Anteris Technologies Pty Ltd (ASX:AVR, NASDAQ:AVR) has secured full regulatory clearance from France's National Agency for Medicines and Health Products Safety (ANSM) for its global pivotal PARADIGM Trial, paving the way for patient recruitment to begin at leading French cardiac centres.
This is a key milestone in Anteris' clinical and regulatory strategy for its DurAVR® Transcatheter Heart Valve (THV), expanding the study's footprint in Europe and supporting efforts to generate the data required for future regulatory submissions.
France is regarded as one of Europe's most important transcatheter aortic valve replacement (TAVR) markets, with a strong network of experienced investigators and high-volume treatment centres. The clearance enables Anteris to activate French trial sites and recruit patients with severe calcific aortic stenosis into the study.
“Securing French regulatory clearance is an important step in the execution of the PARADIGM Trial,” Anteris vice chairman and CEO Wayne Paterson said. “France represents a strategically important market with highly experienced centres and investigators, reinforcing the quality and conduct of the study.”
The company said it continues to advance its broader clinical strategy, with site activations and patient enrolment progressing across both the United States and Europe.
PARADIGM Trial to compare DurAVR against existing TAVR devices
The PARADIGM Trial is a prospective randomised controlled study designed to evaluate the safety and effectiveness of the DurAVR® THV against commercially available transcatheter aortic valve replacement devices.
The head-to-head trial is expected to enrol around 1,000 patients in an "all-comers" randomised cohort, with participants assigned on a 1:1 basis to receive either the DurAVR valve or an approved commercial TAVR device.
The study's primary endpoint is a composite measure of all-cause mortality, stroke and cardiovascular hospitalisation one year after the procedure. The trial is designed to demonstrate that DurAVR is at least non-inferior to currently available TAVR technologies.
Successful completion of the PARADIGM Trial is expected to play a central role in Anteris' regulatory pathway and commercialisation plans for DurAVR, which has been developed to treat patients suffering from severe aortic stenosis.