Here’s what you should know:
1. SGS, a certification company, revoked the CE mark over ISO 13485 noncompliance, related to quality control issues, Nov. 12.
2. After notifying EndoBarrier of quality issues in May, SGS suspended the CE Mark soon thereafter. As a result of SGS’ action, GI Dynamics will no longer be able to sell the EndoBarrier in the European Union.
3. In a release, the company said it is evaluating whether to appeal the decision. The company is also working to “clarify certain procedural and substantive matters relating to the notice.”
4. The EndoBarrier has long been the subject of controversy. After receiving conditional FDA approval in 2012, the FDA stopped the company from enrolling patients into its ENDO trial in May 2015, before GI Dynamics discontinued the trial in July 2015.
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