FDA Approval of ORBERA™ Intragastric Balloon Offers New Weight Loss Option for Patients with Obesity
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, which is approved for use in patients with a body mass index (BMI) of 30 to 40, 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 spectrum of treatment options for obesity.
“I am pleased to see the FDA approve the ORBERA Intra-Gastric Balloon. With this device, we can provide additional care to so many patients in need. Along with counseling, medications, other endoscopic procedures, and proven and effective bariatric surgery, patients with obesity now have hope and evidence to provide them successful support,” said John M. Morton, MD, MPH, president of the ASMBS.