Safety and Efficacy of the Woven EndoBridge Device for Wide-Neck Bifurcation Intracranial Aneurysms: 1-Year Results of the W-EB DB Study.

Objective: This Woven EndoBridge Database (W-EB DB) study was conducted using data from a nationwide, multicenter database to evaluate the safety and efficacy of the W-EB device (MicroVention, Aliso Viejo, CA, USA; distributed by Terumo, Tokyo, Japan) for the treatment of wide-neck intracranial bifurcation aneurysms in Japanese patients. In this paper, we confirm the clinical usefulness of the W-EB device in Japanese patients based on the comparable 1-year post-procedure outcomes to those reported from overseas. Methods: This W-EB DB study was a post-marketing, open-label, non-randomized cohort study conducted using the database of the Japanese Society of Neuroendovascular Therapy (JSNET). A total of 128 participants (including 103 patients with unruptured aneurysms and 25 patients with ruptured aneurysms) treated with the W-EB device between December 2020 and December 2025 at any of the 12 participating centers were included in this study. Clinical data collected from the database consisted of the patient demographics, comorbidities, aneurysm characteristics (location, size, and neck width), procedural details, and follow-up outcomes. The safety endpoints were the incidences of subarachnoid hemorrhage (SAH), rebleeding, cerebral infarction, and other adverse events occurring within 1 year after the procedure. The efficacy endpoints were the aneurysm occlusion rates and retreatment rates at 180 days and 1 year after the procedure; the aneurysm occlusion status was determined in accordance with the W-EB Occlusion Scale (WOS). We used descriptive statistics to analyze the results. The research within our submission was approved by the institutional ethics review board of Kyoto University (Approval No. R2088). Results: In regard to the safety endpoints, SAH occurred in 1 patient (1.0%) with an unruptured aneurysm, and rebleeding occurred in 1 patient (4.0%) with a ruptured aneurysm. The incidence of cerebral infarction was 7.0%. Most other adverse events were mild, and no new device-related risks were identified. In regard to the efficacy of the device, at 1 year post-procedure, complete occlusion (WOS grade A or B) was achieved in 58 of 95 lesions (61.1%) and adequate occlusion (WOS grade A, B, or C) was achieved in 79 of 95 lesions (83.2%). Retreatment was needed for 5 of 126 lesions (4.0%). The safety and efficacy outcomes were comparable to those reported from multicenter studies conducted in Europe and the United States, with slightly higher complete occlusion rates and similar adequate occlusion and retreatment rates. Conclusion: Favorable safety and effectiveness of the W-EB device were observed at 1 year after device deployment in Japanese patients with wide-neck intracranial aneurysms. These findings are consistent with international reports and support the clinical utility of the W-EB device, given the low incidence of serious complications.