The FDA today approved the Maestro Rechargeable System (EnteroMedics) for treatment of obesity. The novel device is the first to target the nerve pathway between the brain and stomach that controls hunger and satiety, according to a press release.
The Maestro Rechargeable System is indicated for treatment of patients aged at least 18 years with a BMI of 35 to 45 with at least one obesity-related condition and who have failed to lose weight on a weight loss program.
The system, which is the first obesity device approved by the FDA since 2007, includes a rechargeable electrical pulse generator, wire leads and electrodes implanted surgically into the abdomen. Intermittent electrical pulses are sent to the trunks in the abdominal vagus nerve, which is involved in regulating stomach emptying and signaling fullness to the brain.
Patients can charge the device and health care providers can adjust its settings via external controllers.
The FDA based approval on a clinical trial evaluating the safety and efficacy of the Maestro Rechargeable System. The trial included 233 patients with a BMI of at least 35. The researchers compared weight loss and adverse events in 157 patients who received an active Maestro device with 76 patients who received a device that was not activated.
Results showed that the active device group lost 8.5% more of its excess body weight after 12 months when compared with the control group. Further, 52.5% in the active device group lost at least 20% of their excess weight and 38.3% lost at least 25%.
Nausea, pain at the neuroregulator site, vomiting and surgical complications were among the serious adverse events reported in the clinical trial. Additionally, some patients experienced pain, heartburn, problems swallowing, belching, mild nausea and chest pain.
Although the trial failed to meet its primary endpoint of excess weight loss of at least 10% more than the control group with the Maestro system, an FDA advisory committee decided the 18-month data demonstrated sustained weight loss with the device. Therefore, panel members agreed that the device’s benefits outweighed the risks in patients for whom the device is indicated, according to the release.
In addition to results from the clinical trial, the FDA considered responses from an agency-sponsored survey about patient preferences for obesity devices. Results showed that a group of patients would accept the risks associated with the device for the anticipated amounts of weight loss.
The agency is requiring a 5-year post-approval study that will follow at least 100 patients to collect additional data on safety and efficacy as a condition of approval.
“Obesity and its related medical conditions are major public health problems,” William Maisel, MD, MPH, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said in the release. “Medical devices can help physicians and patients to develop comprehensive obesity treatment plans.