The company has also obtained approval to modify and re-deploy existing MGuard Prime EPS stents, which have been returned by clinical and commercial sites worldwide. The European regulatory approval follows a voluntary field action that the company implemented in April 2014.
InspireMD CEO Alan Milinazzo said that the company is pleased to report the approval of its modified manufacturing process for the MGuard Prime EPS and that it can now return to commercial and clinical activities in Europe and other markets outside of the US.
"We expect production of the MGuard Prime EPS to ramp over the next several weeks, as we come back online to support our sales and clinical programs," Milinazzo added.
"Although we are still working on the necessary approvals to resume our MASTER II FDA trial, we can immediately begin accelerating other important clinical programs while we simultaneously reengage our commercial customers."
InspireMD is still awaiting the US Food and Drug Administration’s (FDA) approval of the manufacturing process changes to the MGuard Prime EPS and it expects a late third quarter or early fourth quarter agency review.
The company plans to resume patient enrollment in its MASTER II FDA trial shortly after obtaining the regulatory approval. During the intervening time, the company plans to continue focusing on site activation in order to accelerate enrollment once the study resumes.
