A swallowable gastric balloon designed to remain in the stomach for about 4 months without surgery or anesthesia has received US Food and Drug Administration approval, according to a recent press release.
The US Food and Drug Administration has approved the premarket approval application for the Allurion Gastric Balloon System, expanding access to an estimated 80 million Americans with obesity who fall within the indicated body mass index range.
Allurion Technologies, Inc., announced that the system is indicated for adults aged 22 to 65 years with obesity who have had at least one unsuccessful attempt at a weight loss program. The device is to be used in conjunction with a moderate-intensity lifestyle modification therapy program.
The Allurion Smart Capsule is administered during a 15-minute office visit and does not require surgery, endoscopy, or anesthesia. Once swallowed, the capsule is filled with fluid in the stomach, where it occupies space to promote satiety and reduced caloric intake. The balloon remains in place for approximately 4 months, with an average observed residence time of 15.3 weeks, before a release valve opens and the device passes naturally. A second balloon may be placed 2 months following passage of the first, with up to two balloons permitted during a 10-month period.
“Our goal is to deliver patients metabolically healthy weight loss by helping them lose weight, keep it off, and maintain muscle. The Allurion Smart Capsule offers a safe and effective alternative to [glucagon-like peptide-1s] and bariatric surgery, and it should become a standard tool in the comprehensive treatment of obesity in the United States,” stated Shantanu Gaur, MD, Founder and Chief Executive Officer of Allurion.
According to the company, more than 100 million Americans have obesity, and approximately 80 million have a body mass index within the approved range. The press release cited estimates that 20 million Americans have initiated and discontinued glucagon-like peptide-1 receptor agonists, with projections reaching 40 million by 2027. Prior studies referenced in the release reported that 65% of patients discontinued glucagon-like peptide-1 receptor agonists within the first year, primarily because of adverse effects, with subsequent weight regain.
“The AUDACITY trial results coupled with the real-world experience outside the United States demonstrate the product’s safety and efficacy,” noted Shelby Sullivan, MD, a professor of medicine at the Geisel School of Medicine at Dartmouth University and the principal investigator of the US Food and Drug Administration AUDACITY pivotal trial. The device has been used in more than 200,000 patients outside of the US. In commercial settings outside the US, company-reported findings indicate 14% total body weight loss and more than 20% following 2 treatment cycles.
Source: Allurion Technologies Inc
