ReShape Dual Balloon helping patients to achieve life-changing weight loss without surgery…
A new non-surgical weight loss option is now available. The FDA has approved ReShape Integrated Dual Balloon System which is the first non-surgical weight loss procedure for people with mild-to-moderate obesity.
ReShape is a dual balloon mounted on a flexible shaft that is inserted endoscopically in the stomach and filled with saline. It works by restricting food intake and slowing gastric emptying. Insertion is done during a 30-minute outpatient procedure and the balloon remains in the stomach for six months where it mimics the natural curvature of the stomach to enhance tolerability. The dual balloon structure is designed to minimize the risk of migration or obstruction in the unlikely event of a balloon leakage or deflation. Comprehensive counseling and support services such as in-office sessions will be provided to patients during the six months of treatment and for six months after it is removed.
It is intended for adults with a BMI of 30-40 kg/m2 who have one or more obese-related health conditions such as hypertension, dyslipidemia, or diabetes and have had unsuccessful weight loss with diet and exercise alone.
The device should not be used in patients who are pregnant or using aspirin daily, who have previous GI or bariatric surgery or in patients who have been diagnosed with inflammatory bowel disease, large hiatal hernia, or symptoms of delayed gastric emptying or active H. Pylori infection.
Patients may experience vomiting, nausea, abdominal pain, gastric ulcers, and feelings of indigestion once the device is in the stomach. Intestinal obstructions have been reported due to deflated balloons passing into the intestines and have required surgical removal. Death due to intestinal obstruction is possible and has been reported with other intragastric balloons.
In the REDUCE clinical trials (n=326), obese patients who had the ReShape Balloon procedure lost 14.3 pounds compared to the control group, which lost 7.2 pounds on diet and exercise alone. The results showed a 2.3 times greater weight loss in the ReShape group compared to the control group. Six months after the balloon was removed, patients treated with ReShape Balloon kept off an average of 9.9 pounds of the 14.3 pounds they lost. The study also showed significant and sustained improvements in co-morbidities through the six-month treatment, and these improvements continued for an additional six months after the Dual Balloon was removed, which included reductions in triglycerides, high and low density lipoproteins, systolic and diastolic blood pressures, waist and hip circumferences, as well as high patient satisfaction.
- For adults with a BMI of 30-40 kg/m2 who have one or more obese-related health conditions such as hypertension, dyslipidemia, or diabetes and have had unsuccessful weight loss with diet and exercise alone.
- Six months after the balloon was removed, patients treated with ReShape Balloon kept off an average of 9.9 pounds of the 14.3 pounds they lost.
- REDUCE trials showed a 2.3 times greater weight loss (14.3 pounds vs 7.2 pounds) in the ReShape group compared to control group placed on diet and exercise alone.
Han, Da Hee. “New Balloon Device Approved To Treat Obesity.” Monthly Prescribing Reference (MPR). Haymarket Media, Inc, 29 July 2015. Web. 30 July 2015.