Anteris Global PARADIGM Pivotal Trial of DurAVR THV Cleared in France

June 8, 2026—Anteris Technologies Global Corp. announced that its PARADIGM global pivotal trial has received full regulatory clearance from the French National Agency for Medicines and Health Products Safety to study the company’s DurAVR transcatheter heart valve (THV) in patients with severe calcific aortic stenosis.

Anteris stated that the authorization, which enables patient recruitment to commence at leading centers in France, is a milestone in its clinical and regulatory strategy for the DurAVR device. The global clinical strategy continues to advance with site activations and patient enrollment across the United States and Europe.

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

The head-to-head study will enroll approximately 1,000 patients randomized 1:1 in the all-comers cohort. The trial will assess noninferiority on a primary composite endpoint of all-cause mortality, all stroke, and cardiovascular hospitalization at 1 year postprocedure, stated Anteris.