ArticleJournal of neuroendovascular therapy2025
Vascular Reconstruction Device for Coil Embolization of Wide-Neck Type Cerebral Aneurysm: Findings from a Post-Marketing Surveillance Study in Japan.
Article in Journal of neuroendovascular therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Objective: Endovascular treatment of wide-neck cerebral aneurysms with conventional coiling alone remains challenging. Stent-assisted coiling using a vascular reconstruction device offers an alternative strategy. This study evaluated the safety and effectiveness of the Enterprise Vascular Reconstruction Device (Cerenovus, Irvine, CA, USA) in patients with wide-neck cerebral aneurysms. Methods: Post-marketing surveillance records were collected for all Enterprise stent usage using case report forms at 30 days and at 1, 2, and 3 years post-procedure. A total of 738 cases, including 411 on-label cases, were analyzed across 83 hospitals. Results: Stent deployment was successful in 98.8% of cases, and the overall procedure success rate was 93.9% immediately post-procedure. The aneurysm occlusion rate was 92.90%, with 73.7% classified as Raymond-Roy class I/II immediately post-procedure. Among the 411 on-label cases, 17 patients (4.1%) demonstrated worsening of the modified Rankin Scale score, but no deaths were attributable to the utilization of the Enterprise device. The postoperative ischemic stroke complication rate was low (4.5%) but increased significantly in patients with a proximal parent artery diameter <2.5 mm (18.6%) and in those aged ≥65 years (8%). Multivariable logistic regression revealed that age ≥65 years, diabetes, hypertension, and a past medical history of ischemic stroke were significant risk factors for postoperative ischemic stroke. Conclusion: Vascular reconstruction device implantation was effective and safe for treating wide-neck cerebral aneurysms.
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