FDA approves ReShape Medical®’s weight loss treatment
Weight loss company ReShape Medical won FDA premarket approval for its ReShape Dual Balloon system, indicated to facilitate weight loss in obese adult patients, according to an FDA release.
The system is designed to be inserted endoscopically into the stomach, where it remains for 6 months to help patients feel full, San Clemente, Calif.-based ReShape said. The balloon is meant to be temporary and patients with the device receive supervised diet and exercise plans to maintain weight loss following its removal, according to ReShape.
“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,” FDA Office of Device Evaluation acting director Dr. William Maisel said in a press release.