EnteroMedics Maestro Rechargeable System Briefing Documents For The FDA Gastroenterology and Urology Devices Panel

On January 14, 2015, the U.S. Food and Drug Administration (FDA) approved an obesity treatment called the Maestro Rechargeable System that features an implanted vagus nerve stimulation device. The system provides vagal blocking therapy (VBLOC) that targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness. The system was developed by EnteroMedics. The Maestro System is intended for adults who have not been able to lose weight with a supervised weight loss program over the past five years, and who have a body mass index (BMI) of 35 to 45 with at . . .