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NAVITOR™
TAVI SYSTEM
TAVI

Stable delivery. Remarkable performance. Future ready.

NAVITOR™ TAVI SYSTEM

Navitor™ combines Navitor™ valves (available in four sizes) with the FlexNav™ delivery system to provide one TAVI system, optimized to give favorable clinical outcomes while maintaining enhanced deliverability and ease of use.

NAVITOR™ VALVE FEATURES

INTELLIGENT DESIGN

Advancing the forefront of innovative design, the Navitor™ valve brings together smart PVL-sealing technology, exceptional single-digit gradients,1,2 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)1,2 by expanding to fill calcification-related gaps between the annulus and the valve.

SMART SEALING MITIGATES PVL  | 30-DAY ECHO CORE LAB DATA1,2

 

Exceptional hemodynamics

Large effective orifice areas.1,2

Single-digit gradients.1,2

30-day Echo Core Lab Data1,2



2.0 cm2

EOA



7.4 mmHg

Mean gradient

HEMODYNAMIC IMPACT

Non-tapered stent and large effective orifice areas resulting in single-digit gradients are associated with improved cardiac function, long-term durability, and minimal prosthesis-patient mismatch.1,2

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 nontapered 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.4-7

 ABBOTT
LINX™ AC*4-7		MEDTRONIC
AOA‡8*		BOSTON SCIENTIFIC
BIOFIX‡*		EDWARDS
THERMAFIX‡9,10*
PRODUCTSNAVITOR™EVOLUT‡ PROACURATE NEO2‡SAPIEN‡ 3
Reduces free aldehydes✔✔Not Publicly Available✔
Extracts lipids✔ Not Publicly Available✔
Minimizes uptake of cholesterol✔ Not Publicly Available 
Stabilizes leaflet collagen✔ Not Publicly Available 

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

‡Indicates a third-party trademark, which is the property of its respective owner.

Uncompromised coronary access


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

VALVE SIZENAVITOR™*11EVOLUT‡ PRO*12
23 mm14.6 F12.1 F
25 mm16.3 F n/a
26 mmn/a  11.8 F
27 mm18.7 Fn/a
29 mm21.0 F11.9 F

*There is no clinical data currently available that evaluatevs the long-term impact of anticalcification tissue treatment in humans. ‡Indicates a third-party trademark, which is the property of its respective owner.

29 MM
NAVITOR™ VALVE*11

36 cells total

9 cells in the annulus
section of the stent

29 MM
EVOLUT‡ PRO VALVE*12

135 cells total 

15 cells in the annulus
section of the stent

*Based on Abbott coronary access testing

FLEXNAV™ DELIVERY SYSTEM FEATURES

STABILITY AND ACCURACY

  • Low profile and highly flexible catheter enables excellent deliverability,
    even in patients with small access vessels and tortuous anatomies
  • Controlled deployment provides stable and accurate valve placement
  • Recapturable,* repositionable,* and retrievable* design

*Until fully deployed.
†14 F equivalent integrated sheath diameter for patients requiring 23 mm or 25 mm valve.

14 F† DELIVERY SYSTEM
WITH 5.0 mm MINIMUM
VESSEL DIAMETER

FLEXNAV™ DELIVERY SYSTEM FEATURES

STABILITY AND ACCURACY

  • Low profile and highly flexible catheter enables excellent deliverability,
    even in patients with small access vessels and tortuous anatomies
  • Controlled deployment provides stable and accurate valve placement
  • Recapturable,* repositionable,* and retrievable* design

14 F† DELIVERY SYSTEM
WITH 5.0 mm MINIMUM
VESSEL DIAMETER

*Until fully deployed.
†14 F equivalent integrated sheath diameter for patients requiring 23 mm or 25 mm valve.

Uncompromised small vessel access
 NAVITOR
WITH FLEXNAV™13		EVOLUT‡ PRO
WITH ENVEO‡ PRO12		ACURATE NEO2‡ 
WITH ISLEEVE‡14,15		SAPIEN‡ 3
WITH ESHEATH‡16,17
Delivery System Profile
(Outer Diameter)		6.0 mm
6.3 mm		6.7 mm6.0 mm7.6 mm
8.2 mm
Minimum Vessel
Diameter		5.0 mm
5.5 mm		5.5 mm5.5 mm5.5 mm
6.0 mm


‡Indicates a third-party trademark, which is the property of its respective owner.

