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
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