FDA Considering New Surgically Implanted Weight-Loss Device For Patients With Severe Obesity
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ATLANTA (CBS Atlanta) – A new surgically implanted weight-loss device for patients with severe obesity is one step closer to being permitted for use in the U.S.
A Food and Drug Administration advisory committee is meeting Tuesday to consider the pre-market application of the device called the Maestro Rechargeable System, CBS News reports.
It works by delivering an electronic signal called VBLOC therapy to the trunks of the vagus nerve. The vagus nerve is a cranial nerve which extends from the brain stem to the abdomen and plays a huge role in transmitting feelings of hunger.
The device decreases hunger pangs, digestive enzyme secretion and calorie absorption, while increasing the feeling of fullness, the manufacturer, EnteroMedics Inc., stated.
The Minnesota-based company explained that it could be an alternative for extremely overweight people who have failed at weight loss programs, but don’t or can’t have the extreme bariatric surgery done.
The system is available for commercial use in Australia and doctors have also implanted it in several patients at Hadi Hospital in Kuwait City, Kuwait. It is powered by an internal battery that can be recharged by an external mobile charger. Controllable electrical pulses are sent to the vagus nerve trunks in the abdominal region.
Researchers found that an average of just over 26 percent of excess weight was lost by patients who had undergone treatment with the device over 12 months in a study. The study, which involved 239 patients, also showed that nearly 57 percent of patients with the device lost 20 percent or more of their excess weight, CBS News reports.
Pain and gastrointestinal symptoms, including heartburn, difficulty swallowing, belching and nausea were the most common reported side effects.
The Centers for Disease Control and Prevention reported that more than one third of U.S. adults are obese.