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Obalon Balloon

Obalon outcomes show 9.9% reduction in total body weight

Clinical results presented from over 1,300 patients treated at 108 sites with Obalon’s non-surgical weight loss solution in commercial setting

Clinical data from a large-scale commercial study assessing the safety and efficacy of the Obalon Balloon System, has reported that average weight loss data on patients receiving three balloons and six months of therapy was 21.7lbs, resulting in a 9.9% reduction in total body weight and a 3.5 point decrease in BMI compared to baseline values. The data was presented at the American Society for Metabolic and Bariatric Surgery (ASMBS) Annual Meeting at Obesity Week 2018, by Dr Rachel Moore, bariatric surgeon and weight loss specialist.

The Obalon Balloon System is a non-surgical, fully-reversible device for weight loss. The system is a swallowable intragastric balloon system indicated for temporary use to facilitate weight loss in adults with obesity (BMI30-40) who have failed to lose weight through diet and exercise. It is intended to be used as an adjunct to a moderate intensity diet and behaviour modification programme.

The Obalon balloon system consists of a balloon folded inside a capsule that is swallowed by the patient, with no sedation or anaesthesia required. Once the balloon reaches the stomach, it is remotely inflated with gas via a micro-catheter that is then removed, leaving a lightweight, buoyant balloon in the stomach. Over the next three months of treatment, two additional balloons are swallowed and inflated. At the end of the six-month treatment period, all three balloons are removed via an outpatient endoscopy under conscious sedation.

The study, which included 1,300+ patients from 108 treatment sites in the US, reported that the top quartile of those patients lost an average of 39lbs, resulting in a 16.8% reduction in total body weight and a 6.2 point decrease in BMI compared to baseline values. Consistent with prior controlled clinical trial results, the rate of serious adverse events (SAEs) reported was 0.14%, with SAEs occurring in two of the 1,343 patients evaluated for safety. No deaths were reported. Non-serious adverse events occurred in 14.3% of patients, also consistent with prior controlled clinical trial results.

Furthermore, 88% of patients treated received three balloons and achieved weight loss that was statistically higher than patients receiving only one or two balloons, 82% of patients completed all six months of therapy and 97% completed at least three months of therapy.

“This large real-world data set validates the Obalon Balloon System as an important tool for battling the obesity epidemic,” said Dr Moore. “The clinically meaningful weight loss and excellent safety profile can provide clinicians and patients with an important weight loss option for patients who may not qualify for or will not consider bariatric surgery.”

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