BackgroundPrevious research has shown promising results for treating intracranial aneurysms (IAs) with a flow redirection endoluminal device (FRED). In this systematic review and meta-analysis, we aimed to assess the safety and efficacy of this device by providing pooled estimates using the data from previous studies.MethodsA systematic literature search of Web of Sciences, PubMed, Scopus, and Embase was performed until October 8th, 2023. After selecting the final articles, relevant data were extracted. Parameters relating to safety and efficacy were pooled using STATA software. Heterogeneity was assessed using I-squared and Cochran's Q. Funnel plots and Egger's regression methods were used to evaluate publication bias. Sensitivity analysis was also performed using the leave-one-out method.ResultsThe data of 37 studies were used for meta-analysis. The rates of immediate adequate occlusion and complete occlusion were 0.51 (95% CI: 0.31-0.71) and 0.34 (95% CI: 0.16-0.53), respectively, while the rates of the adequate and complete occlusion at the latest follow-up were 0.90 (95% CI: 0.84-0.94) and 0.75 (95% CI: 0.65-0.84), respectively. The periprocedural complications rate was 0.04 (95% CI: 0.03-0.06), and the overall complications rate was 0.12 (95% CI: 0.09-0.15). The rate of good functional outcome was 0.99 (95% CI: 0.99-1.00) and the successful implantation rate was 1.00 (95% CI: 1.00-1.00). There was substantial heterogeneity among the reports for most of the evaluated parameters.ConclusionFRED had high safety and efficacy in treating IAs, as evidenced by its high occlusion and low complication rates.