EndoBarrier® Therapy is a revolutionary, non-surgical, non-pharmaceutical treatment proven to help people living with uncontrolled type 2 diabetes and obesity achieve rapid and dramatic reductions in blood sugar levels, as well as substantial weight loss. EndoBarrier Therapy is a convenient and discreet treatment for people whose diabetes medications are no longer effective, who are at risk for serious health complications from their diabetes and/or weight and who want to avoid surgery or the progression to daily insulin injections. This first-of-its-kind therapy is helping patients around the world fight their battle against type 2 diabetes and obesity while providing a pathway to a healthier lifestyle.
Clinical data suggest that treatment with EndoBarrier Therapy by affecting key gastrointestinal hormones involved in insulin sensitivity, glucose metabolism, and satiety.1 Additionally, initial studies have suggested that patients maintain blood sugar control and weight loss even after removal of the device.2,3
EndoBarrier is approved and commercially available in multiple countries outside the U.S.; and GI Dynamics is conducting a pivotal clinical trial of EndoBarrier (the ENDO Trial) in the U.S. for the treatment of patients who have uncontrolled type 2 diabetes and are obese. If you are interested in learning more about the U.S. pivotal trial (The ENDO Trial), please visit www.endobarriertrial.com.
EndoBarrier® is not approved for sale in the U.S. and is limited by federal law to investigational use only in the United States. EndoBarrier® has CE mark approval in Europe, TGA approval in Australia, and medical device registration approval from the Israeli Ministry of Health for the treatment of patients with type 2 diabetes and/or obesity for 12 months.
In clinical studies, the most common complications were nausea, vomiting and upper abdominal pain. Other risks, which are not likely but could occur, include infection, trauma and bleeding.
If you are pregnant or are thinking about becoming pregnant, EndoBarrier® Therapy is not recommended.
As with any medical procedure, it is important to discuss with your doctor the potential risks and benefits as they apply to your health to help determine if EndoBarrier Therapy might be right for you.
1 C de Jonge, JW Greve, N Bouvy, et al, “Endobarrier Gastroin- testinal Liner treatment rapidly improves diabetes parameters paralleled by increased postprandial GLP-1 and PYY levels in obese type 2 diabetic patients.” Department of Surgery, Maastricht University Medical Centre, presented at IFSO 2011, Hamburg, Germany.
2 Moura, GHD, et al, “One Year Results of an Endoscopic, Duodenal-Jejunal Exclusion Device for Weight Loss and Control of Type 2 Diabetes.” Hospital das Clinicas, University of São Paulo, São Paulo, Brazil. DT&T, February 2012, Vol 14, no.2:183-189.
3 Escalona, A., et al, “Weight Loss and Metabolic Improvement in Morbidly Obese Subjects Implanted for 1 Year with an Endoscopic Duodenal-Jejunal Bypass Liner.” Department of Digestive Surgery. Faculty of Medicine Pontificia Universidad Católica de Chile. Annals of Surgery, June 2012, Vol 255, Issue 6, p 1080–1085.