The Medical Letter on Drugs and Therapeutics
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1476
August 31, 2015
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ReShape and Orbera - Two Gastric Balloon Devices for Weight Loss
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August 31, 2015 (Issue: 1476)
Revised 8/15/17: See adverse effects, last paragraph

The FDA has approved the ReShape Integrated Dual Balloon System (ReShape Medical) and the Orbera Intragastric Balloon System (Apollo Endosurgery) for up to 6 months of use in adults with a BMI of 30-40 who have not been able to maintain weight loss with a weight loss program and, for ReShape, who have at least one obesity-related comorbidity. Both devices have been available in the European Union and elsewhere for years (20 years for Orbera). Three other devices, the LAP-Band, the Realize adjustable gastric band, and the Maestro Rechargeable System, are FDA-approved for long-term treatment of obesity.1

THE DEVICES — The ReShape Dual Balloon device consists of two silicone balloons attached to a central silicone shaft. The balloons are placed in the stomach endoscopically and inflated with a ... more      

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