Novel Non-Surgical Temporary Balloon Device Approved for Obesity Treatment

The US Food and Drug Administration (FDA) recently granted approval for the ReShape Integrated Dual Balloon System (ReShape Dual Balloon) to treat obese adults without the need for invasive surgery.

The device is intended for weight reduction in obese adult patients with a BMI of 30 to 40 kg/m² and is limited to patients with one or more obesity-related conditions like high blood pressure, high cholesterol, and diabetes.

This balloon device is specifically recommended for patients who have not succeeded at previous weight loss attempts through diet and exercise alone.

In a clinical trial with a total of 326 obese participants between the ages of 22 and 60, 187 patients were randomly selected to receive the ReShape Dual Balloon, and the remaining individuals were administered an endoscopic procedure without inserting the device.

Study results indicated the balloon device group lost a mean of 14.3 pounds, whereas the control group only lost an average of 7.2 pounds. Furthermore, six months after removing the ReShape Dual Balloon device, patients in the treatment group successfully kept off a mean of 9.9 pounds of the original 14.3 they had lost.

Researchers reported the potential side effects for the procedure included headache, muscle pain, and nausea.

Through a minimally invasive endoscopic procedure (usually lasting less than 30 minutes), the ReShape Dual Balloon device is inserted through the mouth to the stomach and then inflated with a sterile solution.

It’s important to note this device does not alter the stomach’s natural anatomy — it is simply meant to be a temporary fix and should be removed approximately six months following insertion.

William Maisel, MD, MPH, acting director of the Office of Device Evaluation, FDA’s Center for Devices and Radiological Health, commented in a news release, “Those with obesity, significant weight loss, and maintenance of that weight loss often require 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.”