ReShape starts gastric balloon study
This article was originally published in Clinica
Executive Summary
ReShape Medical (San Clemente, California) has begun a US trial of its gastric balloon device under an Investigational Device Exemption (IDE). The trial will assess the safety and effectiveness of the non-surgical, dual-balloon device in aiding weight loss. ReShape Balloons occupy space in the stomach to reduce its capacity for food. The balloons remain in place for six months and are then removed. They are designed for overweight patients who can’t or won’t undergo surgery. The placement procedure does not involve general anaesthesia and takes around 15 minutes.