The Gospel of the Obese FDA recently approved a new weight-loss medical device
On January 14, the US Food and Drug Administration officially approved a new type of weight loss medical device. Unlike drugs, this implant device directly affects the vagus rhythm of the human body through electrical stimulation, thereby controlling the user's perception of hunger and satiety, thereby reducing caloric intake. This is the first time the FDA has approved a new type of weight loss medical device since 2007. Currently, this device is only approved for adult patients who are unable to control weight or extremely severe obesity (BMI between 35 and 45 and have at least one related complication), and we often see strong builds. Europeans and Americans, in fact, their obesity ratio is very high.
The weight loss device, called the Maestro® Rechargeable System, consists of a subcutaneously implanted neurorrhythm regulator and two implant electrodes that act on the vagus nerve, which require surgery to complete the implant. The device intermittently sends electrical impulses to the vagus nerve that connects the stomach and brain, affecting the user's perception of hunger and satiety. The device can be charged via an external charger and transmit coil and can be adjusted for individual mode of operation. When the device is no longer needed, it can be removed by surgery at any time. Current research shows that this device can inhibit the nerve activity between the brain and the stomach, but its exact weight loss mechanism is still not very clear.
Maestro rechargeable system that can help you lose weight
The safety and efficacy of the device was validated in a clinical study involving 233 patients with severe obesity who had a BMI of more than 35. The study found that after 12 months of treatment, the treatment group lost 8.5% more weight than the control group. In the treatment group, approximately half of the subjects lost at least 20% of their excess body weight. This result did not meet the original goal of “10% more weight loss than the control group,†but the FDA advisory committee found that data at 18 months showed that the device had sustained weight loss. The committee believes that the benefit of this device outweighs the risk for severely obese people with indications. After considering the research data, expert opinions and the willingness of patients with severe obesity, the FDA officially approved the launch of this weight-loss device. After the launch, the manufacturer must continue to collect information on the safety and effectiveness of the equipment and conduct a more complete assessment of it.
Clinical studies have shown that the device may cause side effects including nausea, vomiting, pain at the implant site, difficulty swallowing, and chest pain.
William Maisel, chief scientist at the FDA Center for Medical Devices and Radiation Health, said: "Obesity and its associated diseases are very important public health issues, and medical devices can help doctors and patients build more comprehensive obesity treatments. Program."
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