FDA approves Obalon Balloon System for obesity- Obalon Therapeutics

Obalon Therapeutics announced that it has received approval from the FDA of the Obalon Balloon System, a novel, nonsurgical, fully-reversible device for weight loss. The Obalon Balloon System is a swallowable intragastric balloon system indicated for temporary use to facilitate weight loss in adults with obesity (BMI of 30 � 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.

In the clinical trial, 387 patients in the United States across fifteen clinical trial sites were randomized in a double-blind, sham-controlled study. The patients in the clinical trial 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 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, which is twice as many people than in the sham-control group. The clinical trial data will be presented at Obesity Week.

Comment: The Obalon Balloon System is expected to be available in early 2017 to physicians who complete the Obalon Balloon System training program.