Spatz FGIA Spatz3 Adjustable Balloon System

The Spatz3 Adjustable Balloon System® is indicated for temporary use in weight-loss therapy for overweight and obese patients who have significant health risks related to their weight and have failed to achieve and maintain weight loss with a supervised weight-control program. The maximum placement period for the Spatz3 Adjustable Balloon System is 12 months, and must be removed at that time or earlier. It is indicated for : • Pre-surgical temporary use for weight loss in morbidly obese patients (BMI 40 and above or a BMI of 35 with co-morbidities) prior to bariatric or other surgery, in order to reduce surgical risk. • Temporary use for weight loss in overweight and obese patients (BMI > 27) who have failed to achieve and maintain weight-loss with a supervised weight control program. The system is to be used in conjunction with a long-term supervised diet and behaviour modification program designed to increase the possibility of long term weight-loss maintenance.