Minnesota-based EnteroMedics (NSDQ:ETRM) is getting another shot at the FDA with a rescheduled date with the agency’s Gastroenterology & Urology Devices Panel, according to an updated FDA committee meeting announcement.
EnteroMedics is seeking approval for its VBLOC neurostimulation therapy for treatment of patients with morbid obesity. The device uses mild electrical stimulation to activate the vagus nerve located between the stomach and the esophagus in order to help modify physiological cravings and help patients form better eating habits
EnteroMedics will meet June 17, 2014, with the FDA’s expert review panel, which will examine safety and efficacy data on the VBLOC system and make a recommendation on premarket approval for the device. The FDA is not bound by its panels’ decisions, but usually follows their lead.
FDA regulators confirmed the panel date after bumping EnteroMedics from its May 2014 date, which was canceled due to a "significant scheduling conflict," regulators said.
The panel date is good new for EnteroMedics, which has hit some hurdles on the road to premarket 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 timelines.
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.