FDA approves novel medical device to treat obesity

January 15, 2015 – The FDA on Wednesday, January 14 approved a novel medical device by EnteroMedics, Inc. that controls hunger and appetite by targeting the nerve pathway between the brain and the stomach.  The device, called the Maestro Rechargeable System, is a pacemaker-like device that is implanted surgically into the abdomen and works by sending electrical pulses that signal to the brain that the stomach is empty.  The FDA approved the medical device on the basis of a twelve month clinical trial (ReCharge Study) that showed that patients with the device lost 8.5% more weight than those patients in a control group.  The approval was contingent on EnteroMedics conducting a 5-year post-approval study of the product to monitor at least 100 patients.  This is the first new medical device for obesity approved by the FDA in over ten years.