People who have struggled to lose weight through traditional means may now have new hope: The Food and Drug Administration has approved a new balloon device for weight loss.

The device is implanted endoscopically through the mouth without requiring surgery during a 30-minute procedure while the patient is sedated. Once implanted, the two connected balloons are filled with a blue-colored saline solution that works to take up space in the stomach in order to simulate a feeling of fullness.

The balloon device intends to fill a gap in weight-loss options for patients opposed to or unable to undergo weight-loss surgery.

The device, called the ReShape Integrated Dual Balloon System, is meant to be a temporary solution for those trying to lose weight and is only recommended for use short-term use. Candidates must be medically categorized as obese, have a body mass index of 30 or higher and have at least one other risk factor for heart disease.

Obese people who do not qualify for weight-loss surgery may also benefit from the device. However, patients who have had previous bariatric or gastrointestinal surgery should not use the device.

The new device is an improved version of an earlier device that was recalled in 1992 due to the possibility of rupture. In the new device, if one of the two balloons ruptures, the other balloon will hold it in place in the stomach, preventing it from the patient’s blocking arteries.

The patient will be able to detect when a balloon has ruptured because the blue dye in the saline solution will color the patient's urine. A doctor can then easily remove the device and replace it with a new one.

In order for the device to be successful after implantation, patients should maintain a healthy diet and exercise plan to keep weight off while installed and after its removal. The device does not alter the anatomy of the stomach in any way.

In a clinical trial involving 326 obese patients, participants lost an average of 7 percent of their body weight. Patients without the device in the same trial lost 3.3 percent of their total body weight.

During the trial, 15 percent of patients experienced extreme nausea and had to have the device removed. Additionally, 35 percent of patients developed ulcers from the device rubbing against the lining of the stomach, but researchers stated that these ulcers were superficial.

In rare cases, participants experienced heart attack, stomach tears, infections, allergic reactions and breathing difficulties. Patients were able to keep off an average of 9.9 pounds six months after the device was removed.

The cost of the system, produced by ReShape Medical Inc. in California, is about $6,200 and is not currently covered by insurance, so those who wish to receive the device will have to pay out-of-pocket. The system will be available throughout the United States by providers who are trained to perform the procedure.

Those interested in receiving the device will be able to search for providers near them via the ReShape website.