Vascular Reconstruction Device for Coil Embolization of Wide-Neck Type Cerebral Aneurysm: Findings from a...

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.

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.

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.

Vascular reconstruction device implantation was effective and safe for treating wide-neck cerebral aneurysms.