The Artisse Intrasaccular Device: A New Intrasaccular Flow Diverter for the Treatment of Cerebral Aneurysms.

Abstract

Background and purpose: This animal study was designed to evaluate in vivo the acute and short-term safety and efficacy of the new Artisse intrasaccular device (ISD) for aneurysm occlusion and to gain knowledge about the behavior in the aneurysms.

Materials and methods: The device was implanted in 7 white New Zealand rabbits with bifurcation aneurysms. Immediate and 90-day angiographic follow-up as well as histologic and scanning electron microscope imaging were evaluated.

Results: Immediate postinterventional angiograms showed excellent flow reduction in all aneurysms. Progressive improvements of occlusion rate could be observed in 5 of 7 aneurysms. One device migration was noted due to undersizing, resulting in corresponding worsening of occlusion rate. Three-month microscopic examinations demonstrated excellent biocompatibility. Notably, the Artisse ISD showed increased connective tissue formation within the aneurysm sac, which correlated with the angiographic results.

Conclusions: The new Artisse ISD adapted well to aneurysm morphology and created immediate contrast stasis and excellent neck coverage. While angiographic results showed only moderate adequate occlusion at 3 months, histologic data showed excellent biocompatibility and good connective tissue formation within the aneurysm sac in all aneurysms treated with the Artisse ISD. Sizing and correct positioning appear to be crucial for adequate occlusion.