Intelligence Feed event · Policy · 2026-10-20

    Anteris wins German BfArM clearance for DurAVR PARADIGM heart valve trial

    Question

    Anteris wins German BfArM clearance for DurAVR PARADIGM heart valve trial

    Direct answer

    Medical technology company Anteris Technologies secured regulatory clearance from Germany's Federal Institute for Drugs and Medical Devices (BfArM) to launch the PARADIGM trial in Germany. The trial investigates the DurAVR Transcatheter Heart Valve in patients suffering from severe aortic stenosis. The approval initiates patient enrollment across German cardiology centers, expanding clinical generation outside the United States. Progression of the PARADIGM trial represents a necessary milestone toward European regulatory filings and eventual commercial distribution.

    Original publisher
    Market Ontology
    Evidence through
    2026-10-20
    Published
    2026-10-20
    Revision
    1 · 2026-10-20

    Cite as: Market Ontology, “Anteris wins German BfArM clearance for DurAVR PARADIGM heart valve trial”, revision 1, evidence through 2026-10-20. https://marketontology.com/market-events/2026-10-20/anteris-wins-german-bfarm-clearance-for-duravr-paradigm-heart-valve-trial-31081a

    POLICY
    Anteris wins German BfArM clearance for DurAVR PARADIGM heart valve trial
    Medical technology company Anteris Technologies secured regulatory clearance from Germany's Federal Institute for Drugs and Medical Devices (BfArM) to launch the PARADIGM trial in Germany. The trial investigates the DurAVR Transcatheter Heart Valve in patients suffering from severe aortic stenosis. The approval initiates patient enrollment across German cardiology centers, expanding clinical generation outside the United States. Progression of the PARADIGM trial represents a necessary milestone toward European regulatory filings and eventual commercial distribution.
    AVREW
    Impact
    63
    OCT 20
    SIG
    88%
    AVREW
    Anteris wins German BfArM clearance for DurAVR PARADIGM heart valve trial
    Medical technology company Anteris Technologies secured regulatory clearance from Germany's Federal Institute for Drugs and Medical Devices (BfArM) to launch the PARADIGM trial in Germany. The trial investigates the DurAVR Transcatheter Heart Valve in patients suffering from severe aortic stenosis. The approval initiates patient enrollment across German cardiology centers, expanding clinical generation outside the United States. Progression of the PARADIGM trial represents a necessary milestone toward European regulatory filings and eventual commercial distribution.
    → Regulatory trial clearance from BfArM opens German patient enrollment, progressing clinical validation required for European CE Mark commercial access for the DurAVR valve.
    Impact
    Medical technology company Anteris Technologies secured regulatory clearance from Germany's Federal Institute for Drugs and Medical Devices (BfArM) to launch the PARADIGM trial in Germany. The trial investigates the DurAVR Transcatheter Heart Valve in patients suffering from severe aortic stenosis. The approval initiates patient enrollment across German cardiology centers, expanding clinical generation outside the United States. Progression of the PARADIGM trial represents a necessary milestone toward European regulatory filings and eventual commercial distribution.
    Affected
    AVREW
    Transmission
    Regulatory trial clearance from BfArM opens German patient enrollment, progressing clinical validation required for European CE Mark commercial access for the DurAVR valve.

    How this development reaches the affected companies

    AssetExposure and channelDirectionEvidence
    AVRclinical pathway milestone progress toward European commercializationUp1-4wBfArM clearance allows Anteris to initiate PARADIGM patient recruitment in Germany.
    EWtranscatheter aortic valve replacement competitive landscapeWatch1-3mDurAVR targets the severe aortic stenosis market dominated by established TAVR manufacturers.

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    What happened next

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