MINNEAPOLIS, May 5, 2026 — Leads & Copy —
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) has announced the enrollment and successful treatment of the first U.S. patients in its DurAVR® Transcatheter Heart Valve (“THV”) global pivotal trial, known as the “PARADIGM Trial.” The trial focuses on patients with severe calcific aortic stenosis.
The procedures were performed by Dr. Azeem Latib at Montefiore Medical Center in New York. The PARADIGM Trial is a prospective randomized controlled trial designed to evaluate the safety and effectiveness of the DurAVR® THV in comparison to commercially available transcatheter aortic valve replacements (TAVRs).
Dr. Latib, Principal Investigator and Director of Interventional Cardiology and Director of Structural Heart Interventions at Montefiore, expressed encouragement with the early procedural experience using the DurAVR® THV System. He noted that the trial is designed to address clinically significant questions, assessing the impact of flow patterns on left ventricular recovery in addition to standard safety metrics and hemodynamics. He considers the enrollment initiation a critical step in generating evidence for future patient care.
Wayne Paterson, Vice Chairman and CEO of Anteris, stated that the first patient enrollments were achieved within a week of CMS approval, due to the collaboration between the Anteris team and physician partners. He emphasized that this marks a major milestone for the PARADIGM Trial as U.S. study sites begin to come online and expand recruitment capability.
The PARADIGM Trial will enroll approximately 1,000 patients in the ‘All Comers Randomized Cohort,’ randomizing patients 1:1 to receive either the DurAVR® THV or a commercially available and approved TAVR. The trial will assess non-inferiority on a primary composite endpoint, measuring all-cause mortality, all stroke, and cardiovascular hospitalization at one year post-procedure.
Anteris Technologies Global Corp. is a global structural heart company focused on creating, developing, and commercializing medical devices to restore healthy heart function. The company’s lead product, DurAVR® THV, is a biomimetic valve designed to mimic the performance of a healthy human aortic valve. It uses a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology.
ADAPT® tissue has been FDA-cleared and used clinically for over 10 years, distributed for use in over 55,000 patients globally. The DurAVR® THV System includes the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System.
For further information about the trial, refer to ClinicalTrials.gov with the identifier NCT07194265.
Source: Anteris Technologies Global Corp.
