BIB™ System Intragastric Balloon - Balloon, gastric, appetite-suppressing

Intended purpose

The system is a gastric balloon inflated in the stomach for temporary use in weight-loss therapy in patients meeting criteria based on Body Mass Index (BMI) and applicable health reasons, as specified. The system works by creating a feeling of satiety and reducing the desire for food. Patients are to be evaluated and the system removed or replaced every six months (180 days).