FDA approves non-surgical obesity device
The US Food and Drug Administration (FDA) has approved a balloon device to treat obesity without the need for invasive surgery
The ReShape Integrated Dual Balloon System, by ReShape Medical, is intended to facilitate weight loss in obese adult patients.
The device works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood.
The ReShape Dual Balloon device is delivered into the stomach via the mouth through a minimally invasive endoscopic procedure.
The outpatient procedure usually takes less than 30 minutes while the patient is under mild sedation.
Once in place, the balloon device is inflated with a sterile solution, which takes up room in the stomach but does not alter the stomach’s natural anatomy.
It is meant to be temporary and should be removed six months after it is inserted.
The ReShape Dual Balloon is indicated for weight reduction in obese adult patients with a body mass index (BMI) of 30 to 40 kg/m2.
The device is limited to patients with one or more obesity-related conditions such as high blood pressure, high cholesterol, and diabetes.
The ReShape Dual Balloon was studied in a clinical trial with obese participants aged 22 to 60 who had at least one obesity-related health condition.
In the study, 187 individuals received the ReShape Dual Balloon and lost 14.3 pounds on average (6.8% of their total body weight) when the device was removed at six months.
William Maisel, MD and acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said: “For those with obesity, significant weight loss and maintenance of that weight loss often requires a combination of solutions including efforts to improve diet and exercise habits.”
“This new balloon device provides doctors and patients with a new non-surgical option that can be quickly implanted, is non-permanent, and can be easily removed.”