Core Insights - Anteris Technologies has initiated the global pivotal trial for its DurAVR Transcatheter Heart Valve (THV) aimed at patients with severe calcific aortic stenosis, marking a significant step towards commercialization [1][2] - The PARADIGM Trial will provide comparative evidence on the safety and effectiveness of the DurAVR THV against existing transcatheter aortic valve replacements (TAVRs) [3][4] Company Overview - Anteris Technologies is a global structural heart company focused on developing innovative medical devices to restore heart function, with a strong presence in both Australia and the United States [7] - The DurAVR THV is designed to treat aortic stenosis and is the first biomimetic valve, utilizing Anteris' patented ADAPT tissue technology, which has been clinically used for over 10 years [8][9] Trial Details - The PARADIGM Trial is a prospective randomized controlled trial that will enroll approximately 1,000 patients, comparing the DurAVR THV to commercially available TAVRs [4][6] - The primary endpoint of the trial is to assess non-inferiority in terms of all-cause mortality, stroke, and cardiovascular hospitalization at one year post-procedure [4]
Anteris Technologies Announces First Patients Treated in DurAVR® THV Global Pivotal Trial (the “PARADIGM Trial”)