Anteris Kicks Off U.S. Enrollment in DurAVR Pivotal Trial

Event summary

  • First U.S. patients treated in Anteris' PARADIGM trial for severe calcific aortic stenosis.
  • Trial compares DurAVR® THV against commercially available TAVRs in 1,000-patient randomized study.
  • Procedures performed by Azeem Latib at Montefiore Medical Center.
  • PARADIGM evaluates non-inferiority on composite endpoint of mortality, stroke, and cardiovascular hospitalization at one year.

The big picture

Anteris' PARADIGM trial marks a critical step in validating its DurAVR® THV against incumbent TAVR technologies. The focus on left ventricular recovery and flow patterns differentiates the study from traditional safety and efficacy metrics, potentially setting a new benchmark for structural heart interventions. Success in this trial could position Anteris as a formidable competitor in the $10B+ transcatheter aortic valve replacement market.

What we're watching

Trial Execution
The pace at which Anteris enrolls patients in the U.S. will determine the trial's timeline and potential approval path.
Competitive Positioning
Whether DurAVR® THV can demonstrate non-inferiority against established TAVR options will shape its market adoption.
Regulatory Dynamics
How CMS approval and trial results influence future reimbursement and commercialization strategies.