The US Food and Drug Administration (FDA) has granted approval for Obalon Therapeutics' new nonsurgical and fully-reversible balloon system for weight loss.
Obalon balloon system is a nonsurgical, fully-reversible, swallowable intragastric device that will be temporarily used to facilitate weight loss in adults with obesity (BMI of 30 – 40kg/m²).
The company noted that the system will be used as an adjunct to a moderate intensity diet and behavior modification programme.
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, which is then 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 carried out a randomised, double-blind and sham-controlled clinical trial which included 387 patients across 15 sites in the US.
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 intends to report the results of the study at Obesity Week later this year 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.”
The company noted that the system is expected to be available in early next year to physicians who complete the Obalon Balloon System training programme.