Apollo Endosurgery has received approval from the US Food and Drug Administration (FDA) for its Orbera Intragastric Balloon, a non-surgical solution developed to help patients in weight loss.
The new incision-less and non-surgical weight loss solution will help adult patients suffering from obesity, with a body mass index (BMI) of 30 to 40, to lose and maintain weight.
The new ballon is part of the Orbera Managed Weight Loss System, a comprehensive and non-surgical two-part program that includes a balloon filling space in a patient’s stomach to reinforce proper portion control.
Apollo Endosurgery CEO Todd Newton said: "While new to the United States, Orbera is a weight loss device with more than 220,000 balloons distributed in over 80 countries and approximately 230 published papers documenting its clinical results."
Apollo conducted the US pivotal Orbera clinical trial, which is a multicenter, prospective, randomized and non-blinded comparative study that included patients suffering from obesity with a BMI between 30 and 40 in a 1:1 ratio.
In the trial, around 125 patients were randomized to the treatment group and 130 patients were randomized to the control group.
The treatment group experienced placement of the Orbera balloon followed by removal after six months and they concurrently involved in a 12-month behavioral modification program.
The control group solely participated in the 12-month behavioral modification program and for patients in the treatment group, the device was removed at month six with regular office visits continuing through one year.
According to the firm, the trial demonstrated that the average person lost 3.1 times the weight as compared with diet and exercise alone within six months.
Image: Orbera Intragastric Balloon. Photo: courtesy of Business Wire.