Flow diversion in the treatment of intracranial aneurysms using the novel FRED X device: An early experience from a single high-volume center.

Background: The Flow Re-Direction Endoluminal Device X (FRED X) offers several benefits over other flow-diverter devices including an antithrombotic coating, optimized in-vessel stability, and increased flexibility for easier device placement. We present a to-date experience of the safety and utility of the FRED X device in the repair of posterior and anterior circulation aneurysms.

Methods: A retrospective review was conducted on all endovascular procedures that utilized the FRED X device at our center from May 2022 to November 2023.

Results: 77 patients (72.7% women, mean age 58.9), underwent a total of 85 procedures using the FRED X device. Indications included treatment of incidentally discovered aneurysms, acute dissections, aneurysm rupture, repair of residual filling following prior intervention, and use of FRED X for recanalization of non-aneurysmal extracranial stroke. 31.3% of the aneurysms were in the posterior circulation, 68.7% were in the anterior circulation. 9.4% of patients presented with SAH due to acute aneurysm rupture. Patients treated with FRED X were separated into OFF-Label (40.0%) or ON-label (60.0%) indications. Occlusion rate at 6-month follow-up were 72.2% in the OFF-label group, 66.7% in the ON-label group, and 68.4% overall. Rate of major periprocedural complications was 1.2% and the cumulative rate of postprocedural complication at follow-up was 5.3%.

Conclusion: This study shows that FRED X treatment of intracranial aneurysms is safe in both OFF-label and ON-label indications. Continued follow-up of our patient population will further establish the safety, efficacy, and long-term stability of this device.