Long-term safety and efficacy of the FRED X flow diverter for intracranial aneurysms: a multicenter study of 154 patients.
Publication/Presentation Date
7-1-2025
Abstract
OBJECTIVE: The Flow-Redirection Endoluminal Device X (FRED X) is a newer generation flow diverter with surface modifications aimed at minimizing thrombogenicity. At present, data on its long-term efficacy are limited. This multicenter study presents the largest series within the United States describing the device's efficacy, safety, and long-term outcomes in treating cerebral aneurysms of varying morphology.
METHODS: Patients treated with the FRED X for a cerebral aneurysm between February 2022 and February 2024 at 6 high-volume centers across the United States were included. Data were collected regarding demographics, clinical presentation, and procedural efficacy. Angiographic and clinical follow-up outcomes were assessed at 6 and 12 months.
RESULTS: A total of 154 patients with 162 aneurysms were treated with 164 FRED X devices over the study period. Overall, 81.8% of the cohort was female with a mean age of 56.8 years. The authors observed satisfactory rates (≥ 99.3%) of device deployment and good wall apposition and neck coverage. One hundred forty-seven (95.5%) patients were functionally independent at discharge (modified Rankin Scale scores 0-2). Rates of adequate occlusion (Raymond-Roy Occlusion Scale score I or II) increased from 84.2% at 6 months to 83.5% at the 12-month follow-up, while rates of in-stent stenosis decreased. All patients (100%) who underwent follow-up were functionally independent at 6 months, and 95.9% were functionally independent at 12 months.
CONCLUSIONS: This multicenter cohort study demonstrates the ease of FRED X deployment with an adequate safety profile, with low rates of procedural complications and favorable outcomes on follow-up. Rates of aneurysm occlusion increased over time, with a subsequent decrease in stent-associated complications.
Volume
143
Issue
1
First Page
232
Last Page
242
ISSN
1933-0693
Published In/Presented At
Roy, J. M., El Naamani, K., Amaravadi, C., Majmundar, S., Mouchtouris, N., Paul, A. R., Field, N. C., Zhang, Y., Burkhardt, J. K., Kühn, A. L., Puri, A., Levy, E., Gooch, M. R., Jabbour, P., Rosenwasser, R. H., & Tjoumakaris, S. I. (2025). Long-term safety and efficacy of the FRED X flow diverter for intracranial aneurysms: a multicenter study of 154 patients. Journal of neurosurgery, 143(1), 232–242. https://doi.org/10.3171/2024.10.JNS241233
Disciplines
Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods
PubMedID
40020234
Department(s)
Administration and Leadership
Document Type
Article