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.
Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary, If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision.