Anteris Technologies (ASX:AVR) has reached a critical operational milestone for its global PARADIGM Trial, securing U.S. Medicare reimbursement eligibility through the Centres for Medicare & Medicaid Services (CMS).
This national coverage determination allows study sites to receive reimbursement for procedures involving the company’s DurAVR® Transcatheter Heart Valve, a move intended to enable the activation of U.S. clinical sites and patient enrollment.
The PARADIGM Trial is a large-scale, head-to-head study comparing Anteris’ biomimetic valve against currently approved commercial alternatives in approximately 1,000 patients.
By utilizing the CMS "Coverage with Evidence Development" (CED) model, the trial can proceed with subsidized costs while generating the long-term safety and effectiveness data required for full market approval.
The DurAVR® valve has a "biomimetic" design, created from a single piece of the company’s patented ADAPT® anti-calcification tissue to replicate the blood flow of a healthy human heart.
With the financial framework now in place, Anteris is positioned to continue advancing its efforts in the structural heart market and to further evaluate DurAVR® as a potential treatment option for patients with life‑threatening aortic stenosis.