FDA approves Allurion Gastric Balloon System

The FDA has approved the premarket approval (PMA) application for the Allurion Gastric Balloon System (AGBS), featuring the Allurion Smart Capsule. The Allurion Program is a weight-loss platform that combines the FDA PMA approved Allurion Gastric Balloon System, featuring the Allurion Smart Capsule, with the Allurion Virtual Care Suite, including the Allurion Mobile App for consumers featuring the Iris AI platform, Allurion Insights for healthcare providers, and the Allurion Connected Scale.

“Today’s approval is a watershed moment for Allurion and for obesity care in the United States,” said Dr Shantanu Gaur, Founder and Chief Executive Officer. “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 GLP-1s and bariatric surgery, and it should become a standard tool in the comprehensive treatment of obesity in the US.”

In the US, the AGBS is indicated to promote short-term limited weight loss in adult individuals with obesity between the ages of 22 years and 65 years with a body mass index (BMI) ≥ 30 kg/m² and ≤ 40 kg/m² who have had at least one unsuccessful attempt at a weight loss program. The residence time for each balloon is variable with an average observed residence time of 15.3 weeks. The AGBS is to be used in conjunction with a moderate intensity lifestyle modification therapy program. The AGBS consists of up to two Allurion Balloons placed during a ten-month period.

“Allurion’s innovative solution is an important tool within the continuum of obesity care,” said Dr Jaime Ponce, President and Medical Director of the Weight Loss Center of Chattanooga and former President of the American Society for Metabolic and Bariatric Surgery (ASMBS). “For patients with a BMI between 30 and 40 seeking meaningful health improvements, the Allurion Smart Capsule could be an attractive option, especially for those seeking a structured alternative to medications or surgery.”

The Allurion Smart Capsule is a state-of-the-art innovation covered by over 50 patents globally. The Smart Capsule is swallowed in a 15-minute office visit without the need for surgery, endoscopy or anaesthesia, filled with fluid once inside the stomach, and resides inside for approximately four months. During that time, it occupies space within the stomach, helping patients feel full and eat less. After approximately four months, the patented Release Valve opens, and it passes out of the body naturally. Another Smart Capsule can be swallowed two months after the passage of the first. Unlike medications that need to be administered daily or injected weekly, Allurion‘s approach results in approximately four months of treatment from a single administration.

“Obesity is a critical issue in the US, and many patients are looking for alternatives or complements to existing options, including GLP-1 medications,” said Dr Shelby Sullivan, Professor of Medicine at the Geisel School of Medicine at Dartmouth University and Principal Investigator on the AUDACITY FDA pivotal trial. “The AUDACITY trial results coupled with the real-world experience outside the United States demonstrate the product’s safety and efficacy. The solution offers an option that many people are looking for. It has a finite time in the body, is repeatable when necessary, and it does not require patients to take long-term medications for weight loss. As a standalone or complementary tool to fight obesity, Allurion has an important role to play for both patients and physicians.”

Outside the US, the Allurion Smart Capsule has already been deployed to treat over 200,000 patients with results reported in over 30 peer-reviewed medical journal publications. In a commercial setting outside the United States, when combined with the Allurion Virtual Care Suite featuring Allurion’s AI-powered behaviour change program and personalized follow-up from the physician’s care team, data demonstrate that patients achieve total body weight loss of 14% and over 20% with two cycles of therapy. When combined with a low dose of GLP-1s and the Allurion Virtual Care Suite, patients achieve a total body weight loss of over 20% with favourable improvements in muscle mass.