FRED X flow diversion stent for intracranial aneurysms: a systematic review and meta-analysis

Ali Mortezaei; Muhammed Amir Essibayi; Leila Ghorbi; Jamal Behnood; Khaled M. Taghlabi; Ibrahim Mohammadzadeh; Bardia Hajikarimloo; Mohammad Amin Habibi; Ahmed Abdelsalam; Jayro Toledo; Luis Guada; Redi Rahmani; David J. Altschul; Alex N. Hoang; Adib A. Abla; Robert M. Starke; Amir H. Faraji

doi:10.1007/s00234-025-03755-2

FRED X flow diversion stent for intracranial aneurysms: a systematic review and meta-analysis

Ali Mortezaei, Muhammed Amir Essibayi, Leila Ghorbi, Jamal Behnood, Khaled M. Taghlabi, Ibrahim Mohammadzadeh, Bardia Hajikarimloo, Mohammad Amin Habibi, Ahmed Abdelsalam, Jayro Toledo, Luis Guada, Redi Rahmani, David J. Altschul, Alex N. Hoang, Adib A. Abla, Robert M. Starke, Amir H. Faraji

Research output: Contribution to journal › Review article › peer-review

Abstract

Background: The Flow Re-Direction Endoluminal Device X (FRED^TM-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^TM-X. Methods: 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. Results: 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%). Conclusion: 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.

Original language	English (US)
Journal	Neuroradiology
Early online date	Sep 19 2025
DOIs	https://doi.org/10.1007/s00234-025-03755-2
State	E-pub ahead of print - Sep 19 2025

Keywords

FRED X
Flow Re-Direction Endoluminal Device X
Flow diversion
Intracranial aneurysms

ASJC Scopus subject areas

Radiology Nuclear Medicine and imaging
Clinical Neurology
Cardiology and Cardiovascular Medicine

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10.1007/s00234-025-03755-2

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Mortezaei, A., Essibayi, M. A., Ghorbi, L., Behnood, J., Taghlabi, K. M., Mohammadzadeh, I., Hajikarimloo, B., Habibi, M. A., Abdelsalam, A., Toledo, J., Guada, L., Rahmani, R., Altschul, D. J., Hoang, A. N., Abla, A. A., Starke, R. M., & Faraji, A. H. (2025). FRED X flow diversion stent for intracranial aneurysms: a systematic review and meta-analysis. Neuroradiology. Advance online publication. https://doi.org/10.1007/s00234-025-03755-2

Mortezaei, A, Essibayi, MA, Ghorbi, L, Behnood, J, Taghlabi, KM, Mohammadzadeh, I, Hajikarimloo, B, Habibi, MA, Abdelsalam, A, Toledo, J, Guada, L, Rahmani, R, Altschul, DJ, Hoang, AN, Abla, AA, Starke, RM & Faraji, AH 2025, 'FRED X flow diversion stent for intracranial aneurysms: a systematic review and meta-analysis', Neuroradiology. https://doi.org/10.1007/s00234-025-03755-2

@article{ad1cba27c18b42e08b20e37be850d77b,

title = "FRED X flow diversion stent for intracranial aneurysms: a systematic review and meta-analysis",

abstract = "Background: The Flow Re-Direction Endoluminal Device X (FREDTM-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 FREDTM-X. Methods: 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. Results: 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\%). Conclusion: 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.",

keywords = "FRED X, Flow Re-Direction Endoluminal Device X, Flow diversion, Intracranial aneurysms",

author = "Ali Mortezaei and Essibayi, \{Muhammed Amir\} and Leila Ghorbi and Jamal Behnood and Taghlabi, \{Khaled M.\} and Ibrahim Mohammadzadeh and Bardia Hajikarimloo and Habibi, \{Mohammad Amin\} and Ahmed Abdelsalam and Jayro Toledo and Luis Guada and Redi Rahmani and Altschul, \{David J.\} and Hoang, \{Alex N.\} and Abla, \{Adib A.\} and Starke, \{Robert M.\} and Faraji, \{Amir H.\}",

note = "{\textcopyright} 2025. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.",

year = "2025",

month = sep,

day = "19",

doi = "10.1007/s00234-025-03755-2",

language = "English (US)",

journal = "Neuroradiology",

issn = "0028-3940",

publisher = "Springer Science and Business Media Deutschland GmbH",

}

TY - JOUR

T1 - FRED X flow diversion stent for intracranial aneurysms

T2 - a systematic review and meta-analysis

AU - Mortezaei, Ali

AU - Essibayi, Muhammed Amir

AU - Ghorbi, Leila

AU - Behnood, Jamal

AU - Taghlabi, Khaled M.

AU - Mohammadzadeh, Ibrahim

AU - Hajikarimloo, Bardia

AU - Habibi, Mohammad Amin

AU - Abdelsalam, Ahmed

AU - Toledo, Jayro

AU - Guada, Luis

AU - Rahmani, Redi

AU - Altschul, David J.

AU - Hoang, Alex N.

AU - Abla, Adib A.

AU - Starke, Robert M.

AU - Faraji, Amir H.

PY - 2025/9/19

Y1 - 2025/9/19

N2 - Background: The Flow Re-Direction Endoluminal Device X (FREDTM-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 FREDTM-X. Methods: 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. Results: 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%). Conclusion: 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.

AB - Background: The Flow Re-Direction Endoluminal Device X (FREDTM-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 FREDTM-X. Methods: 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. Results: 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%). Conclusion: 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.

KW - FRED X

KW - Flow Re-Direction Endoluminal Device X

KW - Flow diversion

KW - Intracranial aneurysms

UR - https://www.scopus.com/pages/publications/105016724352

UR - https://www.scopus.com/inward/citedby.url?scp=105016724352&partnerID=8YFLogxK

U2 - 10.1007/s00234-025-03755-2

DO - 10.1007/s00234-025-03755-2

M3 - Review article

C2 - 40970960

AN - SCOPUS:105016724352

SN - 0028-3940

JO - Neuroradiology

JF - Neuroradiology

ER -

FRED X flow diversion stent for intracranial aneurysms: a systematic review and meta-analysis

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Keywords

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