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TAVI

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

30-DAYNAVITOR™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 Implantation15.0%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.

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/Trace79.7%

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.

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.

References
  1. Sondergaard, L. 30-day outcomes from a next generation TAVI device with an active sealing cuff. Presented at: EuroPCR conference; May 18-20, 2021.
  2. Forrest JK, Mangi AA, Popma JJ, et al. Early outcomes with the Evolut PRO repositionable self-expanding transcatheter aortic valve with pericardial wrap. J Am Coll Cardiol Intv. 2018;11:160-168.
  3. Möllmann H. Transcather aortic valve implantation for severe aortic stenosis with the Acurate neo2 valve system: 30-day safety and performance outcomes. Abstract presented at: PCR London Valves; September 10, 2018; London, UK.
  4. Webb J, Gerosa G, Lefèvre T, et al. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol. 2014;64:2235-43.
  5. Abbott data on file CL1014440.
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