Apollo Endosurgery has announced that the FDA has completed the review of the final Post-Approval Study (PAS) Report for the ORBERA Intragastric Balloon System and accepted that all post-approval study requirements have been fulfilled. The ORBERA Post Approval Study was a requirement following the US FDA's approval of ORBERA in August of 2015. The study was a multi-centre, open label, prospective study with a primary safety endpoint and its secondary endpoint being effectiveness. All study endpoints were successfully met.
According to the company, the ORBERA Intragastric Balloon System is an incision-less, non-surgical weight loss solution designed for adult patients suffering from obesity, who are not appropriate for or considering surgery, but for whom diet and exercise or pharmaceutical interventions have not worked. During the procedure, the thin and deflated ORBERA balloon is placed into the stomach. It is then filled with saline and the patient can generally go home a few hours later. After up to six months, through another non-surgical procedure, the ORBERA balloon is deflated and then removed.
Once the balloon is in place, the patient works with their physician and their staff in a formal lifestyle modification programme to meet their long-term weight loss goals. Coaching takes place over 12 months while the balloon is in place. The program is designed to help the patient develop sustainable, healthy habits that will help keep weight off over time.
Notable PAS statistics include:
11 Study Sites
258 Patients with BMI between 30-40 at the time of their enrolment
Serious Adverse Event (SAE) rate for the study was 8.9%
Primary endpoint of the study was a SAE rate of less than 15%
ORBERA's pivotal trial SAE rate was 9.6%
Total Body Weight Loss (TBWL) results of patients in the study was 12.5%
Secondary endpoint of the study was TBWL at time of balloon removal of at least 7.5%
TBWL at the time of balloon removal in the ORBERA pivotal study was 10.2%
No risks outside of ORBERA's Direction-for-Use were identified by the study.
There were no instances of death, gastric perforation, bowel obstruction or acute pancreatitis. The most common SAE were nausea and vomiting, which tended to resolve within the first month after placement.
"As anticipated, the conclusion of the ORBERA post approval study confirms the impressive, medically-relevant weight loss from ORBERA that physicians can expect for their patients with underlying medical conditions that require them to lose up to 10% of their total body weight,” said Dr Christopher Gostout, Chief Medical Officer at Apollo Endosurgery. “The study also confirms a predictable safety result for properly selected and managed patients. The ORBERA balloon is the most studied intragastric balloon globally and the post approval study results are very consistent with ORBERA's long-standing published literature from Europe, Latin America and Asia Pacific regions.”