Anteris Unlocks French Patient Sites for 1,000-Patient Heart Valve Trial
Anteris secures French regulatory clearance for PARADIGM trial
Anteris Technologies has received full regulatory clearance from the French National Agency for Medicines and Health Products Safety (ANSM) for its DurAVR® Transcatheter Heart Valve global pivotal trial in patients with severe calcific aortic stenosis. The authorisation enables patient recruitment to commence at leading French centres, as the Company continues to advance site activations and patient enrolment across the United States and Europe.
France represents a strategically important market with highly experienced centres and investigators. The regulatory clearance marks a significant milestone in the Company’s clinical and regulatory strategy as it continues site activations and patient enrolment across multiple regions. The multi-country approach diversifies execution risk and supports timely trial completion.
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What is the PARADIGM trial?
The PARADIGM Trial is a prospective randomised controlled trial designed to evaluate the safety and effectiveness of the DurAVR® Transcatheter Heart Valve compared to commercially available transcatheter aortic valve replacements (TAVRs). This head-to-head study design represents the gold standard for demonstrating competitive clinical performance against established devices.
The trial is enrolling approximately 1,000 patients in the All Comers Randomised Cohort with 1:1 randomisation between patients receiving the DurAVR® THV and those receiving commercially available and approved THVs. The PARADIGM Trial aims to assess non-inferiority on a primary composite endpoint measured at one year post-procedure.
The primary composite endpoint includes:
- All-cause mortality
- All stroke
- Cardiovascular hospitalisation
For further information, the trial is registered at ClinicalTrials.gov under identifier NCT07194265. A successful head-to-head trial against established competitors could differentiate DurAVR® in the large and growing TAVR market, supporting the pathway toward commercialisation.
Medicare reimbursement eligibility for the PARADIGM Trial was secured in late April 2026 under a CMS Coverage with Evidence Development framework, removing a significant financial barrier to US site participation and accelerating the enrolment ramp that now runs in parallel with European activations.
The DurAVR® valve’s biomimetic design advantage
The DurAVR® THV is described as the first biomimetic valve, shaped to mimic the performance of a healthy human aortic valve and aim to replicate normal aortic blood flow. The balloon-expandable valve is made using a single piece of moulded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology.
ADAPT® tissue is FDA-cleared and has been used clinically for over 10 years. The technology has been distributed for use in over 55,000 patients worldwide, providing a decade-long track record of real-world performance. The DurAVR® THV System comprises the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System.
The biomimetic design and proven tissue technology form the foundation of Anteris’ differentiation thesis in the competitive structural heart market, where valve durability and haemodynamic performance are key differentiators.
CEO perspective on European expansion
Wayne Paterson, Vice Chairman and Chief Executive Officer
“Securing French regulatory clearance is an important step in the execution of the PARADIGM Trial. France represents a strategically important market with highly experienced centres and investigators, reinforcing the quality and conduct of the study.”
The CEO’s comments emphasise the strategic value of the French regulatory authorisation beyond simply adding recruitment sites. The involvement of highly experienced French centres and investigators reinforces the quality and conduct of the study, which may support regulatory submissions and commercial adoption decisions in the future.
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Global clinical strategy momentum
Anteris continues to advance its global clinical strategy, with ongoing site activations and patient enrolment underway across the United States and Europe. The French regulatory clearance is additive to existing momentum rather than a standalone event.
Anteris enrolled the first US patients in the PARADIGM Trial within one week of receiving CMS approval, a pace of execution that signals strong site readiness ahead of the broader international rollout now extending to France.
Multi-region enrolment diversifies execution risk by reducing dependence on any single market for trial completion. The geographic spread also positions the Company to demonstrate DurAVR® THV performance across diverse patient populations and clinical practice settings, which may support broader commercial adoption if the trial demonstrates non-inferiority.
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