Allurion Technologies has submitted the first three modules of its premarket approval application (PMA) to the FDA for the Allurion Balloon. The company expects to file the fourth and final module of the PMA containing the clinical data from its AUDACITY trial early in 2025.
"These submissions are a critical milestone for Allurion, and I commend our team for their efforts," said Dr Shantanu Gaur, Allurion’s Founder and CEO. "We are pleased to capitalize on the opportunity that the FDA provides through its modular submission program to improve the efficiency of our application process."
In a traditional PMA application, the applicant submits all PMA data at the same time, and the FDA begins its PMA review only upon receipt of all of the required information. In a modular PMA application, the FDA allows applicants to submit discrete sections of the application for review to improve the efficiency of the process.
The Allurion Gastric Balloon is the world’s first and only swallowable, procedureless gastric balloon for weight loss and was designed to address various shortcomings of legacy gastric balloons. It is swallowed as a capsule and placed under the guidance of a health care provider without surgery, endoscopy or anaesthesia. The placement takes approximately 15 minutes during an outpatient visit. Approximately four months later, a patented ReleaseValve opens, allowing the balloon to empty and pass out of the body naturally. Over 150,000 patients have already been treated with the Allurion Balloon outside the US.
The Allurion Balloon is being evaluated in AUDACITY, a randomised, pivotal controlled trial in 550 patients at 17 sites in the US. The trial completed enrolment in the third quarter of 2023, two months ahead of schedule. The company expects the trial to conclude by the end of 2024.