Obalon balloon system receives FDA approval

Obalon Therapeutics has received approval from the FDA for its swallowable intragastric balloon for temporary use in obese adults.

The balloon is intended to help patients with body mass indexes of 30 or more lose weight when partnered with a healthy diet and a behavior modification program. The balloon is a temporary fix for weight loss and must be removed after six months of use.

Folded inside a capsule that is swallowed, the balloon is inflated with gas using a remote micro-catheter once it reaches the stomach. Over the next three months, two more balloons are swallowed and inflated before all three are removed after the six months using an endoscopy.

A clinical trial was conducted on 387 patients split into a placebo and balloon group, both set receiving diet counseling 25 minutes every three weeks. Nearly two-thirds (65 percent) of the patients experienced weight loss of at least 5 percent of their total body weight, twice as much weight lost as the placebo group.

"We're excited to bring this novel technology to the approximately 70 million adults in the United States who are struggling with obesity.  For physicians, we believe that the Obalon technology represents an important new option for both their practices and their patients who are obese and looking to lose weight," stated Andy Rasdal, CEO of Obalon Therapeutics. "I'd also like to recognize the FDA for their efficient and interactive review of our product, which represents another option for physicians and patients in the battle against the obesity epidemic."