Clinical TrialMay 5, 2026, 06:02 AM
Anteris enrolls first US patients in DurAVR® THV global pivotal trial
AI Summary
Anteris Technologies Global Corp. announced the successful enrollment and treatment of the first U.S. patients in its DurAVR® Transcatheter Heart Valve (THV) global pivotal trial, known as the PARADIGM Trial. These procedures, performed at Montefiore Medical Center in New York, mark a significant milestone for the company, expanding recruitment capabilities for the trial. The PARADIGM Trial is a prospective randomized controlled study designed to evaluate the safety and effectiveness of the DurAVR® THV compared to commercially available transcatheter aortic valve replacements in approximately 1000 patients.
Key Highlights
- First U.S. patients enrolled and successfully treated in Anteris' DurAVR® THV global pivotal PARADIGM Trial.
- Procedures were performed by Dr. Azeem Latib at Montefiore Medical Center, New York.
- The PARADIGM Trial is a prospective randomized controlled trial evaluating DurAVR® THV against commercially available TAVRs.
- Approximately 1000 patients will be enrolled in the 'All Comers Randomized Cohort' with 1:1 randomization.
- The trial will assess non-inferiority on a primary composite endpoint at one year post-procedure.
- DurAVR® THV is the first biomimetic valve, designed to mimic a healthy human aortic valve.
- The valve uses ADAPT® tissue, Anteris' patented anti-calcification technology, used clinically for over 10 years in 55,000+ patients.
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