AMERICAN SOCIETY FOR METABOLIC AND BARIATRIC SURGERY VIEWS NEW BALLOON DEVICE FOR OBESITY AS BRIDGE BETWEEN MEDICATIONS AND BARIATRIC SURGERY
GAINESVILLE, FL – July 29, 2015 – The U.S. Food and Drug Administration (FDA) yesterday approved a new balloon device called the ReShape Integrated Dual Balloon System, that may help fill a treatment gap between medications and surgery for people with obesity and one or more obesity-related conditions, according to the American Society for Metabolic and Bariatric Surgery (ASMBS), the nation’s largest organization for bariatric surgeons.
“I am pleased and gratified that after careful review the FDA has approved this new device for the treatment of patients with obesity or body mass index (BMI) of 30 to 40. We are at the dawn of a new age in obesity treatment with the addition of this safe and effective treatment option,” said John M. Morton, MD, MPH, president of the ASMBS and director of the Bariatric and Metabolic Inter-Disciplinary (BMI) Clinic at Stanford Health in California. “Much like cardiac disease, we are seeing demonstration of the full continuum of care for obesity from primary prevention and FDA-approved medications to the endoscopic ReShape Dual Balloon to established, effective bariatric surgery procedures. The ReShape Dual Balloon offers a bridge between medications and surgery similar to a cardiac stent in cardiac disease.”