GI Dynamics, Inc. is to transition its EndoBarrier® Gastrointestinal Liner from clinical research status to commercial availability in Netherlands. Endobarrier is a novel, non-surgical device for the treatment of type 2 diabetes and/or obesity, and to date, nearly 100 patients have been treated with the EndoBarrier in clinical trials conducted in the Netherlands.
The EndoBarrier is a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the wall of the intestine. It has been clinically proven to lower HbA1c levels, achieve weight loss of more than 20 percent and improve other important metabolic functions including cholesterol, blood sugar and triglycerides.
The EndoBarrier has received European CE mark approval and is commercially available in Chile, the United Kingdom, the Netherlands, Austria and Germany where in December we reported that it was to be made available through two additional centres of excellence. The EndoBarrier has also received TGA approval and will soon be available in Australia.
Clinical trials conducted in the Netherlands have been critical to understanding the effects of the EndoBarrier. Findings from one study presented at the 47th Annual Meeting of the European Association for the Study of Diabetes revealed that the EndoBarrier affects certain gastrointestinal hormones involved in insulin sensitivity, glucose metabolism and satiety, and that these changes allow for rapid and sustained improvement of type 2 diabetes.
“We have studied the EndoBarrier for several years and are very happy with the improvements in blood sugar and weight loss our patients have achieved,” said Ignace Janssen, M.D., clinical study investigator and bariatric surgeon, Vitalys Obesitas Centrum, Rijnstate Hospital, Arnhem, Netherlands. “Our clinical experience has given us a keen understanding of the type 2 diabetes patients and/or obese patients who would be good candidates for EndoBarrier therapy. Additionally, it has helped us develop the optimal treatment program that will help ensure successful outcomes for our patients.”
Martin Kirch, director of Vitalys Clinics added, “The EndoBarrier is filling a gap in our treatment paradigm. In particular, we believe it can help obese diabetic patients in the lower BMI range. The EndoBarrier provides an approach to better manage type 2 diabetes and related comorbidities for these patients.”
“We are delighted that the EndoBarrier is now being offered commercially through this Center of Excellence in the Netherlands,” said Stuart A. Randle, president and chief executive officer, GI Dynamics. “In particular, the success this center has had implanting the EndoBarrier under conscious sedation is very exciting and could potentially translate into reduced costs and even more rapid recovery. These are important milestones for the company as we expand from clinical to commercial use in key European markets.”
Source: GI Dynamics, medlatest staff