Abstract
BACKGROUND Untreated intracranial aneurysms can rupture and result in high rates of morbidity and mortality. Although there are numerous approved endovascular aneurysm treatment devices, most require dual anti‐platelet therapy, are minimally biocompatible, or are prone to recanalization. Neurovascular Controlled Uniform Rapid Embolic (NeuroCURE) is an innovative polymer gel material with long‐term stability, biocompatibility, and hemocompatibility developed for the treatment of large, wide‐neck aneurysms. METHODS Sidewall aneurysms were surgically created in 10 canines and NeuroCURE was injected through a 0.025 microcatheter under a single balloon inflation period. Aneurysm treatment was angiographically assessed post‐embolization and pre‐term with Raymond–Roy occlusion classification and a qualitative flow grade scale. Aneurysm neck stability and biocompatibility was histologically assessed to grade platelet/fibrin thrombus, percent endothelialization, and neointimal formation. Aneurysm sac stability was assessed by NeuroCURE sac content, inflammation, and neo‐angiogenesis scales. RESULTS Explanted aneurysms exhibited a smooth surface at the aneurysm neck with nearly complete neointimal coverage at 3‐months. By 6‐months, neck endothelialization was 100% in all animals (average Raymond–Roy occlusion classification of 1.2), with no instances of aneurysm recanalization or parent vessel flow compromise. Biocompatibility assessments verified a lack of inflammatory response, neo‐angiogenesis, and platelet/fibrin thrombus formation. CONCLUSION The NeuroCURE material promotes progressive occlusion of wide‐necked side wall aneurysms over time without the need for dual antiplatelet agents. NeuroCURE also promotes neointimal tissue infill without dependence on thrombus formation and thus resists aneurysm recanalization. NeuroCURE remains a compelling investigational device for the treatment of intracranial aneurysms.