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Multicenter Study
. 2025 Jun;35(2):379-384.
doi: 10.1007/s00062-024-01487-z. Epub 2025 Jan 23.

Treatment of Intracranial Aneurysms with the FRED X Flow Diverter Stent: Mid-term Angiographic and Safety Results

David W Wen  1   2 , James Ayre  3 , Mani Puthuran  4 , Paul Maliakal  3 , Souhyb Masri  4 , Richard Pullicino  4 , Aubrey Smith  3 , Feyi Babatola  4 , Gilbert Gravino  4 , Nasr Abdelsalam  4 , Hamed Nejadhamzeeigilani  3 , Arun Chandran  4
Affiliations
Multicenter Study

Treatment of Intracranial Aneurysms with the FRED X Flow Diverter Stent: Mid-term Angiographic and Safety Results

David W Wen et al. Clin Neuroradiol. 2025 Jun.

Abstract

Purpose: The aim of our study was to assess the mid-term efficacy and safety of the FRED X flow diverting stent (FDS) in the treatment of intracranial aneurysms. The FRED X FDS is relatively new with limited data on its longer-term effectiveness and safety profile.

Methods: Patients with intracranial aneurysms treated with the FRED X FDS at two UK centres, between March 2021 and July 2022 with at least 18 months follow-up, were retrospectively reviewed. Clinical, procedural and imaging data was analyzed.

Results: Twenty-two patients with 24 aneurysms treated with the FRED X device, and had completed at least 18 months of follow-up, were included in this study. The rate of complete aneurysm occlusion (Raymond-Roy Class I) was 83.3% at a mean follow-up duration of 21.5 months. One case of major adverse event (4.3%) related to a post-procedural stroke which is also the only case of permanent neurological deficit (4.3%) in our cohort. Three cases of minor adverse events (13.0%) and 2 cases of asymptomatic adverse events (8.7%) were also recorded.

Conclusion: Use of the FRED X FDS to treat intracranial aneurysms has acceptable safety profile and efficacy in the mid-term.

Keywords: Aneurysm; Endovascular; Flow diverter; Neurointervention; Stent.

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Conflict of interest statement

Declarations. Conflict of interest: D.W. Wen, J. Ayre, M. Puthuran, P. Maliakal, S. Masri, R. Pullicino, A. Smith, F. Babatola, G. Gravino, N. Abdelsalam and H. Nejadhamzeeigilani declare that they have no competing interests. A. Chandran has a consulting and proctoring agreement with Microvention, United Kingdom. Ethical standards: This study was registered with and approved by the local institutional review boards (Hull Royal Infirmary—Ref ID: 2023.063, The Walton Centre—Ref ID: N420). Written and informed consent was acquired from patients or their next of kin prior to every procedure. Further individual consent was waived as per institutional policies as the data for this study was collected retrospectively in an anonymized manner.

References

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