New data shows promising results for the EndoBarrier Gastrointestinal Liner, an experimental weight loss device being evaluated for patient safety and effectiveness.
The EndoBarrier Gastrointestinal Liner, or GI Sleeve is an innovative and non-surgical approach to weight loss that is designed to eliminate or reduce the risks and side effects associated with pharmaceutical or surgical options, while providing similar benefits. The GI sleeve is a teflon liner that is placed in the GI tract endoscopically (via the mouth) to create a barrier between food and the wall of the intestine.
According to the study findings, morbidly obese patients enrolled in the clinical trial achieved significant weight loss and a resolution of type 2 diabetes with the EndoBarrier Technology.
The clinical trials treated 37 patients; 26 patients received the EndoBarrier and 11 patients were in the diet control group. The EndoBarrier was implanted for 12 weeks in 23 patients and 24 weeks in 3 patients.
During the study period, patients in both the EndoBarrier and diet control groups followed the same diet. The starting average weight and BMI were similar between the two groups.
After 12 weeks, the patients who received the EndoBarrier achieved a mean excess weight loss (EWL) of 19.0 %, an amount substantially greater than the 6.9% EWL achieved by patients in the control group who did not get the implant. The EWL was 24.3% in the patients who kept the EndoBarrier implanted for 24 weeks.
The clinical weight loss study was conducted at the Maastricht University Medical Hospital in the Netherlands and was the first European experience with the EndoBarrier. The full study can currently be accessed online at http://journals.lww.com/annalsofsurgery/toc/publishahead and will also be published in an upcoming print issue of Annals of Surgery. The study has also been recorded with ClinicalTrials.gov.
The study was sponsored by GI Dynamics, a company focused on finding effective, non-surgical treatments for type 2 diabetes and obesity and the developer of the EndoBarrier Technology.
In addition to this study, hundreds of patients have been treated with the EndoBarrier System in clinical trials in South America, Europe, and the US.
While the EndoBarrier is still considered an investigational device in the United States, it has the potential to revolutionize the way we treat individuals with obesity and type 2 diabetes.
Source:
GI Dynamics Press Release 10-27-2009
Related Articles:
