FDA Approved

The U.S. Food and Drug Administration (FDA) today approved the ORBERA™ Intragastric Balloon, a new non-surgical intervention for the treatment of obesity. The device is approved for use in patients with a body mass index (BMI) of 30 to 40, and was shown in a clinical trial to be more effective for weight loss than diet and exercise alone. The American Society for Metabolic and Bariatric Surgery (ASMBS) welcomes this expansion to the treatment for obesity.

“I am pleased to see the FDA approve ORBERA. With this Intra-Gastric Balloon, we can provide additional care to so many patients who need it. Along with other methods such as counseling, medications, other endoscopic procedures, and proven and effective bariatric surgery, patients with obesity now have hope and evidence to provide them success,” said John M. Morton, MD, MPH, president of the ASMBS.

APPROVAL FOR THE ORBERA INTRAGASTRIC BALLOON HAS CONDITIONS. THE ORBERA INTRAGASTRIC BALLOON SYSTEM IS INDICATED FOR USE AS AN ADJUNCT TO WEIGHT LOSS FOR ADULTS WITH OBESITY WITH BODY MASS INDEX (BMI) OF 30 AND 40 KG/M2 AND IS TO BE USED WITH A LONG-TERM SUPERVISED DIET AND BEHAVIOR MODIFICATION PROGRAM DESIGNED TO INCREASE THE POSSIBILITY OF SIGNIFICANT LONG-TERM WEIGHT LOSS AND MAINTENANCE OF THAT WEIGHT REDUCTION.

ORBERA IS INDICATED FOR ADULT PATIENTS WHO HAVE FAILED MORE CONSERVATIVE WEIGHT REDUCTION ALTERNATIVES, SUCH AS SUPERVISED DIET, EXERCISE AND BEHAVIOR MODIFICATION PROGRAMS, AND OTHERS. THE MAXIMUM PLACEMENT PERIOD FOR ORBERA IS 6 MONTHS.

*Patient Results May Vary.