Composition of the panel is deliberately balanced between two interventional cardiologists still in the operational environment and two that are chiefly focused on research and academia;
In the theme of ‘moving the conversation forward’ they are introducing concept of ‘laminar flow’ as crucial to understanding both performance and durability. Anteris is confident in achieving non-inferiority in both mean gradient and effective price area (EOA). They are talking about ways of measuring laminar flow — hopefully something to be included in this trial;
They also raise the concept of durability of device necessarily raises the stakes for clinical performance for the long-term. It’s not enough for a device to last a long time — it also has to be benefits to the patient’s overall cardiovascular health.