Initial Japanese Experience with Orbera365® Intragastric Balloon System

Background Intragastric balloon (IGB) therapy is a low-invasion treatment for obesity. In Japan, the most commonly used IGB is Orbera® IGB of 6 months placement. We introduced Orbera365® IGB of 1-year placement for the first time in Japan.
Methods Although some sheath parts are different, in Orbera365® IGB and Orbera® IGB, the material of the balloon is the same. Orbera365® IGB was placed through the mouth while observing with nasal endoscopy. Orbera365® IGB was positioned in the gastric fundus under endoscopic guidance, inflated with saline (400-700 mL of 1,000 mL saline mixed with 10mL of 1% methylene blue). The filling catheter was then removed, and the procedure was completed.
Results We placed Orbera365® IGB in 18 patients between December 2019 and February 2021. Although the balloons of 14 patients remain in the stomach, we removed the balloons of 4 patients. The average age and BMI of 4 patients were 40.0±14.2 years, 38.8±2.9 kg/m² at the balloon placement. In one of 4 patients, the balloon was deflated in 9 months after the IGB placement, but other 3 patients could be placed for 1-year without deflation. The average weight loss and percent excess weight loss at the balloon removal of 4 patients were 12.5±9.8 kg and 42.5±32.3%. We have no severe complications.
Conclusion Orbera365® IGB was effective for reducing weight. However, more cases are necessary to confirm the efficacy and safety of Orbera365® IGB.