GI Dynamics’ (ASX:GID) EndoBarrier implant proved safe and effective in curbing both obesity and Type II diabetes in a as little as 6 months, according to a study presented at the American Diabetes Assn. meeting in Philadelphia.
In a clinical trial comparing 34 obese patients with Type II diabetes implanted with the EndoBarrier gastrointestinal liner with 39 diet-controlled patients, those with the implant had an average body-weight loss of 9.3% versus 5.7% for the diet group.
EndoBarrier patients also experienced an average 1.3% decrease in HbA1c testing, which measures blood sugar levels, as compared with the diet-controlled group.
"The results from this study demonstrate that EndoBarrier therapy is a well-tolerated and effective treatment for Type II diabetes, resulting in significant improvements in blood sugar levels and weight-loss in patients with Type II diabetes," study presenter Dr. Dr. Parweez Koehestanie said in prepared remarks. "Importantly, while EndoBarrier is approved for up to 12 months of use, these data highlight the clinical benefits that patients can experience as early as six months following implant."
The findings may be an important factor in the company’s ongoing bid for FDA approval to market the EndoBarrier implant in the U.S. An FDA panel last month concluded that riskier medical devices intended to help obese patients lose weight should result in more weight-loss than lower-risk methods.
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