GI Dynamics Inc. is shutting down the U.S. pivotal trial for its Endobarrier device for obese patients with diabetes after talks with FDA failed to yield a plan for addressing elevated rates of liver infection in the trial. But the company suggests development of the product will continue.
The July 30 announcement that the ENDO trial is being terminated comes almost five months after the company disclosed that the study was placed on hold by FDA
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?