Vascular Reconstruction Device for Coil Embolization of Wide-Neck Type Cerebral Aneurysm: Findings from a Post-Marketing Surveillance Study in Japan.

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. Th

SUBMITTER: Kawamura Y 

PROVIDER: S-EPMC12530950 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature