About ORBERA™

For more than 20 years, the global medical community has been using gastric balloons from the makers of ORBERA™ to help thousands of people lose weight. Orbera is the No. 1 global market leader for gastric balloons with more than 300,000 placements worldwide. The Orbera Intragastric Balloon System was FDA-approved by the U.S. Food and Drug Administration on August 5, 2015.

Orbera Important Safety Information

Complications that may result from the use of the Orbera Gastric Balloon System include the risks associated with any endoscopic procedure and those associated with the medications and methods used in this procedure, as well as your ability to tolerate a foreign object placed in your stomach.

For important safety information, please visit www.orbera.com/isi.

Orbera Clinical Trial

The U.S. ORBERA™ clinical trial studied patients suffering from obesity with a BMI range of 30 to 40. A total of 125 patients were randomized to the treatment group, and 130 patients to the control group. The treatment group underwent gastric balloon placement followed by removal after 6 months, while concurrently participating in a 12-month program of behavior modification. The control group participated in the behavior modification program only.

At 6 months, the Orbera treatment group lost more than three times as much weight as the control group. The gastric balloon group also lost significantly more weight than the control group over the course of the study and maintained significant weight loss through month 12.

Obesity in America

Obesity has become a critical health issue in the United States. In all more than 1 in 3 U.S. adults are obese, with obesity rates continuing to rise. According to the U.S. Centers for Disease Control and Prevention, this pervasive chronic disease increases the risk of health problems such as heart disease, diabetes and high blood pressure. It is one of the leading causes of preventable deaths.

Obesity is generally caused when a person's intake of calories is higher than the calories burned through exercise and physical activity. A variety of behavioral, environmental and genetic factors (which can include an unhealthy diet, inactivity, lack of sleep, pregnancy, medications, medical problems and metabolism) can have an influence on this chronic condition.

Those who suffer from obesity should be treated as they would with any other disease. The development of new, minimally-invasive solutions like the Orbera Gastric Balloon will help transform this epidemic and treat patients before their disease progresses and presents the need for more invasive treatment.