Support Built for a Field That Moves Fast
Neurovascular intervention is a field where device design and clinical practice both advance quickly. A study that begins under one standard of care can finish under another, and that change is a known risk factor for neurovascular trials.
This sheet outlines how RQM+ supports manufacturers of flow diverters, stents, coils, liquid embolics, and thrombectomy systems across regulatory, clinical, laboratory, and reimbursement work, with specialists working as one team on the same program from the start.
What’s Inside
- How RQM+ builds regulatory strategy across the full neurovascular sub-category range, from embolic coils to next generation thrombectomy systems, for both U.S. and EU pathways
- How endpoints and comparators are planned to stay valid as thrombectomy and flow-diversion practice advances over the life of a study
- How Jordi Labs, our in-house, FDA-recognized laboratory, runs validated analytical chemistry across catheter polymer extractables and leachables (E&L), hydrophilic coating characterization, nitinol surface analysis, and liquid-embolic chemistry
- How Lumo™, our AI materials science platform, flags biocompatibility and E&L risks early
- Why health economics planning for novel neurovascular device categories is matched to where each category is heading as new coverage pathways take shape
Who This Is For
Regulatory, clinical, quality, and market access leaders at companies developing flow diverters, stents, embolic coils, liquid embolics, or thrombectomy systems.
A neurovascular trial must be designed for the standard of care it will finish under. This sheet shows how RQM+ plans for that from the start.
