• FDA approves Anteris' PARADIGM global clinical trial to evaluate the DurAVR® Transcatheter Heart Valve
• PARADIGM is a prospective randomized controlled trial comparing DurAVR® to commercially available TAVR devices
• Trial designed to support a future PMA submission to the FDA for the DurAVR® THV

Anteris Technologies has announced that it has received U.S. Food and Drug Administration (FDA) approval to initiate PARADIGM, its global Investigational Device Exemption (IDE) clinical trial. The PARADIGM Trial is designed to evaluate the DurAVR® Transcatheter Heart Valve (THV) in patients with severe calcific aortic stenosis and to support a future PMA submission. The trial is a prospective randomized controlled trial (RCT) that will evaluate the safety and effectiveness of the DurAVR® THV compared to commercially available transcatheter aortic valve replacements (TAVRs). The PARADIGM Trial will enroll approximately 1000 patients across the United States, Europe, and Canada in the 'All Comers Randomized Cohort' with 1:1 randomization of patients who will receive either the DurAVR® THV or TAVR using commercially available and approved THVs. The trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke, and cardiovascular hospitalization at one year post-procedure. The PARADIGM Trial is designed to provide the robust clinical evidence required to support an application to the FDA for Premarket Approval (PMA) in the United States, with CE Mark approval anticipated to progress in parallel to the PMA.

The PARADIGM Trial represents a significant milestone and a key step forward in advancing the DurAVR® Transcatheter Heart Valve technology worldwide for patients living with aortic stenosis, a debilitating and progressive condition.