GI Dynamics won CE Mark approval for its EndoBarrier gut liner and said it plans to launch the product across the pond during the first half of 2010.
The Lexington, Mass.-based company developed the EndoBarrier, a plastic sleeve that lines the small intestine, to treat obesity and Type 2 diabetes. The device prevents food from being absorbed by the body, inducing weight loss and helping control the symptoms of diabetes.
A series of clinical studies showed that patients treated with the EndoBarrier reduced their average blood glucose levels, lowered other diabetic factors including fasting blood glucose and weight and helped morbidly obese patients lose significant amounts of weight.
GI Dynamics said the CE Mark cover six months of EndoBarrier treatment for patients with Type 2 diabetes and obesity.