LEXINGTON, Mass. & Sydney--(BUSINESS WIRE)--
GI Dynamics, Inc. (ASX: GID.AX - News) today announced new data results that demonstrate the feasibility and safety of re-implantation of EndoBarrier, a breakthrough device for the treatment of type 2 diabetes and/or obesity. These data were presented for the first time by Alex Escalona, M.D., Department of Digestive Surgery, Pontificia Universidad Catlica de Chile, Santiago, Chile, during an oral session on Thursday, April 26, 2012, at the 5th Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders, European Chapter (IFSO-EC) in Barcelona.
In addition, information about EndoBarrier Therapy, including how it works, key benefits and clinical results to date, will be presented by Jan Willem Greve, M.D., Ph.D., Gastrointestinal and Bariatric Surgery, Atrium Medical Center Parkstad, Heerlen, the Netherlands, during a roundtable discussion at the Metabolic Surgery Symposiumat IFSO-EC on Friday, April 27, 2012.
The efficacy of first-time EndoBarrier Therapy in weight loss and blood sugar control have been well established, and these results demonstrate that EndoBarrier can be safely re-implanted in patients who have previously undergone treatment with the device, said Dr. Escalona. Re-implantation of the EndoBarrier may facilitate additional weight loss and improvements in diabetes and other co-morbid conditions, and additional studies evaluating these clinical benefits are ongoing. We believe this is very exciting news for patients who may benefit from another period of EndoBarrier Therapy.
Twenty-four obese patients with an average weight of 109 kg (239.8 lbs.) and an average body mass index (BMI) of 44 completed 12 months of EndoBarrier Therapy, achieving a mean weight loss of 20 percent (22 kg/44.4 lbs) and excess weight loss of 47 percent. Following their initial treatment period and at least 31 weeks of follow-up post EndoBarrier removal, these patients were invited to participate in a re-implant study. In this study, 19 of the eligible 24 obese patients were re-implanted with the EndoBarrier. The mean time from EndoBarrier removal to re-implant was 39.4 weeks (range: 31-52 weeks). All of the patients who participated in the study were successfully re-implanted with EndoBarrier and there were no procedure-related complications.
We are pleased to have these data presented showcasing the ability to successfully re-implant the EndoBarrier, and we look forward to sharing data on the efficacy of second time EndoBarrier Therapy later this year, said Stuart A. Randle, president and CEO, GI Dynamics, Inc.
About EndoBarrierTherapy
EndoBarrier is a breakthrough device for the treatment of type 2 diabetes and/or obesity that has been clinically demonstrated to lower HbA1c levels, achieve weight loss of more than 20 percent, and improve important metabolic measures including cholesterol, blood sugar and triglycerides.1 It has been studied in 13 clinical trials and has been used in more than 500 patients. EndoBarrier is a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the wall of the intestine. Once implanted, EndoBarrier Therapy affects certain gastrointestinal hormones involved in insulin sensitivity, glucose metabolism and satiety, and these changes allow for rapid and sustained improvement of type 2 diabetes and weight loss.2
EndoBarrier received CE Mark approval for Europe in 2010 as well as approval by the Therapeutic Goods Administration in Australia in 2011 for the treatment of type 2 diabetes and/or obesity. EndoBarrier is currently commercially available in select European markets, Chile and Australia. For more information, please visit http://www.endobarrier.com.
1Moura, 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 So Paulo, So Paulo, Brazil. DT&T, February 2012, vol 14, no.2:183-189.
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GI Dynamics Announces New Data Demonstrating Feasibility of EndoBarrier® Re-Implantation
