Anteris obtains FDA approval to initiate PARADIGM pivotal trial for DurAVR THV

Anteris Technologies Global Corp.

FDA approved global IDE trial for DurAVR THV in severe aortic stenosis patients.
PARADIGM is a prospective RCT enrolling ~1,000 patients 1:1 across US, Europe, Canada.
Primary endpoint: all-cause mortality, all stroke, cardiovascular hospitalization at one year.
Trial co-chaired by Dr. Michael J. Reardon (Houston Methodist) and Prof. Stephan Windecker (Bern).
First patients already treated in Denmark; trial supports future PMA and parallel CE Mark approval.

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