FDA approves Orbera intragastric balloon for weight loss in obese adults

The FDA has approved the Orbera intragastric balloon for weight loss in obese adults with a BMI of 30 to 40 for whom invasive surgery is not an option and for whom diet, exercise or medications have not worked, the manufacturer announced today.

“While new to the United States, Orbera [Apollo Endosurgery] is a weight loss device with more than 220,000 balloons distributed in over 80 countries and approximately 230 published papers documenting its clinical results,” Todd Newton, CEO of Apollo Endosurgery, said in a press release. “Orbera is a proven, innovative and nonsurgical solution to help fight the obesity epidemic and treat patients before their disease progresses and requires more invasive treatments. With the FDA approval of Orbera, Apollo can now offer this safe and effective solution to patients and their physicians in the United States.”

According to the release, Orbera is a 20- to 30-minute endoscopic procedure performed under a mild sedative, in which the grapefruit-sized balloon is placed in the stomach when deflated and then filled with saline to promote portion control. Patients typically return home the same day, and the balloon is deflated and removed at 6 months through a similar procedure.

“For many, the weight loss journey leaves patients with little support or options other than diet and exercise and traditional surgery. The approval of Orbera fills this gap in available treatments and is an exciting development for health care professionals who are committed to providing patients with less invasive options that can assist them in reaching their long-term weight loss goals,” Christine Ren-Fielding, MD, a New York-based bariatric surgeon, said in the release. “Orbera gives us a new weight loss option to help address what has become a critical health issue in the United States.”

The Orbera balloon is part of the Orbera Managed Weight Loss System, a 12-month individually tailored support program which combines the balloon with nutritional coaching and exercise, according to the press release.

The approval follows results from a U.S. clinical trial showing a 3.1-fold increase in average weight loss over 6 months in 125 patients randomly assigned to the Orbera system compared with 130 patients assigned to the diet and exercise component of the system alone. The treatment group also achieved a mean of 38.4% excess weight loss at 6 months (when the device was removed), 10.2% mean total body weight loss at 6 months (compared with 3.3% for controls) and significantly more weight loss overall compared with controls over the study period, which they maintained through 12 months.

Disclosures: Newton is an employee of Apollo Endosurgery. Healio Gastroenterology was unable to determine Ren-Fielding’s relevant financial disclosures at the time of publication.