Federal health regulators say they have approved an inflatable medical balloon that helps patients lose weight by filling up space in the stomach.
The Food and Drug Administration cleared Reshape Medical’s balloon system to treat obesity in adults.
The balloon is inserted into the stomach using an endoscope and then filled with saline solution. Patients are sedated during the procedure, which takes less than 30 minutes, according to an FDA release.
The FDA previously approved another balloon device for weight loss but it was withdrawn in 1992 due to a safety issue in which the balloon could rupture and block patients’ arteries.
Weight loss balloons are an alternative approach to gastric banding devices like the LAP-Band, which shrink the size of the stomach but can also cause infection and nausea.
Filed Under: Industry regulations
