The EndoBarrier® Gastrointestinal Liner is a breakthrough product designed to help patients regain control of type 2 diabetes and obesity.

The EndoBarrier is not approved for sale in the United States and is considered investigational.

The EndoBarrier has received European CE mark approval in Decemebr 2009 and is commercially available in Chile, Germany, the United Kingdom, the Netherlands and Austria.

The EndoBarrier has received Australian Therapeutic Goods Administration (TGA) approval in July 2011 and will soon be available in Australia.

The TGA has approved the use of the EndoBarrier for up to 12 months for the treatment of type 2 diabetes and obesity. With this approval, GI Dynamics will be able to commercially launch the EndoBarrier in Australia.

There is an urgent need for less invasive, yet effective treatments for type 2 diabetes and obesity

Type 2 diabetes, which accounts for approximately 90 percent of all cases of diabetes, occurs when the pancreas has reduced effectiveness in insulin production associated with an increase in insulin resistance. The diagnosis of type 2 diabetes usually occurs after the age of 40 and is often, but not always, associated with obesity.

The EndoBarrier is implanted inserted endoscopically (via the mouth) into the intestine and doesn’t require any surgery or incisions. It acts as a physical barrier between food and that part of the intestine wall where the EndoBarrier is present.

This action delays digestion and intervenes with the body’s metabolic functions, which results in improved diabetes control and weight loss, thus mimicking the effects of gastric bypass surgery without the risks associated with surgery.

The effects of the EndoBarrier on glucose control are rapid. The Endobarrier may be implanted for up to 12 months of use and has shown benefits in three-month, six-month and 12-month studies. The device is easily removed, also endoscopically, during a simple, outpatient procedure.

The EndoBarrier Or Gastrointestinal Liner is a NEW WLWS (Weigh Loss Without Surgery) OPTION.

The EndoBarrier, a non-surgical therapy to treat type 2 diabetes and obesity, received European CE mark approval for the treatment of type 2 diabetes and obesity in December 2009.

The EndoBarrier is fundamentally a gastrointestinal impermeable barrier or a gastric sleeve that prevents food from coming in contact with the intestinal wall.

The Endobarrier sleeve can be placed without surgery into the patient’s small intestine to help them achieve weight loss.

The device is implanted endoscopically through the mouth and is placed in such a way that it lines the first two feet of the small intestine. This helps to prevent easy absorption of food as long as it remains in the sleeve and has huge impact on the person’s intake of nutrients and calories. The digestive enzymes are on the outside of the liner and the food and the digestive juices do not mix until 2 feet downstream in the small intestines.

Clinical trials to date involving more than 280 patients have demonstrated the significant weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner.

Features and benefits include:

• The EndoBarrier is implanted and removed endoscopically.

• The implantation can be carried out as a day procedure

• The overall metabolic effect that results from the implantation of the device is similar to the complicated Roux-en-Y gastric bypass surgical procedure

• Glycemic control in Type 2 diabetes

• Weight loss

• Procedure is reversible

• Safe alternative to gastric bypass

• Non invasive procedure

• Rapid recovery

• Lower costs

It could be a safe way for those who awaiting surgery to lose weight prior to the surgery.

Late December 2009, GI Dynamics, a leader in non-surgical, endoscopic treatments for type 2 diabetes and obesity, announced that it has received European CE mark approval for the EndoBarrier, a non-surgical therapy to treat type 2 diabetes and obesity. The CE marking (an acronym for the French “Conformite Europeenne” or European conformity) certifies that a product has met EU requirements for marketing in Europe.

Another study recently announced a study that highlights the enhanced weight loss effects of combining the EndoBarrier Gastrointestinal Liner with a new EndoBarrier Flow Restrictor. The EndoBarrier Flow Restrictor provides an adjustable restriction at the outlet.

Undoubtedly we will hear a lot more about this Weight Loss without Surgery procedure when more data is becoming available soon, now approval has been given in Europe.