The system combines the Lexington-based bariatric device maker’s flagship gastrointestinal liner, a plastic sleeve that’s inserted through the mouth into the intestine to prevent the absorption of nutrients from food, and its latest product, a flow restrictor that limits the amount of food that can pass from the stomach into the gastrointestinal tract.
Used together in the 12-week study, the two devices promoted median percentage excess weight loss of 39.6 percent in 10 morbidly obese patients (the subjects had body mass indices ranging from 35.8 to 47.8; the National Institutes of Health define obesity as BMIs over 30). Median weight loss was 36.7 pounds and the median total body weight loss was 15.4 percent.
The most common side effects included mild to moderate abdominal pain, nausea and vomiting.
Earlier trials of the EndoBarrier alone in more than 250 patients also showed weight loss and improvement in diabetes symptoms. More studies of how the two devices work together are underway, GI Dynamics said.