The FDA say the new dual balloon device offers a non-surgical option that can be quickly implanted, is non-permanent and can be easily removed.
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.
Trial participants lost 14 lbs on average
For the approval, the FDA reviewed a clinical trial of 326 obese patients aged from 22 to 60 whose BMI was in the range 30-40 kg/m2 and who had at least one obesity-related condition.
The trial randomly assigned the patients to either have the Dual Balloon inserted, or to undergo an identical "dummy" endoscopic procedure but where the device was not fitted.
The results showed that at the end of 6 months, when the device was removed, the 187 patients who were fitted with the Dual Balloon on average lost 14.3 lbs (6.5 kg), equivalent to 6.8% of their body weight.
In contrast, the control group on average lost 7.2 lbs (3.3 kg, 3.3% of their body weight).
And 6 months after the device was removed, the group that had it fitted managed to keep off an average of 9.9 lbs (4.5 kg) of the 14.3 lbs they lost.
The insertion procedure may have side effects. These include muscle pain, nausea and headache. In rare instances, this may also lead to severe allergic reaction, tearing of the esophagus, infection, breathing problems and heart attack. Once the Dual Balloon is inserted, patients may also experience nausea, vomiting, feelings of indigestion, abdominal pain and stomach ulcers.
Patients who have had bariatric or other kinds of gastrointestinal surgery should not be fitted with the device, and neither should patients diagnosed with inflammatory intestinal or bowel disease, who have symptoms of delayed gastric emptying or active H. pylori infection, or who have a large hiatal hernia. Pregnant women and patients taking aspirin every day should also avoid it, the FDA advises.
Device 'fills a significant gap'
"Many Americans have struggled with a lack of effective weight loss options when their BMI is in the 30-40 range," states Dr. John Morton, President of the American Society for Metabolic and Bariatric Surgery.
He says options like the ReShape Dual Balloon address a significant gap that exists between diet and exercise on the one hand and weight loss medications and surgery on the other.
The following video shows an animation of the insertion and removal of the ReShape Dual Balloon, which is made by ReShape Medical Inc., in San Clemente, CA.
Dr. William Maisel, acting director of the FDA Center for Devices and Radiological Health's Office of Device Evaluation says for obese patients to achieve significant weight loss and keep it off, they often need to combine solutions, including improving their diet and taking more exercise. He says that:
"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."
In the journal Chemistry & Biology, researchers describe how mice fed a high-fat diet that were given a single dose of the compound daily for 7 days, improved their glucose tolerance and shed about 5% of their body weight.