FDA approves nonsurgical balloon device for bariatric patients

Editor's Note

The Food and Drug Administration on July 28 approved a new balloon device to treat obesity without the need for a surgical procedure.

The ReShape Integrated Dual Balloon System (ReShape Medical Inc, San Clemente, California) is inserted into the stomach endoscopically and then filled with saline. Patients are mildly sedated during the procedure, which takes less than 30 minutes.

The balloon works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not fully understood, the FDA says.

The U.S. Food and Drug Administration today approved a new balloon device to treat obesity without the need for invasive surgery. The ReShape Integrated Dual Balloon System (ReShape Dual Balloon) is intended to facilitate weight loss in obese adult patients.