The procedure is limited to patients who suffer from mild to moderate obesity with a BMI of 30-40 and a related health condition who haven’t succeeded at diet and exercise alone and do not want or qualify for bariatric surgery, according to a press release.
“For years, a significant gap has existed in treatment options for obesity with limited, effective therapies available,” said Dr. Zeid Keilani, bariatric surgeon with Palmetto Health. “We often see patients who are clinically obese and in desperate need of medical intervention to help them lose weight, when diet and exercise alone have failed and surgery is not an option. This provides the group of ‘in-between’ patients with access to a nonsurgical, reversible option to encourage new habits and lasting results.”
The ReShape dual balloon is inserted in the stomach during an outpatient procedure, where it remains for six months, according to a press release. The balloon serves as a built-in portion control so the patient may feel full and less hungry.
The balloon, which does not change or alter the natural anatomy of the stomach, is removed after six months and the patient receives frequent in-office diet and exercise coaching sessions.
The Food and Drug Administration conducted a clinical study of 326 patients 22 to 60 years old at eight sites in the United States.
In the study, 187 individuals randomly selected to receive the ReShape balloon lost 14.3 pounds on average (6.8% of their total body weight) when the device was removed at six months, while the control group (who underwent an endoscopic procedure but were not given the device) lost an average of 7.2 pounds (3.3% of their total body weight), the FDA said in a press release.