InspireMD announced today that it has received CE-mark recertification under the European Union’s (EU) new Medical Device Regulation (MDR) regulatory framework for its CGuard embolic prevention system (EPS), which is a carotid stent device intended to facilitate the prevention of stroke.
The MDR replaced the previous Medical Device Directive (MDD) framework, which had governed the approval and marketing of medical devices in the EU until May 2021.
Marvin Slosman, chief executive officer of InspireMD, stated: “The transition from MDD to MDR has been challenging and has required us, and others in the medical device industry, to be comprehensive and persistent in our approach to addressing changes in requirements, timelines and priorities during this process. We are very pleased to have now received formal recertification of our CE mark under MDR, allowing us to continue to work to make CGuard EPS the standard of care for carotid artery revascularisation in our existing commercial territories while also advancing our new product pipeline using the pathway provided under MDR.
“In parallel, our work on the premarket approval application (PMA) for the C-GUARDIANS US IDE [investigational device exemption] trial continues to progress nicely, and we look forward to primary endpoint results in mid-2024, followed by submission of the final module of the PMA application to FDA in the second half of this year. We continue to aggressively work toward multiple value-creating milestones, including the potential US approval of the CGuard Prime EPS stent system in the first half of 2025.”
As per a company press release, InspireMD seeks to utilise its proprietary MicroNet technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free, long-term outcomes.