Recapturable*, repositionable*, and retrievable* design

See progress as you go

Feel every advancement

Open and close with ease

TAKE THE TENSION OUT OF TAVI

Lock in placement accuracy

Dial in the details

  • A deployment indicator gives you a clear visualization of the valve’s deployment progress.

  • The simple deployment wheel provides both audible and tactile feedback as you deploy the valve.

  • Two macro-slide buttons make it easy for you to open and close the distal end of the delivery system during valve loading and post-deployment.

  • The stability layer ensures stable, predictable valve deployment to achieve accurate valve placement.

  • The automatic lock button prevents full valve deployment until you’ve got the valve right where you want it.

  • With the unique micro-adjustment wheel, you can close gaps between the valve capsule and the atraumatic nosecone.

FlexNav TAVI system features

See progress as you go

A deployment indicator gives you a clear visualization of the valve’s deployment progress.

Feel every advancement

The simple deployment wheel provides both audible and tactile feedback as you deploy the valve.

Open and close with ease

Two macro-slide buttons make it easy for you to open and close the distal end of the delivery system during valve loading and post-deployment.

TAKE THE TENSION OUT OF TAVI

The stability layer ensures stable, predictable valve deployment to achieve accurate valve placement.

Lock in placement accuracy

The automatic lock button prevents full valve deployment until you’ve got the valve right where you want it.

Dial in the details

With the unique micro-adjustment wheel, you can close gaps between the valve capsule and the atraumatic nosecone.

*Until fully deployed.

Enhanced flexibility

FlexNav™ Delivery System offers three-dimensional flexibility at the distal end and throughout its entire working length.

Atraumatic nosecone

Large-Cell framework

Flexible capsule

Hydrophilic coating

Integrated sheath

  • Atraumatic nosecone and smooth transitions are designed to
    reduce risk of vascular complications and calcium dislodgement.

  • The large-cell framework of the NavitorTM valve reduces metal mass, resulting in a more flexible capsule.

  • The capsule is more flexible because it does not require bilateral metal rails or extra nitinol braiding, resulting in enhanced flexibility.18

  • Hydrophilic coating reduces friction by 98%,19 providing lubricity to guide the system through vasculature.

  • Integrated sheath for low 14 F delivery profile.20*
    * 14 F equivalent integrated sheath diameter for patients requiring 23 mm or 25 mm valve.

FlexNav TAVI system offers 3D flexibility
1
2
3
4
5
  1. Atraumatic nosecone and smooth transitions are designed to reduce risk of vascular complications and calcium dislodgement.
  2. The large-cell framework of the NavitorTM valve reduces metal mass, resulting in a more flexible capsule.
  3. The capsule is more flexible because it does not require bilateral metal rails or extra nitinol braiding, resulting in enhanced flexibility.17
  4. Hydrophilic coating reduces friction by 98%,18 providing lubricity to guide the system through vasculature.
  5. Integrated sheath for low 14 F delivery profile.19*
    * 14 F equivalent integrated sheath diameter for patients requiring 23 mm or 25 mm valve.
Feedback from FlexNav™ Delivery System user*
“

In terms of delivery of the valve, the FlexNav™ is now a leader by far. It has the best access for sheathless approach… It cuts through like (a) hot knife through butter.

Interventional Cardiologist, Ireland*

*The testimonial does not provide any indication, guide, warranty or guarantee as to the response patients may have to the treatment or effectiveness of the product or therapy in discussion. Opinions about the treatment discussed can and do vary and are specific to the individual’s experience and might not be representative of others.

