New device to treat obesity approved by FDA

87534169According to the Centers for Disease Control and Prevention (CDC), more than a third of U.S. adults are obese. Bariatric surgery in which either an inflatable band is placed around the stomach to reduce stomach size or in which the stomach and part of the small intestine are bypassed is perhaps the most effective means of combatting extreme obesity. There may now be other options. This week, the Food and Drug Administration (FDA) approved a new device to treat obesity known as the Maestro Rechargeable System.

The device, developed by EnteroMedics Inc., is implanted surgically into the abdomen and sends electrical signals to the vagus nerve. The vagus nerve is part of the parasympathetic nervous system, which is responsible for regulating the body s internal organs. This nerve is a key factor in signalling the brain as to the presence of hunger or its absence. According to a 12-month clinical study, patients using this device lost 8.5 percent more weight than those in a control group, but EnteroMedics must conduct further studies that follow at least 100 patients for five years as part of the approval process in order to assess effectiveness and further evaluate safety.

Currently, the device is approved for individuals 18 and older with a body-mass index of 35 to 45 (a BMI of 30 is obese), who have not been successful in losing weight with other weight-loss programs. They must also have at least one other obesity-related condition.

ACSH s Ariel Savransky says, This device seems like it may be a good option for a less-invasive procedure to combat obesity. However, many individuals do not respond to hunger cues and may often eat well past the point of fullness so I would be eager to see how the use of this device plays out. I would urge that the implantation of this device be coupled with healthy lifestyle counseling to teach patients how to eat well and exercise.