Israeli medical device company InspireMD has received the CE Mark for its CGuard Prime Embolic Prevention System (EPS) under the European Medical Device Regulation (MDR).
The CGuard Prime is designed to prevent strokes by optimising the deliverability and deployment of the CGuard stent.
It incorporates user feedback and leverages the unique MicroNet mesh technology.
The CGuard Prime EPS is engineered to reduce embolic events by trapping debris against the vessel wall, thereby preventing plaque prolapse and embolisation, which are primary causes of stroke.
The system is particularly beneficial for patients at high risk of surgical complications, offering a less invasive treatment option with sustained embolic protection.
The CGuard EPS features a novel mesh-covered carotid stent that combines the largest open-cell frame with the smallest mesh pore size available.
The design ensures lasting protection against plaque prolapse and embolisation, with effectiveness demonstrated beyond five years.
InspireMD aims to set industry standards in carotid stenting through its unique MicroNet technology, which promises acute results and durable, stroke-free long-term outcomes.
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 United States 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, a MedTech contract research organisation (CRO), announced the CGUARDIANS II study under a previous outsourcing partnership.
The study includes InspireMD’s CGuard Prime 80cm carotid stent system for use in Transcarotid Artery Revascularization (TCAR) procedures.
