Treating Morbid Extreme Obesity – Part 2 of 3
And “Obesity and its allied medical conditions are major public health problems,” Dr William Maisel, chief scientist in the FDA’s Center for Devices and Radiological Health, said in an intermediation news release. “Medical devices can help physicians and patients to develop comprehensive obesity treatment plans”. As part of the FDA approval, Minnesota-based EnteroMedics must conduct a five-year post-approval muse about that will follow at least 100 patients and collect additional safety and effectiveness data.
The clinical trial for Maestro did not meet its original goal: That people with the device misplace at least 10 percent more excess weight than the control group, the FDA noted. However, an agency advisory panel decided that statistics from the trial proved that the device could cause sustained avoirdupois loss. The panel also agreed that the benefits of the device outweighed the risks in patients who meet the set criteria.
However, based on the mixed results from the clinical trial, it’s likely that many weight drubbing doctors will not immediately adopt the device and recommend its use, said Dr Maria Pena, director of the Center for Weight Management at North Shore-LIJ’s Syosset Hospital in Syosset, NY. “Before we sway we’re going to put something within you that requires a surgical intervention, we always ask whether it’s worth it. It seems like it does work in promoting weight loss, but we don’t remember 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”. One other weight-loss expert was more definitive about the promise of the new device. “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,” said Christopher Ochner, an rotundity and nutrition expert at The Mount Sinai Hospital in New York City.