Obalon Therapeutics has secured approval from the US Food and Drug Administration (FDA) for its new nonsurgical and fully-reversible balloon system.
Obalon ballon system is a swallowable intragastric device that will be temporarily used to facilitate weight loss in adults with obesity (BMI of 30 – 40 kg/m2).
According to the company, the system will be used as an adjunct to a moderate intensity diet and behavior modification program.
The system includes a balloon folded inside a capsule, which is swallowed by the patient. It requires no sedation or anesthesia.
After reaching the stomach, the balloon will be remotely inflated with gas through a micro-catheter. Later, the catheter will be removed by leaving the lightweight and buoyant balloon in the stomach.
Two additional balloons are swallowed and inflated over the next three months of treatment. All three balloons are removed through an outpatient endoscopy under conscious sedation at the end of the six-month treatment period.
The company conducted randomized, double-blind and sham-controlled clinical trial by recruiting 387 patients across 15 sites.
In the trial, 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 company will present the results of the study at Obesity Week this fall in New Orleans.
Obalon CEO Andy Rasdal said: “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.”