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TAVI

NAVITOR™ TAVI SYSTEM

Advancing the forefront of innovative design, the Navitor™ Transcatheter Aortic Valve Implantation (TAVI) System combines the smart sealing Navitor™ valve with the stability and accuracy of the FlexNav™ delivery system to achieve excellent clinical outcomes in patients with aortic stenosis.

SMART SEALING. EXCEPTIONAL STABILITY. UNCOMPROMISED ACCESS.

Navitor TAVI system offers intelligent design advantages, including smart PVL-sealing NaviSeal™ Cuff, stable and accurate placement, exceptional single-digit gradients,1 and uncompromised small vessel access and coronary access to consistently achieve excellent outcomes across a spectrum of routine to challenging anatomies.

               Navitor Valve

Navitor aortic valve

Intelligent design.

  • Smart PVL-sealing NaviSeal Cuff
  • Exceptional single-digit gradients1
  • Uncompromised coronary access

FlexNav Delivery System

FlexNav delivery system

Stability and accuracy.

  • Low profile 5.0 mm minimum vessel diameter for uncompromised small vessel access
  • Enhanced flexibility for excellent deliverability
  • Stable deployment and accurate valve placement

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

Discover features and benefits of the Navitor TAVI System.

Navitor valve for transcatheter aortic valve implantation

Transcatheter aortic valve implantation (TAVI) is a minimally invasive treatment for patients with aortic valve stenosis. The Navitor valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are considered high or extreme surgical risk.2

 

Physician on patient response*

Professor Ganesh Manoharan, MD, Interventional Cardiologist, Ireland

“80% of our patients had trivial or no PVL (paravalvular leak). The remaining two or three (patients) had mild PVL… The vast majority… (of) our patients went home the next day or the day after.”

*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.

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 TAVI.3

  • 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

    Navitor TAVI valve with exceptional hemodynamics

    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.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 property of its respective owner.

  • Uncompromised coronary access.
    Navitor valve design preserves coronary access for future intervention

    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 evaluates the long-term impact of anticalcification tissue treatment in humans.

    29 mm NavitorTM Valve*11

    29 mm Navitor valve design

    36 cells total

    9 cells in the annulus
    section of the stent

    29 mm Evolut‡ Pro Valve*12

    Navitor valve design with less cells compared to Evolut Pro

    135 cells total 

    15 cells in the annulus
    section of the stent

    *Based on Abbott coronary access testing.

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

FlexNav delivery system

*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™2    		EVOLUT‡ PRO
    WITH ENVEO‡ PRO12    		ACURATE NEO2‡ 
    WITH ISLEEVE‡13,14    		SAPIEN‡3
    WITH ESHEATH‡15,16
    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 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.17

    • Hydrophilic coating reduces friction by 98%,18 providing lubricity to guide the system through vasculature.

    • Integrated sheath for low 14 F delivery profile.19*
      * 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*

Overall deliverability

Interventional Cardiologist, Ireland*

“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.”

*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.

CLINICAL DATA


See the latest clinical data for the Navitor TAVI System
 

see clinical data

MAT-2105699 v5.0 | Item approved for OUS use only.

References

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

  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. Navitor™ TAVI System Instructions for Use.
  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: 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.
  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.
  8. Gross J. Calcification of bioprosthetic heart valves and its assessment. J Thorac Cardiovasc Surg. 2003;125:6-8.
  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. Boston Scientific Acurate neo2‡ Instructions for Use.
  14. Boston Scientific iSleeve‡ Instructions for Use.
  15. Edwards Sapien‡ 3 Instructions for Use.
  16. Koehler Sapien‡ 3 eSheath OD BMRI 2015.
  17. Abbott data on file 90368819.
  18. Abbott data on file 90346620.
  19. Portico™ TAVI System Instructions for Use.
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