F.D.A. Approves Surgical Implant To Treat Obesity
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The Food and Drug Administration on Wednesday approved a surgically implanted device to treat obesity in some adults.
Called the Maestro system, the implant is the first to generate an intermittent electrical pulse that blocks nerve signals from the brain to the stomach, reducing hunger pangs.
The device is approved for use only in adults with a body mass index of 35 to 45 who have at least one other obesity-related condition, such as Type 2 diabetes. Candidates also must have already tried to shed pounds in a supervised weight loss program within the past five years.
In a yearlong trial, 157 obese adults who received the device lost 8.5 percent more of their excess weight than 76 patients in the control group who received a sham implant. The result fell short of the goal of 10 percent, but an F.D.A. advisory committee concluded that the benefits of the implant outweighed the risks.
Serious side effects included nausea, pain near the implant, vomiting and surgical complications. The device can be recharged by the patient, and clinicians can adjust its settings.
The manufacturer, EnteroMedics, hopes to offer the implant at roughly 20 centers nationwide by the end of 2015. The price has not been set, and insurers have not decided whether to cover it.
