Doctors led by James Ponce have reported that a dual-balloon implant helped patients lose more weight than diet and exercise alone. The device is not intended to be a replacement for bariatric surgery but could fill a need for patients who don't qualify for surgery.
Currently there are no gastric balloons approved for use in the U.S., because clinical trials from the 1980s of other intragastric balloons, documented serious complications and some deaths.
In the current study the dual balloon device seeks to prevent some of those complications. The idea is that should one 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 complications.
In the current study 326 patients with a body mass index of 30-40 kg/m2 were treated with either endoscopic insertion of the balloon, or a sham endoscopy. Both groups were also put on a diet and exercise program, and were followed for 6 months and directly compared. The average placement time for placement of the balloon was 8 minutes, and removal time took about 14 minutes.
Individuals who received the dual balloon device lost 25% of their weight compared to only 11% of those who received the sham procedure. Individuals experienced some nausea, vomiting, and abdominal discomfort during the first several days that was managed with support and medication as needed, and usually resolved.
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. There were no deaths, and no extended hospital stays.
Device maker ReShape Medical has already submitted the data to the FDA for approval and a panel is expected early next year, with an approval decision by the middle of 2015.
Reference: Ponce J, et al "The REDUCE pivotal trial: A randomized sham-controlled trial of a dual intragastric balloon for the treatment of obesity" Obesity Week 2014; Abstract A104.