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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.

EXCELLENT OUTCOMES IN CLINICAL TRIAL RESULTS

30-DAY1,2

1 YEAR1,2

FIND OUT MORE:

Clinical trials  CLINICAL INSIGHTS

Clinical outcomes

30-DAY

30-DAYNAVITOR™1,2
N=120		EVOLUT‡ PRO3
N=60		ACURATE NEO2‡4
N=120		SAPIEN‡ 35
N=96*
All-Cause Mortality0.0%1.7%3.3%2.1%
Disabling Stroke0.8%1.7%1.7%0.0%
Life-Threatening Bleeding2.5%11.7%5.0%3.1%
Acute Kidney Injury Stage 2/31.7%1.7%0.8%1.0%
Major Vascular Complications0.8%††10.0%3.3%4.2%
New Permanent Pacemaker
Implantation		15.0%11.8%16.1%14.5%

1-YEAR

1-YEARNAVITOR™1,2
N=120		EVOLUT‡ PRO6
N=60		ACURATE NEO2‡4
N=120		SAPIEN‡ 37
N=96*
All-Cause Mortality4.2%11.8%11.9%8.4%
Disabling Stroke0.8%1.7%1.7%1.1%
Life-Threatening Bleeding5.0%NR8.5%NR
Acute Kidney Injury Stage 2/31.7%NR0.8%NR
Major Vascular Complications0.8%NR3.3%NR
Naive Pacemaker Implantation16.8%**15.9%18.8%15.7%



NOTE: Data not from head-to-head studies. Data provided for informational purposes only.

NOTE: Reference data reflects results from prospective, multicenter clinical studies with contemporary valves in high- and extreme-risk surgical patients conducted in support of CE Mark approval (except Sapien‡ 3 study cohort includes mixed high and intermediate risk patients).

††CEC adjudicated as related to procedure but not to device.

* Transfemoral access cohort.

** Of the 18 subjects who required new permanent pacemaker implantation PPI through 1 year, 13 had pre-existing conduction abnormalities.

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

Smart sealing

30-DAY

PVL 30-DAY ECHO CORENAVITOR™1,2
N=118		EVOLUT‡ PRO3
N=58		ACURATE NEO2‡4
N=100		SAPIEN‡ 35
N=113*
None/Trace79.7%72.4%35.0%74.3%
Mild20.3%27.6%62.0%22.1%
Moderate0.0%0.0%3.0%3.5%
Severe0.0%0.0%0.0%0.0%

1-YEAR

PVL 1-YEAR ECHO CORE LAB DATANAVITOR™1,2
N=104		EVOLUT‡ PRO6
N=46		ACURATE NEO2‡4
N=81		SAPIEN‡ 37
N=100*
None/Trace70.2%89.1%60.5%84.0%
Mild28.8%10.9%37.0%14.0%
Moderate1.0%0.0%2.5%2.0%
Severe0.0%0.0%0.0%0.0%

Based on number of subjects with data evaluable by the echo core lab.

NOTE: Data not from head-to-head studies. Data provided for informational purposes only.

NOTE: Reference data reflects results from prospective, multicenter clinical studies with contemporary valves in high- and extreme-risk surgical patients conducted in support of CE Mark approval (except Sapien‡ 3 study cohort includes mixed high and intermediate risk patients).

* Includes data on subjects implanted via transapical and transaortic access.

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

Exceptional hemodynamics

30-DAY

30-DAY
ECHO CORE LAB DATA		NAVITOR™1,2EVOLUT‡ PRO3ACURATE NEO2‡4SAPIEN‡ 35
Mean Gradient (mmHg)7.4
(N=118)		6.4
(N=55)		7.9
(N=104)		10.6
(N=119*)
EOA (cm2)2.0
(N=101)		2.0
(N=47)		1.7
(N=99)		1.5
(N=97*)

1-YEAR

1-YEAR
ECHO CORE LAB DATA		NAVITOR™6EVOLUT‡ PRO6ACURATE NEO2‡4SAPIEN‡ 37
Mean Gradient (mmHg)7.5
(N=107)		7.1
(N=44)		7.6
(N=85)		10.9†
(N=86)
EOA (cm2)1.9
(N=88)		2.0
(N=40)		1.7
(N=77)		1.5†
(N=64)

Based on number of subjects with data evaluable by the echo core lab.

NOTE: Data not from head-to-head studies. Data provided for informational purposes only.

NOTE: Reference data reflects results from prospective, multicenter clinical studies with contemporary valves in high- and extreme-risk surgical patients conducted in support of CE Mark approval (except Sapien‡ 3 study cohort includes mixed high and intermediate risk patients).

* Includes data on subjects implanted via transapical and transaortic access.

† Paired Analysis

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

BRINGING YOU...

Clinical case clubs | Educational tools | Hot topics
Expert opinions | Live & online discussions
 

TV

Transfemoral TAVI

Navitor Vision 35 implantation

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

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. Smith, D. One-year clinical trial results with a next-generation aortic transcatheter heart valve. Presented at: EuroPCR conference; May 17–20, 2022.
  3. Forrest JK, Mangi AA, Popma JJ, et al. Early outcomes with the Evolut PRO repositionable self-expanding transcatheter aortic valve with pericardial wrap.
    JACC Cardiovasc Interv. 2018;11(2):160–168. doi.org/10.1016/j.jcin.2017.10.014.
  4. Möllmann H, Holzhey DM, Hilker M, et al. The ACURATE neo2 valve system for transcatheter aortic valve implantation: 30-day and 1-year outcomes. Clin Res Cardiol. 2021 Dec;110(12):1912–1920. doi.org/10.1007/s00392-021-01882-3.
  5. Webb J, Gerosa G, Lefèvre T, et al. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol. 2014;64(21):2235–2243. doi.org/10.1016/j.jacc.2014.09.026.
  6. Wyler von Ballmoos MC, Reardon MJ, Williams MR, et al. Three-year outcomes with a contemporary self-expanding transcatheter valve from the Evolut PRO US clinical study. Cardiovasc Revasc Med. 2021 May;26:12–16. doi.org/10.1016/j.carrev.2020.11.007.
  7. Webb, J. 1-year outcomes from the Sapien‡ 3 Trial. Presented at: EuroPCR conference; May 19–22, 2015.

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