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