Clinical safety and effectiveness of a swallowable gas-filled intragastric balloon system for weight loss: consecutively treated patients in the initial year of U.S. commercialization

Surgery for Obesity and Related Diseases : Official Journal of the American Society for Bariatric Surgery
Rachel L MooreShelby Sullivan

Abstract

Obesity is the most common chronic disease in the United States today. Additional therapies are needed to improve obesity treatment. A swallowable, gas-filled intragastric balloon system was approved for the treatment of obesity by Food and Drug Administration in September 2016 and commercialization started January 2017. A registry was made available to physicians to capture evidence of safety and effectiveness with use. United States private clinics, surgery centers, and hospitals. This study is a retrospective analysis of a prospective registry of patients with body mass index (BMI) ≥25 kg/m2 that initiated therapy in the first year. Data on demographics, procedural timing, weight loss, adverse events, and device deficiencies were captured. The final analysis comprised 1343 patients across 108 treating physicians (mean age 45.7 ± 10.8 yr, 78.6% female, baseline BMI of 35.4 ± 5.4 kg/m2). Nonserious and serious adverse events were reported in 14.2% and .15% of patients, respectively. There were 7 balloon deflations, none caused obstruction. Weight loss in the indicated use (BMI 30-40 kg/m2) was 9.7 ± 6.1 kg and 10.0 ± 6.1% total body weight loss (TBWL). Weight loss in other BMI categories was 8.2 ± 5.6 kg or 10.3 ± 7.0% total b...Continue Reading

Citations

Feb 19, 2020·The American Journal of Gastroenterology·Shelby SullivanMatthew Kroh
Jun 5, 2020·Current Obesity Reports·Christine StierBarham Abu Dayyeh
Apr 10, 2019·Current Treatment Options in Gastroenterology·Joshua A Turkeltaub, Steven A Edmundowicz
Oct 22, 2020·Asian Journal of Endoscopic Surgery·Masayuki OhtaSeigo Kitano
Feb 12, 2021·Minimally Invasive Therapy & Allied Technologies : MITAT : Official Journal of the Society for Minimally Invasive Therapy·Lyz Bezerra Silva, Manoel Galvão Neto
Mar 21, 2020·Techniques in Vascular and Interventional Radiology·Leena Khaitan, Brian Shea
Mar 22, 2021·The Surgical Clinics of North America·Michael J Klingler, Matthew Kroh
Apr 10, 2021·Gastroenterology·Raj ShahM Hassan Murad
Apr 13, 2021·The American Journal of Gastroenterology·Pichamol Jirapinyo, Christopher C Thompson

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