backup designed to be permanently implanted in the LAA to trap blood clots and prevent stroke.
The committee reviewed the results of the two randomized clinical trials, PROTECT AF and PREVAIL, as well as trials from the Continued Access Protocol (CAP) and CAP2. Clinical data for WATCHMAN included at least 2,400 patients and at least 6,000 patient-years in the subsequent clinical studies. Currently, WATCHMAN is approved to be sold in at least 70 countries around the world.
"I'm encouraged that the Panel recognized the importance of having the WATCHMAN Device as an option for appropriate patients," Dr. Vivek Reddy, director of the Cardiac Arrhythmia Service at Mount Sinai Medical Center and co-principal investigator of the PROTECT AF and PREVAIL studies, told MarketWatch.
The panel also provided recommendations on the use of the device and its target population. The panel agreed that the device could work well and could be beneficial to people who are in need of a long-term anticoagulation device and couldn't take a blood thinner warfarin.
The FDA can overrule the approval. The federal agency already ignored two recommendations for the same device previously. But WATCHMAN's maker Boston Scientific argued that the agency should approve it this time, according to the Wall Street Journal.
"We need an alternative treatment strategy for high-risk patients," Shephal K. Doshi, an electrophysiologist at the Pacific Heart Institute and an investigator in the Watchman trials, told panel members. "For some of our patients, Watchman can be that option."
