New weight loss device makes you feel full
How does the new weight loss device work?
The Maestro Rechargeable System, the first U.S. Food and Drug Administration (FDA) approved weight loss device since 2007, consists of a rechargeable electrical pulse generator, wire leads and electrodes implanted surgically into the abdomen.
It works by sending intermittent electrical pulses to the trunks in the abdominal vagus nerve, which is involved in regulating stomach emptying and signalling to the brain that the stomach feels empty or full.
External controllers allow the patient to charge the device and allow health care professionals to adjust the device’s settings in order to provide optimal therapy with minimal side effects.
Who should use it?
The device has been approved to treat patients aged 18 and older who have not been able to lose weight with a weight loss programme, and who have a body mass index of 35 to 45 with at least one other obesity-related condition, such as type 2 diabetes.
Is it safe?
The safety and effectiveness of the Maestro Rechargeable System, manufactured by EnteroMedics of St. Paul, Minnesota, were evaluated in a clinical trial that included 233 patients with a BMI of 35 or greater.
The weight loss and adverse events of 157 patients who received the active Maestro device (the experimental group) were compared to 76 patients in the control group who received a Maestro electrical pulse generator that was not activated. The study found that, after 12 months, the experimental group lost 8,5 percent more of its excess weight than the control group.
An FDA Advisory Committee (the Gastroenterology and Urology Devices Panel) found the 18-month data supportive of sustained weight loss, and agreed that the benefits of the device outweighed the risks for use in patients who met the criteria in the device’s proposed indication.
Serious adverse events reported in the clinical study included nausea, pain at the neuroregulator site, vomiting, as well as surgical complications. Other adverse events included pain, heartburn, problems swallowing, belching, mild nausea and chest pain.
“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.”
Watch the news on the weight loss device
In the following ABC News report, you can learn more about the new weight loss device.
World News Videos | ABC World News
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