UPDATED: FDA approves first weight-loss balloon, giving the obese a minimally invasive option
ReShape Medical®’s Integrated Dual Balloon System just burst regulatory barriers, becoming the first device of its kind to earn the FDA’s stringent PMA approval for novel, high-risk devices. The Fierce 15 company’s device consists of two salt water-filled silicon balloons that reduce appetite by taking up space in the stomach “or by other mechanisms that are not yet fully understood,” according to the FDA.
Indeed, the Dual Balloon is a new treatment paradigm in the fight against obesity, which includes just three other FDA-approved devices.
“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,” said Dr. William Maisel, acting director of the Office of Device Evaluation at the FDA’s device arm (CDRH), in a statement. “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.”