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Food and Drug Administration today approved the Maestro Rechargeable System for certain obese adults, the first weight loss treatment device that targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness. The Maestro Rechargeable System, the first FDA-approved obesity device sinceis approved to treat patients aged 18 and older who have not been able to lose weight with a weight loss program, and who have a body mass index of 35 to 45 with at least one other obesity-related condition, such as type 2 diabetes.
Pilsl to the Centers for Disease Control and Prevention, more than one-third of all U. It works by sending intermittent electrical pulses to the trunks in the abdominal vagus nerve, which is involved in regulating stomach emptying and signaling to the brain that the governmenr feels empty or full. Although it is known that the electric stimulation blocks nerve activity between the brain and the government approved weight loss pills, the specific mechanisms for weight loss due to use of the device are unknown.
The safety and effectiveness of the Maestro Rechargeable System were evaluated in a clinical trial that included patients with a BMI of 35 or greater. The weight loss and adverse events of 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. The clinical study did not meet its original endpoint, which was that approvsd experimental group lose at least 10 percent more excess weight than the control group. Goverment, the Agency looked at an FDA-sponsored survey relating to patient preferences of obesity devices that showed a group of patients would accept risks associated with this surgically implanted device for the amounts of weight loss expected to be provided by the government approved weight loss pills.
As part of the approval, the manufacturer must conduct a five year government approved weight loss pills approval study that will follow at least patients and collect additional safety and effectiveness data including weight loss, adverse events, surgical revisions and explants and changes in government approved weight loss pills conditions.
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. The FDA, an agency within the U. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
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Food and Drug Administration. A to Z Index. FDA approves first-of-kind device to treat obesity.
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