For the treatment of type 2 diabetes and obesity
GI Dynamics has received European CE mark approval for the EndoBarrier, a non-surgical therapy to treat type 2 diabetes and obesity. The CE marking certifies that a product has met EU requirements for marketing in Europe.
Clinical trials involving more than 270 patients have demonstrated the significant weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner, said the company.
EndoBarrier is a non-surgical medical device based on the EndoBarrier Technology platform for treating type 2 diabetes and obesity. It is placed in the GI tract endoscopically (via the mouth) to create a barrier between food and the wall of the intestine.
A growing body of pre-clinical and clinical evidence supports the potential for EndoBarrier to change the treatment landscape for people living with type 2 diabetes, said the company.
Stuart Randle, chief executive officer of GI Dynamics, said: “The growing body of clinical data demonstrates the EndoBarrier is well positioned to offer a meaningful, non-surgical approach to controlling diabetic factors and facilitating weight loss in patients suffering from the twin epidemics of type 2 diabetes and obesity. With European marketing approval in hand, we look forward to initiate our commercialization plans in Europe in the first half of 2010.”