O-052 The pennsylvania post-market multicenter experience with flow re-direction endoluminal device (FRED)

Abstract

<h3>Background</h3> The Flow Re-direction Endoluminal Device (FRED) is a novel self-expanding double-layer nitinol braided flow diverter that recently received FDA approval. However, early post-market studies from the United States are lacking. <h3>Objective</h3> Report our short-term multicenter experience. <h3>Methods</h3> 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. <h3>Results</h3> Sixty-one patients (median age 58, 82% females) underwent 65 FRED treatment procedures for 72 aneurysms. The majority (86.1%) of 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% retreated. Permanent ischemic complications were encountered in 2.8% of the cases, with no procedural mortality. A modified Rankin Scale of 0–2 was documented in 98.1% of the patients at the last clinical follow-up (median 6.1 months). <h3>Conclusion</h3> 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. However, more extensive multicenter studies with more extended follow-up data are needed to assess the long-term safety and durability of the device. <h3>Disclosures</h3> <b>M. Salem:</b> None. <b>S. Kvint:</b> None. <b>P. Hendrix:</b> None. <b>F. Al Saiegh:</b> None. <b>A. Gajjar:</b> None. <b>O. Goren:</b> None. <b>B. Gross:</b> None. <b>P. Jabbour:</b> None. <b>M. Lang:</b> None. <b>C. Schirmer:</b> None. <b>S. Tjoumakaris:</b> None. <b>C. Griessenauer:</b> None. <b>J. Burkhardt:</b> None.