Introduction: Aneurysm recanalization remains a major challenge in the treatment of
intracranial aneurysms with current endovascular technology. Our group has built two versions of a novel aneurysm intrasaccular occlusion device (AIOD) that is intended to address challenges associated with current occlusion devices. The purpose of this study was to perform pilot, proof-of-concept in vivo testing of this new AIOD in swine
and canines.
Methods: Two versions of the AIOD, constructed in either a "coil-in-shell" or "gel-inshell" configuration, were implanted in surgically created sidewall aneurysms in swine for acute occlusion studies, as well as sidewall and bifurcation aneurysms in canines to assess long-term occlusion efficacy. Occlusion at all time points was evaluated by angiography, and neointimal healing at 12 weeks post-implantation in canines was evaluated via histological examination.
Results: Angiographic analysis showed that both the coil-in-shell and gel-in-shell
devices achieved complete aneurysm occlusion immediately following device delivery in sidewall aneurysms in swine. In longer-term canine studies, initial occlusion ranged from 71.3%-100%, which was stable with no recurrence in any of the sidewall aneurysms at the 6 or 12 week time points. Histological analysis demonstrated 0.68 ±0.41mm mature fibromuscular tissue at the neck of the aneurysm, endothelialization of
the luminal surface, and no significant inflammatory response.
Conclusions: Although the processes for sizing and delivering this novel AIOD must be
addressed to improve initial occlusion, they exhibit significant promise with respect to minimizing aneurysm recurrence and facilitating thick neointimal coverage at the aneurysm neck.
Patient Care: Novel intrasaccular flow diverter which could make aneurysm treatment simpler and better long term occlusion of aneurysm
Learning Objectives: Novel cerebral aneurysm intrasaccular flow diverter made out of novel material which could demonstrate bioactivity