Clinical HemodynamicsDurAVR achieved very low transvalvular gradients, large effective orifice areas, and no moderate or severe paravalvular leak, suggesting superior blood flow characteristics that can reduce symptom burden and need for reintervention.
Regulatory ProgressFDA IDE approval for the PARADIGM PMA trial enables initiation of US enrollment and represents a key regulatory milestone that advances the device toward potential market authorization.
Trial Design And Competitive DifferentiationThe randomized, international PARADIGM trial compares DurAVR head to head with incumbent TAVR platforms and is structured to highlight laminar flow restoration and long term durability, which could drive physician adoption if superiority is demonstrated.