Abstract
BACKGROUND AND PURPOSE: The development of new generation flow-diverting devices will improve the result of flow diversion in challenging aneurysms. The Flow-Redirection Endoluminal Device system is a dual-layer flow-diversion device. The purpose of this study was to evaluate the effectiveness and safety of the Flow-Redirection Endoluminal Device in a sidewall aneurysm model and in the abdominal aorta in rabbits. MATERIALS AND METHODS: Single Flow-Redirection Endoluminal Devices were implanted in the right common carotid artery across sidewall, vein-pouch aneurysms and within the abdominal aorta in 22 New Zealand white rabbits and followed for 1 (n = 5), 3 (n = 5), 6 (n = 4), and 12 months (n = 8). Aneurysm occlusion was graded on a 3-point scale based on digital subtraction angiography (grade I, complete occlusion; grade II, near-complete occlusion; and grade III, incomplete occlusion). Toluidine blue and basic fuchsin staining was used for the evaluation of thrombus organization within the aneurysm and neck coverage with neointima. A scanning electron microscope was used for confirmation of the patency of branch vessels along with DSA. RESULTS: Grades I and II occlusion rates were noted in 19 (86%) and 3 (14%) aneurysms, respectively, which indicated a 100% rate of complete or near-complete occlusion. No parent artery and branch artery occlusion was shown on DSA. Histologic images indicated partial or complete intraluminal thrombus organization and neointima coverage across the aneurysm neck. A scanning electron microscope indicated that all the vessel branches along the length of the device remained patent. CONCLUSIONS: The Flow-Redirection Endoluminal Device in experimental aneurysms demonstrated high rates of progressive and complete aneurysm occlusion while preserving the patency of branch vessels.