We’ve been following InspireMD, Inc., with its clever MGuard embolic protection stent (EPS) technology, for a few years now. In April of this year the company initiated a Voluntary Field Recall of its Mguard Prime EPS following reports of stent dislodgements. Now it has issued a press release confirming receipt of European approval to resume the manufacturing of its MGuard Prime EPS stent with a modified stent securement process . The Company also received approval to modify and re-deploy existing MGuard Prime EPS stents that have been returned by clinical and commercial sites worldwide.
The failures that prompted the recall of MGuard Prime EPS primarily occurred during the preparation of the Mguard Prime EPS, upon removal of the protective sleeve or during withdrawal of the Mguard Prime EPS into the guide catheter. There have been no reports of any patients being actually harmed in the reported events.
Inspire MD, having identified the root cause of these dislodgements needed to seek and gain approval from the European regulatory agency to modify all existing units of the Mguard Prime EPS in order to improve stent retention and performance, approval which it has now duly received.
InspireMD is still awaiting U.S. FDA approval of the manufacturing process changes to the MGuard Prime EPS. The Company anticipates a late Q3 or early Q4 agency review and intends to resume enrollment in its MASTER II FDA trial shortly after regulatory approval is obtained. In the meantime, the Company intends to continue focusing on site activation in order to accelerate enrollment once the study resumes.
Alan Milinazzo, CEO of InspireMD, stated, “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 reengage our commercial customers.”
Source: Inspire MD, Inc., PR Newswire