Clinical Development ProgressWith the clinical trial design accepted in the US and enrollment commencement already in play OUS, Anteris is positioned to make significant strides in the DurAVR clinical development program and move down the US and OUS regulatory pathways.
Clinical Trial ResultsNew data from the DurAVR Small Aortic Annuli Pooled Cohort demonstrated stellar one-year hemodynamic outcomes as well as safety and efficacy results.
Regulatory ApprovalAnteris announced that the FDA issued IDE approval for the PARADIGM PMA trial, which will allow the company to move toward initiation of enrollment in the US.