The FDA has approved Allurion Technologies’ gastric balloon system, a swallowable weight loss device that does not require surgery, endoscopy or anesthesia.
The device is indicated for adults with a body mass index of 30 to 40 kg/m², potentially expanding access to treatment for roughly 80 million Americans with obesity, according to a Feb. 23 news release from the company. During an office visit, patients swallow the capsule, which is then filled with fluid in the stomach. The balloon remains in place for about four months before naturally passing from the body. A second capsule may be administered two months after the first.
Company leaders said the capsule offers a time-limited alternative to GLP-1 medications and bariatric surgery. The device has been used in more than 200,000 patients outside the U.S. and is supported by more than 30 peer-reviewed publications. Reported outcomes include 14% total body weight loss after one treatment cycle and more than 20% after two cycles, the release said.
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