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This multicentre study evaluated the safety, efficacy and follow-up outcomes of the FRED X flow-diversion device in patients with intracranial aneurysms treated at six high-volume centres in the United States between February 2022 and February 2024. A total of 154 patients with 162 aneurysms were treated using 164 devices; 81.8% of patients were female, and the mean age was 56.8 years. Device deployment, wall apposition and neck coverage were reported as satisfactory in at least 99.3% of cases. At hospital discharge, 147 patients (95.5%) were functionally independent, defined as a modified Rankin Scale score of 0–2. Adequate aneurysm occlusion, defined as Raymond–Roy Occlusion Scale grade I or II, was reported in 84.2% of cases at 6 months and 83.5% at 12 months. Among patients with follow-up assessments, functional independence was reported in 100% at 6 months and 95.9% at 12 months. Rates of in-stent stenosis decreased during follow-up. The authors concluded that FRED X demonstrated high technical feasibility, an acceptable safety profile and favourable clinical outcomes, although further comparative studies are needed to establish its long-term performance across different aneurysm populations.
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This multicentre study evaluated the safety, efficacy and follow-up outcomes of the FRED X flow-diversion device in patients with intracranial aneurysms treated at six high-volume centres in the United States between February 2022 and February 2024. A total of 154 patients with 162 aneurysms were treated using 164 devices; 81.8% of patients were female, and the mean age was 56.8 years. Device deployment, wall apposition and neck coverage were reported as satisfactory in at least 99.3% of cases. At hospital discharge, 147 patients (95.5%) were functionally independent, defined as a modified Rankin Scale score of 0–2. Adequate aneurysm occlusion, defined as Raymond–Roy Occlusion Scale grade I or II, was reported in 84.2% of cases at 6 months and 83.5% at 12 months. Among patients with follow-up assessments, functional independence was reported in 100% at 6 months and 95.9% at 12 months. Rates of in-stent stenosis decreased during follow-up. The authors concluded that FRED X demonstrated high technical feasibility, an acceptable safety profile and favourable clinical outcomes, although further comparative studies are needed to establish its long-term performance across different aneurysm populations.
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