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The US Food and Drug Administration (FDA) has approved a first-of-its-kind weight loss treatment device that electronically suppresses hunger signals traveling between the stomach and the brain. The Maestro Rechargeable System, which is manufactured by EnteroMedics of St Paul, Minnesota, consists of an electrical pulse generator, wire leads, and electrodes that are implanted into the abdomen and intermittently send electrical pulses to the vagus nerve.
Tracy Hampton, PhD
A new device targets the brain-stomach nerve connection that controls feelings of hunger and satiety.
The system may be suitable for patients who are morbidly obese or who are obese and have one or more obesity-related conditions. “Obesity and its related medical conditions are major public health problems,” said William Maisel, MD, MPH, 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,” he said. Health care professionals can adjust the settings on the device to optimize treatment.
In a phase 3 clinical trial that evaluated the safety and effectiveness of the device, the 162 patients in the study who received the active device lost 8.5% more excess weight after 12 months than the 77 patients who received a Maestro electrical pulse generator that was not activated (Ikramuddin S et al. JAMA. 2014;312:915-922). The average excess weight loss in the group with the active device was 24.4%, while the average excess weight loss in the group in which the device was not activated was 15.9%. Although the study did not meet its original end point of at least 10% more excess weight loss in the experimental group compared with the control group, an FDA Advisory Committee found that the 18-month data were supportive of sustained weight loss, with benefits that outweighed risks. Adverse events that were more frequent in the group with the active device were mild or moderate and included heartburn, indigestion, and abdominal pain.