|GI Dynamics got the FDA's blessing to start a pivotal trial for EndoBarrier--courtesy of GI Dynamics|
GI Dynamics ($GID) got the go-ahead from the FDA to begin a pivotal trial for EndoBarrier, a device designed to help Type 2 diabetics lose weight.
GI is set to kick off a 25-site trial of 500 patients, looking to support a future PMA for the tube-shaped device that separates food from the intestinal wall. The company is looking for reduced blood sugar and body weight in the 12-month study, and earlier trials have found the device to spur weight loss of about 20% over a year.
EndoBarrier has moved quickly through the regulatory process, as GI snagged a conditional FDA approval in August that allowed the company to skip a pilot trial for the device. Now, with a pivotal trial on the way and a PMA not too far off, EndoBarrier has progressed ahead of schedule, CEO Stuart Randle said.
The device got its CE mark in 2010 and is currently available in countries around the world, including Australia, the U.K. and Germany. GI implanted the non-surgical device into its first patients back in April, sending the Lexington, MA, company's stock up 7% on the Australian Securities Exchange.
- read GI's statement