Asked what this has to do with the pivotal trial and got this response.
Thank you for your enquiry. Our commercialisation strategy to date has predominantly focused on the US market. Study NCT06510855 will further our commercialisation plans in Europe in addition to providing additional data to support the premarket application (PMA) to the FDA for both aortic stenosis and a potential secondary indication in valve-in-valve patients.
Clinical trials, page-19
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