Anteris Technologies secures CMS reimbursement for trial site activation

Anteris Technologies (AVR) has secured U.S. Medicare reimbursement eligibility for the global pivotal PARADIGM Trial under a Centers for Medicare & Medicaid Services, or CMS, national coverage policy. Eligible procedures performed at participating U.S. study sites are covered under the Transcatheter Aortic Valve Replacement, or TAVR, National Coverage Determination 20.32. This milestone is expected to facilitate U.S. site activation, accelerating operational momentum across participating centers. The PARADIGM Trial will evaluate the safety and effectiveness of the DurAVR Transcatheter Heart Valve, or THV, compared to commercially available transcatheter aortic valve replacements, or TAVRs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure.