Apollo Endosurgery, Inc. has started its U.S. post-approval study of the ORBERA intragastric balloon, a medical device used to assist adult patients suffering from obesity in losing and maintaining weight. The first patient in the study was enrolled earlier this month in New Orleans.
ORBERA is an incision-less, non-surgical weight loss procedure designed for adult patients suffering from obesity, who are not appropriate for or considering invasive surgery, but for whom diet and exercise or pharmaceutical interventions have not worked.
In a non-surgical (endoscopic) procedure, the thin and deflated ORBERA balloon is placed into the stomach. It is then filled with saline until it’s about the size of a grapefruit. The procedure typically takes about 20 to 30 minutes and the patient can generally go home the same day. At six months, through another non-surgical procedure, the balloon is deflated and then removed.
Once the balloon is in place, the patient receives an individually tailored support program to help keep them motivated, coordinate their program and help them work through weight loss barriers to meet their long-term weight loss goals.
Coaching takes place over 12 months, even though the balloon is removed after six months. The program is designed to help the patient develop sustainable, healthy habits that will help keep weight off over time.
The post-approval study is a prospective, multicenter, open-label study designed to demonstrate the safety and effectiveness of the device as an adjunct to weight reduction for obese adults 22 years of age and older with a Body Mass Index (BMI) of ≥ 30 kg/m2 and BMI ≤ 40 kg/m2. The study will involve approximately 255 subjects at up to 20 U.S. sites.
The pivotal U.S. clinical trial first announced in May 2015 was a multicenter, prospective, randomized, non-blinded comparative study where a total of 255 patients suffering from obesity with a BMI between 30 and 40 were randomized to treatment or control in a 1:1 ratio.
The treatment group (125 patients) underwent placement of the ORBERA balloon followed by removal after six months. They concurrently participated in a 12-month behavioral modification program. The control group (130 patients) participated in the 12-month behavioral modification program alone.
Detailed findings from the trial include:
- At month six, the treatment group achieved a mean of 38.4 percent excess weight loss
- Mean total body weight loss at six months was 10.2 percent for the treatment group compared to 3.3 percent total body weight loss for the control group
- The treatment group lost 3.1 times as much weight as the control group at six months
- The treatment group also 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
The U.S. Food and Drug Administration approved the ORBERA intragastric balloon in August 2015. More than 220,000 ORBERA balloons have been distributed worldwide in more than 80 countries.