InspireMD pulls its MGuard Prime EPS stent after receiving reports of dislodgement during implantation procedures and suspends a U.S. clinical trial pending FDA review. InspireMD (OTC:NSPR) said it issued a voluntary field action after receiving reports that its MGuard Prime EPS stent can dislodge during implantation procedures. "These reports have 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. To date, there have been no reports of any patients being harmed in these recent reports reviewed by the company," according to a press release.
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