Medtronic : Data Confirms Superior Valve Performance Of Evolut TAVR System In Small Annulus Patients

(RTTNews) - Medtronic plc (MDT) released the two-year results of the SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial, international head-to-head comparative trial of transfemoral transcatheter aortic valve replacement (TAVR). In patients with aortic stenosis and a small aortic annulus, results showed comparable composite outcome of mortality, disabling stroke, and heart failure hospitalization, and continued superior valve performance as measured by bioprosthetic valve dysfunction (BVD) at two years for Evolut TAVR compared to SAPIEN.

The SMART two-year data demonstrated that Evolut TAVR continues to show significantly less BVD, which can be a predictor of adverse outcomes, compared to SAPIEN TAVR.

Additional results demonstrated that Evolut TAVR showed the following relative to SAPIEN TAVR: five times less prosthetic valve thrombosis and nine times less hemodynamic structural valve dysfunction.

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