NAVITOR™
TAVI SYSTEM
TAVI

 

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 paravalvular leak (PVL)-sealing NaviSeal™ Cuff, stable and accurate placement, exceptional single-digit gradients,1,2 and uncompromised small vessel access and coronary access to consistently achieve excellent outcomes across a spectrum of routine to challenging anatomies.

NAVITOR™ VALVE

DESIGN

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

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-DAY1,2

 

DISCOVER FEATURES AND BENEFITS
OF THE NAVITOR™ TAVI SYSTEM.

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AORTIC STENOSIS    WATCH TAVI SUMMIT 2023

 

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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 Instructions 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.
 

Caution: These products are intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available)or at eifu.abbottvascular.com or at medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions.

Illustrations are artist’s representations only and should not be considered as engineering drawings or photographs. Photos on file at Abbott.

© Abbott 2023. All rights reserved. 9-EH-5-14383-01 07-2023

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