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TV

TAVI Summit - Cardiac imaging

Cardiac imaging in AS - bioprosthetic valve dysfunction
 

M. Saad

TAVI Summit - Cardiac imaging and morphology

Cardiac imaging in AS - cardiac damage and morphology focus
 

A. Cook

TAVI Summit - Cardiac imaging

Cardiac imaging in AS - cardiac damage
 

L. Sondergaard

TAVI Summit - Cardiac imaging and morphology

Cardiac imaging in AS - conduction system and morphology focus
 

A. Cook

TAVI Summit - Cardiac imaging

Cardiac imaging in AS - conduction system
 

D. Buckert

TAVI Summit - Cardiac imaging and morphology

Cardiac imaging in AS - coronary access and morphology focus
 

A. Cook

TAVI Summit - Cardiac imaging

Cardiac imaging in AS - coronary access
 

M. Mullen

TAVI Summit - Live case from Berlin

Live case from Berlin on refining TAVI
 

H. Dreker, A. Unbehaun, M. Kukucka and Team SHIP

TAVI Summit - PreTAVR CT analysis

New indications in the horizon - PreTAVR CR analysis
 

W.K. Kim

TAVI Summit - TAVR in bicuspid

TAVI in bicuspid younger patient PRO/CON
 

L. Testa

References
  1. Søndergaard L, Walton AS, Worthley SG, et al. Thirty-day and one-year outcomes of the Navitor transcatheter heart valve in patients with aortic stenosis: the prospective, multicentre, global PORTICO NG study. Eurointervention 2023;EIJ-D-22-01108. eurointervention.pcronline.com/article/thirty-day-and-one-year-outcomes-of-thenavitor-transcatheter-heart-valve-in-patients-with-aortic-stenosis-the-prospective-multicentre-global-portico-ng-study.
  2. Søndergaard, L. 30-day outcomes from a next generation TAVI device with an active sealing cuff. Presented at: EuroPCR conference; May 18–20, 2021.
  3. Pibarot P, Hahn RT, Weissman NJ, et al. Assessment of paravalvular regurgitation following TAVR: a proposal of unifying grading scheme. JACC Cardiovasc Imaging. 2015;8(3):340–360. doi.org/10.1016/j.jcmg.2015.01.008.
  4. Frater RWM, Seifter E, Liao K, et al. Advances in Anticalcific and Antidegenerative Treatment of Heart Valve Bioprostheses. Austin, TX: Silent Partners Inc; 1997:105–114.
  5. Kelly SJ, Ogle, MF, Carlyle WC, et al. Biocompatibility and calcification of bioprosthetic heart valves. Society for biomaterials. Sixth World Biomaterials Congress Transaction. 2000;13534.
  6. Vyavahare N, Hirsch D, Lerner E, et al. Prevention of bioprosthetic heart valve calcification by ethanol preincubation: efficacy and mechanisms. Circulation.
    1997;95(2):479–488. doi.org/10.1161/01.CIR.95.2.479.
  7. Vyavahare N, Hirsch D, Lerner E, 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):577–585.https://doi.org/10.1002/(SICI)1097-4636(19980615)40:4%3C577::AID-JBM9%3E3.0.CO;2-C.
  8. Gross JM. Calcification of bioprosthetic heart valves and its assessment. J Thorac Cardiovasc Surg. 2003;125:S6–8. doi.org/10.1067/mtc.2003.208.
  9. Tod TJ, Dove JS. The association of bound aldehyde content with bioprosthetic tissue calcification. J Mater Sci: Mater Med. 2016;27:8.
    doi.org/10.1007/s10856-015-5623-z.
  10. Meuris B, De Praetere H, Strasly M, et al. A novel tissue treatment to reduce mineralization of bovine pericardial heart valves. JTCVS. 2018;156(1):197–206. doi.org/10.1016/j.jtcvs.2018.01.099.
  11. Data on file at Abbott. 90664679
  12. Medtronic CoreValve Evolut‡ PRO Instructions for Use.
  13. Navitor™ TAVI System Instruct ions for Use.
  14. Boston Scientific ACURATE neo2‡ Instructions for Use.
  15. Boston Scientific iSleeve‡ Instructions for Use.
  16. Edwards Sapien‡ 3 Instructions for Use.
  17. Koehler Sapien‡ 3 eSheath OD BMRI 2015.
  18. Abbott data on file 90368819.
  19. Abbott data on file 90346620.
  20. Portico™ TAVI System Instructions for Use

‡Indicates a third-party trademark, which is the property of its respective owner.

© Abbott 2024. All rights reserved. 9-EH-5-14383-01 08-2024 REV B

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