Two year data for CoreValve in Aortic Valve Disease-Medtronic

Medtronic announced data showing that transcatheter aortic valve replacement (TAVR) with the CoreValve System continued to provide safe and effective treatment, while maintaining good rates of survival to two years for patients who were considered too ill or frail to have their Aortic Valves replaced through traditional open-heart surgery. Two year results from 305 patients treated with the CoreValve System in the Extreme Risk Study of the CoreValve US Pivotal Trial shows that all-cause mortality (36.5 percent) and major stroke (5.1 percent) at two years were low for this extreme risk cohort. The CoreValve device continued to demonstrate sustained favorable hemodynamic performance at two years as evidenced by low, single-digit mean gradients (blood flow resistance) of 8.7 mmHg; this is consistent with one month and one year rates (8.7 mmHg and 8.9 mmHg, respectively).

Low rates of paravalvular leak (PVL) seen at one year were maintained, with just 4.4 percent of all treated patients experiencing moderate to severe PVL at two years. The study also found that the marked improvement patients experienced in heart failure symptoms at one year (as measured by NYHA Class) was maintained at two years: 92 percent of heart failure patients improved at least one class by two years, and 58 percent of patients improved at least two classes by two years. Data were presented at the Transcatheter Cardiovascular Therapeutics 2014 Conference.