Medtronic's Evolut Aortic Valve Replacement Shows Positive Outcomes Even After Two Years

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  • Medtronic Plc MDT has announced the complete two-year outcomes from a low-risk trial comparing the Evolut transcatheter aortic valve replacement (TAVR) system to open-heart surgery in characteristically younger, healthier aortic stenosis patients.
  • Data were presented at the EuroPCR 2021 e-Course.
  • The results showed the Evolut TAVR platform was non-inferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at two years (4.3% for TAVR versus 6.3% for surgery).
  • At two years, the study showed that improved safety shown early on for TAVR was sustained over time.
  • Better hemodynamic (blood flow) performance for TAVR with statistically significantly lower mean aortic valve gradient (9.0 mm Hg versus 11.7 mm Hg) was seen.
  • A larger effective orifice area than surgery (2.2 cm2 versus 2.0 cm2) at two years was observed.
  • Numerically lower rates of death in the TAVR arm (3.5% versus 4.4%), heart failure hospitalizations (5.3% versus 7.1%), and disabling stroke (1.5% versus 2.7%) compared to surgery at two years were reported.
  • The prosthesis-patient mismatch was lower for TAVR than surgery at two years, with a difference of 2.1% versus 4.9% in the severe category.
  • Valve thrombosis rates showed no signs of increase and remained low at two years.
  • Price Action: MDT shares are up 0.76% at $126.49 during the market session on the last check Tuesday.
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