Move over gastric bypass surgery, there is a new surgical option when it comes to fighting obesity that is sure to disrupt the market.
The FDA has approved the Maestro Rechargeable System, the first weight loss treatment device that targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness.
This is the first FDA-approved obesity device since 2007.
It consists of a rechargeable electrical pulse generator, wire leads and electrodes implanted surgically into the abdomen, and 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.
Although it is known that the electric stimulation blocks nerve activity between the brain and the stomach, the specific mechanisms for weight loss due to use of the device are unknown, according to the FDA.
External controllers allow the patient to charge the device and allow health care professionals to adjust the device’s settings in order to provide optimal therapy with minimal side effects.
“Obesity and its related medical conditions are major public health problems,” said William Maisel, M.D., M.P.H., Deputy Director for Science and Chief Scientist in the FDA’s Center for Devices and Radiological Health, in a press relase. “Medical devices can help physicians and patients to develop comprehensive obesity treatment plans.”
The device is approved to treat patients aged 18 and older who have not been able to lose weight with a weight loss program, and who have a body mass index of 35 to 45 with at least one other obesity-related condition, such as type 2 diabetes.