GI Dynamics’ EndoBarrier
This article was originally published in The Gray Sheet
Firm gains CE mark approval of its EndoBarrier gastrointestinal liner device to treat obesity and type 2 diabetes. A sham-controlled pilot trial presented at the First World Congress on Interventional Therapies for Type 2 Diabetes in New York in September showed that EndoBarrier reduces average blood glucose levels in patients with type 2 diabetes (1"The Gray Sheet" Oct. 6, 2008, p. 22). Another recently published study shows EndoBarrier imitates the treatment effect of Roux-en-Y bypass surgery, including weight loss and improved metabolic function in rats with diet-induced obesity (2"The Gray Sheet" Nov. 24, 2008, p. 16). The company is planning to conduct larger, long-term trials in 2009
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G.I. Liner: GI Dynamics' EndoBarrier gastrointestinal liner significantly reduces average blood glucose levels in patients with type 2 diabetes, according to results of a three-month, 18-patient, sham-controlled pilot study presented at the First World Congress on Interventional Therapies for Type 2 Diabetes in New York Sept. 16. The data, presented by Lee Kaplan, M.D./Ph.D, Harvard Medical School, show that the 12 patients treated with EndoBarrier in the trial experienced a mean reduction in average blood glucose of 2.9% from a baseline of 8.9%, compared to a reduction of 0.76% from a baseline of 9% in the six patients in the sham control group. EndoBarrier is an endoscopically implantable barrier that creates a duodenal-jejunal bypass to prevent food from contacting the intestinal wall. Investigators believe the bypass reduces a patient's uptake of both nutrients and calories and creates a similar metabolic effect as Roux-en-Y gastric bypass surgery, which has been shown to promote weight loss and resolution of type 2 diabetes. The firm plans to launch a major trial of an enhanced version of EndoBarrier in 2009