Study Shows Repeat Endobarrier® Use Is Safe

In short

We recently covered news of  GI Dynamics’ activities in Europe as it progresses with its Endobarrier® sleeve. The device is best described as a sophisticated sort of open-ended plastic bag with a proximal anchoring configuration, which is inserted in the small intestine and through which bowel contents pass without their contents being absorbed by the gut. The product is indicated for use in patients being treated for obesity or type 2 diabetes.

Now the company is trumpeting a new clinical study, the results of which indicate that the device can be used for a second time on previous implantees without any negative surgical or other consequences.

Background

A new study into the use of GI Dynamics’ Endobarrier was presented last week in an oral session at the 5th Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders, European Chapter (IFSO-EC) in Barcelona. According to presenter Alex Escalona, M.D., Department of Digestive Surgery, Pontificia Universidad Católica de Chile, Santiago, Chile the results specifically demonstrate the feasibility and safety of re-implantation of EndoBarrier®.

The study

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, 19 of the eligible 24 obese patients were re-implanted with the device. All of the patients who participated in the study were successfully re-implanted and there were no procedure-related complications.

Clinician comments

“The efficacy of first-time EndoBarrier Therapy in weight loss and blood sugar control have been well established in patients suffering type 2 diabetes or obesity. New 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.

Company comments

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.

Souirce: GI Dynamics. Inc.