Advertisement
LEXINGTON, Mass. & SYDNEY--(BUSINESS WIRE)--GI Dynamics, Inc. today announced the transition of the EndoBarrier® Gastrointestinal Liner (the EndoBarrier), a novel, non-surgical device for the treatment of type 2 diabetes and/or obesity, from clinical research to commercial use in the Netherlands. To date, nearly 100 patients have been treated with the EndoBarrier in clinical trials conducted in the Netherlands.

"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."

The EndoBarrier has received European CE mark approval and is commercially available in Chile, Germany, the United Kingdom, the Netherlands and Austria. The EndoBarrier has also received TGA approval and will soon be available in Australia.

"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."

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.

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.

In the Netherlands, it is estimated that there were more than 800,000 people living with type 2 diabetes in 2010, and that number is expected to increase to nearly 1.1 million by 20201. The International Diabetes Federation has estimated that approximately 320 million people have type 2 diabetes worldwide. Type 2 diabetes, which accounts for approximately 90 percent of all cases of diabetes, occurs when the pancreas has reduced effectiveness in insulin production associated with an increase in insulin resistance. The diagnosis of type 2 diabetes usually occurs after the age of 40 and is often, but not always, associated with obesity.

About GI Dynamics

GI Dynamics, Inc. is pioneering the development and commercialization of effective, non-surgical treatments targeting the large and growing global patient populations with type 2 diabetes and obesity. The companys flagship product, the EndoBarrier®, is a novel, non-surgical device proven to lower blood glucose levels and promote weight loss in diabetic patients and/or obese patients during the implant period. GI Dynamics currently markets the EndoBarrier in select regions in Europe and South America and is planning near-term commercial expansion into Australia and additional European countries. Founded in 2003, GI Dynamics is headquartered in Lexington, Massachusetts. For more information, please visit www.gidynamics.com.

1 Booz & Company, "Diabetes Care in the Netherlands: Improving Health and Wealth," 14 November 2011

Posted by Sean Fenske, Editor-in-Chief, MDT

Advertisement
Advertisement