Anteris Technologies Global Corp. has enrollment treatment of the first patients in the United States as part of its global PARADIGM clinical trial evaluating the DurAVR Transcatheter Heart Valve (THV) system. The procedures were conducted at Montefiore Medical Centre in New York, marking a milestone in the study’s progress.

The PARADIGM trial is designed to assess the safety and effectiveness of the DurAVR THV in patients suffering from severe calcific aortic stenosis, a condition that restricts blood flow due to narrowing of the aortic valve. The study will compare the investigational device directly with currently available Transcatheter Aortic Valve Replacement (TAVR) therapies.

This prospective, randomised controlled trial plans to enroll approximately 1,000 patients globally. Participants will be randomly assigned in a 1:1 ratio to receive either the DurAVR THV or a commercially available TAVR device. The primary endpoint of the study focuses on demonstrating non-inferiority in terms of all-cause mortality, stroke and cardiovascular-related hospitalisation within one year of the procedure.

Beyond standard safety and performance metrics, the trial will also evaluate the impact of blood flow dynamics on left ventricular recovery, aiming to generate clinically meaningful insights that could shape future treatment approaches.

The initiation of US patient enrollment follows regulatory clearance and reflects close collaboration between Anteris and clinical investigators. With additional study sites expected to join, the company aims to accelerate recruitment and expand the evidence base supporting its next-generation heart valve technology.

Anteris continues to focus on developing innovative medical devices to improve outcomes for patients with structural heart diseases, with the PARADIGM trial representing a key step in advancing its DurAVR platform toward broader clinical adoption.