The EndoBarrier for Weight Loss – DSM – Diabetes Self Management

A novel device has been shown to have a dramatic effect on weight loss and diabetes improvement but it isn’t available in the United States. It was undergoing a clinical trial, but the U.S. Food and Drug Administration (FDA) shut the trial down. Why? The device appeared to be implicated in the formation of hepatic abscess, which is a pus-filled pocket of fluid within the liver.

The name of the device is EndoBarrier, and it’s manufactured by GI Dynamics, a Boston-based medical technology firm. The company calls it “The first endoscopically delivered device therapy for the treatment of Type 2 diabetes and obesity.” In a way, you can think of it as a weight-loss therapy that, according to GI Dynamics, is more effective than pills or injections, but not as drastic as weight-loss surgery. It’s especially useful for diabetes patients “for whom surgery is not an option,” the company says.

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What is the EndoBarrier?

The EndoBarrier is an implantable sleeve, about 2 1/2 inches long, that is endoscopically placed (using a long, thin device inserted into the body) into the first part of the small intestine, forming a barrier between food and the receptors in the intestinal wall. Its operation is similar to that of the Roux-en-Y gastric bypass bariatric procedure, which has become one of the most frequently used types of weight-loss surgery. The EndoBarrier stays in place for a year and then is removed.

Although it’s been shown to lead to weight loss and improved blood sugar levels in people with type 2 diabetes and obesity, the EndoBarrier has never been approved for use in the United States. In 2010, a study was started evaluating use of the device in the treatment of type 2 diabetes and obesity in some 3,000 patients, but the FDA stopped the trial because the EndoBarrier had a hepatic abscess rate of 3.5%. Both health professionals and patients were disappointed with the FDA’s decision because EndoBarrier had a good record in aiding weight loss and lowering blood sugar. Now it seemed that a valuable tool in the fight against diabetes was being taken away.

New EndoBarrier data

But the story doesn’t end there. GI Dynamics recently launched a new pivotal clinical trial in the United States. By mid-2022, data on more than 1,000 patients who had used the EndoBarrier in this study determined that it had …….


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