FDA approves ReShape Integrated Dual Balloon System
ReShape Medical® has received FDA approval for its ReShape Integrated Dual Balloon System, a first-of-its-kind non-surgical weight loss procedure for people with mild to moderate obesity. The ReShape Procedure provides a new option for adults with a BMI 30-40 with a related comorbidity who have been unsuccessful at diet and exercise alone, and do not want or do not qualify for bariatric surgery.
“Many Americans who face the risk and consequences of obesity have struggled with a lack of effective weight loss options when their BMI is in the 30-40 range,” said Dr John Morton, President of the American Society for Metabolic and Bariatric Surgery. “Options like ReShape address a significant gap that exists between diet and exercise, weight loss medications and surgery, offering a minimally invasive, reversible option which we hope will promote long-term healthy habits.”