A329 Safety and efficacy of a surface-modified flow diverter: a post-approval study

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Background/Introduction Flow diversion is an established treatment for intracranial aneurysms. FRED™ X (Terumo Neuro) is a dual-layer, self-expanding flow diverter indicated for wide-necked saccular or fusiform aneurysms, localized between the petrous to terminus ICA segments. We report the first prospective U.S. post approval study determining the effectiveness and safety of the device. Radiological and clinical outcomes were determined by a core laboratory and a clinical events committee (CEC). Objective/Purpose This study aims to evaluate the safety and efficacy of the FRED™ X flow diverter for the treatment of ICA aneurysms. The FRED™ X incorporates X Technology surface modification designed to reduce thrombogenicity. Methods/Case Description The study enrolled 153 subjects (≥22 years, mRS ≤2) with a single, mostly unruptured, target ICA aneurysm at 23 U.S. centres. The primary safety endpoint was death or major stroke within 30-days, or neurological death or major ipsilateral stroke within 12-months. The primary effectiveness endpoint was complete occlusion, ≤50% parent artery stenosis, and no retreatment within 12-months. Results/Findings Among 153 enrolled subjects, mean age was 56.6 years and 89.5% were female. Most aneurysms were located in the ophthalmic (36.6%) or supraclinoid (24.2%) ICA. Succesful deployment was achieved in 99.3% (152/153), with 98.7% (150/152) of procedures completed using a single device. Composite primary safety endpoint events occurred in 3.3% (5/153). Major stroke within 30-days occurred in 2.6% (4/153). Neurological death within 12-months occurred in 2.0% (3/153). All but one neurological death and one ipsilateral stroke occurred within 30-days. At 12-months, 91.3% (116/127) had stable or improved mRS scores versus baseline. The primary effectiveness endpoint was met in 63.5% (73/115) at 12-months. Complete aneurysm occlusion (Raymond Roy I) was achieved in 66.1% (76/115), parent artery stenosis >50% occurred in 4.3% (5/115), and retreatment in 1.7% (2/115). Discussion/Conclusions/Learning Points FRED™ X has a favourable safety and effectiveness for the treatment of wide-necked ICA aneurysms.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.