|The EndoBarrier in the intestine--Courtesy of GI Dynamics|
GI Dynamics announced the final results from the U.S. pivotal trial of its endoscopically delivered device to treat Type 2 diabetes and obesity. The trial ended early due to a higher-than-normal incidence of liver abscess, which can be fatal.
The device, dubbed EndoBarrier, is for people whose diabetes medications don't work anymore, or who are at risk of complications from diabetes and obesity. It is a flexible, tube-shaped liner that works as a shield between food and part of the intestinal wall. This allows the food to essentially bypass the duodenum in a nonsurgical alternative to gastric bypass. It is CE marked.
The Australian company said the device made "meaningful improvements" in hemoglobin A1c (HbA1c) levels and weight reduction compared to a group that underwent sham treatment. The device's overall safety profile was positive, except for a "higher than anticipated rate of hepatic abscess," GI Dynamics said. The trial was terminated in July last year with data from 325 of the planned 500 participants. It started removing the device from its existing patients.
The rate of hepatic abscess in the trial was about 3.5%, almost 5 times the rate of commercially available units outside the U.S. There are three major forms of hepatic abscess, the most common of which, pyogenic hepatic abscess, is fatal if left untreated. Even with timely treatment, life-threatening sepsis can develop.
"While the issue of hepatic abscess needs to be addressed further, this demonstration of benefit underscores the promise of this endoluminal device," said the study's principal investigator, Dr. Lee Kaplan, in a statement. The company is working to minimize hepatic abscess and is collaborating with the FDA on a revised clinical trial.
- here's the announcement