Background: The Enterprise Vascular Reconstruction Device and Delivery System (Cordis; the Enterprise stent) was approved for use in conjunction with coiling of wide-necked aneurysms in 2007. No published long-term aneurysm occlusion or complication data exist for the Enterprise system.
Objective: We compiled data on consecutive patients treated with Enterprise stent-assisted coiling of aneurysms from 9 high-volume neurointerventional centers.
Methods: A 9 center registry was created to evaluate large volume data on the delayed safety and efficacy of the Enterprise stent system. Pooled data were compiled for consecutive patients undergoing Enterprise stent-assisted coiling at each institution prior to May 2009.
Results: Two-hundred twenty-nine patients with 229 aneurysms, 32 of which were ruptured aneurysms, were included in the study. Mean clinical and angiographic follow-up was 619.6 ± 26.4 days and 655.7 ± 25.2 days, respectively. Mean aneurysm size was 9.2 ± 0.4 mm. Fifty-nine percent of patients demonstrated 100% coil obliteration and 81% had 90% or higher occlusion at last follow-up angiography. A total of 19 patients (8.3%) underwent retreatment of their aneurysms during the follow-up period. Angiographic in-stent stenosis was seen in 3.4% and thromboembolic events occurred in 4.4%. Overall, 90% of patients who underwent Enterprise-assisted coiling had a modified Rankin Scale score of 2 or less at last follow-up. A poor modified Rankin Scale score was strongly associated with rupture status (P < .001).
Conclusion: Although this study is limited by its retrospective nature, the Enterprise stent system appears to be an effective, safe, and durable treatment for intracranial aneurysms when used in conjunction with coiling.