A peer-reviewed, evidence-based journal that promotes clinical development and metabolic insights in total bariatric patient care for the healthcare professional
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14 Emerging Technologies Bariatric Times • March 2016 reflux were the most common adverse events at 33.7 percent, 29 percent, and 18.3 percent, respectively. Early removal rate was 7.5 percent. There is one article reporting international data on the dual intragastric balloon system. 10 Lopez- Nava et al examined the effectiveness of the dual intragastric balloon among 60 patients (11 men, 49 women) with obesity (initial BMI of 38.8kg/m 2 ) that underwent endoscopic placement of a dual intragastric balloon filled with a total of 900cc of saline (450cc in each balloon). Study participants had the balloon system in place for at least six months and received regular counseling from a multidisciplinary team. The authors observed a mean EWL of 47.1 percent and a decrease in mean BMI from 38.8kg/m 2 to 32.7kg/m 2 . On average, patients lost 15.4 percent of their initial body weight, and the rate of early balloon removals for intolerance was two percent. UNITED STATES EXPERIENCE The Orbera Intragastric Balloon System was approved by the FDA on August 5, 2015, based on the US pivotal study. 11 In this randomized, multicenter clinical trial for adults with a body mass index of 30 to 40kg/m 2 , patients were split between the Orbera Intragastric Balloon System with lifestyle modification arm and the lifestyle modification only arm. A total of 273 patients were randomized across the two groups with 137 ReShape ® Integrated Dual Balloon Orbera ™ Intragastric Balloon F IGURE 1. Placement. Step 1. Place uninflated b alloons FIGURE 2. Placement. Step 2. I nflate proximal and distal balloon FIGURE 3. Removal. Step 1. Puncture and aspirate balloons FIGURE 4. Removal. Step 2. Remove with loop snare FIGURE 5. Placement. Step 1. Place uninflated balloon FIGURE 6. Placement. Step 2. Inflate balloon Removal. Step 1. Punctured for fluid aspiration FIGURE 7. Removal. Step 2. Remove with a retrieval-grasping tool F IGURE 8. Rhodes Index for R eShape balloon- treated p atients Adapted from Ponce J, Woodman G, Swain J, et al. The REDUCE pivotal trial: a prospective randomized controlled pivotal trial of a dual intragastric balloon for the t reatment of obesity. Surg Obes Relat Dis. 2015;11:874–881. FIGURE 9. Abdominal Pain VAS scores for ReShape balloon- treated patients Adapted from Ponce J, Woodman G, Swain J, et al. The REDUCE pivotal trial: a prospective randomized controlled pivotal trial of a dual intragastric balloon for the treatment of obesity. Surg Obes Relat Dis. 2015;11:874–881.