EndoBarrier Gastrointestinal Liner, a non surgical alternative to gastric bypass surgery, has won European approval to treat diabetes and obesity.
Developed by GI Dynamics, EndoBarrier is implanted via the mouth in an outpatient procedure. EndoBarrier creates a barrier between food and the wall of the small intestine, to control movement of food through the intestines.
Preventing food from coming into contact with the intestinal wall EndoBarrier may alter the activation of hormonal signals that originate in the intestine, thus mimicking the effects of a Roux-en-Y gastric bypass procedure without surgery.
Pre-clinical and clinical evidence suggests that EndoBarrier Gastrointestinal Liner could help people living with type 2 diabetes, obese people at risk for type 2 diabetes, and people with severe weight problems.
Clinical data demonstrate that obese patients with uncontrolled type 2 diabetes using the EndoBarrier Gastrointestinal Liner achieved near normalization of glycemic control in just one week.
In addition, patients treated with EndoBarrier achieved a mean reduction of 2.4% in HbA1c glucose levels at 24 weeks.
Patients treated with EndoBarrier also achieved reductions in other diabetic factors including fasting blood glucose and weight.
“With over 200 million people worldwide currently affected by type 2 diabetes, these data are encouraging as they show the potential of non-surgical therapeutics in controlling diabetic factors and facilitating weight loss in patients suffering from the twin epidemics of type 2 diabetes and obesity,” said Stuart A. Randle, chief executive officer of GI Dynamics.
GI Dynamics presented interim data from its ongoing clinical study of the EndoBarrier Gastrointestinal Liner in obese patients with type 2 diabetes at GASTRO 2009 organized by the United European Gastroenterology Federation (UEGF), World Gastroenterology Organisation (WGO), World Organisation of Digestive Endoscopy (OMED) and British Society of Gastroenterology (BSG), in London.
Non-surgical EndoBarrier is designed to eliminate or reduce the risks and side effects associated with pharmaceutical regimens as well as surgical options.
EndoBarrier treatment can be performed easily and quickly without any incisions, thus reducing patient anxiety and recuperative time. Unlike traditional pharmaceutical approaches, non-surgical therapeutics remove the burden of dose regimen compliance from the patient.
Non-surgical therapeutics also hold the potential to improve the patient’s overall health, by providing the control necessary to institute lifestyle and nutritional improvements to maintain therapeutic effect, while being easily removed once the desired effect has been attained and lifestyle changes implemented.
Clinical trials involving more than 250 patients have demonstrated the dramatic weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner, GI Dynamics said in an official release.
GI Dynamics’ EndoBarrier Gastrointestinal Liner may provide rapid improvement in glycemic control and significant weight loss by modifying metabolic pathways.
GI Dynamics is also developing the EndoBarrier Flow Restrictor, which is designed to further enhance the effectiveness of the liner by doubling the amount of weight-loss that can be achieved using the liner alone.
Each device in the EndoBarrier portfolio is designed to assist patients gain control of their blood sugar and achieve a healthier body mass index (BMI).
GI Dynamics is collaborating with experts in endocrinology, gastroenterology, bariatric surgery and medical weight loss on these efforts.
Based in Lexington, Massachusetts, GI Dynamics is backed by investors including Advanced Technology Ventures, Catalyst Health Ventures, Cutlass Capital, Domain Associates, Johnson & Johnson Development Corporation, and Polaris Venture Partners.