InspireMD has obtained CE mark approval for its new CGuard RX rapid exchange system for MicroNetTM covered carotid stent technology.
The approval has been granted to the new system for its MicroNetTM covered embolic prevention system (EPS). It allows clinicians to place the CGuard technology using an easy-to-use delivery system.
InspireMD CEO Alan Milinazzo said: "We are very pleased to have received the CE mark approval for our CGuard RX rapid exchange system.
"This is an important milestone for the Company as it creates significant near term commercial opportunities for us."
The CGuard EPS utilises the same MicroNet technology featured on the MGuard and MGuard Prime coronary embolic protection systems, noted the company.
The MicroNet technology is a single fiber knitted mesh wrapped on an open cell stent platform, developed to trap debris that can dislodge and travel downstream after a patient is treated with traditional stenting methods.
InspireMD noted that CGuard EPS is not approved by FDA for sale in the US.
The company also announced the positive sixth month follow up data from its CGuardTM CARotid Embolic protection Study using microNET (CARENET) trial at the Leipzig InterveNtional Course (LINC) meeting in Leipzig, Germany.