Global Pivotal PARADIGM Trial of Anteris’ DurAVR THV Begins United States Enrollment

May 11, 2026—Anteris Technologies Global Corp. announced that the first patients in the United States have been enrolled in the PARADIGM global pivotal trial of the DurAVR transcatheter heart valve (THV) for the treatment of severe calcific aortic stenosis.

According to the company, PARADIGM is a prospective randomized controlled trial that will evaluate the safety and effectiveness of the DurAVR THV compared to commercially available transcatheter aortic valve replacement (TAVRs) devices.

Anteris stated that the head-to-head study will enroll approximately 1,000 patients in an all-comers randomized cohort with 1:1 randomization of patients who will receive either the DurAVR THV or TAVR.

The trial will assess noninferiority on a primary composite endpoint of all-cause mortality, all stroke, and cardiovascular hospitalization at 1 year postprocedure, noted the company.

The trial’s initial procedures were performed by PARADIGM Principal Investigator Azeem Latib, MD, at Montefiore Medical Center in New York New York. Dr. Latib is Director of Interventional Cardiology and Director of Structural Heart Interventions at Montefiore.

“Performing the first United States cases in the global PARADIGM trial is a significant achievement for trial investigators, and our early procedural experience with the DurAVR THV system has been highly encouraging,” commented Dr. Latib in the Anteris press release.

Dr. Latib continued, “PARADIGM is specifically designed to answer clinically meaningful questions and go beyond the usual safety metrics and hemodynamics by also looking at the impact of flow patterns on left ventricular recovery. Initiating enrollment represents a critical step toward generating the evidence needed to inform future patient care.”