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
Clinical Outcomes
30-DAY
30-DAY | NAVITOR™1 N=260 | EVOLUT‡ PRO2 N=60 | SAPIEN‡ 33 N=583 |
---|---|---|---|
All-Cause Mortality | 1.9% | 1.7% | 2.2% |
Disabling Stroke | 1.9% | 1.7% | 0.9% |
Life-Threatening Bleeding | 3.8% | 11.7% | 10.2% |
Acute Kidney Injury Stage 2/3 | 1.9% | 1.7% | 1.7% |
Major Vascular Complications | 4.2%* | 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.
Smart Sealing
30-DAY
PVL 30-DAY ECHO CORE LAB DATA | NAVITOR™1 N=248 | EVOLUT‡ PRO2 N=58 | SAPIEN‡ 33 N=1597* |
---|---|---|---|
None/Trace | 79.8% | 72.4% | 55.9% |
Mild | 20.2% | 27.6% | 40.7% |
Moderate | 0.0% | 0.0% | 3.4% |
Severe | 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 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).
Excellent Hemodynamics
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).
‡ Indicates a third-party trademark, which is property of its respective owner.
MAT-2214676 v1.0 | Item approved for U.S. use only.