Artivion Begins Pivotal Trial for Arcevo LSA Hybrid Stent Graft System
Reuters
Nov 06
<a href="https://laohu8.com/S/AORT">Artivion</a> Begins Pivotal Trial for Arcevo LSA Hybrid Stent Graft System
Artivion Inc. announced the initiation of the ARTIZEN pivotal trial to evaluate the safety and effectiveness of the Arcevo™ LSA Hybrid Stent Graft System for the treatment of acute and chronic aortic arch pathologies. The prospective, multicenter, non-randomized trial will enroll 132 participants across the U.S. and Europe, with each participant followed for up to five years and a focus on one-year outcomes. The trial's primary endpoints include all-cause mortality, new permanent disabling stroke, new permanent paraplegia or paraparesis, unanticipated aortic reoperation in the treated segment, and left subclavian artery occlusion. The results of the trial have not yet been presented. The study is designed to support a future application for Premarket Approval (PMA) of the Arcevo LSA device with the U.S. Food and Drug Administration.
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