GI Dynamics wins FDA nod for pivotal US EndoBarrier trial

GI Dynamics (ASX:GID) said today it won FDA investigational device exemption approval to launch a pivotal trial of its EndoBarrier device designed for treating patients with type 2 diabetes and obesity, pending Institutional Review Board approval. The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and enters the intestinal tract to treat type 2 diabetes and obesity, the Lexington, Mass.-based company said. The approval is a boon for the company, which has faced a number of hurdles with its device over the past few years, including shutting down an initial FDA-approved study, being pulled off the shelves in Australia and losing its CE Mark approval in the European Union. “It’s the first good news and a positive sign of all of the hard work the team has been putting in over the last two years. This is the first sign that the results are starting to turn around, so we’re very excited about it,” CEO Scott Schorer, who took over the company in March 2015, told MassDevice.com in an interview. Schorer, a veteran of the medical device industry, has been working to turn around the company, driven by the EndoBarrier’s potential to help individuals living with obesity and type 2 diabetes. “There’s an extraordinary amount of support for this technology, we couldn’t let it fail, and we don’t plan on letting it fail,” Schorer said. “We’re in a much better pl...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Diabetes Food & Drug Administration (FDA) Regulatory/Compliance Weight loss GI Dynamics Source Type: news