Comaneci-assisted embolization of wide-necked aneurysms: results from the SUCCESS postmarket US study.
Publication/Presentation Date
11-19-2025
Abstract
BACKGROUND: Wide-necked intracranial aneurysms present unique challenges for endovascular treatment. The Comaneci device is a novel temporary bridging device designed to assist coil embolization without parent vessel occlusion.
METHODS: The SUccess in Comaneci-assist Coils Embolization Surveillance Study (SUCCESS) was a multicenter, prospective, postmarket surveillance study conducted at 17 US centers. Ninety consecutive patients with wide-necked intracranial aneurysms were treated with Comaneci-assisted coiling. The primary effectiveness endpoint was successful aneurysm occlusion (Raymond-Roy class I/II) at procedure end. Primary safety endpoints included periprocedural events within 24 hours and clinical outcomes at discharge and 30 days.
RESULTS: Of 90 enrolled patients (mean age 63 years, 63% female), 32 (36%) presented with ruptured aneurysms. Most common locations were anterior communicating (33%), internal carotid (20%), and posterior communicating arteries (19%). Successful occlusion was achieved in 85.6% of cases at procedure end and 94.7% at 6 months. Good clinical outcome (modified Rankin Scale (mRS) 0-2) was maintained from baseline (73%) through 30 days (81%) and 6 months (83%). Thromboembolic events occurred in 5.5% of cases, all asymptomatic. Device-related complications were minimal, with coil entanglement in 0.3% of deployed coils and no instances of deployment/retrieval failure. All-cause mortality was 4.4%, confined to the ruptured aneurysm cohort.
CONCLUSIONS: The SUCCESS study demonstrates high rates of successful aneurysm occlusion with Comaneci-assisted coiling, with occlusion rates persisting through 6 month follow-up. The safety profile was favorable, with low rates of thromboembolic events compared with other assist techniques. These results support the use of the Comaneci device for wide-necked aneurysm treatment in both ruptured and unruptured settings.
TRIAL REGISTRATION NUMBER: NCT04518670.
ISSN
1759-8486
Published In/Presented At
Davies, J. M., Taqi, M. A., Coon, A. L., Lin, L. M., Bohnstedt, B., Mascitelli, J., Levy, E. I., Siddiqui, A., Birnbaum, L., Rodriguez, P., Noufal, M., Taussky, P., Kilburg, C., Gooch, M. R., Puri, A. S., Diaz, O., Fifi, J. T., Majidi, S., Yoo, A. J., Soomro, J., … Hanel, R. A. (2025). Comaneci-assisted embolization of wide-necked aneurysms: results from the SUCCESS postmarket US study. Journal of neurointerventional surgery, jnis-2025-024136. Advance online publication. https://doi.org/10.1136/jnis-2025-024136
Disciplines
Diagnosis | Medicine and Health Sciences | Other Analytical, Diagnostic and Therapeutic Techniques and Equipment | Radiology
PubMedID
41260918
Department(s)
Department of Radiology and Diagnostic Medical Imaging
Document Type
Article