Neurostimulation devices maker EnteroMedics (NSDQ:ETRM) officially submitted its pre-market approval application to the FDA for review of the Maestro VBLOC neuro-blocking system in treatment of obesity, metabolic diseases and other gastrointestinal disorders.
EnteroMedics’ Maestro device stimulates the Vagus nerve, located between the stomach and the esophagus, in order to alter a patient’s eating habits by modifying their physiological cravings.
Maestro delivers VBLOC therapy through 2 laparoscopically implanted leads that intermittently block the vagus nerves using high-frequency, low-energy electrical impulses.
The therapy is powered by an internal battery, which is recharged via an external mobile charger and transmit coil that the patient uses for a short time each week.
"The Maestro System is a unique, neuroscience-based approach to the treatment of this epidemic disease, one which offers the potential to fill a significant gap in the obesity treatment spectrum," EnteroMedics president & CEO Mark Knudson said in prepared remarks. "In the hundreds of patients treated to date, in addition to showing clinically meaningful weight loss, VBLOC Therapy has demonstrated an excellent benefit-to-risk profile; a criterion identified by the Agency as central to the review and approvability of new obesity treatment devices."
In a pre-PMA application meeting with FDA earlier this year, the federal watchdog agency said that, should the FDA accept the application for review, EnteroMedics can anticipate presenting the Maestro PMA before a future FDA advisory committee panel.