(HealthDay News) — A new implant designed to curb the appetite by electrically stimulating intra-abdominal vagus nerve trunks is under review Tuesday by a key advisory committee of the U.S. Food and Drug Administration.
The neuromodulator device is aimed at severely obese adults who have failed to slim down using traditional methods, but don’t want, or can’t have, weight-loss surgery, the manufacturer, EnteroMedics Inc., said in its application for FDA approval. The Maestro Rechargeable System, as it’s called, sends electrical signals to suppress neural signals carried by the vagus nerve trunks. This results in decreased hunger pangs, decreased digestive enzyme secretion and calorie absorption, and increased satiety, the St. Paul, MN, manufacturer said.
In clinical trials, obese people with a Maestro implant lost an average 8.5% more weight than others who received a fake implant, the device maker said. The implant’s safety and effectiveness will be evaluated by the gastroenterology and urology devices panel of the FDA’s Medical Devices Advisory Committee.
“The Maestro Rechargeable System is a safe and effective treatment option for obese individuals who have failed more conservative weight reduction interventions such as diet/exercise and pharmacotherapy, but are not able or willing to undergo more aggressive bariatric surgical options,” the device company said in FDA briefing papers. However, the Maestro is unsafe during MRI scans and will have to be removed if a person needs an MRI, according to the FDA. The advisory panel has been asked to consider this as a potential risk in its evaluation.