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GI Dynamics’ EndoBarrier

This article was originally published in The Gray Sheet

Executive Summary

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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Research In Brief

Negative pressure wound therapy: Data presented by Smith & Nephew Oct. 23 at the Annual Clinical Symposium on Advances in Skin and Wound Care show that gauze-based negative pressure wound therapy significantly reduced wound dimensions in a prospective, multi-center clinical evaluation of 131 non-grafted patients. The weekly reduction rates in wound area, depth and volume were 8.3%, 15.8% and 20.5%, respectively, Smith & Nephew said. There also was a significant reduction in wound exudate levels from baseline to treatment discontinuation, and a significant increase in the percentage area of the wound bed composed of red granulation tissue over the course of treatment. In a subset analysis of 23 patients with split-thickness skin grafts (STSG) treated with NPWT, the average graft "take" was 83%, including an average take of 50% for diabetics and 95% for non-diabetics. Smith & Nephew markets the Renasys line of NPWT devices

Research In Brief

Is MTWA useful? Two new studies cast doubt on the potential for microvolt T-wave alternans (MTWA) testing to predict ventricular tachyarrhythmic events in heart failure patients. Results of a 490-patient substudy of Medtronic's Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) published in the journal Circulation found that MTWA testing did not predict arrhythmic events or mortality, suggesting that MTWA is "not useful as an aid in clinical decision making on implantable cardioverter defibrillator therapy among patients with heart failure and left-ventricular diastolic dysfunction," according to authors Michael Gold, Medical University of South Carolina, et al.. Results of the 575-patient Microvolt T Wave Alternans Testing for Risk Stratification of Post-Myocardial Infarction Patients (MASTER) trial, recently published in the Journal of the American College of Cardiology, found that the risk of ventricular tachyarrhythmia did not correlate to differences in MTWA test results in heart failure patients with an ICD that was implanted to prevent sudden cardiac death (1"The Gray Sheet" Nov. 12, 2007, p. 17). More studies needed: In an editorial accompanying the Gold study in Circulation, an expert on mechanisms of cardiac arrhythmias, David Rosenbaum, Case Western Reserve University in Cleveland, points out that the SCD-HeFT substudy suggests MTWA "does indeed track susceptibility to sudden cardiac death in a population where primary prevention strategies are highly relevant ... Further advances in risk stratification will also require trials where therapy is randomized on the basis of risk markets that reflect electrophysiological substrates for sudden cardiac death.

Research In Brief

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

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