Efficacy and safety of a novel flow-disruptor device in a rabbit aneurysm model: a preliminary study.

Abstract

This study aimed to evaluate the efficacy and safety of a novel flow-disruptor (NFD), designed to function as both a flow diverter and disruptor, in a rabbit aneurysm model. Elastase-induced aneurysms were created in 21 rabbits and treated with the NFD. Animals were randomly assigned to follow-up evaluations at 1 month (n = 7), 2 months (n = 7), and 3 months (n = 7). Angiographic and histological analyses were performed to assess aneurysm occlusion rates and neointimal formation. Immediate angiography demonstrated near-complete or complete flow disruption in 52% of aneurysms. Follow-up angiography revealed favorable aneurysm occlusion rates, reaching 76% (16 of 21 cases). Histologically, successful neointimal formation across the aneurysm neck was observed when the device was appropriately implanted in the aneurysmal sac. However, intentional device tip protrusion into the parent artery resulted in variable occlusion outcomes. The NFD demonstrated promising aneurysm occlusion rates and safety in a rabbit aneurysm model when appropriate wall apposition and tip embedding were achieved. Nevertheless, the intended protrusion design feature produced inconsistent effects due to anatomical limitations of the rabbit elastase-induced aneurysm model. Further studies with refined delivery systems, advanced imaging, and diverse aneurysm models are warranted to validate and optimize the clinical potential of the NFD.