2080 Multicenter Early US Feasibility Study & Periprocedural Safety of LVIS EVO for the Treatment of Intracranial Aneurysms

INTRODUCTION: Stent development has focused recently on low-profile, self-expandable stents compatible with 0.0165-inch microcatheters. The LVIS EVO is the second generation version of the Low-Profile Visualized Intraluminal Support (LVIS) with improved visibility as a result of drawn filled tube (DFT) wires consisting of an inner platinum wire and an outer nitinol wire. The LVIS EVO underwent a limited premarket release (PMR) in December 2023. METHODS: This is a multicenter retrospective observational study evaluating patients who underwent treatment of an intracranial aneurysm with an LVIS EVO stent after the limited PMR. All physicians who had placed an LVIS EVO stent were asked to input their cases after IRB approval was obtained. The data was then sent to a single center for analysis. RESULTS: 53 patients with 55 aneurysms underwent treatment with the LVIS EVO stent at 15 institutions. 100% of cases had successful deployment. Coils were placed in 48 cases (87.2%) and a microcatheter was jailed in 98% of those cases. The EVO was used as a standalone flow diverter in 5 cases and as an adjunct to a WEB device in 1 case. There were no delayed thromboembolic or hemorrhagic complications. CONCLUSIONS: The LVIS EVO is a braided, self-expanding, retrievable stent with enhanced visibility and smaller cell size. The DFT technology results in improved visibility of the stent allowing for more controlled stent positioning and visualization of vessel wall apposition. All cases in our series had complete neck coverage and good wall apposition. There were no thromboembolic or hemorrhagic complications.