Clinical Performance And SafetyDurAVR delivered single-digit mean gradients, large effective orifice areas, no moderate or severe paravalvular leaks, and low one-year all-cause mortality, reflecting strong hemodynamic performance and safety in small annulus patients.
Device Design And Competitive DifferentiationBiomimetic valve design produced a striking laminar flow signature and very low prosthesis–patient mismatch, supporting claims of more physiologic flow and potential durability advantages versus incumbent TAVR systems.
Regulatory MilestoneFDA IDE approval for the PARADIGM PMA trial enables U.S. enrollment and advances the device toward a premarket approval pathway, reducing regulatory uncertainty for potential commercialization.