TAVI

NAVITOR™ WITH FLEXNAV™ TAVI SYSTEM CLINICAL DATA

Smart Sealing. Exceptional Stability. Uncompromised Access.

EXCELLENT OUTCOMES
IN CLINICAL TRIAL RESULTS

 

30-DAY1

0%

MODERATE OR
SEVERE PVL

0%

ALL CAUSE
MORTALITY

0.8%

DISABLING
STROKE

0.8%

MAJOR VASCULAR
COMPLICATIONS

7.4mmHg

MEAN
GRADIENT

1-YEAR1

1.0%

MODERATE PVL
(0% SEVERE PVL)

4.2%

ALL CAUSE
MORTALITY

0.8%

DISABLING
STROKE

0.8%

MAJOR VASCULAR
COMPLICATIONS

7.5mmHg

MEAN
GRADIENT

  • CLINICAL OUTCOMES

    30-DAY

    30-DAYNAVITOR™1
    N=120
    EVOLUT PRO2
    N=60
    ACURATE NEO2‡3
    N=120
    SAPIEN 34
    N=96*
    All-Cause Mortality0.0%1.7%3.3%2.1%
    Disabling Stroke0.8%1.7%1.7%0.0%
    Life-Threatening Bleeding2.5%11.7%5.0%3.1%
    Acute Kidney Injury Stage 2/31.7%1.7%0.8%1.0%
    Major Vascular Complications0.8%††10.0%3.3%4.2%
    New Permanent Pacemaker
    Implantation
    15.0%11.8%16.1%14.5%

     

    1-YEAR

    1-YEARNAVITOR™1
    N=120
    EVOLUT PRO5
    N=60
    ACURATE NEO2‡3
    N=120
    SAPIEN 36
    N=96*
    All-Cause Mortality4.2%11.8%11.9%8.4%
    Disabling Stroke0.8%1.7%1.7%1.1%
    Life-Threatening Bleeding5.0%NR8.5%NR
    Acute Kidney Injury Stage 2/31.7%NR0.8%NR
    Major Vascular Complications0.8%NR3.3%NR
    Naive Pacemaker Implantation16.8%**15.9%18.8%15.7%

    NOTE: Data not from head-to-head studies. Data provided for informational purposes only.

    NOTE: Reference data reflects results from prospective, multicenter clinical studies with contemporary valves in high- and extreme-risk surgical patients conducted in support of CE Mark approval (except Sapien 3 study cohort includes mixed high and intermediate risk patients).

    †† CEC adjudicated as related to procedure but not to device.

    * Transfemoral access cohort.

    ** Of the 18 subjects who required new PPI through 1 year, 13 had pre-existing conduction abnormalities.

  • SMART SEALING

    30-DAY

    PVL 30-DAY
    ECHO CORE
    LAB DATA
    NAVITOR™1
    N=118
    EVOLUT PRO2
    N=58
    ACURATE NEO2‡3
    N=100

    SAPIEN 34

    N=113*

    None/Trace79.7%72.4%35.0%74.3%
    Mild20.3%27.6%62.0%22.1%
    Moderate0.0%0.0%3.0%3.5%
    Severe0.0%0.0%0.0%0.0%

     

    1-YEAR

    PVL 1-YEAR
    ECHO CORE
    LAB DATA
    NAVITOR™1
    N=104
    EVOLUT PRO5
    N=46
    ACURATE NEO2‡3
    N=81

    SAPIEN 36

    N=100*

    None/Trace70.2%89.1%60.5%84.0%
    Mild28.8%10.9%37.0%14.0%
    Moderate1.0%0.0%2.5%2.0%
    Severe0.0%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 provided for informational purposes only.

    NOTE: Reference data reflects results from prospective, multicenter clinical studies with contemporary valves in high- and extreme-risk surgical patients conducted in support of CE Mark approval (except Sapien 3 study cohort includes mixed high and intermediate risk patients).

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

  • EXCEPTIONAL HEMODYNAMICS

    30-DAY

    30-DAY
    ECHO CORE
    LAB DATA

    NAVITOR™1

     

    EVOLUT PRO2
     
    ACURATE NEO2‡3
     

    SAPIEN 34

     

    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*)

     

    1-YEAR

    1-YEAR
    ECHO CORE
    LAB DATA

    NAVITOR™5

     

    EVOLUT PRO5
     
    ACURATE NEO2‡3
     

    SAPIEN 36

     

    Mean Gradient (mmHg)7.5
    (N=107)
    7.1
    (N=44)
    7.6
    (N=85)
    10.9
    (N=86)
    EOA (cm2)1.9
    (N=88)
    2.0
    (N=40)
    1.7
    (N=77)
    1.5
    (N=64)

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

    NOTE: Data not from head-to-head studies. Data provided for informational purposes only.

    NOTE: Reference data reflects results from prospective, multicenter clinical studies with contemporary valves in high- and extreme-risk surgical patients conducted in support of CE Mark approval (except Sapien 3 study cohort includes mixed high and intermediate risk patients).

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

    Paired Analysis

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MAT-2105703 v3.0 | Item approved for OUS use only.

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