FDA Approves Maestro Rechargeable System To Treat Obesity

The Food and Drug Administration approved a new device Wednesday that curbs appetite to help treat obesity.

The Maestro Rechargeable System is implanted in the body and electronically stimulates the stomach nerves so the person feels full. The device is intended to treat morbid obesity.

Clinical trials with the Maestro device implanted in them showed that people with the device, as opposed to a fake implant, lost an average 8.5 percent more weight after one year, reported CBS News.

Half of the trial participants who had the Maestro device lost 20 percent of their excess weight, and 38 percent lost at least 25 percent of their excess weight, reported CBS News.

Maestro was expected to cause people with the device to lose at least 10 percent more excess weight than the control group, which didn't happen. The agency decided to approve the device anyway because statistics from the trial proved that the device could cause sustained weight loss, reported CBS News.

"Although this system by itself is unlikely to turn the tide in the battle against the obesity pandemic, it represents a positive step in the overall approach taken towards treating obesity," Christopher Ochner, an obesity and nutrition expert at The Mount Sinai Hospital in New York City, told CBS News.

But some weight loss doctors may not not immediately adopt the device and recommend its use.

"Before we say we're going to put something within you that requires a surgical intervention, we always ask whether it's worth it," Dr. Maria Pena, director of the Center for Weight Management at North Shore-LIJ's Syosset Hospital in Syosset, N.Y., told CBS News. "It seems like it does work in promoting weight loss, but we don't know how much. Is it worth the hassle of going through surgery? We're going to need more data and more time, because we've tried this in the past and it hasn't been very effective."

The Maestro implant is the first FDA-approved obesity device since 2007.

The FDA approved the device for use in people 18 and older who have a body-mass index (BMI) of 35 to 45. A patient is only permitted to use the device if they previously tried and failed to lose weight through a traditional weight-loss program, and has at least one other obesity-related condition, such as type 2 diabetes, reported CBS News.

Tags
Obesity, Weight, Weight loss, FDA, Food and Drug Administration
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