Anteris Bolsters U.S. Momentum as CMS Reimbursement Unlocks PARADIGM Trial Site Activations
Medicare Coverage for PARADIGM Trial Signals Major Operational Acceleration
Anteris Technologies has achieved a significant milestone: securing U.S. Medicare (CMS) reimbursement eligibility for its global PARADIGM clinical trial. The trial—centered around Anteris’ flagship DurAVR® Transcatheter Heart Valve—now qualifies for coverage under the CMS's Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination 20.32. With CMS support, U.S. site activations are expected to proceed at an accelerated pace, boosting Anteris' competitive profile in the rapidly evolving structural heart device sector.
Coverage with Evidence Development (CED) Model Enhances Trial Reach
This new reimbursement status operates under the Coverage with Evidence Development (CED) framework. In practical terms, this means that clinical procedures in the PARADIGM study, performed at participating U.S. sites, will be reimbursed while collecting critical clinical evidence. The CED model removes a key hurdle for trial sponsors, streamlining site onboarding and patient enrollment—two essential drivers of clinical and commercial momentum.
PARADIGM Trial: Direct Comparison of DurAVR® and Standard TAVRs
The PARADIGM Trial is designed as a prospective, randomized controlled study pitting Anteris’ biomimetic DurAVR® Transcatheter Heart Valve directly against currently marketed transcatheter aortic valve replacements (TAVRs). Roughly 1,000 patients will be randomized either to receive DurAVR® or an approved TAVR implant. The primary endpoint focuses on composite safety—measuring all-cause mortality, stroke, and cardiovascular hospitalization one year after the procedure. This ambitious study structure aims to demonstrate not just non-inferiority, but potentially distinctive advantages in clinical outcomes and durability.
| Trial Feature | Details |
|---|---|
| Trial Name | PARADIGM (ClinicalTrials.gov NCT07194265) |
| Enrollment | ~1,000 patients, All Comers Randomized Cohort |
| Endpoints | All-cause mortality, stroke, CV hospitalization @ 1 year |
| Global Scope | U.S. and international sites; CMS reimbursement for U.S. |
DurAVR® Valve: Biomimetic Engineering and Unique Differentiators
Anteris’ lead product, DurAVR®, employs a biomimetic design to closely replicate natural aortic valve function and blood flow. Made from a single piece of FDA-cleared ADAPT® anti-calcification tissue, DurAVR® incorporates over a decade of clinical application with more than 55,000 global patient uses. The device’s structure and delivery system draw on input from top interventional cardiologists and cardiac surgeons, aiming for enhanced durability and improved patient outcomes compared to traditional TAVRs.
| DurAVR® Distinctions | Market Relevance |
|---|---|
| First biomimetic, balloon-expandable THV | Pursues aortic blood flow normalization |
| Patented, single-mold ADAPT® tissue | FDA clearance; 55,000+ implanted cases |
| Strong scientific and clinical advisory base | Strategy aligns with unmet structural heart needs |
Key Takeaway: CMS Milestone Sets Table for Rapid U.S. Expansion
The CMS reimbursement achievement isn’t just a box checked for Anteris—it’s a strategic unlock. Removing the reimbursement barrier paves the way for robust trial enrollment, provides validation for the company’s technology, and puts Anteris in closer competition with legacy TAVR device makers. For stakeholders, the next key questions will center on enrollment pace, early clinical signals, and how DurAVR®'s real-world performance stacks up as the trial matures through its endpoints.
Investor and Industry Contacts
| Contact | Details |
|---|---|
| Anteris Technologies | investors@anteristech.com | +61 1300 550 310 / +61 7 3152 3200 |
| U.S. Investor Relations | Malini Chatterjee, Ph.D., mchatterjee@bplifescience.com | +1 917 330 4269 |
| Website | www.anteristech.com |
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