Navitor™ TAVI System

SMART SEALING.
EXCEPTIONAL STABILITY.
UNCOMPROMISED ACCESS.

INTELLIGENT DESIGN.

Advancing the forefront of innovative design, the Navitor™ valve brings together smart PVL-sealing technology, exceptional single-digit gradients,1 and uncompromised coronary access to achieve excellent clinical outcomes.

 

SMART SEALING.

REMARKABLE PERFORMANCE.

NaviSeal™ Cuff actively synchronizes to the cardiac cycle, seals, and mitigates Paravalvular Leak (PVL)1 by expanding to fill calcification-related gaps between the annulus and the valve.

SMART SEALING MITIGATES PVL
30-DAY ECHO CORE LAB DATA1

80%

NONE/TRACE

20%

MILD

0%

MODERATE

0%

SEVERE

.

PVL IMPACT

Moderate or greater Paravalvular Leak
increases 1-year mortality and rehospitalization
2.4x-2.7x following TAVI2



EXCEPTIONAL HEMODYNAMICS.

LARGE EFFECTIVE ORIFICE AREAS.1
SINGLE-DIGIT GRADIENTS.1

30-DAY ECHO CORE LAB DATA1

2.0 cm2

EOA

7.4 mmHg

MEAN GRADIENT

HEMODYNAMIC IMPACT.

Non-tapered stent and large Effective Orifice Areas (EOAs) resulting in single-digit gradients are associated with improved cardiac function, long-term durability, and minimal prosthesis-patient mismatch.1



DESIGNED FOR IMMEDIATE FUNCTIONALITY AND DURABILITY.

CONTINUOUS STABILITY.
NO RAPID PACING.

The only self-expanding valve with intra-annular leaflets that immediately function and a non-tapered stent, providing hemodynamic stability for a calm and controlled deployment.

DESIGNED FOR
DURABILITY.

Exclusive Linx™ anticalcification (AC) technology resists calcification in four distinct ways to improve long-term valve performance.3-6

 

ABBOTT
LINX™ AC*1-4

MEDTRONIC

AOA*5

BOSTON SCIENTIFIC BIOFIX*

EDWARDS
THERMAFIX*6

PRODUCTS

NAVITOR™

EVOLUTPRO

ACURATE NEO2

SAPIEN 3

Reduces free aldehydes3,4

Not Publicly Available

Extracts lipids5

 

Not Publicly Available

Minimizes uptake of cholesterol6

 

Not Publicly Available

 

Stabilizes leaflet collagen6

 

Not Publicly Available

 

* There is no clinical data currently available that evaluates the long-term impact of anticalcification tissue treatment in humans.

 

UNCOMPROMISED

CORONARY ACCESS.

Large-cell geometry and intra-annular valve
design preserve coronary access for
future intervention.

VALVE SIZE

NAVITORTM*9

EVOLUT PRO*9

23 mm

14.6 F

12.1 F

25 mm

16.3 F 

n/a

26 mm

n/a  

11.8 F

27 mm

18.7 F

n/a

29 mm

21.0 F

11.9F

29 mm NAVITORTM VALVE*9
36 CELLS TOTAL
9 CELLS IN THE ANNULUS
SECTION OF THE STENT
29 mm EVOLUT PRO VALVE*9
135 CELLS TOTAL 
15 CELLS IN THE ANNULUS
SECTION OF THE STENT

* Based on Abbott coronary access testing.

MAT-2105701 v2.0 | Item approved for Global OUS use only.

References
  1. Abbott data on file CL1014440.
  2. Pibarot P, et al. Assessment of paravalvular regurgitation following TAVR: a proposal of unifying grading scheme. JACC Cardiovasc Imaging. 2015;8(3):340-360. doi: 10.1016/j.jcmg.2015.01.008. PMID: 25772838.
  3. Frater RWM, et al. Advances in anticalcific and antidegenerative treatment of heart valve bioprostheses. Silent Partners Inc. 1997;8:105-13.
  4. Kelly SJ, et al. Biocompatibility and calcification of bioprosthetic heart valves. Society for biomaterials. Sixth World Biomaterials Congress Transaction. 2000;13534.
  5. Vyavahare N, et al. Prevention of bioprosthetic heart valve calcification by ethanol preincubation: efficacy and mechanisms. Circulation. 1997;95(2):479-88.
  6. Vyavahare N, et al. Prevention of calcification of glutaraldehyde-crosslinked porcine aortic cusps by ethanol preincubation: mechanistic studies of protein structure and water-biomaterial relationships. J Biomed Mater Res. 1998;40(4):577-85.
  7. Gross J. Calcification of bioprosthetic heart valves and its assessment. J Thorac Cardiovasc Surg. 2003;125:6-8.
  8. Edwards website, www.webcitation.org/667ClPuMH. This WebCitation captured Edwards’ site on 12MAR2012.
  9. Abbott data on file 90664679.

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