For the first time in 8 years, the FDA has approved a weight-loss device for select obese adults stuck losing the battle of the bulge.

The pacemaker-like Maestro Rechargeable System from EnteroMedics targets nerve activity between the brain and stomach to control feelings of hunger. It's indicated for use in adults with a body mass index between 35 and 45 and at least one other obesity-related health condition who have attempted to lose weight in the previous 5 years with supervised weight management.

Surgeons implant the system's electrical pulse generator, wire leads and electrodes into the abdomen during an outpatient procedure. It then sends electrical pulses to the vagus nerve, which regulates stomach emptying and sends signals of feelings and hunger to the brain. Patients charge the device using external controls and physicians are able to adjust the system's settings to optimize individual weight-loss results.

The findings of an 18-month clinical trial showed the system helped nearly 160 patients lose 8.5% more excess weight over 12 months than patients who did not receive an activated system. Half of the patients lost at least 20% of their excess weight and nearly 40% of patients lost at least a quarter of their extra pounds.

Although the study failed to prove the system caused users to lose at least 10% more excess weight than individuals who did not receive an activated system, the FDA decided the system's potential benefits outweigh its risk for obese individuals who qualify for its use.

EnteroMedics says the device will be in limited use at select bariatric centers sometime this year.

Daniel Cook