GI Dynamics gains FDA nod for obesity device pivotal trial

GI Dynamics' EndoBarrier is a gastrointestinal liner designed to treat Type 2 diabetes and obesity--courtesy of GI Dynamics

GI Dynamics ($GID) plans to launch a pivotal trial for its EndoBarrier device by the end of 2012, now that the FDA has granted conditional approval to proceed and skip over the customary pilot trial. EndoBarrier is a gastrointestinal liner designed to treat Type 2 diabetes and obesity. Company president and CEO Stuart Randle said in a statement that the decision could help speed up the commercialization timeline of EndoBarrier in the U.S. after surgeons implanted EndoBarrier into the first patients earlier this spring. GI Dynamics, which is based in Lexington, MA and Australia, previously gained approval in markets including Australia, Chile and some European countries. Release

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