According to the Centers for Disease Control (CDC), approximately 34.9% of adults and 17% of children in America are obese. The gravity of obesity lies in the health issues that can result from the condition, such as stroke, type 2 diabetes and heart attack. Recently, the FDA approved the first device to treat diabetes since 2007. The new VBLOC® vagal blocking therapy is delivered through the Maestro Rechargeable System, a device manufactured by EnteroMedics in St. Paul, Minnesota.
The Maestro Rechargeable System, consisting of two electrodes and a rechargeable electrical pulse generator, is surgically implanted into the abdomen. The system also consists of an external controller that can be used by patients to charge the device and health care workers to adjust settings. The electrodes, which are placed on nerves between the esophagus and stomach, functions by sending electrical pulses to block signals from the brain to stomach that manage feelings of hunger and fullness. The Maestro Rechargeable System is intended for those 18 and older who have not had success with conventional approaches to losing weight such as diets and supervised weight-loss programs. In addition, candidates need to have a body mass index (BMI) of 35 to 45 kg/m2 and at least one other obesity-related condition.
The clinical trial examining the safety and effectiveness of the Maestro Rechargeable System consisted of 157 patients receiving an active Maestro device (experimental group) and 76 patients receiving an inactive device (control group). Following 12 months, the patients who received the active therapy lost 8.5% more weight than those receiving inactive therapy. Although the goal of the experimental group to lose 10% more excess weight than the control group was not achieved, the study data supported continued weight loss, as 52.5% of the experimental group lost at least 20% of their excess weight, and 38% percent of the same group lost at least 25% of their excess weight. As conditions for approval, EnteroMedics will collect safety and efficacy data for the next few years. However, the Maestro Rechargeable System represents a promising method for reducing obesity and the resulting health issues.
