TAVI

NAVITOR™ WITH FLEXNAV™ TAVI SYSTEM CLINICAL DATA

Smart Sealing. Exceptional Stability. Uncompromised Access.

EXCELLENT OUTCOMES
IN CLINICAL TRIAL RESULTS

For patients with severe aortic stenosis who are at high or greater risk for surgery

 

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
All-Cause Mortality1.9%
Disabling Stroke1.9%
Life-Threatening Bleeding3.8%
Acute Kidney Injury Stage 2/31.9%
Major Vascular Complications4.2%*

*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
None/Trace79.8%
Mild20.2%
Moderate0.0%
Severe0.0%

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


30-DAY

30-DAY
ECHO CORE
LAB DATA

NAVITOR™1

 

Mean Gradient (mmHg)7.4
(N=249)
EOA (cm2)2.0
(N=215)

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

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MAT-2214676 v2.0 | Item approved for U.S. use only.

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