hi groins, I just watched Wayne’ interview and looks like the pivotal trial will be a prospective randomised trial hence the existing available valves will also be used in the trial. The bottomline is that the cost of the trial will be largely similar as the total number of implants for the trial will be more or less the same. We should get paid for the treatment of our valve used in the implant.
btw I am not sure about the how the breakthrough device status fits in. Also the trial will be non-inferiority trial and the requirement will be less comparing to superiority trials.
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