The European Society of Minimally Invasive Neurological Therapy (ESMINT) has welcomed the publication in the Journal of NeuroInterventional Surgery (JNIS) of new clinical evidence standards for high-risk endovascular devices in ischaemic stroke.
Developed through a collaboration between ESMINT, the European Stroke Organisation (ESO), and the European Society of Neuroradiology (ESNR), this consensus document is said to provide the first indication-specific recommendations for the clinical evaluation of high-risk endovascular stroke devices in Europe.
A recent ESMINT press release notes that, as new mechanical thrombectomy devices continue to enter clinical practice, questions remain regarding the level and type of clinical evidence required to demonstrate safety and performance under the European Medical Device Regulation (MDR).
To address this gap, the study group for the present JNIS publication first reviewed the available scientific evidence with methodological support from the Institute for Evidence in Medicine at the University of Freiburg (Freiburg, Germany). And, building on these findings, representatives of ESMINT, ESO and ESNR took part in a structured, three-round consensus process to agree on key recommendations.
These recommendations are intended to offer practical guidance for planning, conducting and reporting clinical studies of single-use endovascular stroke devices to support regulatory approval.
Among the key findings, the panel concluded that prospective observational studies are appropriate for most regulatory scenarios involving thrombectomy devices, while acknowledging that conceptually novel devices may require more rigorous comparative evaluation.
Consensus was also achieved on essential study design elements, including multicentre participation, operator and centre requirements, independent imaging adjudication, endpoint selection, safety monitoring, and data transparency. The document identifies functional independence at 90 days, successful reperfusion and symptomatic intracranial haemorrhage as core outcome domains for future device studies.
Additionally, the consensus document provides recommendations on sample size planning, post-market evidence generation, comparator selection, and study governance.
“This consensus represents an important milestone for our field,” said ESMINT president Anne-Christine Januel (Toulouse University Hospital, Toulouse, France). “Our objective was not to lower evidentiary standards, but to define study approaches that preserve scientific rigour while reflecting the realities of neurointerventional practice. The resulting framework supports robust and clinically meaningful evidence generation across a broad range of regulatory scenarios.”
“Current regulatory frameworks provide important general principles, but they do not address many of the specific challenges encountered in neurointerventional stroke research,” added lead publication author and ESMINT general secretary Christian Taschner (University Hospital Freiburg, Freiburg, Germany). “Our goal was to translate these principles into practical guidance tailored to endovascular stroke therapy. We hope this framework will support investigators, manufacturers, notified bodies and regulators alike.”
The authors further emphasise that these recommendations complement existing MDR, International Organization for Standardization (ISO) and Coordinating Research and Evidence for Medical Devices (CORE-MD) frameworks by translating general regulatory concepts into clinically meaningful standards for neurointerventional research. Beyond stroke therapy, the approach may serve as a model for developing physician-led, indication-specific guidance in other highly specialised medical fields, according to the authors.
