Overview of EndoBarrier Technology
The EndoBarrier Gastrointestinal Liner is an innovative and non-surgical medical device for the treatment of type 2 diabetes and obesity. It works by placing a barrier between food and a portion of the small intestine where digestion occurs and is designed to help patients gain metabolic control.
The EndoBarrier does not require surgical incisions, does not alter the anatomy, and is easily removed upon completion of treatment. Results to date have shown benefits similar to those achieved with weight loss surgery, but without the need for surgery.
In the United States, the EndoBarrier is considered an investigational medical device and is not yet available for use outside of clinical trials.
The EndoBarrier received the European CE mark of approval in December 2009 and is available in select markets outside the United States. Endobarrier locations include Australia, Austria, Chile, Czech Republic, France, Germany, Israel, Italy, Netherlands, Spain, Switzerland, and the United Kingdom.
CLINICAL TRIAL UPDATE: March 5, 2015 - GI Dynamics announced that enrollment in the US pivotal clinical trial of EndoBarrier Therapy (the ENDO Trial) was put on hold by the FDA following four cases of bacterial infection of the liver in patients with the gastric liner. The company has implemented several risk mitigation strategies and is working to submit the requested information to the FDA for their review in an effort to resume enrollment. At this time, monitoring and data collection involving patients currently enrolled in the ENDO Trial will continue.
CLINICAL TRIAL UPDATE: July 30, 2015 - GI Dynamics announced its decision to discontinue its US pivotal clinical trial of EndoBarrier Therapy (the ENDO Trial) following discussions with the FDA. The company said that ending the ENDO Trial at this time will help to ensure adequate resources to further the development of EndoBarrier. The company will conduct a detailed review of results for the ENDO Trial and report its findings in the very near future.
About EndoBarrier Technology
Developed by GI Dynamics, the EndoBarrier Technology platform fits into a new class of metabolic treatment, called non-surgical therapeutics. Non-surgical therapeutics bridge the gap between pharmaceuticals and surgery, offering an effective treatment alternative for patients who are unhappy with the current methods of treating and managing type 2 diabetes or obesity.
The medical devices developed with the EndoBarrier Technology include:
- EndoBarrier Gastrointestinal Liner
- EndoBarrier Flow Restrictor
The EndoBarrier Gastrointestinal Liner, also called a GI sleeve, is a teflon liner that is placed in the gastrointestinal (GI) tract endoscopically (via the mouth) to create a barrier between food and the wall of the intestine. Physicians believe that the hormonal signals that originate in the intestine may be altered when food is prevented from coming into contact with the intestinal wall.
The EndoBarrier Flow Restrictor is an additional mechanism which adds to the therapeutic effects of the liner. It is a membrane with a small opening that is designed to delay gastric emptying by providing adjustable restriction at the stomach outlet.
The EndoBarrier Technology is designed to eliminate or reduce the risks and side effects associated with pharmaceutical therapy or surgical options, while providing similar benefits.
The EndoBarrier Procedure
The EndoBarrier placement is an outpatient procedure that takes about 30 minutes to perform. It is placed in the GI tract endoscopically (via the mouth) and does not require incisions. The medical device is positioned in the duodenal bulb and fastened into place with an anchor. The liner extends approximately 2 feet through the small intestine (duodenum and proximal jejunum).
The EndoBarrier is removed after the treatment period, which has ranged anywhere from three to twelve months in clinical trials. The removal process is a quick (about 15 minutes) and easy endoscopic procedure that is performed using a custom retrieval system.
Results with EndoBarrier
Clinical data has shown that the EndoBarrier Gastrointestinal Liner, when combined with certain diet and lifestyle modifications, can help patients achieve significant weight loss and a rapid improvement in diabetes. The amount of weight loss is approximately doubled when the EndoBarrier Flow Restrictor is used in combination with the EndoBarrier Gastrointestinal Liner.
The following results were achieved by patients who were treated with the EndoBarrier:
- Near normalization of glycemic control in just one week
- A significant reduction in HbA1c glucose levels at 24 weeks
- A reduction in fasting blood glucose levels at 24 weeks
- Excess weight loss of 24.3% at 24 weeks
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.
Cost of EndoBarrier
The EndoBarrier is not yet FDA approved for marketing in the United States and the cost has yet been determined; however, GI Dynamics has indicated that it will be about half the cost of a gastric band procedure and a quarter of the cost of gastric bypass surgery.
The EndoBarrier Technology is a promising new treatment approach for type 2 diabetes and obesity. Although the EndoBarrier is still investigational in the United States, preliminary study results have demonstrated it to be a feasible and safe non-invasive medical device with excellent short-term weight loss results and a significant positive effect on type 2 diabetes.