Core Insights - The NEXUS TRIOMPHE trial data shows a 63% reduction in Major Adverse Event (MAE) rates compared to the reference performance goal, indicating significant clinical improvement for patients with chronic aortic dissection [1][3]. Clinical Outcomes - The trial involved a cohort of 54 patients at high risk for open surgical repair, demonstrating a MAE rate of 13% against a performance goal of 35% (p < 0.001) [4]. - Technical failure rates were reported at 1.9%, significantly lower than the 30% performance goal (p < 0.001) [4]. Device Performance - The NEXUS device is presented as a minimally invasive alternative to open aortic arch replacement, particularly beneficial for high-risk patients [5]. - The trial results are expected to support the clinical module of the PMA filing after one year of follow-up with the primary cohort [6]. Company Overview - Artivion, Inc. specializes in medical devices for cardiac and vascular surgery, focusing on aortic diseases, and markets products in over 100 countries [7].
Artivion Announces Presentation of New Clinical Data from NEXUS TRIOMPHE IDE Trial at the 105th American Association for Thoracic Surgery (AATS) Annual Meeting