Clinical Trial SuccessThe FDA issued IDE approval for the PARADIGM PMA trial, which will allow the company to move toward initiation of enrollment in the US.
Device PerformanceDurAVR achieved very favorable outcomes, consisting of single-digit mean gradients, large EOAs, no moderate or severe PVL and no valve-related mortality, along with 97% freedom from moderate or severe PPM.
Regulatory PathwaysAnteris is positioned to make significant strides in the DurAVR clinical development program and move down the US and OUS regulatory pathways.