GI Dynamics, a medical device manufacturer based in Lexington, Massachusetts, announced that it had successfully launched a trial of its EndoBarrier diabetes-prevention weight loss system. Data from the study will be used to back a premarket approval application with the United States Food and Drug Administration.
According to a press release by the company, GI Dynamics hopes to submit the PMA application by the second half of 2015.
GI Dynamic’s EndoBarrier is a specialized plastic sleeve that is installed inside a patient’s gut. Once inside the gut, the EndoBarrier reduces the amount of food that patients can absorb. While the device is effective for weight loss, GI Dynamics stated that the device does not specifically target overweight patients. Instead, the device is designed to help diabetic patients control their blood sugar levels. Since obesity and diabetes are closely-linked, the EndoBarrier is effective at treating both these health conditions.
The clinical trial will include 25 sites across the United States and up to 500 patients with non-controlled Type II diabetes. Patient data will be assessed over a one-year period.
Stu Randle is the CEO and president of GI Dynamics. In prepared remarks, he said, "The start of our U.S. pivotal trial marks a major milestone on the road to bringing EndoBarrier to the millions of people in this country living with type 2 diabetes." He continued, "We appreciate the support of our investigators and clinical trial sites as we begin the process of enrolling patients and executing this landmark clinical trial."