Navitor™ TAVI

Transcatheter Aortic Valve Implantation (TAVI)

Navitor TAVI System

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,and uncompromised small vessel access and coronary access to consistently achieve excellent outcomes across a spectrum of routine to challenging anatomies.

Intelligent Design.

  • NaviSeal Cuff actively synchronizes to the cardiac cycle, seals, and mitigates PVL1 by expanding to fill calcification-related gaps between the annulus and the valve.
  • Non-tapered stent and large EOAs resulting in single-digit gradients are associated with improved cardiac function, long-term durability, and minimal prosthesis-patient mismatch.1
  • 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.
  • Exclusive Linx™ anticalcification (AC) technology resists calcification in four distinct ways to improve long-term valve performance.*2-5
  • Large-cell geometry and intra-annular valve design preserve coronary access for future intervention.

Stability and Accuracy.

  • Low profile and highly flexible catheter enables excellent deliverability, even in patients with small access vessels and tortuous anatomies.
  • 14 F** delivery system with 5.0 mm minimum vessel diameter.
  • Controlled deployment provides stable and accurate valve placement.
  • Recapturable,*** repositionable,*** and retrievable*** design.

Excellent Outcomes.

  • 79.8% None/Trace Paravalvular Leak (PVL)
  • 20.2% Mild PVL
  • 0% Moderate to Severe PVL
  • 2.0 cm² Effective Orifice Area
  • 7.4 mmHg Mean Gradient
  • 1.9% All-Cause Mortality
  • 1.9% Disabling Stroke
  • 3.8% Life-Threatening Bleeding
  • 1.9% Acute Kidney Injury Stage 2/3
  • 4.2% Major Vascular Complications
Navitor FlexNav

Learn more about Navitor™ TAVI System by visiting the Abbott Structural Heart website

Ordering Information

Navitor™ Transcatheter Aortic Valve

Catalog NumberValve Size (mm)Annulus Use Range Diameter (mm)6Annulus Area (mm²)6Annulus Perimeter (mm)6


FlexNav™ Delivery System

Catalog NumberEquivalent Integrated Sheath Diameter
Valve Capsule Outer Diameter
Integrated Sheath Working Length
Delivery System Working Length
Minimum Vessel Diameter Requirement
FNAV-DS-SM146.030107≥ 5.0
FNAV-DS-LG156.330107≥ 5.5


Navitor™ Loading System

Catalog Number 
NVTR-LS-SMThe Navitor™ loading system facilitates valve preparation/loading onto the FlexNav™ delivery system. The loading system includes a loading funnel, loading base, base insert, loading tube, stent guide and leaflet tester. The SM and LG loading systems contain base inserts to facilitate loading the Navitor valve according to the labeled size on the base insert. In addition, the base insert and loading tube are color-coded to differentiate between the different configurations.

* There is no clinical data currently available that evaluates the long-term impact of anticalcification tissue treatment in humans.
** 14 F equivalent integrated sheath diameter for patients requiring 23 mm or 25 mm valve.
*** Until fully deployed.
 30-Day Echo Core Lab Data


  1. Navitor™ TAVI System IFU.
  2. Frater RWM, et al. Advances in anticalcific and antidegenerative treatment of heart valve bioprostheses. Silent Partners Inc. 1997;8:105-13.
  3. Kelly SJ, et al. Biocompatibility and calcification of bioprosthetic heart valves. Society for biomaterials. Sixth World Biomaterials Congress Transaction. 2000;13534.
  4. Vyavahare N, et al. Prevention of bioprosthetic heart valve calcification by ethanol preincubation: efficacy and mechanisms. Circulation. 1997;95(2):479-88.
  5. 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.
  6. Abbott data on file 90734545/90465559.

Important Safety Information




The Navitor™ Transcatheter Aortic Valve Implantation System is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator).


The valve is contraindicated for patients with inability to tolerate antiplatelet/anticoagulant therapy or nitinol alloy (nickel and titanium), or who have active infections, including endocarditis.


Adverse events potentially associated with the use of transcatheter bioprosthetic heart valves include but are not limited to: access site complications (e.g., pain, bleeding, infection, hematoma, pseudoaneurysm, etc.); acute coronary obstruction; acute myocardial infarction; allergic reaction to antiplatelet agents, contrast medium, or valve components; aortic rupture; ascending aorta trauma; atrio-ventricular node block; cardiac arrhythmias; conduction system injury; conversion to open surgical procedure; death; dissection; embolism; emergent balloon valvuloplasty; emergent percutaneous coronary intervention (PCI); emergent surgery (i.e., coronary artery bypass, heart valve replacement); endocarditis; explantation; heart failure; hemodynamic compromise; hemolysis; hemolytic anemia; hemorrhage; hypotension or hypertension; infection; myocardial ischemia; mitral valve insufficiency; multi-organ failure; non-structural dysfunction (i.e., entrapment by pannus, paravalvular leak, inappropriate sizing or positioning); pannus; pericardial effusion; perforation of the myocardium, ventricle, or a blood vessel; permanent disability; permanent pacemaker; regurgitation; renal insufficiency or renal failure; reoperation; respiratory failure; sepsis; stroke; structural deterioration (i.e., calcification, leaflet tear); thrombosis; tamponade; transfusion; valve embolization or migration; vessel dissection or spasm.

MAT-2300253 v1.0