The Allurion Gastric Balloon System features the Allurion Smart Capsule to deliver an AI-powered solution for weight loss. The swallowable system requires no surgery, endoscopy or anesthesia. Once swallowed, the balloon fills and remains in the stomach for approximately four months before self-emptying and passing out naturally.
Allurion Technologies designed its system for delivery in a 15-minute office visit. It eliminates the need for surgery, endoscopy or anesthesia.
Once about four months pass, the patented release valve opens and the capsule passes. Patients can swallow another Smart Capsule two months after the passage of the first.
Unlike weight loss medications that require daily or weekly administration, Allurion Technologies touts four months of treatment from a single device administration.
Approval comes more than two years after the company initially submitted its modules to the FDA for PMA. Since then, the company reintroduced the balloon system in France about a year ago, having agreed to suspend sales to reduce risks and adverse events.
Outside the U.S., Allurion Technologies reports capsule deployments in more than 200,000 patients.
“Today’s approval is a watershed moment for Allurion and for obesity care in the United States,” said Dr. Shantanu Gaur, founder and CEO. “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 United States.”
