Abstract
This meta-analysis evaluates the clinical and angiographic outcomes of the flow re-direction endoluminal device X (FRED(TM) X) in treating intracranial aneurysms. A systematic review was performed across Medline, Scopus, and Web of Science databases from inception to March 2025. Eligible studies included those reporting clinical and angiographic results of FRED X treatment. Favorable outcomes were defined as those stated explicitly in the studies or a modified Rankin scale score of 0-2. Pooled estimates were calculated using a random-effects model in R. A total of nine studies encompassing 780 patients with 869 aneurysms were included. The weighted mean age was 56.28 years, with 19.1% of patients being men. Most aneurysms were saccular (85.7%), unruptured (92.52%), and located in the anterior circulation (73.6%), primarily in the internal carotid artery. The average aneurysm size was 13.12 mm. All studies employed dual antiplatelet therapy, with antiplatelet response testing performed in eight studies. The mean clinical follow-up period was 9.27 months. The meta-analysis demonstrated favorable neurological outcomes in 97.71% of cases and complete or near-complete occlusion in 86.9%. Procedure-related complications were reported in 9.28% of cases, while in-stent thrombosis or intimal hyperplasia occurred in 4.29%. Overall mortality was low at 0.60%. Subgroup analysis revealed that unruptured aneurysms had a 100% rate of favorable neurological outcomes and an 84.76% rate of complete or near-complete occlusion. Complication and mortality rates were 7.76% and 0.25%, respectively. In addition, favorable outcomes were seen in 100% of ruptured aneurysm cases; however, complete occlusion was achieved in only 59.65%, and the mortality rate was higher at 9.19%. Therefore, FRED X demonstrated high efficacy and procedural safety in the treatment of intracranial aneurysms, offering improved outcomes compared with earlier-generation flow diverters.