-- Anteris Technologies (ASX:AVR) said it has secured US Medicare reimbursement eligibility for its global pivotal PARADIGM Trial under a Centers for Medicare and Medicaid Services (CMS) national coverage policy, according to a Wednesday Australian bourse filing.
The PARADIGM Trial is evaluating the safety and effectiveness of the DurAVR transcatheter heart valve (THV) compared to transcatheter aortic valve replacements (TAVRs), with DurAVR THV being Anteris' product to treat aortic stenosis, a potentially life-threatening condition resulting from the narrowing of the aortic valve, the filing added.
The CMS framework operates under a Coverage with Evidence Development (CED) model, enabling reimbursement with clinical evidence generation.
The company said that securing this reimbursement eligibility is expected to facilitate US site activation and accelerate operational momentum across participating centers.
The company's shares rose 2% in recent Wednesday trade.