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EndoBarrier CE Mark suspended for quality management issues
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GI Dynamics announced that the CE Mark for its EndoBarrier device has been suspended due to “nonconformances related to its quality management system.”
“This action does not call the safety and efficacy of EndoBarrier into question and this action does not constitute a recall,” Scott Schorer, CEO and president of GI Dynamics, said in a press release. “We are working swiftly to address issues within our quality management system that were detailed in a corrective action report from SGS; we will have these nonconformances resolved and have our CE Mark reinstated as quickly as possible.”
The company has been working to address these and other issues since new management took over last spring, and they have hired a chief compliance officer and quality and regulatory experts to address the issues leading to the suspension, according to the press release.
With sufficient inventory already shipped, service should not be interrupted during the suspension, and “all implanted patients may continue treatment subject to normal ongoing evaluation and monitoring by their health care professional,” the release said.
EndoBarrier (duodenal-jejunal bypass liner, GI Dynamics) is an endoscopic implant for the treatment of type 2 diabetes and obesity approved in Europe but restricted to investigational use in the U.S. The implant mimics the intestinal bypass component of Roux-en-Y gastric bypass to induce weight loss and improved glycemic control.
Disclosures: Schorer is employed by GI Dynamics.