Safety and efficacy of the Saccular Endovascular Aneurysm Lattice (SEAL) system for the treatment of wide neck bifurcation aneurysms: final 12 month results from the primary subgroup analysis of the Pre-SEAL First-in-Human Interventional Trial (Pre-SEAL IT).

Abstract

Intrasaccular flow disrupters (IFDs) are increasingly used in endovascular management of intracranial wide neck bifurcation aneurysms (WNBAs). The next generation Saccular Endovascular Aneurysm Lattice (SEAL) system is a self-expanding, dual layered, braided nitinol IFD available in two configurations (SEAL Arc and SEAL Base) without a lead-in marker band. This primary subgroup analysis of the Pre-SEAL First-in-Human Interventional Trial (Pre-SEAL IT; NCT05686733) reports the final clinical and angiographic outcomes of the SEAL system in the management of WBNAs before the investigational device exemption (IDE) pre-marketing approval US based pivotal trial. Pre-SEAL IT is a prospective, multicenter, single arm study, with US based independent imaging core lab adjudication. Primary safety endpoints were major periprocedural stroke, new subarachnoid hemorrhage, or neurologic death up to 12 months. Primary efficacy endpoints were complete (Raymond-Roy occlusion classification (RROC) 1 Woven EndoBridge occlusion scale (WOS) A or RROC 1 WOS B) or adequate occlusion (RROC 1 WOS A, RROC 1 WOS B, or RROC 2 WOS C) without parent artery compromise at 12 months. 13 WNBA aneurysms in 13 patients meeting similar inclusion and exclusion criteria to the Woven EndoBridge Intrasaccular Therapy (WEB-IT) IDE pivotal trial were included in this primary subgroup analysis. Technical success (device delivered and deployed as intended) was 100% (13/13). There were no major periprocedural strokes, new subarachnoid hemorrhages, or neurologic deaths. Independent core lab adjudication showed 11/13 patients (84.6%) achieved complete occlusion and 12/13 patients (92.3%) achieved adequate occlusion at 12 month follow-up. SEAL intrasaccular flow disruption showed high technical success, an acceptable safety profile, and encouraging 12 month occlusion rates in the treatment of WNBAs.