GI Dynamics launches trial targeting FDA approval
|GI Dynamics' EndoBarrier is a gastrointestinal liner designed to treat Type 2 diabetes and obesity--courtesy of GI Dynamics.|
GI Dynamics ($GID) has kicked off its large-scale trial of the diabetes-treating EndoBarrier, and CEO Stuart Randle said the company is on track to file with the FDA in 2015.
GI is enrolling about 500 obese patients with Type 2 diabetes in a multi-center study across the U.S., Randle said in an interview with FierceMedicalDevices, looking for a primary endpoint of lower blood sugar and secondary results of weigh loss and reduced cholesterol.
"We've got a great clinical team, geared up and ready to go with this study," Randle said. "We gathered all the site reps in Chicago late last year, and the excitement and enthusiasm in room was quite palpable."
At the same time, GI is focused on commercializing the device overseas, where it has been CE marked since 2010, Randle said. The two-pronged approach keeps the company's staff busy, he said, but marketing EndoBarrier in foreign markets will prepare GI for the eventual U.S. rollout.
The device, an endoscopically implanted tube that separates food from the intestinal wall, proved in previous studies to rapidly and dramatically reduce blood sugar levels in patients and spur 20% weight loss in the first year after implantation, the company said.
EndoBarrier's path to an IDE trial has been fairly brisk by innovative device standards, but GI had to weather a lawsuit from Gore over the device's patent. But that's all resolved as of last week, with both parties agreeing to no-cash settlement in which GI retains the right to the technology for gastrointestinal uses while granting Gore a nonexclusive license to use it for vascular applications.
Now, Randle said, GI is unencumbered as it collects data to support a PMA application.
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