The EndoBarrier has received European CE mark approval and is commercially available in Chile, Germany, the United Kingdom, the Netherlands and Austria. The EndoBarrier has received TGA approval and will soon be available in Australia.
The EndoBarrier is not approved for sale in the United States and is considered investigational. The EndoBarrier has CE mark approval in Europe and is indicated to treat patients with type 2 diabetes and/or obesity for 12 months.
Clinical trial experience to date involving more than 500 patients has demonstrated significant diabetes improvement and weight loss with the EndoBarrier during the implant period, when combined with certain diet and lifestyle modifications. In addition, while using the EndoBarrier, many patients are also able to decrease their dosage of oral anti-diabetes medications.
The EndoBarrier is implanted into the intestine and 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 EndoBarrier is inserted endoscopically (via the mouth) and doesn’t require any surgery or incisions.
Once in place, the effects of the EndoBarrier on glucose control are rapid. It 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, and initial studies have demonstrated that the EndoBarrier has sustained benefits on glycemic control and weight loss up to six months post-explant.