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GI Dynamics Terminates Pivotal Endobarrier Trial Based On Safety Data

FDA and the company could not come up with a plan to continue the ENDO study for GI's device targeting obese patients with diabetes in response to higher-than-anticipated rates of liver infection. The company suggests, however, that development of the device will continue.

GI Dynamics Inc. is shutting down the U.S. pivotal trial for its Endobarrier device for obese patients with diabetes after talks with FDA failed to yield a plan for addressing elevated rates of liver infection in the trial. But the company suggests development of the product will continue.

The July 30 announcement that the ENDO trial is being terminated comes almost five months after the company disclosed that the study was placed on hold by FDA

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