InspireMD Receives European Approval to Resume Commercial and Clinical Activities for MGuard Prime EPS

June 23, 2014—InspireMD, Inc. announced that it received European regulatory approval to resume the manufacturing of its MGuard Prime embolic protection system (EPS) stent with a modified stent securement process. The company also received approval to modify and redeploy existing MGuard Prime EPS stents that have been returned by clinical and commercial sites worldwide. 

The European regulatory approval follows a Voluntary Field Action that the company implemented on April 30, 2014.
 
InspireMD advises that it will immediately begin re-engaging in its commercial and clinical activities in Europe and other markets outside of the United States.

In the United States, InspireMD is still awaiting US Food and Drug Administration (FDA) approval of the manufacturing process changes to the MGuard Prime EPS. The company anticipates a late third quarter or early fourth quarter FDA review and intends to resume enrollment in its MASTER II FDA trial shortly after this regulatory approval is obtained. In the meantime, the company will focus on site activation in order to accelerate enrollment when the study resumes, stated InspireMD.