The manufacturer of the weight loss device ReShape Duo Balloon could be available as early as next year in the United States pending Food and Drug Administration (FDA) Approval.

What is the ReShape Duo Balloon?

Reshape Duo Gastric Balloon

The ReShape Duo Balloon weight loss component works similar to that of gastric banding or gastric sleeve, where the stomach is restricted to limit the amount of food consumed.

The objective of this simple procedure is to offer obese individuals who do not want to undergo weight loss surgery to have an alternative option that does not require surgery while still providing decent weight loss results.

How Does it Work?

The ReShape Duo Balloon works by being placed into the stomach of a patient using an endoscope, which is a non-surgical instrument that is guided down patients esophagus with a tiny camera guiding it into the stomach.

From there, it is inflated with saline that helps make the patient feel full after a modest calorie intake. There are no incisions or stitches needed for this outpatient surgical procedure. The procedure total takes about 20 minutes.

Most patients complain of nausea as the common side effects that can last for a few days. Six months later, the balloon is removed with the same endoscopic surgical procedure.

Related: Mexico Gastric Balloon Surgery in Mexico

Study of ReShape Duo Results

ReShape Duo Balloon to Offer Alternative to Weight Loss SurgeryIn the study of ReShape Duo results and effectiveness, 326 obese patients were evaluated in two different groups.

The first group of patients received the balloon while the second group of patients underwent a sham endoscopic procedure. Patients in both groups participated in the same nutrition and exercise counseling/therapy throughout the study and for six months time period.

It’s important to note that this study is ongoing and the device’s manufacturer, ReShape Medical, will not and cannot release data. However, President and CEO Rick Thompson said that patients who had the balloon installed achieved a significantly greater percentage of weight loss than those in the sham group.

ReShape Duo Balloon Expected Weight Loss

In many instances, patients lost 25% or more of their excess weight.

According to the results of an earlier and smaller study, two-thirds of ReShape Duo Balloon patient kept weight off or continued to lose weight, which shows benefits to the device and how it can outlast ordinary jumpstart weight loss programs. Based on these results, the company expects a U.S. launch of the product in mid to late 2015.

The study’s researchers believe that even a 5% weight loss can have a significant effect on a patient’s overall health. However, 25% or more rates are impressive and not uncommon with the balloon and those studied.

This type of non-surgical gastric balloon procedure is designed in such a way to reduce migration risk that can happen when a balloon deflates and moves to the intestines, which causes a blockage. If this happens, the dye will be visible in the urine, which eliminates the risk of not knowing when a potential risk has occurred.

Who is Gastric Balloon for?

Many doctors including Dr. Stanley Rogers, chief of minimally invasive procedure and director of the bariatric surgery center at UCSF believe that the stomach balloons will play a role in patients needed to lose weight before surgeries such as gastric bypass. It also provides a safer weight loss route for those with many co-morbidities who are not candidates for the surgery.

The surgery may also be an excellent option for those who need to lose weight before joint replacement surgeries such as the knee or the hip. Their weight loss will help to reduce their risk of complication following surgery.