IMPORTANT SAFETY INFORMATION
The Spatz3 Adjustable Balloon System (hereinafter referred to as Trissa) is indicated for temporary use in weight-loss therapy for adults with a Body Mass Index (BMI) of 30 kg/m2 and above with one or more weight-related comorbid conditions who have failed to lose weight through diet and exercise alone.
The maximum placement period for the Trissa Adjustable Balloon System is 12 months, and it must be removed at that time or earlier.
The Trissa Adjustable Balloon 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.
The Trissa Adjustable Balloon System is not recommended for patients who have undergone previous weight loss surgery, or have conditions that may increase the risk of poor results (e.g., inflammatory or cardiopulmonary diseases, GI conditions), who are unwilling or unable to comply with the required dietary program, who have alcohol or drug addictions, or who currently are or may become pregnant within the timeframe that the balloon is in place.
Caution: Inflation volumes greater than 700 ml are not recommended. Placement of the Trissa Adjustable Balloon System requires an endoscopic procedure with sedation. All surgery carries some risk. Weight, age, and medical history determine your specific risks. Check with your doctor to see if the Trissa Adjustable Balloon System is a practical option for you.