FDA Okays Obesity Balloon Device Belly balloon is latest in a flood of new obesity therapeutics The FDA has approved a gastric balloon to treat obesity, adding to a fat-busting device arsenal that includes gastric banding and a vagal nerve stimulator. The ReShape dual balloon system is indicated for obese adults who have a body mass index (BMI) of 30 to 40, and at least one other obesity-related comorbidity such as hypertension, high cholesterol, or diabetes. It's placed into the stomach using an endoscope, and once it's inflated it is meant to diminish obesity by triggering feelings of fullness, "or by other mechanisms that are not yet understood," according to the FDA press release.
The outpatient procedure takes less than 30 minutes, according to the agency, which noted that the temporary device should be removed 6 months after insertion. In a 326-patient clinical trial, patients on…
