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.
The device is meant to be an alternative to invasive surgical weight loss procedures, ReShape Medical CEO Richard Thompson told MassDevice.com earlier this year.
“What’s particularly different about our type of therapy is there’s a feedback mechanism going on here. The patient eats a small meal, feels full, loses weight. The next day they eat a small meal, they feel full, they lose weight. Using behavior modification therapy and diet and exercise counseling you can really cement that relationship,” Thompson said in an interview.
In April, the FDA waived a requirement that ReShape appear before an advisory committee for its premarket approval application, according to a MassDevice.com interview with Thompson.
In February, the company closed a nearly $7 million funding round with existing internal investors, according to an SEC filing. ReShape Medical has raised more than $46.5 million since its inception.
Last fall ReShape released results from its Reduce US pivotal trial that it said showed patients with the device lost 2.3 times more weight than patients using just diet and exercise.