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Medical Devices / Submissions and Approvals

FDA Approves ReShape Medical Balloon for Weight Loss

Aug. 3, 2015

ReShape Medical has received FDA approval for its integrated dual balloon system, a first-of-its-kind non-surgical weight loss procedure for people who do not want or qualify for bariatric surgery.

The balloon is in inserted into the stomach through an endoscopic procedure and filled with saline solution. It remains in the stomach for six months so patients feel less hungry and are satisfied with smaller portions.

The FDA announced that 326 obese patients participated in a clinical trial where 187 who were randomly selected to receive the balloon lost an average of 14.3 pounds or 6.8 percent of their body weight hen the device was removed at six months. The control group lost an average of 7.2 pounds or 3.3 percent of their body weight. Six months later, the patients who received the balloon had kept off 9.9 pounds of the original 14.3 pounds.

The FDA states the device should not be used in patients who have had gastrointestinal or bariatric surgery or have been diagnosed with inflammatory intestinal or bowel disease, large hiatal hernia, symptoms of delayed gastric emptying or active H. Pylori infection. — John Bechtel