GI Dynamics loses CE mark, right to sell device for obesity, diabetes in EU

Medical device company GI Dynamics announced its CE Mark for EndoBarrier, an endoscopic alternative to bariatric surgery, has been rescinded by its notified body SGS due to quality management issues.

As a result, the company can no longer sell the device in the European Union.

“The company is evaluating its options including grounds for appeal of the decision, consulting with its advisors and has initiated communications with SGS to clarify certain procedural and substantive matters relating to the notice,” according to a press release from GI Dynamics.

As Healio Gastroenterology and Liver Disease previously reported, the company announced in May that its CE mark was suspended pending resolution of nonconformities related to its quality management system. At that time, Scott Schorer, CEO and president of GI Dynamics, said the company had been “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.” In the May press release, he also added that the CE Mark suspension “does not call the safety and efficacy of EndoBarrier into question and this action does not constitute a recall.”

SGS withdrew EndoBarrier’s CE Certificate of Conformity effective November 12.

EndoBarrier (duodenal-jejunal bypass liner, GI Dynamics) is an endoscopic implant for the treatment of type 2 diabetes and obesity, previously 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. – by Adam Leitenberger

Disclosures: Schorer is employed by GI Dynamics.