InspireMD’s CGuard Prime Embolic Prevention System (EPS) has secured CE Mark approval under the European Medical Device Regulation (MDR) for stroke prevention.
Leveraging MicroNet mesh, the CGuard Prime EPS decreases early and late embolic events.
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The system was designed based on user feedback, enhancing the deliverability and deployment of the CGuard stent.
It is intended to trap debris against the vessel wall and prevent plaque prolapse and embolisation.
This mesh-covered carotid stent widens narrowed carotid arteries in high-risk individuals who require a less invasive treatment option.
CGuard’s dual-layer design is said to unite the largest open-cell frame of carotid stents with the smallest mesh pore size.
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By GlobalDataAccording to the company, the MicroNet is designed to prevent plaque protrusion through the stent, offering embolic protection shown for up to a 48-month period.
Additionally, SmartFit technology of the system prevents the requirement for a tapered version and provides support for accurate vessel wall apposition.
InspireMD CEO Marvin Slosman said: “Securing CE Mark certification under the EU MDR is a major milestone that demonstrates InspireMD’s commitment to advancing our next-generation platforms, regulatory rigour, and execution.
“This approval clears the path for the commercial launch of CGuard Prime EPS across our current CE-marked served markets, taking a pivotal step forward in our growth as a commercial-stage company and further strengthening our leadership in carotid stenting innovation.
“Additionally, this is the same platform that we intend to launch in the US later this year, subject to FDA approval, enabling greater scale as we move towards offering a unified platform across our served markets.”
Earlier this year, InspireMD and NAMSA started the pivotal, single-arm CGUARDIANS II study to assess the CGuard Prime 80cm carotid stent system’s usage in transcarotid artery revascularisation (TCAR) procedures.
