According to an announcement made by GI Dynamics Inc., new data results demonstrate that the EndoBarrier®, a new device for the treatment of type 2 diabetes and/or obesity, is feasible and can be re-implanted safely.
EndoBarrier is a pioneering device for the treatment of type 2 diabetes and/or obesity. 13 clinical trials in over 500 patients demonstrated several of the device’s benefits, including decreasing HbA1c levels, achieving a loss of weight of more than 20%, as well as improving significant important metabolic measures, such as cholesterol, blood sugar and triglycerides.
The device consists of a thin, flexible, tube-shaped liner that is implanted to form a physical barrier between food and a portion of the wall of the intestine. Once implanted, EndoBarrier Therapy influences certain gastrointestinal hormones that play a part in insulin sensitivity, glucose metabolism and satiety. These changes allow for rapid and sustained improvement of type 2 diabetes and weight loss.
The study involved 24 obese patients with an average weight of 109 kg or 239.8 lbs. and an average body mass index (BMI) of 44. After completing 12 months of EndoBarrier Therapy all participants achieved an average weight loss of 20%, i.e. 22 kg or 44.4 lbs and excess weight loss of 47%.
After the participants’ initial treatment period and a minimum of 31 weeks after the removal follow-up of the EndoBarrier, the participants were given the opportunity to participate in a re-implant study, which was taken up by 19 patients. The average time period from the removal of the EndoBarrier to re-implant was 39.4 weeks (range: 31-52 weeks) and all 19 were successfully re-implanted with EndoBarrier. The researchers noted no procedure-related complications.
Alex Escalona, M.D., from the Department of Digestive Surgery at Chile’s Pontificia Universidad Católica in Santiago, Chile presented the data for the first time during an oral session on at the 5th Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders, European Chapter (IFSO-EC) in Barcelona.
Jan Willem Greve, M.D., Ph.D., from the Gastrointestinal and Bariatric Surgery at the Atrium Medical Center Parkstad in Heerlen in The Netherlands will also present information about EndoBarrier Therapy, including its working mechanism, key benefits and clinical results to date during a roundtable discussion at the Metabolic Surgery Symposium at IFSO-EC.
Dr. Escalona declared:
“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. 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.”
Stuart A. Randle, president and CEO, GI Dynamics, Inc. concludes:
“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.”
In Europe, EndoBarrier has received CE Mark approval in 2010 and in Australia, the device was approved by the Therapeutic Goods Administration for the treatment of type 2 diabetes and/or obesity.
EndoBarrier is currently commercially available in certain European markets as well as in Chile and Australia.
Written By Petra Rattue