Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approval of Intragastric Balloon System

Device assists adults with weight management

Indications: The ORBERA Intragastric Balloon System is indicated for adult obese patients who have a body mass index (BMI) of 30 to 40 kg/m2 who have been unable to lose weight through diet and exercise.

Mechanism of action: The temporary system is placed into the stomach through the mouth, helps patients lose weight and should be removed after 6 months.

Efficacy and safety: In a clinical trial, 255 patients who used the system lost an average of 22 pounds. The device should not be used in patients who already have an intragastric balloon, have had prior gastrointestinal or bariatric surgery, or have any inflammatory disease of the GI tract.

Citation: FDA website. ORBERA intragastric balloon system. Updated August 6, 2015. Accessed August 11, 2015.

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