And to add to my post above (I hate that we only get 3 minutes to make edits), the Edwards trial followed patients for 2 years on all endpoints but the Medtronic trial only took 1 year for the primary endpoint and 2 years for the secondary endpoints. From what Wayne has said, I think he's expecting only a one year pivotal FDA trial but he hasn't said anything overly specific. He has said that he expects approval in Europe earlier than in the US with the European CE study to begin next year.
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