New Balloon Device Approved to Treat Obesity
The Food and Drug Administration (FDA) has approved ReShape Integrated Dual Balloon System, the first non-surgical weight loss procedure for people with mild-to-moderate obesity.
The ReShape Balloon is intended for adults with a body mass index (BMI) of 30–40kg and one or more related health conditions (eg, hypertension, high cholesterol, diabetes) who have been unsuccessful with diet and exercise alone, and do not want or are unqualified for bariatric surgery.
The dual balloon mounted on a flexible shaft is placed endoscopically in the stomach and filled with saline during a 30-minute outpatient procedure. It remains in the stomach for six months and conforms to the natural shape of the stomach, not altering its anatomy. During therapy and for six months after it is removed, patients receive comprehensive counseling and support services including in-office coaching sessions. The ReShape Balloon is designed to reduce the potential for a deflated balloon to travel from the stomach into the intestines.
In the REDUCE clinical trial (n=326), obese patients that had the ReShape Balloon procedure lost 2.3 times as much weight as the control group that only received diet and exercise coaching (14.3 pounds vs. 7.2 pounds). Six months after the balloon removal, patients treated with the ReShape Balloon kept off an average of 9.9 pounds of the 14.3 pounds they lost. The study also demonstrated measurable and sustained improvements in comorbidities as well as strong patient satisfaction.
The ReShape procedure will be available first in select markets following clinicians' training and support programs.
For more information call (844) YES-RESHAPE or visit ReShapeReady.com.