NAVITOR™ WITH FLEXNAV™ TAVI SYSTEM CLINICAL DATA
Deliverability Redefined. A Future Optimized.
EXCELLENT OUTCOMES
IN CLINICAL TRIAL RESULTS
30-DAY1
0%
MODERATE OR GREATER
PARAVALVULAR LEAK
0%
ALL CAUSE
MORTALITY
0.8%
DISABLING
STROKE
0.8%
MAJOR VASCULAR
COMPLICATIONS
7.4mmHg
MEAN
GRADIENT
CLINICAL OUTCOMES
30-DAY | NAVITOR™1 N=120 | EVOLUT‡ PRO2 N = 60 | ACURATE NEO2‡3 N=120 | SAPIEN‡ 34 N=96* |
---|---|---|---|---|
All-Cause Mortality | 0.0% | 1.7% | 3.3% | 2.1% |
Disabling Stroke | 0.8% | 1.7% | 1.7% | 0.0% |
Life-Threatening Bleeding | 2.5% | 11.7% | 5.0% | 3.1% |
Acute Kidney Injury Stage 2/3 | 1.7% | 1.7% | 0.8% | 1.0% |
Major Vascular Complications | 0.8%†† | 10.0% | 3.3% | 4.2% |
New Permanent Pacemaker Implantation | 15.0% | 11.8% | 16.1% | 14.5% |
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 high and extreme risk surgical patients conducted to support CE Mark approval.
* Transfemoral access cohort.
†† 0% TAVI delivery system access site-related, 0.8% non-TAVI delivery system access site-related, and 0% non-access site-related.
SMART SEALING
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/Trace | 79.7% | 72.4% | 35.0% | 74.3% |
Mild | 20.3% | 27.6% | 62.0% | 22.1% |
Moderate | 0.0% | 0.0% | 3.0% | 3.5% |
Severe | 0.0% | 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: Referenced data reflect results from prospective, multicenter clinical studies with contemporary valves in high and extreme risk surgical patients conducted to support CE Mark approval.
* Includes data on subjects implanted via transapical and transaortic access.
EXCEPTIONAL HEMODYNAMICS
30-DAY ECHO CORE LAB DATA | NAVITOR™5
| 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*) |
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 high and extreme risk surgical patients conducted to support CE Mark approval.
* Includes data on subjects implanted via transapical and transaortic access.
MAT-2105703 v2.0 | Item approved for Global OUS use only.