WEDNESDAY, Jan. 14, 2015 (HealthDay News) -- A new electrical stimulation device designed to control obesity by targeting the nerve pathways between the brain and stomach that regulate hunger and fullness has been approved by the U.S. Food and Drug Administration.
The Maestro Rechargeable System is the first FDA-approved obesity device since 2007, the agency said Wednesday in a news release. The system is sanctioned for adults with a body-mass index (BMI) of between 35 and 45, with another obesity-related condition such as type 2 diabetes, who haven't been able to lose enough weight with an approved weight loss program.
"Obesity and its related medical conditions are major public health problems," said Dr. William Maisel, deputy director for science and chief scientist in the FDA's Center for Devices and Radiological Health. "Medical devices can help physicians and patients to develop comprehensive obesity treatment plans."
The Maestro system includes a rechargeable pulse generator and wire electrodes that are implanted in the abdomen. The electrodes stimulate the vagus nerve, which carries signals to the brain that the stomach feels empty or full, the FDA said.
The device's safety and effectiveness were evaluated in studies involving 233 people with a BMI of 35 or greater, a height-to-weight measurement that indicates clinical obesity. People who used the device for 12 months lost about 8.5 percent more excess weight than people who didn't use the device, the FDA said.
The most serious side effects included nausea, device-site pain, vomiting and surgical complications. More common but less serious side effects included heartburn, problems swallowing, belching, mild nausea and chest pain.
As a condition of approval, device maker EnteroMedics must conduct a five-year, follow-up study involving at least 100 users, the FDA said.
EnteroMedics is based in St. Paul, Minn.
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