June 4, 2018
Apollo Endosurgery, Inc. (“Apollo”) (Nasdaq:APEN), a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, announced Digestive Disease Week presentation of a meta-analysis that concluded fluid-filled balloons, like the ORBERA® Intragastric Balloon, have superior weight loss results to gas-filled balloons.
This meta-analysis reviewed twenty-one (21) randomized clinical trials with 877 patients, including trials for all three FDA-approved intragastric balloons and assessed weight loss metrics at 6 and 12 months (6 months after balloon removal). The study was led by physicians at the Mayo Clinic (Rochester, MN), Massachusetts General Hospital (Boston, MA) and Digestive Center for Diagnosis & Treatment (Damascus, Syrian Arab Republic).
The study showed fluid-filled balloons resulted in 60% more total body weight loss at 6 months compared with gas-filled balloons, with SUCRA (Surface Under the Cumulative Ranking) probabilities demonstrating superiority of liquid-filled intragastric balloons at all time points. ORBERA had the highest average weight loss of any of the intragastric balloons included in the meta-analysis.
The authors attributed the greater weight loss with ORBERA and fluid filled balloons to their impact on the gastric emptying process. The authors theorize that the gas-filled balloons are less effective because of their “inability to significantly delay gastric emptying.” The authors also reported that all balloon types are associated with similar adverse events although fluid-filled balloons maybe associated with more symptoms and worse tolerance given their more pronounced impact on gastric emptying.
“Gastric emptying is the key to how ORBERA helps patients lose weight. When a patient has an ORBERA balloon in their stomach it acts like a valve that slowly allows food they eat to pass through their stomach. Without a balloon a normal meal will typically pass through a patients stomach in 20-30 minutes. Now with an ORBERA balloon in their stomach, we have data that a large portion of that meal would still be in their stomach 2 hours after eating. This delayed emptying helps patients feel full, helps them learn proper portion control and most importantly helps them lose a clinically significant amount of weight,” said Dr. Christopher Gostout, MD, Chief Medical Officer at Apollo.
The abstract for this study can be found here.