FDA approves novel weight-loss device
- The FDA has approved the Maestro Rechargeable System, a weight-loss device that works by sending intermittent electrical impulses to the abdominal vagus nerves via surgically-implanted electrodes.
- The Maestro system is intended for use in obese individuals aged 18 and older who also have an additional obesity-related condition, such as type II diabetes.
- The underlying science is based on the fact that the abdominal vagus nerve is involved in regulating stomach emptying and signaling to the brain that the stomach either feels full or empty; however, the specific mode of action (MOA) is not fully understood.
According to the Centers for Disease Control and Prevention (CDC), 34.9% of adults in the US, or 78.6 million people, are obese. Obesity is a major contributing factor for diabetes, heart disease, stroke and certain types of cancer. Overall, obesity generates roughly $147 billion per year in medical costs, despite numerous medical and lifestyle-based interventions. The advent of an implantable device aimed at individuals with a BMI between 35 and 45 is a novel approach to regulating hunger and intended to complement other weight-loss efforts.
- Pharma Times FDA approves first-of-a-kind obesity device