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, excellent 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

Intelligent design.

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

FlexNav Delivery System

Stability and accuracy.

  • Low profile 5.0 mm minimum vessel diameter for uncompromised small vessel access1
  • Enhanced flexibility for excellent deliverability
  • Stable deployment and accurate valve placement

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

Discover features and benefits of the Navitor TAVI System.

For patients with symptomatic severe aortic stenosis

Transcatheter aortic valve implantation (TAVI) provides an alternative, minimally invasive treatment option for people living with symptomatic severe aortic stenosis who are not candidates for open-heart surgery due to age, frailty, or other conditions that make surgery too risky. There are multiple factors, health conditions, indications and screenings that are utilized to determine if a patient is an eligible candidate for TAVI. The STS score allows physicians to calculate a patient’s risk of mortality and morbidities for a TAVI procedure. It is one of several sources of information in the decision-making and eligibility process.

TAVI with the Navitor valve can offer several key benefits. It is less invasive than open-heart surgery, with minimal scarring and a shorter hospital stay and recovery time.

Once the Navitor valve has been implanted, patients may experience immediate improvement in quality of life or may feel better gradually. Improvement may include:

  • Increased physical activity
  • Increased energy
  • Decreased or no chest pain
  • Decreased or no shortness of breath
  • Decreased severity of all or most previous symptoms

*For educational purposes only; not real patient cases.

Quality of Life and Recovery Time

John*, 84 years, male

John had severe symptomatic aortic stenosis and an STS score of 8%. He was experiencing chronic fatigue and had limited activity due to chronic back pain. Since John lives independently, his doctor determined John is a good candidate for TAVI when considering his recovery time for TAVI vs. open heart surgery.

History of Coronary Artery Disease and COPD

Carl*, 75 years, male

Carl had severe symptomatic aortic stenosis and an STS score of 8%. He experienced chest pain and shortness of breath. He has COPD, diabetes and a history of coronary artery disease so he went to his doctor right away to get checked out. His doctors determined he’d be a good candidate for TAVI given he may need additional coronary interventions (stents) in the future. 

Intelligent design.

Advancing the forefront of innovative design, the Navitor valve brings together smart PVL-sealing technology, excellent 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)2 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 PVL increases 1-year mortality and rehospitalization 2.4x-2.7x following TAVI.3

  • Excellent 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.4-7

     ABBOTT
    LINX™ AC*4-7

    MEDTRONIC

    AOA‡8*

    EDWARDS
    THERMAFIX‡9,10*
    PRODUCTSNAVITOR™EVOLUT PRO

    SAPIEN 3

    Reduces free aldehydes
    Extracts lipids 
    Minimizes uptake of cholesterol  
    Stabilizes leaflet collagen  

    *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.

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

    VALVE SIZENAVITOR™*11EVOLUT PRO*11
    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

    *Based on Abbott coronary access testing.

    29 mm NavitorTM Valve*11

    36 cells total

    9 cells in the annulus
    section of the stent

    29 mm Evolut Pro Valve*11

    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

*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™1
    EVOLUT PRO
    WITH ENVEO PRO12
    SAPIEN3
    WITH ESHEATH‡13
    Delivery System Profile
    (Outer Diameter)
    6.0 mm
    6.3 mm
    6.7 mm7.6 mm
    8.2 mm
    Minimum Vessel
    Diameter
    5.0 mm
    5.5 mm
    5.5 mm5.5 mm14
    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.15

    • Hydrophilic coating reduces friction by 98%,16 providing lubricity to guide the system through vasculature.

    • Integrated sheath for low 14 F delivery profile.1*
      * 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.15
    4. Hydrophilic coating reduces friction by 98%,16 providing lubricity to guide the system through vasculature.
    5. Integrated sheath for low 14 F delivery profile.1*
      * 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, United States of America*

“The system is a major advancement. With release, it didn’t move at all. And this was in a relatively horizontal aorta. We were able to end up being two to three mm in both the non-coronary and the left coronary side. Perfect implant. Very impressed. Big improvement”

*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.

MAT-2214014 v1.0 | Item approved for U.S. use only.

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