The U.S. Food and Drug Administration (FDA) approved the use of an internal electronic device to combat adult obesity on Wednesday.
The Maestro Rechargeable System targets the nerve pathway between the brain and the stomach to control the feelings of hunger and fullness.
The rechargeable electric pulse generator, wires and electrodes are implanted in the abdomen and send intermittent electrical pulses to the trunks of the abdominal nerve that signals the brain.
{mosads}The device is recharged and adjusted by external controllers.
The device is only approved to treat patients 18 and older who have not been able to lose weight by dieting, have a body mass index of 35 to 45 and who have an obesity-related condition like Type 2 diabetes, FDA said in a news release.
“Obesity and its related medical conditions are major public health problems,” said William Maisel, the director for science and chief scientist in the FDA’s Center for Devices and Radiological Health.
“Medical devices can help physicians and patients to develop comprehensive obesity treatment plans.”
As part of the approval process, the manufacturer has agreed to study the use of the device in at least 100 patients for five years.
Side effects reported include nausea, pain at the neuroregulator site, vomiting and surgical complications.