The US Food and Drug Administration has approved the Orbera Intragastric Balloon System (Apollo Endosurgery) as a weight-loss device.
The system deposits a balloon in the stomach, through the mouth, via a minimally invasive endoscopic procedure with the patient under mild sedation, a process that takes around 30 minutes, according to the manufacturer.
Once in place, the silicon balloon is filled with up to 500 cc of saline so that it expands and induces a feeling of satiety. The maximum placement period is 6 months, after which it is deflated and removed.
The system is indicated as an adjunct to weight reduction for obese adults with body mass index of 30 to 40 kg/m2 who have been unable to lose weight through diet and exercise. It is to be used in conjunction with a long-term supervised diet and behavior-modification program, which are to be continued after device removal.
Data on the use of the system in 125 individuals with BMI 30 to 40 kg/m2 were presented earlier this year at Digestive Disease Week 2015. The participants lost an average of 22 pounds (10%) of their body weight after the balloon had been in place for 6 months and maintained 19 pounds of that weight loss 3 months after it was removed.
By contrast, 130 people who received a 12-month behavior-modification program but did not receive the balloon lost an average of just 7.0 pounds (3% of their body weight).
Serious adverse events were more common in the balloon group than in the control group (9.6% vs 7.0%). Nausea, vomiting, and abdominal pain were occasionally reported but were manageable. No deaths occurred. Early explantation was requested by 22% of the patients.
Approval of the Orbera comes just a little over a week after the FDA approved a similar device, the ReShape Dual Balloon (ReShape Medical).
Both devices have been available outside the United States, the ReShape since 2011 and Orbera for over 20 years.
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Cite this: FDA Approves Another Balloon Device for Weight Loss - Medscape - Aug 07, 2015.