A recent review conducted by the American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee evaluated therapeutic endoscopic technologies for obesity treatment, including the ORBERA Intragastric Balloon from Apollo Endosurgery in Austin, Texas. The review was published in the journal Gastrointestinal Endoscopy and is entitled “ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies.”
Obesity is a serious public health problem worldwide, and its burden and associated comorbidities require urgent treatment measures. Endoscopic bariatric therapies (EBT) are an effective and minimally invasive therapeutic approach for weight loss and reduction of obesity-related comorbidities. EBTs can be based on several mechanisms of action such as gastric restriction or manipulation, malabsorption and neuro-hormonal alterations.
“Endoscopic bariatric therapies offer a viable, safe alternative for patients who have been unsuccessful at weight loss with diet and exercise. They may also be appropriate for patients who are not suitable for, or are unwilling to undergo, a more invasive surgical procedure,” explained the chair of the ASGE Bariatric Endoscopy Task Force Dr. Christopher C. Thompson in a news release.
The U.S. Food and Drug Administration have recently approved two new EBT for obesity: the ReShape Integrated Dual Balloon System, approved on July 29, and the ORBERA Intragastric Balloon, approved on August 6.
“The ASGE is pleased that the FDA has approved these new devices and looks forward to providing the support and education that will allow our members to use these devices as part of a multidisciplinary weight management program in patients with obesity,” said the ASGE President Dr. Douglas O. Faigel. “Gastrointestinal endoscopists will have an important role to play in combatting this difficult and growing epidemic.”
In the study, EBTs were reviewed based on diagnostic/therapeutic thresholds defined in 2012 as part of the Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) initiative.
Researchers found that EBTs can be an effective treatment option for obese patients, and that they are most beneficial when incorporated in a multidisciplinary treatment program. The ORBERA device in particular was found to meet or even exceed the PIVI efficacy thresholds, namely by inducing a mean minimum of 25% excess weight loss 12 months after the intervention, and a total body weight loss of at least 5% (in fact it was of 11.27% 12 months after the device implantation). Importantly, the ORBERA Intragastric Balloon had an incidence of serious adverse events that was equal or lower than 5% as established by PIVI as an acceptable safety profile. These conclusions were drawn based on a number of studies comprising in total 1,683 patients.
Intragastric balloon devices such as the ORBERA are composed of one or more balloons that are introduced in the patient’s stomach through the mouth using a minimally invasive endoscopic procedure while the patient is under mild sedation. The balloons help patients feel full quicker so that they eat smaller amounts and limit caloric intake.
The research team concluded that the ORBERA device meets the PIVI criteria and that it can therefore be considered a useful resource in the management of obesity. The authors recommend that EBT should be performed as part of a comprehensive, multidisciplinary treatment program that also includes nutritional support, behavioral medicine and nursing care, among other components important for obesity management.