The U.S. Food and Drug Administration (FDA) recently approved the Maestro Rechargeable System, a unique treatment for obesity that is surgically implanted and targets the nerves between the brain and the stomach.
The device was developed by EnteroMedics and works by sending an intermittent electrical pulse to the nerve that sends the message from the stomach to the brain that the stomach is full. It is approved for use by adults older than 18, who have a Body Mass Index of 35 or higher and have at least one other co-morbidity, such as Type 2 diabetes.
“Obesity and its related medical conditions are major public health problems,” William Maisel, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said. “Medical devices can help physicians and patients to develop comprehensive obesity treatment plans.”
The FDA approval requires that a five-year post-approval test be conducted that collects data from at least 100 patients. Before the FDA approval, approximately half of the 233 test patients being followed lost approximately 20 percent of their excess body weight. Approximately 40 percent of the patients lost approximately 25 percent of their excess weight.
Negative effects reported during the Maestro Rechargeable System trial included nausea, pain at the implant site, vomiting, chest pain, heartburn and various surgical complications.
The Maestro Rechargeable System is the first FDA-approved obesity device since 2007.
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