EnteroMedics said Wednesday that the FDA’s Gastroenterology-Urology Devices Panel will meet May 29 to review its Maestro rechargeable system delivering VBLOC vagal blocking as a treatment for morbid obesity. The system works by blocking nerve signals that control hunger and fullness.
The FDA accepted the company’s PMA in July, based on 18 months of data from an ongoing randomized, double-blind, sham-controlled Phase III pivotal study of 239 patients ages 18 to 65 in the U.S. and Australia. The subjects have a body mass index of greater than 40-45 kg/m2 or greater than 35 to 39.9 kg/m2 with one or more obesity-related conditions, type 2 diabetes that is well-controlled or have failed to respond to diet and exercise programs within the previous five years.
According to EnteroMedics, patients implanted with the Maestro system had “statistically significant and clinically meaningful excess weight loss,” averaging EWL of about 25 percent, with more than half of patients achieving at least a 20 percent EWL. The device also had a strong safety profile, the company said.
The Maestro Rechargeable System with VBLOC therapy consists of an implanted neuroregulator and two electrodes, delivered laparoscopically to the trunks of the vagus nerve. The implant, which can be configured and controlled externally by a physician, uses high-frequency but low-energy electrical signals sent along the vagus nerve to reduce appetite and limit stomach expansion by controlling blood glucose, digestive enzyme secretion and gastric acid secretion. The system, which is charged via an external mobile charger and transmit coil worn by patients, is best used intermittently, the company said, so that the body does not compensate for the change in digestive function.
The device is CE-marked in Europe and approved for marketing in Australia. — Lena Freund
Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.