Core Insights - Anteris Technologies has received regulatory clearance from the Danish Medicines Agency to initiate the global pivotal trial for the DurAVR Transcatheter Heart Valve (THV) in patients with severe calcific aortic stenosis, known as the PARADIGM Trial, with patient recruitment expected to start in Q4 2025 [1][2][3] Company Overview - Anteris Technologies is a global structural heart company focused on designing, developing, and commercializing advanced medical devices aimed at restoring healthy heart function [12] - The company's lead product, the DurAVR THV, is designed to treat aortic stenosis and is the first biomimetic valve that mimics the performance of a healthy human aortic valve [13] PARADIGM Trial Details - The PARADIGM Trial is a prospective randomized controlled trial that will evaluate the safety and effectiveness of the DurAVR THV compared to commercially available transcatheter aortic valve replacements (TAVRs) [7][8] - The trial aims to enroll approximately 1,000 patients with a 1:1 randomization between the DurAVR THV and TAVR, assessing non-inferiority on a primary composite endpoint of all-cause mortality, all stroke, and cardiovascular hospitalization at one year post-procedure [8] Regulatory and Market Implications - The successful completion of the PARADIGM Trial could lead to multiple approvals and labels for the DurAVR THV, marking a significant milestone in the company's commercialization planning phase [5] - Anteris is also awaiting an Investigational Device Exemption (IDE) application review by the U.S. FDA, which is expected to facilitate the initiation of study sites in the U.S. [6]
Anteris Receives First European Regulatory Clearance to Commence DurAVR® THV Global Pivotal Trial (the “PARADIGM Trial”)