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
Clinical Outcomes
30-DAY
30-DAY | NAVITOR™1 N=260 |
---|---|
All-Cause Mortality | 1.9% |
Disabling Stroke | 1.9% |
Life-Threatening Bleeding | 3.8% |
Acute Kidney Injury Stage 2/3 | 1.9% |
Major Vascular Complications | 4.2%* |
*3.1% access site-related, and 1.2% non-access site-related.
Smart Sealing
30-DAY
PVL 30-DAY ECHO CORE LAB DATA | NAVITOR™1 N=248 |
---|---|
None/Trace | 79.8% |
Mild | 20.2% |
Moderate | 0.0% |
Severe | 0.0% |
Based on number of subjects with data evaluable by the echo core lab.
Excellent Hemodynamics
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.
‡ Indicates a third-party trademark, which is property of its respective owner.
MAT-2214676 v2.0 | Item approved for U.S. use only.