*In rare cases, the Allurion Balloon may require endoscopic or surgical intervention for removal.

The AUDACITY Study. 48-week LOCF results in mITT population. Data on File (2025)
This information is extracted from the instructions for use of the Allurion Gastric Balloon System. Version number CS137- 02-ENG (to be updated with US IFU). If you have any questions regarding this document, please consult your doctor.
- Studies conducted and data collected outside the United States:
Ienca R, Al Jarallah M, Caballero A, et al. The Procedureless Elipse Gastric Balloon Program: Multicenter Experience in 1770 Consecutive Patients. Obes Surg. 2020;30(9):3354-3362. doi:10.1007/s11695-020-04539-8
Dejeu D, Dejeu P, Bradea P, Muresan A, Dejeu V. Evaluating Weight Loss Efficacy in Obesity Treatment with Allurion's Ingestible Gastric Balloon: A Retrospective Study Utilizing the Scale App Health Tracker. Clin Pract. 2024;14(3):765-778. Published 2024 May 6. doi:10.3390/clinpract14030061.
Caballero A, Giardiello C, Schiano Di Cola R, Rosa M, Juneja G, Pagan A, Murcia S, Formiga A, Freda A, Ienca R. Weight Loss Maintenance 1 Year after the Swallowable Gastric Balloon: Results from an International Multicenter Study. Obes Surg. 2025 Jul 17. doi: 10.1007/s11695 -025 -08074 - 2. Epub ahead of print. PMID: 40676353.
The app was not part of the Audacity study, however it has been an integral part of the studies performed outside of US and is provided as part of Allurion Gastric Balloon System to patients outside of US.

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References