ESMINT is pleased to announce the publication of the multisociety consensus paper Clinical Evidence Standards for High-Risk Endovascular Devices in Ischemic Stroke.
Developed under the leadership of ESMINT in collaboration with the European Stroke Organisation (ESO) and the European Society of Neuroradiology (ESNR), the consensus provides the first indication-specific recommendations for the clinical evaluation of high-risk endovascular stroke devices in Europe.
> Read the full publication in JNIS
Mechanical thrombectomy has transformed the treatment of acute ischemic stroke and is now the standard of care for large-vessel occlusion. As new thrombectomy devices continue to enter clinical practice, the consensus addresses the need for clear guidance on the clinical evidence required to demonstrate safety and performance under the European Medical Device Regulation (MDR).
The recommendations were developed through a structured, evidence-based consensus process. Following a comprehensive review of the available scientific literature, experts from ESMINT, ESO, and ESNR agreed on practical recommendations for planning, conducting, and reporting clinical studies of single-use endovascular stroke devices.
Among other topics, the document provides guidance on study design, endpoint selection, safety monitoring, data transparency, post-market evidence generation, and study governance. The framework aims to support investigators, manufacturers, notified bodies, and regulators while promoting robust, clinically meaningful evidence generation.
The full publication is now available in the Journal of NeuroInterventional Surgery (JNIS) and represents an important milestone in establishing indication-specific clinical evidence standards for neurointerventional stroke devices.
ESMINT extends its sincere thanks to all authors, reviewers, collaborating societies, and contributors whose expertise and commitment made this important publication possible.
Additional resources
> Read the full publication in JNIS
> Download the Press Release (PDF)
