Mortezaei Ali, Essibayi Muhammed Amir, Ghorbi Leila, Behnood Jamal, Taghlabi Khaled M, Mohammadzadeh Ibrahim, Hajikarimloo Bardia, Habibi Mohammad Amin, Abdelsalam Ahmed, Toledo Jayro, Guada Luis, Rahmani Redi, Altschul David J, Hoang Alex N, Abla Adib A, Starke Robert M, Faraji Amir H
Student Research Committee, Gonabad University of Medical Sciences, Gonabad, Islamic Republic of Iran.
Department of Neurological Surgery and Montefiore-Einstein Cerebrovascular Research Lab, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, United States.
Neuroradiology. 2025 Sep 19. doi: 10.1007/s00234-025-03755-2.
The Flow Re-Direction Endoluminal Device X (FRED-X, MicroVention, Inc., Terumo Corporation, USA), introduces a dual-layer structure and antithrombotic surface technology, designed to address the limitations of earlier devices in reducing material thrombogenicity and promoting better vessel endothelialization for brain aneurysm. Herein, we present the first systematic review and meta-analysis summarizing available literature to reach a consensus regarding the safety and effectiveness of FRED-X.
A literature search was performed in four electronic databases, PubMed/MEDLINE, Embase, Google Scholar, and Web of Science, for studies that evaluated FRED-X in managing intracranial aneurysms. Proportions were pooled employing the inverse variance method, and binary outcomes were analyzed using odds ratio (OR) and 95% confidence interval (CI). The primary outcome was an aneurysm occlusion at the final follow-up.
Eight studies involving 480 patients and 531 aneurysms were included. Most patients were female (81.5%), with a mean age of 56.2 years. Most aneurysms were unruptured (84.1%, 95%CI = 66% - 96.5%) and located in the anterior circulation (86.7%, 95%CI = 75.9% - 94.8%), primarily in the internal carotid artery (64.2%). Procedural data showed a mean procedure time of 68.2 (SD = 38.1) minutes and a fluoroscopy time of 23.5 (SD = 11.7) minutes. The mean aneurysm size was 6.4 mm (SD = 5.1). In-stent stenosis occurred in 1.2% of cases. Adequate occlusion was achieved in 85.9% (95%CI = 79% - 91.8%) of patients at the last follow-up. Symptomatic complications occurred in 4% (95%CI = 0.7% - 9%) of patients, and the overall mortality rate was 0.34% (95%CI = 0.0% - 1.7%).
The FRED-X flow diverter is safe and effective in treating intracranial aneurysms. It has low complication rates, minimal in-stent stenosis, and efficient procedural metrics. Long-term studies must confirm its durability and potential for broader applications.
血流改向腔内装置X（FRED-X，美国泰尔茂公司旗下的MicroVention公司）引入了双层结构和抗血栓表面技术，旨在解决早期装置在降低材料血栓形成性和促进脑动脉瘤更好的血管内皮化方面的局限性。在此，我们进行了首次系统评价和荟萃分析，总结现有文献，以就FRED-X的安全性和有效性达成共识。
在四个电子数据库PubMed/MEDLINE、Embase、谷歌学术和科学网中进行文献检索，查找评估FRED-X治疗颅内动脉瘤的研究。采用逆方差法汇总比例，并使用比值比（OR）和95%置信区间（CI）分析二元结局。主要结局是最后一次随访时动脉瘤闭塞情况。
纳入八项研究，涉及480例患者和531个动脉瘤。大多数患者为女性（81.5%），平均年龄56.2岁。大多数动脉瘤未破裂（84.1%，95%CI=66%-96.5%），位于前循环（86.7%，95%CI=75.9%-94.8%），主要位于颈内动脉（64.2%）。手术数据显示平均手术时间为68.2（标准差=38.1）分钟，透视时间为23.5（标准差=11.7）分钟。平均动脉瘤大小为6.4毫米（标准差=5.1）。支架内狭窄发生率为1.2%。最后一次随访时，85.9%（95%CI=79%-91.8%）的患者实现了充分闭塞。4%（95%CI=0.7%-9%）的患者出现有症状并发症，总死亡率为0.34%（95%CI=0.0%-1.7%）。
FRED-X血流导向装置治疗颅内动脉瘤安全有效。它具有低并发症发生率、最小的支架内狭窄和有效的手术指标。长期研究必须证实其耐久性和更广泛应用的潜力。
