FRED X Flow Diversion Stent for Intracranial Aneurysms: A Systematic Review and Meta-analysis

Introduction: Flow diversion devices have shown promising results in the management of aneurysms. The novel Flow Redirection Endoluminal Device with X technology (FRED X) represents the latest advancement of the recently FDA-approved FRED device. While FRED X has demonstrated potential benefits, including reduced thrombogenicity and improved vessel healing, pooled data is still lacking to substantiate these findings across larger patient populations. This study aims to evaluate the feasibility and safety of FRED X, providing a comprehensive assessment of its clinical efficacy in aneurysm management.

Methods: We conducted the study adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The four electronic databases were systematically searched up to September 2024.

Results: We included eight studies with a total of 722 patients (739 aneurysms). There was a significantly higher proportion of unruptured aneurysms at presentation (odds ratio 21.1, 95% CI: 6.6–67.3, P=0.0004) and saccular morphology (81%, P< 0.0001). The mean procedure time was 75.04 minutes (range = 61.6 – 95, SD = 41.2). Aspirin and Plavix was the significantly most common antithrombotic regimens (66.1%, 95CI: 43.7% - 85.4%, P< 0.0001). In-stent stenosis was occurred in 1.95% (95%CI: 0.37% - 4.3%) of patients. At the last follow-up, complete occlusion was achieved in 62% (95%CI: 57.7% - 66%), while adequate occlusion was achieved in 80.6% (95%CI: 77.5% - 83.5%) of patients. Additionally, mortality rate at last follow-up was 0.2% (95%CI: 0.0% - 1%). Overall and symptomatic complications were reported in 13.9% (95%CI: 9.6% - 18.7%) and 4.3% (95%CI: 1.2% - 8.6%) of patients, respectively. There was no significant difference between unruptured vs ruptured aneurysms in mortality rate (P=0.14), overall (P=0.23) and symptomatic (P=0.24) complications.

Conclusion : FRED X is a safe and feasible option capable of achieving a high rate of occlusion and favorable functional outcomes.