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The U.S. Food and Drug Administration 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.
Who Should Use This System
The FDA approved the device for the treatment of obese adults who have a body mass index (BMI) of at least 40, and who are 18 and over. Also, those with a BMI of at least 35, who have an obesity-related condition, such as high blood pressure, high cholesterol or type 2 diabetes.
How it Works
The surgery to implant the device is about 60 – 90 minute, done while under general anesthesia.
The Maestro Rechargeable System consists of a rechargeable electrical pulse generator, wire leads and electrodes implanted surgically into the abdomen. The system is programmed to deliver a pulse, 5 minutes on and 5 minutes off to the trunks in the abdominal vagus nerve, and turn off during the hours you sleep. The abdominal vagus nerve is involved in regulating stomach emptying and signaling 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.
“The battery lasts at least 8 years, at which point it can be replaced relatively easily, probably with a local anesthetic”says EnteroMedics spokeswoman Jody Dahlman.
It has been reported however, a committee of outside advisors to the FDA concluded that the benefits of the Maestro System outweighed its risks. Most of the panel members agreed that the device was safe, but they were less enthusiastic about whether it worked: Four voted “yes” and five voted “no.”
The safety and effectiveness of the Maestro Rechargeable System 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. About half (52.5 percent) of the patients in the experimental group lost at least 20 percent of their excess weight, and 38.3 percent of patients in the experimental group lost at least 25 percent of their excess weight.
The clinical study did not meet its original endpoint, which was that the experimental group lose at least 10 percent more excess weight than the control group. However, 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.
Source: US FDA