FDA approve dual gastric balloon for treatment of obesity
Regulators in the US have approved a new dual gastric balloon device designed to help adult obese patients lose weight.
The device comprises two balloons that are inserted into the stomach and inflated without the need for surgery. The device is meant to be a temporary measure and should be removed after 6 months. Removal is also via a non-surgical procedure.
The US Food and Drug Administration (FDA) note that the ReShape Integrated Dual Balloon System:
“… likely works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood.”
The Dual Balloon does not alter the anatomy of the stomach.
To help achieve and maintain weight loss, patients implanted with the Dual Balloon are advised to follow a medically supervised diet and exercise plan both while the device is in place and then for 6 months after it is removed.
The device is inserted during an outpatient visit. The procedure lasts no more than half an hour and is performed while the patient is under mild sedation.
A trained physician inserts the deflated balloons using an endoscope. This is a tube with a camera on the end that goes into the mouth, down the throat and into the stomach. The camera allows the physician to guide the placement of the deflated balloons.
Once in the stomach, the physician inflates the balloons by filling them with a sterile salt solution and then releases them and removes the endoscope.
The device is for obese adults whose body mass index (BMI) lies in the range 30-40 kg/m2. It is intended for patients who have not been able to lose weight through diet and exercise alone and is limited to those with one or more obesity-related conditions such as high blood pressure, high cholesterol and diabetes.