Anteris secured French ANSM clearance to begin patient recruitment in its pivotal PARADIGM trial of the DurAVR Transcatheter Heart Valve for severe calcific aortic stenosis. The randomized study will enroll 1,000 patients across France, the US and Europe to evaluate non-inferiority on a one-year composite endpoint.
Anteris received full approval from the French National Agency for Medicines and Health Products Safety to initiate patient enrollment in the global pivotal PARADIGM Trial on its DurAVR Transcatheter Heart Valve. This clearance enables leading cardiovascular centers in France to begin screening and recruiting subjects with severe calcific aortic stenosis.
The prospective randomized controlled trial will enroll approximately 1,000 all-comers randomized 1:1 to receive either the DurAVR THV or commercially approved TAVRs, assessing non-inferiority on a composite endpoint of all-cause mortality, stroke and cardiovascular hospitalization at one year. The DurAVR system features a biomimetic valve made from a single-piece ADAPT anti-calcification tissue and is delivered via the balloon-expandable ComASUR system.
Beyond France, Anteris is activating trial sites and enrolling patients across the United States and Europe as part of its worldwide PARADIGM Trial rollout. This multi-region approach aims to validate DurAVR’s safety and effectiveness in diverse patient populations and support future regulatory submissions.
