The revamped device has a new stent securement process, allowing the company to begin manufacturing new stents and to re-deploy existing inventory that had been returned, InspireMD said. The MASTER II trial in the U.S. is still on hiatus.
InspireMD pulled the devices off the market in April after receiving reports that its MGuard Prime EPS stent could dislodge during implantation procedures, usually during preparation of the stent, removal of the protective sleeve or during withdrawal into the guide catheter. No patients were reportedly harmed by the defect, the company noted.
"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.," CEO Alan Milinazzo said in prepared remarks. "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."
InspireMD has still to await FDA approval to resume manufacturing and sales in the U.S., and the company hopes to undergo review by the 3rd or 4th quarter this year. The MASTER II trial will resume shortly after. In the meantime, InspireMD is looking to continue enrolling potential study sites so that researchers can take off running once the FDA gives the OK.