RegulatoryApr 28, 2026, 06:02 AM
AVR Secures US Medicare Reimbursement for PARADIGM Trial
AI Summary
Anteris Technologies Global Corp. (AVR) announced it has secured U.S. Medicare reimbursement eligibility for its global pivotal PARADIGM Trial under a Centers for Medicare & Medicaid Services (CMS) national coverage policy. This coverage, under the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination 20.32, operates via a Coverage with Evidence Development (CED) model. This milestone is expected to accelerate U.S. site activation and operational momentum for the trial, which will evaluate the DurAVR Transcatheter Heart Valve against commercially available TAVRs.
Key Highlights
- U.S. Medicare reimbursement eligibility secured for PARADIGM Trial.
- Coverage under CMS national policy for TAVR NCD 20.32.
- CMS framework uses Coverage with Evidence Development (CED) model.
- PARADIGM Trial to enroll approximately 1000 patients.
- Trial evaluates DurAVR THV vs. commercially available TAVRs.
- Primary endpoint: all-cause mortality, stroke, cardiovascular hospitalization at one year.
- ClinicalTrials.gov identifier: NCT07194265.