The weight-loss devices maker will now meet with an FDA advisory panel on June 17 for review of its application for VBLOC vagal blocking therapy in treatment of morbid obesity. The prior date, May 29, posed a "significant scheduling conflict" for the federal watchdog agency, EnteroMedics said.
The company is hoping to land the advisory committee’s recommendation for approval of its flagship Maestro implant, which uses mild electrical pulses to stimulate the vagus nerve located between the stomach and the esophagus. Clinical studies have shown that stimulating the vagus nerve may help modify physiological cravings and help patients form better eating habits.
The panel date is good new for EnteroMedics, which has hit some hurdles on the road to pre-market approval for its landmark device. The FDA last year asked the company to provide more data on its device testing and clinical data, including information on user training and post-approval studies. EnteroMedics said at the time that the additional requests would not hamper its progress or hurt its estimated time-lines.
EnteroMedics submitted its FDA application in June 2013, hoping to land indication to treat obesity, metabolic diseases and other gastrointestinal disorders. The Maestro system has been on the European market since winning CE Mark approval in 2011.