FDA Approves Obalon Balloon System

First swallowable, gas-filled weight loss balloon in U.S.

The FDA has given the green light to the Obalon Balloon System (Obalon Therapeutics), a nonsurgical, fully reversible device for weight loss. The swallowable intragastric balloon system is indicated for temporary use to facilitate weight loss in adults with obesity (i.e., a body mass index of 30 to 40 kg/m2) who have failed to lose weight through diet and exercise. The system is intended to be used as an adjunct to a moderate- intensity diet and behavior-modification program.

The system consists of a balloon folded inside a capsule that is swallowed by the patient, with no sedation or anesthesia required. Once the balloon reaches the stomach, it is remotely inflated with gas via a microcatheter, which is then removed, leaving a lightweight, buoyant balloon in the stomach. During the next three months of treatment, two additional balloons are swallowed and inflated. At the end of the six-month treatment period, all three balloons are removed via outpatient endoscopy under conscious sedation.

A total of 387 patients were enrolled in a double-blind, sham-controlled study conducted in the United States. The patients received either three Obalon balloons or three sham placebo-like devices that looked similar to the balloons but were filled with sugar. The patients in both groups were given minimal diet counseling of 25 minutes every three weeks. Both of the study’s co-primary weight loss endpoints were met, with approximately 65% of patients who received the Obalon balloon system experiencing clinically meaningful weight loss of at least 5% of their total body weight––twice as many patients than in the sham-control group.

The system is expected to be available in early 2017 to physicians who have completed a training program.