Recently-Approved Devices > ReShape Integrated Dual Balloon System - P140012
The FDA has recently approved the ReShape Integrated Dual Balloon System to be marketed. The ReShape Integrated Dual Balloon System (Reshape Dual Balloon) is a weight-loss system of gastric balloons that occupy space in the stomach. The system consists of two attached balloons that are filled and sealed separately. The balloons are placed into the stomach through the mouth using a minimally invasive endoscopic procedure while the patient is under mild sedation. Once in place, the balloons are filled with about 2 cups of salt water (saline) and a blue dye (methylene blue). If a balloon breaks, blue dye will appear in the patient’s urine. When it is time to remove the balloons, they are first deflated then removed using another endoscopic procedure.