The EndoBarrier for Weight Loss

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The EndoBarrier for Weight Loss

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 a hepatic abscess rate of only 1.1%. These new data were presented at the European Association for the Study of Diabetes (EASD) 2022 Annual Meeting by Bob Ryder, MD, leader of the Association of British Clinical Diabetologists (ABCD) reviews of new diabetes therapies and devices. Dr. Ryder had led two trials of the EndoBarrier. Also, in September 2019 a new multi-center, double-blinded, randomized trial to evaluate the safety and effectiveness of the EndoBarrier System involving 240 participants was begun in the United States. This trial is scheduled to be completed in early 2023 or 2024 and now hopes are high that it may soon be on the market.

In an interview with the medical website Medscape, Leszek Czupryniak, MD, who served as the session moderator at the EASD meeting, said, “It’s an interesting device that has been around for quite some time already. This was a vast group with very impressive results. The most interesting thing was that you have it implanted for a year and then it changes your life so much. You lose weight, it probably changes your lifestyle, and then you’re able to maintain this lost body weight for years.”

Want to learn more about weight management? Read “Tried and True Weight-Loss Techniques,” “Losing Weight Without Feeling Hungry,” and “Seven Ways to Lose Weight.”

Joseph Gustaitis

Joseph Gustaitis

Joseph Gustaitis on social media

A freelance writer and editor based in the Chicago area, Gustaitis has a degree in journalism from Columbia University. He has decades of experience writing about diabetes and related health conditions and interviewing healthcare experts.

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