GI Dynamics gets FDA conditional OK for a trial of its EndoBarrier obesity treatment

GI Dynamics Inc., a medical device company with offices in Lexington, announced Thursday that it has received conditional approval from the Food and Drug Administration to start a pivotal clinical trial of its EndoBarrier device for the treatment of patients who have uncontrolled type 2 diabetes and who are obese.

According to the company’s website, the EndoBarrier is placed in the intestine through a small tube that is inserted through the mouth, mimicking the effects of gastric bypass, without the risks associated with surgery. As described by GI Dynamics, the device is a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the wall of the intestine.

Estimates indicate that type 2 diabetes affects more than 23 million people in the United States and about 320 million people worldwide, GI Dynamics noted in its press release.

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The EndoBarrier is already approved and commercially available in such markets as Chile, Australia, and several European countries, the company said.