For many obese individuals, traditional diet and exercise methods are not enough to provide the significant weight loss necessary to improve health. For many obese and morbidly obese individuals, the answer often comes down to surgery. However, surgery comes with its own set of risks and is costly as well as dangerous. For individuals who are not willing or able to undergo weight loss surgeries, such as gastric bypass, EnteroMedic’s has developed the Maestro.
The Maestro System consists of a subcutaneously implanted rechargeable neuroregulator and two electrodes that are laparoscopically implanted by a bariatric surgeon. The system then uses the electrodes to block vagal nerve signals during the patient’s waking hours, thereby controlling appetite. In a study lasting one year, over 200 morbidly obese Americans and Australians were selected for trials 157 received the Maestro System and 76 received a placebo device. Neither group was given special diet and exercise instructions, only 15 minute counseling sessions throughout the study. Patients using the Maestro System lost, on average 24% of their excess weight, as opposed to 16% of placebo patients. In addition, patients who received the Maestro system seemingly kept the weight off after the trial was over, but 40% of those who received the placebo device regained the weight lost in 6 months.
On the heels of this study comes an 8-1 approval from an FDA panel, greatly improving the Maestro System’s chances of receiving an official FDA approval. If the device is approved, it will be used primarily for patients whose body mass index (BMI) exceeds 40, but may also be used for patients who have a BMI of 35 if their weight has caused health complications.