Anteris Clears Medicare Hurdle to Fast Track 1,000 Patient Heart Valve Trial
Anteris Technologies clears key reimbursement hurdle for U.S. PARADIGM Trial
Anteris Technologies has secured U.S. Medicare reimbursement eligibility for its global pivotal PARADIGM Trial under a Centers for Medicare & Medicaid Services national coverage policy. Eligible procedures performed at participating U.S. study sites are covered under the Transcatheter Aortic Valve Replacement National Coverage Determination 20.32. This coverage operates under a Coverage with Evidence Development model, enabling reimbursement whilst clinical evidence is generated within the trial.
The company expects this milestone to facilitate U.S. site activation and accelerate operational momentum across participating centres. The trial is registered on ClinicalTrials.gov under identifier NCT07194265.
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What is Coverage with Evidence Development and why does it matter?
Coverage with Evidence Development is a CMS framework that allows Medicare to reimburse investigational procedures performed within approved clinical trials. Under this mechanism, hospitals can bill Medicare for procedures conducted as part of qualifying studies, removing the financial burden that would otherwise fall on participating institutions.
Without CED approval, hospitals would bear procedure costs themselves, creating a significant disincentive to participate in clinical research. For Anteris, securing this coverage clears the financial path for U.S. hospitals to activate as PARADIGM Trial sites.
This approval signals regulatory engagement and addresses a common gating factor in pivotal U.S. medtech trials. Reimbursement eligibility typically increases site willingness to enrol patients, directly impacting trial enrollment velocity.
The PARADIGM Trial design
The PARADIGM Trial is a prospective randomised controlled trial comparing the DurAVR Transcatheter Heart Valve against commercially available transcatheter aortic valve replacements. The study will enrol approximately 1,000 patients in the All Comers Randomised Cohort with 1:1 randomisation between the DurAVR THV and commercial TAVR systems.
The trial will assess non-inferiority on a primary composite endpoint measured at one year post-procedure. Key trial parameters include:
- Enrollment target: Approximately 1,000 patients
- Randomisation ratio: 1:1 (DurAVR THV vs commercial TAVR)
- Primary endpoint components: All-cause mortality, all stroke, cardiovascular hospitalisation
- Assessment timeframe: 1 year post-procedure
This head-to-head study design will generate the first randomised data comparing DurAVR against established market leaders. A positive readout would validate the biomimetic design thesis and support a differentiated commercial position in the structural heart device market.
DurAVR THV and the biomimetic valve thesis
The DurAVR THV is described as the first biomimetic valve, shaped to mimic the performance of a healthy human aortic valve and replicate normal aortic blood flow. The device uses 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, distributed for use in over 55,000 patients worldwide. This clinical history provides a foundation of real-world performance data supporting the tissue platform’s safety profile.
The complete DurAVR THV System comprises three components:
- The DurAVR valve
- ADAPT anti-calcification tissue
- The balloon-expandable ComASUR Delivery System
The PARADIGM Trial will test whether the biomimetic design translates into clinical outcomes that match or exceed current-generation TAVR devices. Given TAVR has become the standard of care for many aortic stenosis patients, head-to-head trial data is critical for market entry and commercial differentiation.
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What comes next for Anteris
With Medicare reimbursement secured, the company has stated it expects this milestone to facilitate U.S. site activation. The focus now shifts to activating participating centres and enrolling patients across the trial network.
Site activation represents the next visible operational milestone. Investors should monitor enrollment updates as a gauge of trial execution and site engagement.
The PARADIGM Trial aims to establish non-inferiority against commercially available TAVR systems on a composite endpoint at one year. Study completion and data readout timing will depend on enrollment velocity across activated sites.
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