The implant, the Maestro Rechargeable System, has been approved for the treatment of people 18 years and older who have not been successful in losing weight with a program of weight loss and who have between a 35 and 45 body weight index with a minimum of one condition that is obesity related such as diabetes.
The Food and Drug Administration approved the implant, which is the first treatment device for weight loss that targets nerves between the brain and stomach that controls the sense of hunger and fullness.
BMI measures the body fat of an individual based on the person’s weight and height and is used to define categories for obesity.
The U.S. Center for Disease Control said that over one third of all adults in the U.S. are obese. The CDC says that people suffering from obesity are at a higher risk of stroke, heart disease, type 2 diabetes and certain forms of cancer.
The system is made up of an electrical pulse generator that is rechargeable, wire leads and a set of electrodes implanted through surgery inside the abdomen.
It functions by sending electrical pulses on an intermittent basis to trunks inside vagus nerve in the abdomen, which regulates the stomach emptying as well as signals the brain that the stomach is either full or empty.
Although it already is known that nerve activity is blocked by electrical stimulation between the stomach and the brain, the specific mechanisms for losing weight due to the device’s use are not known.
External controls allow the patient to give the device a new charge and give healthcare professionals the ability to adjust the settings on the device to provide optimal therapy with a minimal amount of side effects.
The system’s effectiveness and safety were evaluated through a clinical trial that involved 233 patients that had a 35 or greater BMI.
The loss of weight and adverse effects of 157 patients who had received the active device were compared to 76 patients who received the device that was not activated.
The clinical study found following 12 months that those in the group with the activated device lost 8.5% more than the ones in the inactivated group.