ReShape Medical has announced that the first patient has been fitted with the ReShape Dual Balloons, thus launching the start of a U.S. Investigational Device Exemption (IDE) clinical study into the safety and effectiveness of this non-surgical device for weight loss.

According to the company press release, the ReShape Balloons are designed to be a treatment for the millions of individuals who are overweight and struggle with weight loss, but either do not qualify for weight loss surgery or do not want to undergo one of the surgical options such as gastric bypass or lap band surgery.

The ReShape procedure involves placing inflatable gastric balloons into the stomach to occupy existing space in order to reduce food capacity and lessen hunger sensations. This method does not alter the natural anatomy of the body in any way.

The ReShape system is comprised of two intragastric, inflatable balloons that are attached to each other by a flexible tube. The empty balloons are inserted into the stomach via endoscopic surgery. Once placed into the stomach, the balloons are filled with a saline solution. The quick 15-minute, out-patient procedure requires only deep conscious sedation. Adjustment and recovery may take a few days. After six months, the balloons are removed.

While diet and exercise are an important aspect to any method of weight loss, the ReShape device itself does not limit the kinds of foods you can eat, just the quantity. The balloons simply occupy space in your stomach to help you eat less and feel full faster.

The ReShape Balloons have been tried in Europe with positive results to date, but is limited to investigational use in the United States as it is not yet approved by the FDA. For interested individuals, the ReShape Medical website provides more information about the ReShape clinical study.

Source:

Press Release: ReShape Medical Announces Initiation of U.S. Clinical Study for Weight Loss