Obese individuals struggling to lose weight now have a new FDA-approved weight loss treatment device, the Maestro Rechargeable System, which pinpoints the nerve passage between the stomach and the brain that controls your appetite (FDA 2015).
Just like the recently FDA-approved weight loss drug Saxenda, this obesity device is for individuals 18 and over who have struggled to lose weight with a weight loss program, and who have at least one other obesity-related health condition such as type 2 diabetes. Diet and exercise are the most important factors for fat loss and this new device can make an effective combination in my opinion.
“Obesity and its related medical conditions are major public health problems,” said William Maisel, M.D., M.P.H., 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.”
According to the FDA, the Maestro Rechargeable System consists of a rechargeable electrical pulse generator, wire leads and electrodes surgically implanted into the abdomen. This device is effective by sending intermittent electrical pulses to the trunks in the abdominal vagus nerve, which regulates the stomach in signaling the brain that the stomach feels full or empty. Patients can charge the device with external controllers and I believe it’s very convenient how health care professionals can adjust the settings.
How safe is the Maestro Rechargeable System?
In the clinical study, 233 patients with a body mass index (BMI) of 35 or above received the device but the 157 patients who received the active devices lost 8.5 percent more excess weight after 1 year, compared to the 76 patients who received a non-activated Maestro electrical pulse generator (FDA 2015).
As a part of the approval, the manufacturer must conduct a 5 year post approval study to collect additional safety and effectiveness data. Serious adverse side effects reported were nausea, vomiting and complications from surgery. Other adverse effects included pain, problems swallowing, heartburn, chest pain and mild nausea.
With this new weight-loss device approved by the FDA, obese individuals now have a new option to combine with traditional diet and exercise.
The Maestro Rechargeable System is manufactured by EnteroMedics of St. Paul, Minnesota.
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Source: FDA.gov “FDA approves first-of-kind device to treat obesity” 14 January 2015 U.S. Food and Drug Administration