I have changed my view and now believe the Georgia FIH trial assisted with the FDA EFS category B rating which provides the ability to sell the device during the trial, pending CMS approval.
I believe the Georgia trial moved DurAVR past being experimental.
Designation as Category A means that the device is both; experimental and investigational, with the initial questions centred around the safety and efficacy. Category B means the device is investigational but not experimental for its intended use. This further means that the underlying questions around the safety and efficacy of the device type have been resolved and that the FDA has determined that the device type can be both safe and effective.
3D printed heart valves, page-28
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