麻豆传媒

BOSTON -- A dual-balloon implant helped patients lose more weight than diet and exercise alone, with a reasonable safety profile, researchers said here.

In the REDUCE trial, the ReShape Duo intragastric dual-balloon helped patients shed a larger proportion of their body weight than those who had a sham procedure, , of Hamilton Medical Center in Dalton, Ga., and colleagues reported at the Obesity Week meeting.

No gastric balloon is approved for use in the U.S., although there are some on the market in Europe and South America. Disastrous trials from the 1980s of other intragastric balloons, which involved serious complications and some deaths, have caused U.S. researchers to shy away from the technology.

But the current device seeks to prevent some of those complications by including two balloons instead of one. The idea is that should done balloon rupture, the other will keep it "afloat" in the stomach so that it prevents the device from migrating into the small bowel and causing an obstruction or perforation, Ponce said.

He added that there's also an "alert" system in case one of the balloons does rupture: they're filled with a dye that will turn the urine blue or green if it's released into the gastrointestinal tract.

For their study, Ponce and colleagues randomized 326 patients with a body mass index of 30-40 kg/m² to either endoscopic insertion of the balloon, or to a sham endoscopy. Both groups were also put on a diet and exercise program, and were followed for 6 months, at which time the balloons were removed, and patients in the control group were given the opportunity to have a balloon placed.

Ponce said the average placement time was 8 minutes, and removal time took about 14 minutes.

He and his colleagues found that patients who received the dual balloon device lost a significantly greater proportion of their body weight than those who got the sham procedure (25.1% versus 11.3%, P=0.004, in an intention-to-treat analysis).

There was some nausea, vomiting, and abdominal discomfort during the first several days, they reported, but it was managed with support and medication as needed, and usually resolved.

Ultimately, 264 patients received the device, and Ponce said there were good safety results.

A single balloon deflated in 6% of patients, and there was no device migration. Deflation always occurred in the distal balloon, not the proximal balloon, Ponce said, adding that the distal balloon is under more pressure and is more exposed to stomach acids.

Still, the device had to be removed early in 15% of patients because of intolerance, and 35% of patients had gastric ulcers when the device was removed.

Ponce noted that the team modified the design of the device, and thereafter ulceration rate was reduced substantially -- from 40% with the original design to 10% with the new design (P=0.001).

There were no deaths, and no extended hospital stays, but Ponce said three patients experienced more serious adverse events: one got pneumonia, one had an infection in the neck from a small perforation in the esophagus, and one had a tear in the esophagus that required clipping to avoid bleeding.

Ponce emphasized that the device is not intended to be a replacement for bariatric surgery.

"This fills a need for patients who don't qualify for bariatric surgery," he told 麻豆传媒. "Today we have diet, exercise, and some medications, then you jump to surgery. We don't have anything in between. For people who have failed on medications and diet, the balloon gives them another chance to try."

Device maker ReShape Medical has already submitted the data to the FDA for approval. Ponce said a panel is expected early next year, with an approval decision by the middle of 2015.

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