What I would love to see now is some detail about the study. We know there will be 15 patients enrolling from early 2023. How long is this expected to take and how long from full enrolment will we potentially get FDA approval assuming all goes well. Considering we implanted 5 in one day. getting full enrolment shouldn't take long. Do we then need to wait 12 months? or is the 3 or 6 month data adequate? Anyway if anyone has detail would love to see them posted.
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- Ann: FDA Approves Early Feasibility Study for DurAVR THV System
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