GI Dynamics ’ 2nd Chance at an EndoBarrier Pivotal Trial

GI Dynamics’ fortunes might be changing, as the embattled device maker has crossed the last hurdle in its bid for the approval of a new pivotal trial to evaluate its obesity and diabetes treatment device, the EndoBarrier. The company recently announced it had received Institutional Review Board approval to launch a pivotal trial of the EndoBarrier. GI Dynamics has struggled significantly with the device in the past (more on that later), but until recently it has had some success. In August of 2018, FDA gave a nod to the EndoBarrier’s pivotal trial. The last step was for the firm to secure IRB approval, which is required by FDA and is an essential step to allow the pivotal trial to proceed. Western IRB (WIRB) is serving as the company’s central IRB. “When we announced that the FDA approved our Investigational Device Exemption (IDE) for the pivotal trial of EndoBarrier, the approval was conditional upon IRB approval,” Scott Schorer, president and CEO of GI Dynamics, said in a release. “This IRB approval now satisfies that condition. In parallel, we continue to push forward with the clinical study sites that will be part of the 18-1 study and we anticipate being in a position to announce these clinical sites shortly.” The study, referred to as 18-1 is a randomized (3:1) controlled double-blinded clinical trial designed to measure the efficacy and safety o...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news