Apollo Endosurgery, Inc. announced the presentation of the largest global review of intragastric balloons titled “Brazilian Intragastric Balloon Consensus after more than 40,000 cases” at ObesityWeek 2017 – the combined annual meetings for both American Society for Metabolic & Bariatric Surgery (ASMBS) and The Obesity Society (TOS).
According to the company, this presentation reported the results of a consensus meeting held in Sao Paulo, Brazil in June 2016 of 39 endoscopists with up to 17 years of experience providing intragastric balloon therapy to patients. The group aggregated retrospective data on their experience with intragastric balloons in over 40,000 cases. The expert meeting was held to discuss and evaluate clinical and technical aspects of intragastric balloons (indications, contraindications, techniques, adverse events, multidisciplinary follow-up) with the aim of reaching a consensus on best practice guidelines based on scientific literature and their extensive experience. The threshold for inclusion in the meeting was a minimum experience of 300 intragastric balloon procedures.
Key data reported encompassed experience from 41,886 intragastric balloon procedures conducted by the endoscopists:
- Mean percentage total body weight loss of all patients was 18.4% (+/- 2.9%).
- ORBERA® was used in 78.2% (32,753) of the reported intragastric balloon procedures.
- Adverse event rate after the adaptation period was 2.5%, the most common being hyperinflation and device deflation.
- Of the five types of intragastric balloons discussed, ORBERA had the lowest incidence of adverse events at 2.0%.
- Early removal rate due to intolerance was 2.2%.
- There were twelve (<0.03%) deaths during the presence of an intragastric balloon, of which three (<0.01%) were considered device related.
Dr. Manoel Galvao Neto, lead author of the study and Clinical Associate Professor of Surgery at Florida International University and Coordinator of the Esophaegeal Motility Lab at Hospital Estadual Mario Covas in São Paulo, Brazil. notes, “The Brazilian market has been one of the pioneers in intragastric balloon therapy and is today very advanced with over 40,000 patient experiences represented by those in attendance at the consensus.” He adds, “The majority of the experience is with ORBERA and our conclusion was that intragastric balloons such as ORBERA lead to very satisfactory weight loss and a very low rate of adverse events.”
“This is a remarkable study that captures the experience of physicians who collectively have placed more than 40,000 intragastric balloons, the vast majority with our ORBERA balloon,” reported Todd Newton, CEO of Apollo Endosurgery. “To our knowledge, it is the first of its kind regarding intragastric balloons and the results reinforce the very strong safety and efficacy profile of ORBERA.”
The full peer-reviewed manuscript of this study titled “Brazilian Intragastric Balloon Consensus (BIBC): practical guidelines based on experience of over 40,000 cases” was recently accepted for publishing by Surgery for Obesity and Related Diseases (“SOARD”), which is the official scientific journal of the American Society for Metabolic and Bariatric Surgery (“ASMBS”).