EndoBarrier Device Fails Safety Assessment in Obese Diabetic Patients

Pivotal U.S. trial terminated because of liver abscess

Final results have been reported from a U.S. pivotal study of the EndoBarrier device (GI Dynamics, Inc.) in subjects with uncontrolled type-2 diabetes and obesity. The study was terminated early because of a higher-than-normal incidence of liver abscess, which can be fatal.

The EndoBarrier device is an endoscopically delivered, flexible, tube-shaped liner that acts as a shield between food and part of the intestinal wall. This allows the food to bypass the duodenum in a nonsurgical alternative to gastric bypass.

The ENDO trial demonstrated clinically meaningful improvements in hemoglobin A1c levels and weight reduction with the EndoBarrier device compared with a sham procedure in 325 subjects. However, the rate of hepatic abscess was 3.5%––almost five times the rate seen with commercially available units outside the U.S. Moreover, device-related serious adverse events requiring early removal occurred in 10.9% of the EndoBarrier group.

The study was ended in July 2015 with data from 325 of 500 planned participants. GI Dynamics immediately started removing the device from its existing patients.

The study results were presented at the American Diabetes Association’s 76th Scientific Sessions, held on June 10–14 in New Orleans, Louisiana.

The EndoBarrier device is commercially available outside the U.S. but is not approved for use in this country.

Sources: GI Dynamics; June 23, 2016; and FierceMedicalDevices; June 23, 2016.