A new device called the Maestro Rechargeable System has been approved by the United States Food and Drug Administration (FDA) for the treatment of obesity.
The FDA has approved the device for patients ages eighteen and older who were unable to lose weight with weight loss programs. To be eligible for treatment with the Maestro System, patients must have a body mass index between 35 to 45 as well as an obesity-related condition such as type 2 diabetes.
If a patient receives approval to use the Maestro System, the device is surgically implanted into the abdomen. It sends electrical pulses to the abdominal vagus nerve, a nerve that signals fullness or hunger to the brain and regulates stomach emptying. These pulses block the nerve activity between the brain and stomach, but it is currently unknown how exactly this causes weight loss.
Image Source: ilbusca
The device was tested for safety and effectiveness in a clinical trial. Of the 233 participants, 157 had an active Maestro device implanted in their abdomen and made up the experimental group, while 76 participants had an inactive device and were used as the control group. After a year, the experimental group lost 8.5% more excess weight than the control group. Although the goal of the study was to have 10% more excess weight loss, the FDA Advisory Committee decided that the results showed a satisfactory amount of weight loss to be approved for obesity treatment. After approval, the manufacturer will conduct a five-year study involving at least 100 participants to further study the effectiveness of the device and to find any side effects that may occur.
Feature Image Source: Obese by Marjan Lazarevski
