Recent Device Approvals: ORBERA™ Intragastric Balloon System

The FDA has recently approved the ORBERA™ Intragastric Balloon System to be marketed. The ORBERA Intragastric Balloon System is a weight-loss system that uses a gastric balloon that occupies space in the stomach. The balloon is placed into the stomach through the mouth, using a minimally invasive endoscopic procedure, while the patient is under mild sedation. Once in place, the balloon is filled with salt water (saline) so that it expands into a spherical shape. The balloon can be filled with different amounts of saline (from 400 to 700 cc) to best match the patient’s body structure.