Background Several flow diverter devices have been developed for use as an alternative to the conventional endovascular approach for treating intracranial aneurysms using coils. The novel Flow Re-Direction Endoluminal Device X (FRED X) (Microvention, Tustin CA, USA) offers several benefits over other 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, as well as in other off- and on-label indications.

Methods A retrospective review was conducted on all endovascular procedures that utilized the FRED X device at the Queens Medical Center in Honolulu, Hawaii 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 with subarachnoid hemorrhage, repair of residual filling following prior intervention with coil or Pipeline stent, aneurysm thrombosis presenting as stroke, and use of FRED X for recanalization of non-aneurysmal extracranial stroke. 51.8% of the aneurysms were in the posterior circulation, 48.2% were in the anterior circulation, and. 8.2% of patients presented with SAH due to acute aneurysm rupture. To date, a total of 56 (65.9%) procedures have had initial follow-up angiograms at 6-months post procedure. Patients treated with FRED X were categorized based on whether they underwent procedures for OFF-Label (37.6%) or ON-label (62.4%) indication. Occlusion rate correlated with the size of the aneurysm. No major procedural complications were observed in either group. Occlusion rate at 6-month follow-up were 72.2% in the OFF-label group, and 66.7% in the ON-label group. 2 patients (5.1%) in the ON-label group presented with in-stent stenosis due to endothelial hyperplasia at follow-up. The stenosis caused transient ischemic attacks in one of these patients.

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

Disclosures T. Clausen: None. R. Nakmura: None. A. Conching: None. J. Choi: None. Y. Zhang: None. F. Hui: None. S. Tsappidi: None.