Anteris’ DurAVR THV Global Pivotal Trial Receives First European Regulatory Clearance 

October 20, 2025—Anteris Technologies Global Corp. announced it has received regulatory clearance from the Danish Medicines Agency to initiate the global pivotal PARADIGM trial evaluating the company’s DurAVR transcatheter heart valve (THV) in patients with severe calcific aortic stenosis. Patient recruitment in Denmark is expected to begin in the fourth quarter of 2025, advised the company.

According to Anteris, the PARADIGM study will compare the DurAVR THV with currently approved transcatheter aortic valve replacement (TAVR) systems. From this initial European clearance, Anteris plans to expand the trial to additional centers across the United States, Europe, and Canada.

The company stated that the global, multicenter randomized controlled trial will enroll approximately 1,000 patients in an all-comers cohort who will be randomized 1:1 to receive either the DurAVR THV or a commercially available TAVR system. The primary endpoint is a composite of all-cause mortality, stroke, and cardiovascular hospitalization at 1 year postprocedure, assessing noninferiority between treatment arms.

Michael Reardon, MD, and Professor Stephan Windecker, MD, are the Cochairs of the global PARADIGM study.

“The PARADIGM trial enables us to bring promising new technology to patients across all surgical risk groups, building on the growing body of evidence supporting the DurAV THV’s favorable hemodynamic performance,” commented Dr. Reardon and Prof. Windecker in the Anteris press release. “We look forward to contributing meaningful data which could support both [FDA] premarket approval and CE Mark approval.”

The company also noted that its investigational device exemption application remains under review by the FDA, with anticipated approval expected soon to allow initiation of United States sites pending Institutional Review Board authorization.