Clinical Trial SuccessThe DurAVR system demonstrated stellar one-year hemodynamic outcomes as well as safety and efficacy results, with single-digit gradients and no paravalvular leak.
Market DifferentiationThe hierarchical analysis is powered to demonstrate superiority for DurAVR over the Sapien platform and the Evolut system, providing deeper comparisons versus incumbent commercial TAVR devices.
Regulatory AdvancementsThe FDA issued IDE approval for the PARADIGM PMA trial, which will allow the company to move toward initiation of enrollment in the US.