The FDA has approved a new device that treats obesity, and works in the gut, by controlling feelings of hunger. The Maestro Rechargeable System is indicated for adults 18 and older with a BMI of 35 to 45 who have at least one obesity-related condition like high cholesterol, high blood pressure, type 2 diabetes and for whom other weight-loss programs have been ineffective.
The device, needs to be surgically implanted into the abdomen, and works on a nerve that emits electric pulses to the brain and blocks stomach signals of emptiness and fullness. Unfortunately the Maestro did not meet the clinical trial’s primary endpoint (10% more excess weight loss in the treatment group than in the control group); but an advisory panel concluded that its benefits of sustained weight loss outweighed any potential risks.
The manufacturer will conduct a 5-year postapproval study to look at adverse events and changes in obesity-related conditions, among other things. Serious adverse events included nausea, surgical complications, and vomiting.