Performance of the Obalon Balloon in Commercial Use
CE Mark Approval for the Obalon Balloon and commercial availability occurred in Europe, July 2012. Designed to be swallowed, the balloon resides in a gelatin capsule, once in the stomach it is remotely inflated to 250 cc with gas, not needing either endoscopy or sedation. To stimulate further weight loss, an additional balloon is usually swallowed after 30 days and inflated to increase total resident volume throughout the three-month treatment period. A short endoscopy using standard, commercially available tools is necessary to remove the balloons at the end of the three-month period. Eleven centers throughout Belgium, Germany, Italy and Spain produced Safety and efficiency data were collected and reported.
Patients baseline weight information was recorded at the first balloon placement. Throughout the three-month treatment period additional balloons were placed as determined by medical team monitoring patient satiety, progression of weight loss and all symptoms. Throughout the therapy period adverse event data was collected and final weight data were recorded at the time of balloon removal.
A total of one hundred and nineteen patients (75.6% female), a baseline Body Mass Index (mean ± SD) of 33.0±5.5 kg/m, and a mean baseline weight of 93.7±20.6 kg, with a mean age of 41.8±12.2 years received initially a single 250 cc balloon. During the treatment period almost half or fifty-seven (47.9%) patients received a second balloon and 6 (5.0%) received a third balloon. The 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 in one hundred and ten patients that completed at least 8 weeks of treatment. The results are statistically significant (p<0.001). Seventy-five (68.2%) had an excess weight loss of 25% or greater and eighty-four (76.4%) had total body weight loss of 5.0% or greater in just three months of treatment. The adverse events most reported was nausea (10.1%) and vomiting (6.7%). 9 patients (7.6%) requested early removal of balloons, due to a lack of commitment to the therapy period of 3 months. During the endoscopy to remove balloons at the end of the treatment period, one (0.8%) small (<1 cm), non-hemorrhagic ulcer was observed and was reported as possibly related to the contraindicated use of NSAIDs. Also, after balloon removal in a patient diagnosed with eosinophilic esophagitis. one esophageal laceration (0.8%) was observed.
After obtaining CE Mark approval, this data collection and the results reported from the first commercial use of the Obalon Balloon, validate the outcomes from prior controlled clinical studies. A 3-month weight loss results with a high responder rate with a very low adverse events rate and excellent tolerability, are very encouraging results for the use of the Obalon Balloon device for weight loss.