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InspireMD Gets European OK to Resume Manufacturing of its MGuard Prime Embolic Protection System

Approval follows a voluntary field action taken by the company in April.

InspireMD Inc. received European regulatory approval to resume the manufacturing of its MGuard Prime embolic protection system (EPS) stent with a modified stent securement process that

protects patients from plaque debris and blood clots breaking off and traveling distally in the arteries which can lead to life threatening strokes. – See more at: http://www.cxvascular.com/cn-latest-news/cardiovascular-news—latest-news/inspiremd-to-showcase-embolic-systems-with-micronet-technology-and-results-from-master-i-trial-at-europcr-conference-#sthash.xTs8vj5c.dpuf
protects patients from plaque debris and blood clots breaking off and traveling in the arteries, which can lead to life threatening strokes. 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 (VFA) that the company implemented on April 30 of this year, following reports of stent dislodgements that—according to the company—primarily occurred during the preparation of the device, upon removal of the protective sleeve, or during withdrawal of the MGuard Prime EPS into the guide catheter. There were no reports of any patients harmed.

The VFA for InspireMD’s MGuard Prime cobalt chrome EPS did not apply to or impact the company’s MGuard stainless steel EPS or CGuard nitinol products.
 
InspireMD immediately will begin re-engaging in its commercial and clinical activities in Europe and other markets outside of the United States.

Alan Milinazzo, CEO of InspireMD, said: “We are pleased to report the approval of our modified manufacturing process for the MGuard Prime EPS and that we can now return to commercial and clinical activities in Europe and other markets outside of the U.S. 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.  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 re-engage our commercial customers.”

InspireMD continues to wait for U.S. 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, according  InspireMD officials.

InspireMD has locations in Boston, Mass; Tel Aviv, Israel; and Winsen, Germany.

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