Obesity is a health challenge for millions of Americans, but until recently, there have been few therapies and no non-surgical treatments available for these patients. Several companies have been chasing FDA approval for a device treatment that does not require invasive surgery, but ReShape Medical was the first to secure U.S. approval. In late July, FDA approved the ReShape Integrated Dual Balloon System for adults with a body mass index (BMI) of 30-40 kg/m2 who don’t want or are not indicated for bariatric surgery.
The ReShape Dual Balloon does not require surgery, but instead is placed using an endoscope that is inserted into the mouth and threaded down to the patient’s stomach. Once the Dual Balloon is placed in the stomach, it is filled with salt water and left in place for six months. This helps patients feel fuller with less food. While the balloon is in place, patients receive counseling to help encourage healthy lifestyle choices. This coaching continues for another six months after the device is removed.
According to ReShape Medical, a European study showed that ReShape patients had 47% excess weight loss and kept 98% of that weight off at one year following treatment. The company also cites a study that showed ReShape patients lose twice as much as their peers who only received counseling support.
ReShape is now commercially available. While the device’s approval was notable as the first non-surgical option, it was soon followed by FDA approval of another balloon—the ORBERA Intragastric Balloon System from Apollo Endosurgery.
[Image courtesy of RESHAPE MEDICAL]