Apollo Endosurgery Inc, a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, today announced completion of enrollment in the ORBERA® Post Approval Study evaluating the ORBERA intragastric balloon.
The ORBERA Post Approval Study is a multi-center, open-label, prospective study of the safety and efficacy of the ORBERA system within the US. The study was a requirement of the US FDA’s approval of ORBERA in August of 2015. The study has enrolled 281 patients across 11 centers.
The endpoints include the patient’s percentage of total body weight loss at 26 weeks and 12 months after balloon placement and the rate of adverse events at 26 weeks, the indwell time allowed for the balloon. This study includes 12 months of follow-up after balloon placement: six months with the balloon and an additional six months of follow-up after the balloon’s removal. Patient follow up and final study results are expected in early 2020.