WASHINGTON (AP) — Federal health regulators on Tuesday approved an inflatable medical balloon that aids weight loss by filling up space in the stomach.
The Food and Drug Administration cleared Reshape Medical’s balloon as another option for millions of obese Americans who have been unable to lose weight via more traditional methods.
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The FDA previously approved another balloon device for weight loss but it was withdrawn in 1992 due to a safety issue in which the balloon could rupture and block patients’ arteries.