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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

‡ Indicates a third-party trademark, which is property of its respective owner.

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

References
  1. Smith, D. One-year clinical trial results with a next-generation aortic transcatheter heart valve. Presented at: EuroPCR conference; May 17-20, 2022.
  2. Forrest JK, Mangi AA, Popma JJ, 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, Holzhey DM, Hilker M, et al. The ACURATE neo2 valve system for transcatheter aortic valve implantation: 30-day and 1-year outcomes. Clin Res Cardiol. 2021 Dec;110(12):1912-1920.
  4. Webb J, Gerosa G, Lefèvre T, et al. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol. 2014;64:2235-43.
  5. Wyler von Ballmoos MC, Reardon MJ, Williams MR, et al. Three-Year Outcomes With a Contemporary Self-Expanding Transcatheter Valve From the Evolut PRO US Clinical Study. Cardiovasc Revasc Med. 2021 May;26:12-16.
  6. Webb, J. 1-year outcomes from the Sapien 3 Trial. Presented at: EuroPCR conference; May 19-22, 2015.
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