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

1.9%

ALL CAUSE
MORTALITY

1.9%

DISABLING
STROKE

4.2%

MAJOR VASCULAR
COMPLICATIONS

7.4mmHg

MEAN
GRADIENT

30-DAY

30-DAYNAVITOR™1
N=260
EVOLUT PRO2
N=60
SAPIEN 33
N=583
All-Cause Mortality1.9%1.7%2.2%
Disabling Stroke1.9%1.7%0.9%
Life-Threatening Bleeding3.8%11.7%10.2%
Acute Kidney Injury Stage 2/31.9%1.7%1.7%
Major Vascular Complications4.2%*10.0%5.1%

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

NOTE: Referenced data reflect results from prospective, multicenter clinical studies with contemporary valves in pre-market approval studies for comparable patient populations.

*3.1% access site-related, and 1.2% non-access site-related.


30-DAY

PVL 30-DAY
ECHO CORE
LAB DATA
NAVITOR™1
N=248
EVOLUT PRO2
N=58

SAPIEN 33

N=1597*

None/Trace79.8%72.4%55.9%
Mild20.2%27.6%40.7%
Moderate0.0%0.0%3.4%
Severe0.0%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: Referenced data reflect results from prospective, multicenter clinical studies with contemporary valves in pre-market approval studies for comparable patient populations (except Sapien 3 study cohort includes mixed high and intermediate risk patients).

*Echocardiographic findings among patients with 30-day assessments (combined high-risk/inoperable and intermediate cohorts).


30-DAY

30-DAY
ECHO CORE
LAB DATA

NAVITOR™4

 

EVOLUT PRO2
 

SAPIEN 33

 

Mean Gradient (mmHg)7.4
(N=249)
6.4
(N=55)
10.6
(N=1583*)
EOA (cm2)2.0
(N=215)
2.0
(N=47)
1.5
(N=1457*)

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: Referenced data reflect results from prospective, multicenter clinical studies with contemporary valves in pre-market approval studies for comparable patient populations (except Sapien 3 study cohort includes mixed high and intermediate risk patients).

*Echocardiographic findings among patients with 30-day assessments (combined high-risk/inoperable and intermediate cohorts).

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MAT-2214676 v1.0 | Item approved for U.S. use only.

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