Ingestible Balloon Helps Patients Lose Weight

An ingestible intragastric balloon system facilitates weight loss in obese adults who failed to lose weight through diet and exercise.

The Obalon system consists of a balloon folded inside a capsule that is swallowed by the patient, with no sedation or anesthesia required. Once the balloon reaches the stomach, it is remotely inflated via an attached micro-catheter that is subsequently removed, leaving behind a buoyant balloon with a volume of 250cc (about the size of a small orange) that weighs less than six grams. Over the following three months of treatment, two additional balloons are swallowed and inflated, bringing the total maximum displaced volume to750cc.

The nonsurgical weight loss system is fully reversible throughout the course, and at the end of the six-month treatment period, all three balloons are mandatorily removed via endoscopy under conscious sedation. The system is intended for use as an adjunct to a moderate intensity diet and to a behavior modification program. The Obalon balloon system is a product of Obalon (Carlsbad, CA, USA), and has been approved by the U.S. Food and Drug Administration (FDA).

“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,” said Andy Rasdal, CEO of Obalon. “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.”

“The clinical trial design for the Obalon balloon system was highly rigorous and the system demonstrated a favorable safety profile,” said Shelby Sullivan, MD, director of the gastroenterology bariatric and metabolic program at the University of Colorado School of Medicine (Aurora, USA). “We were also pleased to see that patients tolerated the administrations of the Obalon balloon remarkably well, with no recovery time needed. This is in contrast to other currently approved intragastric balloon devices, where most patients cannot immediately return to normal activities.”

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