Medtronic said that the new Conformite Europeenne (CE) Mark is the first ever regulatory approval for VIV procedures, which provide a minimally invasive treatment option for patients whose surgical aortic valves have degenerated and who are at extreme or high risk for surgery and would otherwise go untreated.
The valve-in-valve procedure, in which the CoreValve System is placed inside the degenerated surgical aortic valve through a low-profile, 18Fr delivery catheter, has been approved for use with all four CoreValve sizes (23mm, 26mm, 29mm and 31mm), as well as three delivery approaches (transfemoral, subclavian and direct aortic access).
CoreValve VIV procedures are not currently approved in the United States.
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