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Performance of the Obalon Balloon in Commercial Use

Background

The Obalon Balloon received CE Mark Approval and was commercially launched on a limited basis in Europe beginning in July 2012. The balloon is designed to be swallowed in a gelatin capsule and remotely inflated with gas to 250 cc without endoscopy or sedation. Additional balloons can be swallowed and inflated to increase total resident volume throughout the three-month treatment period to stimulate further weight loss. All balloons are intended to be removed at the end of the three-month period in a short endoscopy using standard, commercially available tools. Safety and efficacy data were collected and reported on the first commercial product uses at eleven centers throughout Belgium, Germany, Italy and Spain.

Methods

Baseline weight information was recorded at the time of first balloon placement in commercial patients. Additional balloons were placed throughout the three-month treatment period as determined by physicians monitoring patient satiety, weight loss progression and symptoms. Adverse event data were collected throughout the therapy period and final weight data were recorded at the time of balloon removal.

Results

119 patients (75.6% female), with a baseline BMI (mean ± SD) of 33.0±5.5 kg/m, mean baseline weight of 93.7±20.6 kg, and mean age of 41.8±12.2 years initially received a single 250 cc balloon. Fifty-seven (47.9%) patients received a second balloon and 6 (5.0%) received a third balloon during the treatment period. 110 patients completed at least 8 weeks of treatment with mean excess weight loss of 50.2±72.5%, percent of total body weight loss of 8.3±4.2%, decrease in BMI of 2.8±1.9 kg/m2, and mean weight loss of 8.0±5.8 kg. These weight loss results were all highly statistically significant (p<0.001). Seventy-five (68.2%) patients had excess weight loss of 25% or greater and 84 (76.4%) had percent of total body weight loss of 5.0% or greater in only three months of treatment. The most commonly reported adverse events were nausea (10.1%) and vomiting (6.7%). 9 patients (7.6%) requested early removal of balloons, which was primarily due to a lack of commitment to the full 3-month therapy period. One (0.8%) small (<1 cm), non-hemorrhagic ulcer was observed during the endoscopy to remove balloons at the end of the treatment period and was reported as possibly related to the contraindicated use of NSAIDs. One esophageal laceration (0.8%) was observed after balloon removal in a patient diagnosed with eosinophillic esophagitis.

Conclusions

The results reported in this data collection from the first commercial uses of the Obalon Balloon after CE Mark approval further validate the outcomes from prior controlled clinical studies. The high responder rate and 3-month weight loss results, combined with very low adverse events rate and favorable tolerability, are encouraging for the use of the Obalon Balloon for weight loss.