FDA clears ReShape Dual Balloon system for obesity treatment in adults
ReShape Medical® has received clearance from US Food and Drug Administration (FDA) to market ReShape Integrated Dual Balloon system for the treatment of obesity in adult patients with a body mass index between 30kg/m² and 40kg/m².
Also called ReShape Dual Balloon, the device is intended to facilitate weight loss in obese adult patients by occupying space in the stomach that may trigger feelings of fullness, or by other mechanisms that are not yet understood.
FDA Centre for Devices and Radiological Health Office of Device Evaluation acting director William Maisel said: “For those with obesity, significant weight loss and maintenance of that weight loss often requires a combination of solutions, including efforts to improve diet and exercise habits.
“This new balloon device provides doctors and patients with a new non-surgical option that can be quickly implanted, is non-permanent and can be easily removed.”