GI Dynamics launches a U.S. trial of its EndoBarrier diabetes device, aiming to use the data to back a pre-market approval application with the FDA.
GI Dynamics (ASX:GID) said today that it's launched a U.S. pivotal trial of its EndoBarrier anti-diabetes weight loss device, hoping to use the study data to back a pre-market approval application with the FDA.
President & CEO Stu Randle told MassDevice.com that the Lexington, Mass.-based company hopes to put a PMA application before the federal watchdog agency "in late 2015."
The EndoBarrier is a plastic sleeve designed to line the gut and prevent the absorption of food. The U.S. trial will span 25 U.S. sites, enrolling up to 500 obese patients with uncontrolled Type II diabetes and assessing changes over a period of 12 months.