Obalon Therapeutics announced that the Food and Drug Administration (FDA) has approved the Obalon Balloon System, a nonsurgical device for weight loss. It is indicated for temporary use to aid weight loss in adults with obesity (BMI 30–40kg/m^2) who have failed to lose weight through diet and exercise. The System is intended for use as adjunct to a behavior modification program and a moderate intensity diet.
The Obalon Balloon System is a swallowable intragastric balloon system that consists of a balloon folded inside a capsule. No sedation or anesthesia is needed and the balloon can be placed in less than 10 minutes. When the balloon reaches the stomach, it is remotely inflated with gas via a micro-catheter that is then removed. During the next 3 months, two other balloons are swallowed and inflated. At the end of 6 months, all three balloons are removed via an endoscopy while the patient is under conscious sedation.
The Obalon Balloon System was evaluated in a randomized, double-blind, sham-controlled study (n=387) across the United States. Study patients received either three Obalon balloons or three sham placebo-like devices that were filled with sugar; all patients received minimal diet counseling of 25 minutes every 3 weeks. The study’s co-primary weight loss endpoints were met with ~65% of patients in the Obalon group experiencing clinically meaningful weight loss of ≥5% of their total body weight; this was twice as many patients than in the sham-control group.
The System is anticipated to launch in early 2017 to physicians who complete the Obalon Balloon System training program.
For more information visit Obalon.com.