GI Dynamics has reported new data results that demonstrate the feasibility and safety of re-implantation of EndoBarrier device.
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 sustained improvement of type 2 diabetes and weight loss.
Previous study including 24 obese patients with an average weight of 109 kg and an average body mass index (BMI) of 44 completed 12 months of EndoBarrier therapy, achieving a mean weight loss of 20% and excess weight loss of 47%.
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 the study, 19 of the eligible 24 obese patients were re-implanted with the EndoBarrier.
Pontificia Universidad Católica de Chile digestive department surgeon Alex Escalona said 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," Escalona added.
GI Dynamics president and CEO Stuart Randle said, "we look forward to sharing data on the efficacy of second time EndoBarrier Therapy later this year."