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. 2025 Jan 27:jnis-2024-022523.
doi: 10.1136/jnis-2024-022523. Online ahead of print.

FRED X flow diversion stenting for unruptured intracranial aneurysms: US multicenter post-market study

Philipp Hendrix  1 , Sina Hemmer  2 , Georgios S Sioutas  3 , Nicholas C Field  4 , Muhammed Amir Essibayi  5 , Mohamed M Salem  3 , Visish M Srinivasan  3 , Amanda Custozzo  4 , Alireza Karandish  5 , David Altschul  5 , Alexandra R Paul  4 , Jan-Karl Burkhardt  3 , Clemens M Schirmer  2 , Oded Goren  2
Affiliations

FRED X flow diversion stenting for unruptured intracranial aneurysms: US multicenter post-market study

Philipp Hendrix et al. J Neurointerv Surg. .

Abstract

Background: The Flow Re-direction Endoluminal Device (FRED) X is a next generation flow-diverting stent for treating intracranial aneurysms. Its surface modification (X technology) aims to minimize device thrombogenicity. Early post-market multicenter data from the US are lacking.

Methods: We conducted a retrospective multicenter analysis of consecutive FRED X procedures performed to treat unruptured intracranial aneurysms at four US centers (March 2022 to January 2024). Cases with ruptured aneurysms or extracranial aneurysm location were excluded (n=10). We assessed patient and aneurysm characteristics, antithrombotic management, safety events, and both clinical and angiographic (effectiveness) outcomes.

Results: In this cohort, 101 patients underwent FRED X stenting for 117 aneurysms. Most aneurysms were saccular in shape (95.7%) and located at the C6-C7 segments of the internal carotid artery (72.6%). Thromboembolic events occurred in 5.9% of the cases, leading to one instance of permanent procedure related morbidity (1.0%). No procedure related mortality (0%) was observed. Device related issues were recorded in 2.0% of cases. At the 6 month follow-up, complete aneurysm occlusion was achieved in 58% of aneurysms. At the last available follow-up (6-12 months), 74.8% of aneurysms were adequately occluded.

Conclusions: FRED X stenting for unruptured intracranial aneurysms demonstrated low rates of neurological morbidity and periprocedural complications. Early aneurysm occlusion rates were appropriate, but further mid-term and long term follow-up is required. These findings support the early safety and effectiveness of the FRED X device for intracranial aneurysm treatment.

Keywords: Aneurysm; Device; Flow Diverter.

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Conflict of interest statement

Competing interests: SH received salary support from MicroVention via an investigator initiated research grant obtained by the senior author OG. NCF received speaking Honoria from NICO. DA is a consultant for Microvention, Stryker, Q’Apel, Synchron, Penumbra, and Cerenovus, and investor of Von Vascular. ARP is a consultant for Microvention, IRRAS, Penumbra, and NICO. JKB is a consultant for Stryker, Medtronic, Cerenovus, Microvention, Q’Apel Medical, BALT, and Siemens. CMS has research grants from Medtronic, Stryker, Penumbra, Cerenovus, Route 92, MIVI, Balt, Microvention, NICO, and NIH/NINDS, consulting agreements with Medtronic, Stryker, Viz.ai, Balt, Microvention, and Werfen, and ownership of NTI and Reist. OG is a consultant for Microvention, Rapid Medical, and Route 92, and received funding from MicroVention. OG received an investigator initiated study research grant from MicroVention.

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