Gastrointestinal liner (Endo-Barrier)

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.

Trials and Approvals
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.

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

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.

A 52-week trial was designed to evaluate the EndoBarrier Gastrointestinal Liner in 22 obese patients with type 2 diabetes. The primary endpoints in the trial include improvement in type 2 diabetes and excess weight loss. To date, the first six of the 22 subjects implanted with the EndoBarrier have successfully reached the 52-week endpoint.
The clinical trial was led by Eduardo G. Moura, M.D., Ph.D., director of endoscopy, digestive surgery department, Hospital das Clinicas, University of Sao Paulo, Brazil.

The average baseline weight for the subjects was 270.5 lbs (± 22.2 1bs), average baseline HbA1c was 9.3% (± 0.8%) and subjects were taking oral anti-diabetes medications. Top-line results for the first six subjects show that on average patients achieved the following results: • • HbA1c decrease of 2.5% (± 0.6%) with 5 of the 6 getting below 7.0%
• 25.9 % excess body weight loss (± 4.6%)
• 35.5 lbs weight loss (± 9 lbs)
• Undoubtedly we will hear a lot more about this Weight Loss without Surgery procedure. More data will be available soon, now approval was given in Europe.


 

Request pricing information of our Affordable Cosmetic Surgery Program.