Navitor™ TAVI System

SMART SEALING.
EXCEPTIONAL STABILITY.
UNCOMPROMISED ACCESS.

EXCELLENT OUTCOMES

In Clinical trial results

30-Day1

0%

SEVERE TO MODERATE
PARAVALVULAR LEAK

0%

ALL CAUSE
MORTALITY

0.8%

DISABLING
STROKE

0.8%

MAJOR VASCULAR
COMPLICATIONS

7.4mmHg

MEAN
GRADIENT
  • CLINICAL OUTCOMES

    30-DAY

    Navitor™1
    N=120

    EVOLUT PRO2
    N = 60

    ACURATE NEO2‡3
    N=120

    Sapien 34

    N=96*

    All-Cause Mortality 

    0.0%

    1.7%

    3.3%

    2.1%

    Disabling Stroke 

    0.8%

    1.7%

    1.7%

    0.0%

    Life-Threatening Bleeding 

    2.5%

    11.7%

    5.0%

    3.1%

    Acute Kidney Injury Stage 2/3 

    1.7%

    1.7%

    0.8%

    1.0%

    Major Vascular Complications 

    0.8%††

    10.0%

    3.3%

    4.2%

    New Permanent Pacemaker Implantation 

    15.0%

    11.8%

    16.1%

    14.5%

    NOTE: Data not from head-to-head studies. Data differences depicted between these trials may not be directly comparable, statistically significant, or clinically meaningful due to differences in trial protocols, endpoints, and/or patient populations. Data provided for informational purposes only.

    NOTE: Referenced data reflect results from prospective, multicenter clinical studies with contemporary valves in high and extreme risk surgical patients conducted to support CE Mark approval.

    * Transfemoral access cohort.

    †† 0% TAVI delivery system access site-related, 0.8% non-TAVI delivery system access site-related, and 0% non-access site-related.

  • SMART SEALING

    PVL 30-DAY
    ECHO CORE
    LAB DATA

    NAVITOR™1
    N=118

    EVOLUT PRO2
    N = 58

    ACURATE NEO2‡3
    N=100

    SAPIEN34
    N=113*

    None/Trace

    79.7%

    72.4%

    35.0%

    74.3%

    Mild

    20.3%

    27.6%

    62.0%

    22.1%

    Moderate

    0.0%

    0.0%

    3.0%

    3.5%

    Severe

    0.0%

    0.0%

    0.0%

    0.0%

    Based on number of subjects with data evaluable by the echo core lab.

    NOTE: Data not from head-to-head studies. Data differences depicted between these trials may not be directly comparable, statistically significant, or clinically meaningful due to differences in trial protocols, endpoints, and/or patient populations. Data provided for informational purposes only.

    NOTE: Referenced data reflect results from prospective, multicenter clinical studies with contemporary valves in high and extreme risk surgical patients conducted to support CE Mark approval.

    * Includes data on subjects implanted via transapical and transaortic access.

  • EXCEPTIONAL HEMODYNAMICS

    30-DAY ECHO CORE
    LAB DATA

    NAVITOR™1

    EVOLUT PRO2

    ACURATE NEO2ⱡ3

    SAPIEN34

    Mean Gradient (mmHg)

    7.4

    (N=118)

    6.4
    (N=55)

    7.9
    (N=104)

    10.6
    (N=119*)

    EOA (cm2)

    2.0
    (N=101)

    2.0
    (N=47)

    1.7
    (N=99)

    1.5
    (N=97*)

    Based on number of subjects with data evaluable by the echo core lab.

    NOTE: Data not from head-to-head studies. Data differences depicted between these trials may not be directly comparable, statistically significant, or clinically meaningful due to differences in trial protocols, endpoints, and/or patient populations. Data provided for informational purposes only.

    NOTE: Referenced data reflect results from prospective, multicenter clinical studies with contemporary valves in high and extreme risk surgical patients conducted to support CE Mark approval.

    * Includes data on subjects implanted via transapical and transaortic access.

MAT-2105703 v1.0 | Item approved for Global OUS use only.

References
  1. Abbott data on file CL1014440.
  2. Forrest JK, et al. Early outcomes with the Evolut PRO repositionable self-expanding transcatheter aortic valve with pericardial wrap. J Am Coll Cardiol Intv. 2018;11:160-168.
  3. Möllmann H. Transcather aortic valve implantation for severe aortic stenosis with the Acurate neo2 valve system: 30-day safety and performance outcomes. Abstract presented at: PCR London Valves; September 10, 2018; London, UK.
  4. Webb J, et al. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol. 2014;64:2235-43.

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