FDA Approves First-of-Kind Weight Loss Treatment Device

FDA Update

On Jan. 14, the U.S. Food and Drug Administration (FDA) approved the Maestro Rechargeable System in the treatment of obesity in certain adults. The device is the first of its kind to be approved by the FDA since 2007. The Maestro Rechargeable System has been approved specifically for use in patients with a body mass index of 35–45 with at least one other obesity-related condition.

“The [device] consists of a rechargeable electrical pulse generator, wire leads and electrodes implanted surgically into the abdomen. It works by sending intermittent electrical pulses to the trunks in the abdominal vagus nerve, which is involved in regulating stomach emptying and signaling to the brain that the stomach feels empty or full,” details the FDA’s announcement.  Potential side effects include nausea, vomiting, pain at the neuroregulator site, surgical complications, as well as other adverse events. The FDA notes that while it is known that electric stimulation blocks signals between the brain and the stomach, the reason for weight loss due to the use of the device remains uncertain. 

 Read the FDA’s announcement.

Clinical Topics: Heart Failure and Cardiomyopathies

Keywords: Abdomen, Adult, Body Mass Index, Brain, Electric Stimulation, Electrodes, Gastric Emptying, Humans, Nausea, Neurotransmitter Agents, Obesity, Pulse, Stomach, United States, United States Food and Drug Administration, Vagus Nerve, Vomiting, Weight Loss


< Back to Listings