Apollo Endosurgery has presented the results of Orbera pivotal trial at the Digestive Disease Week (DDW) 2015 conference in Washington, DC., US.
According to the company, the study demonstrated that Orbera Intragastric Balloon users lost significantly more weight than the control group.
The Mayo Clinic gastroenterologist and advanced endoscopist Dr Barham Abu Dayyeh said: "At the completion of the study, it was clear that the Orbera Intragastric Balloon produced significant weight loss and quality of life benefits, when compared to the study’s control group.
"The results of this study prove that Orbera can be an outstanding tool to aide weight loss and support sustainable, healthy habits, even after it has been removed."
The multicenter, prospective, randomized and non-blinded comparative study included obese patients with a BMI between 30 and 40. They were randomized to treatment or control in a 1:1 ratio.
Apollo randomized 125 patients to the treatment group that underwent placement of the Orbera and 130 patients to the control group, while 78.4% of treatment group and 71.5% of control group completed the full study at week 52.
Apollo noted that Orbera group lost significantly more weight than the control group over the course of the study and was able to maintain significant weight loss through month 12, six months after removal of the device.