FDA Approves New Weight Loss Device

The FDA today approved a device that is intended to help certain obese adults lose weight.

The FDA today approved a device that is intended to help certain obese adults lose weight.

The Maestro Rechargeable System targets the nerve pathway between the brain and the stomach and aims to control feelings of hunger and fullness, according to the FDA.

Potential patients would be adults aged 18 years or older who have struggled to lose weight with a weightloss program. The system was approved for patients who have a body mass index of 35 to 45 and who also have at least 1 obesity-related condition, such as type 2 diabetes.

The system involves an electrical pulse generator, wire leads, and electrodes that are implanted into the abdomen. Intermittent pulses are then sent to the trunks in the abdominal vagus nerve, which informs the brain of feelings of fullness or hunger. The FDA noted that “the specific mechanisms for weight loss due to use of the device are unknown,” but electric stimulation has been shown to block nerve activity between the brain and the stomach.

Patients will be able to recharge the device using external controllers, and health care professionals will also be able to adjust the device’s settings, the FDA stated.

In a study of the system’s efficacy, 157 patients used the Maestro device and 76 patients used an inactivated Maestro device to examine the placebo effect. After 1 year, patients who used the activated system lost 8.5% more weight than the control group. A little more than half of the patients using the activated Maestro device also lost at least 20% of excess weight, and 38.3% of them lost 25% of their excess weight.

“Obesity and its related medical conditions are major public health problems,” said William Maisel, MD, MPH, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, in a press release. “Medical devices can help physicians and patients to develop comprehensive obesity treatment plans.”