Abstract 1122‐000244: The Pennsylvania Post‐Market Multicenter Experience with Flow Re‐Direction Endoluminal Device (FRED)

Introduction : The Flow Re‐direction Endoluminal Device (FRED) is a novel self‐expanding double‐layer nitinol braided flow diverter that recently received FDA approval. Early post‐market studies from the US literature are currently lacking and we here report our short‐term multicenter experience results. Methods : Series of consecutive patients undergoing FRED treatment for intracranial aneurysms were queried from prospectively maintained registries in 4 North‐American Centers in the State of Pennsylvania from February 2020 to June 2021. The pertinent baseline demographics, aneurysmal characteristics, and procedural outcomes were collected and analyzed, with primary outcome of aneurysmal occlusion, and secondary outcome of safety and complications. Results : Sixty‐one patients (median age 58, 82% females) underwent 65 FRED treatment procedures for harbored 72 aneurysms. The majority (86.1%) of aneurysms were unruptured; 80.5% were saccular in morphology and 87.5% were located in the internal carotid artery, with a median size of 7.2 mm (IQR 5.2 ‐11.9mm). Radiographic follow‐up was available in 80.5% of the aneurysms, showing complete occlusion in 79.3%, and near‐complete occlusion in 6.9% of the cases (median follow‐up of 6 months), with a retreatment rate of 2.8%. Permanent ischemic complications were encountered in 2.8% of the cases, with no procedural mortality, and a modified Rankin Scale of 0–2 documented in 98.1% of the patients at the last clinical follow‐up. Conclusions : The results of the early post‐market experience with the FRED device show reasonable safety and adequate aneurysmal occlusion rates comparable to other flow diverters. Larger multicenter studies with longer follow up data are needed to assess the long‐term safety and durability of the device.