Minnesota medical devices maker EnteroMedics (NSDQ:ETRM) touted today that the FDA had accepted for review the company’s premarket approval submission of the Maestro Rechargeable System’s VBLOC implant, a neurostimulation device for treating obesity.
The news sent ETRM shares skyrocketing, trading up by nearly a quarter by the early afternoon today.
The VBLOC system 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 holds the potential to fill a significant gap in the obesity treatment landscape, offering a unique, patient-friendly approach to addressing the long term challenges associated with obesity," EnteroMedics president & CEO Mark Knudson said in prepared remarks. "We look forward to working closely with the FDA during the review process, continuing through an advisory committee panel and approval decision, as we prepare for U.S. commercialization of the Maestro System."
The Maestro system has been on the European market since winning CE Mark approval in 2011.
ETRM shares were trading at $1.29 as of about 12:40 p.m., up 21.5% on the day.