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Introduction Pre-clinical animal and early feasibility human studies demonstrated promising results for treating wide-neck intracranial aneurysms (IAs) with the Saccular Endovascular Aneurysm Lattice (SEAL™) system.Aim of study The SEAL™ Interventional Pivotal IDE PMA Trial (SEAL™ IT) aims to evaluate the clinical outcome of the SEAL™ for IAs. This ongoing multicenter trial will enroll 279 patients with wide-neck bifurcation (WNBA), sidewall (SW), or acutely ruptured IAs across 50 sites.Method Inclusion criteria include age 20–80 years, and wide-neck IA (2–19mm). SEAL™ Device (Galaxy Therapeutics Inc.) treated patients were followed at 24 hours, 3, 6, and 12 months, then annually for 5 years. Efficacy endpoint is occlusion at 12 months without parent artery stenosis or retreatment by an independent lab. Safety endpoints include neurological death through 12 months, stroke within 30 days, and ipsilateral stroke from 30 days to 1 year.Results A total of 194 patients: 144 WNBA, 35 WNSW, 15 ruptured, 75% female; mean age 62.4±11.3 years) have been enrolled; 73.4% bifurcation, 18% sidewall, and 7.6% ruptured aneurysms. Mean aneurysm width was 5.1±2.1mm, and neck 3.6±1.3mm. SEAL Arc was used in 62.5% and SEAL Base in 37.5%. Technical success rate is 100% for WNBA, 97.1% WNSW, 100% ruptured. No peri-procedural permanent strokes were reported after 3 months. The interim complete occlusion rate for the available data was 22/23 (95.7%) and 3/3 (100%); at 3 and 6 months, respectively.Conclusion The preliminary safety and efficacy of the SEAL™ intrasaccular device is promising; final updates will be presented at the ESMINT.Conflict of Interest Yes Osama Zaidat, MD declares that he is the cofounder for Galaxy Therapeutics and hold IP which is patent.