New device to fight obesity approved
The U.S. Food and Drug Administration FDA) has approved the use of a rechargeable device for the first time to help people fight obesity. Called the Maestro, the device stimulates nerves in the stomach to make a person feel full. It's meant for adults who have not been able to successfully lose weight by just diet and exercise.
The Maestro, manufactured by EnteroMedics in St. Paul Minnesota, uses a rechargeable generator base, and electrodes implanted in the abdomen to regulate weight. The electrodes direct signals, via the abdominal vagus nerve, to nerve pathways between the brain and the stomach and that makes a person feel full and not want to eat.
For 12 months, scientists tested 157 patients with the Maestro device and 76 in a control group, where the generator was not activated. Scientists were hoping for a 10 percent weight loss increase, but after a year, the generator helped patients lose 8.5 percent more excess weight than the control group. In addition, the study found that half of the experimental group lost 20 percent of their excess weight, and 38.3 percent lost 25 percent of their excess weight.
The FDA says EnteroMedics must collect additional safety and effectiveness data for the next five years in order to maintain Maestro's approval. The post-approval study will monitor at least 100 patients for adverse effects, changes in obesity related-conditions, and weight-loss effectiveness. Potential adverse effects include nausea, chest pain, vomiting, surgical complication, heartburn belching and trouble swallowing.