Saturday, January 17, 2015

Latest Weight Loss Device Gets FDA Approval

It’s an implant that electrically stimulates stomach nerves thus inhibiting appetite and it’s the newest FDA approved obesity device since 2007. The device called the Maestro Rechargeable System was designed for the morbidly obese and manufactured by EnteroMedics Inc. It sends electrical signals to nerves around the stomach that help control digestion to decrease feelings of hunger and increase feelings of fullness. It’s approved for use in people aged 18 and older who have a body-mass index (BMI) of 35 to 45 and at least one other obesity-related condition, such as type 2 diabetes. Another criterion for the implant is previous failure to lose weight with a traditional weight loss program. The Maestro device has shown promise in helping obese patients lose weight and maintain the loss. According to the CDC, more than one-third of all U.S. adults are obese, and people with obesity are at increased risk of heart disease, stroke, type 2 diabetes and certain cancers, so maybe this device will in time help lower those statistics. As part of the FDA approval, Minnesota-based EnteroMedics must conduct a five-year post-approval study that will follow at least 100 patients and collect additional safety and effectiveness data. But so far it seems that the benefits of the device outweighed the risks (inherent in any kind of surgery) in patients who meet the set criteria.

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