“All three sets of data will be included with results from the US Early Feasibility Study (EFS), to support Anteris’ application for premarket approval, required to market DurAVRTM THV commercially in the United States.”
I think there is more to this statement from the quarterly, perhaps a heads up from the FDA to put in this application for premarket approval.
Ann: DurAVR first successful implantation Valve-in-Valve, page-11
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