The Pennsylvania Postmarket Multicenter Experience With Flow Redirection Endoluminal Device.

Abstract

The flow redirection endoluminal device (FRED) is a novel self-expanding double-layer nitinol braided flow diverter that recently received FDA approval. However, early postmarket studies from the United States are lacking. To report our short-term multicenter experience. Series of consecutive patients undergoing FRED treatment for intracranial aneurysms were queried from prospectively maintained registries at 4 North-American Centers in Pennsylvania (February 2020-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. Sixty-one patients (median age 58 years, 82% female) underwent 65 FRED treatment procedures for 72 aneurysms. Most (86.1%) of the aneurysms were unruptured; 80.5% were saccular in morphology, and 87.5% were located along the internal carotid artery, with a median size of 7.1 mm (IQR 5.2-11.9 mm). Radiographic follow-up was available in 86.1% of the aneurysms, showing complete occlusion in 74.2% (80% in catheter angiography-only group), and near-complete occlusion in 11.3% of the cases (median 6.3 months), with 2.8% re-treated. Permanent ischemic complications were encountered in 2.8% of the cases, with no procedural mortality. A modified Rankin Scale of 0 to 2 was documented in 98.1% of the patients at the last clinical follow-up (median 6.1 months). The results of the early postmarket experience with the FRED device show reasonable safety and adequate aneurysmal occlusion rates comparable with other flow diverters. However, more extensive multicenter studies with more extended follow-up data are needed to assess the long-term safety and durability of the device.