FDA Approves Device for Weight Management
The FDA approved the Maestro Rechargeable System, a new device to treat obesity. This is the first device for weight management approved since 2007.
The Maestro Rechargeable System, manufactured by EnteroMedics Inc, controls hunger and feelings of fullness by targeting the nerve pathway between the brain and stomach. The device is implanted surgically into the abdomen and works by sending electroical pulses that interfere with the activity of the vagus nerve.
The patient can recharge the device, and healthcare professionals can adjust its settings using external controllers.
A 12-month clinical study showed that patients implanted with the device lost 8.5% more weight than the control group. However, the results did not meet the primary goal of the clinical trial, which was to show weight loss of ≥10%. An FDA advisory panel considered additional data and concluded that the benefits of the device outweighed the risks for certain patients.
The device is approved to treat patients ≥18 years of age who have not been able to lose weight through lifestyle changes, those who have a body mass index of 35 mg/k2 to 45 mg/k2, and those who have at least 1 other obesity-related condition.
The manufacturer must conduct a f5-year study that will follow at least 100 patients and collect additional safety and effectiveness data.
Serious side effects reported in the clinical study included nausea, pain, vomiting, and surgical complications.—Kerri Fitzgerald
