Core Insights - Anteris Technologies Global Corp. announced positive one-year clinical outcomes for the DurAVR Transcatheter Heart Valve (THV) in patients with symptomatic severe aortic stenosis and small aortic annuli, demonstrating significant improvements in hemodynamics and safety [1][8]. Clinical Outcomes - The DurAVR THV achieved a mean pressure gradient (MPG) of 8.6 ± 2.6 mmHg and an effective orifice area (EOA) of 2.1 ± 0.2 cm at one year, with no valve-related mortality and no moderate or severe paravalvular leaks [8]. - At 30 days, the prosthesis-patient mismatch was only 1.5%, significantly lower than the 11.2% to 35.3% range seen with current commercial devices, indicating a reduction in a key predictor of valve failure [8]. Study Details - The pooled cohort included 65 patients from the ongoing EMBARK Study and the US Early Feasibility Study (EFS) who received the DurAVR THV [4]. - The encouraging results from over 100 patients will be further validated in the global pivotal trial known as the PARADIGM Trial, which is a prospective, randomized controlled trial comparing the DurAVR THV to existing transcatheter aortic valve replacements [5]. Product Information - The DurAVR THV is designed to mimic the performance of a healthy human aortic valve and is made from Anteris' patented ADAPT tissue, which has been clinically used for over 10 years in more than 55,000 patients worldwide [7]. - The system includes the DurAVR valve, ADAPT tissue, and the balloon-expandable ComASUR Delivery System, aimed at restoring normal aortic blood flow [7]. Company Overview - Anteris Technologies is a global structural heart company focused on developing innovative medical devices to restore heart function, with a significant presence in both Australia and the USA [6].