GI Dynamics Inc. continues to face stumbling blocks in its bid to obtain FDA approval for its endoscopically-delivered device therapy for the treatment of Type 2 diabetes and obesity. The Lexington, Mass-.based company said on Tuesday, that its Endobarrier device failed to meet safety and efficacy endpoints in the ENDO pivotal trial, but noted it would still continue to move forward with plans to gain FDA approval.
The FDA has published its summary of the pivotal trial for the first bioresorbable coronary artery stent, and among the questions the agency will pose to the advisory committee at the meeting today is whether the panelists believe that more follow-up data are needed from the pivotal trial before the FDA can approve the first-of-a-kind Absorb stent.