Quality & Risk Information
Allurion Technologies is committed to designing and manufacturing medical products of the highest quality. In February 2015, Allurion received ISO13485:2003 certification of the quality management system that governs the production and manufacturing of the Elipse System.
This medical device is a regulated healthcare product, which under European regulations bears the CE mark.
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The ElipseTM Balloon is a temporary weight loss aid for adults over the age of 18 who are overweight or obese, defined as a body mass index (BMI) ≥ 27. The Elipse Balloon can only be administered by a healthcare professional who is knowledgeable about the use of the Elipse Balloon. The Elipse Balloon must be used in conjunction with a supervised nutrition and behavior modification program.
Some individuals may not be eligible to receive the Elipse Balloon. Your doctor will take a detailed medical history and perform a physical examination to determine your eligibility. It is important to provide your physician with a complete and accurate medical history.
In rare cases, the Elipse Balloon may require endoscopic or surgical intervention for removal.
To further clarify risks and benefits of the Elipse device, please discuss with your physician.