Some interesting points:
Page 1 Prospectus:
- IDE application submission 2nd half 2012 (I tought we had already made the application)
- CE Mark approval anticipated 2nd half 2012 (previously expected June 2012)
P2:
Class III/Amb IV - 1.5m in USA, 3.7 mill Euro (=5.2m potential patients currently, ?annual increase).
P5 Safety Device Events
1 case of aortic disruption - however was at the time of a re-do surgery for mediastinitis (Would like to know cause of mediastinitis and mechanism of the disruption - ?surgical, ?weakening 2'ry to mediastinitis).
Some interesting points:Page 1 Prospectus:- IDE application...
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