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Medtronic CoreValue ADVANCE study shows low mortality rates

Committed to generating robust clinical data on its CoreValve System for transcatheter aortic valve implantation, Medtronic, unveiled for the first time the complete one-year data from the "real world" Medtronic CoreValve ADVANCE Study. The one-year findings from the rigorous study showed low rates of mortality and stroke, along with significant and sustained hemodynamic performance. Consistent with positive one-month clinical outcomes previously reported, the ADVANCE Study demonstrated a low all-cause mortality rate of 17.9%, a cardiovascular mortality rate of 11.7%, and a very low and stable overall stroke rate of 4.5% at one year. Patients followed to one year also experienced significant and sustained improvements in hemodynamics due to the implanted CoreValve. In addition, patients experienced dramatic symptomatic improvements: while at baseline only 20 percent of patients were classified as New York Heart Association class I or class II, clinical symptoms markedly improved with 85% of patients in NYHA class I or II at 30 days, and 87% of patients in NYHA class I or II at 12 months.