Navitor™ - Clinical Data

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-DAY^1,2

1 YEAR^1,2

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Clinical trials CLINICAL INSIGHTS

Clinical outcomes

30-DAY

30-DAY	NAVITOR™^1,2 N=120	EVOLUT^‡ PRO³ N=60	ACURATE NEO2^‡4 N=120	SAPIEN^‡ 3⁵ N=96*
All-Cause Mortality	0.0%	1.7%	3.3%	2.1%
Disabling Stroke	0.8%	1.7%	1.7%	0.0%
Life-Threatening Bleeding	2.5%	11.7%	5.0%	3.1%
Acute Kidney Injury Stage 2/3	1.7%	1.7%	0.8%	1.0%
Major Vascular Complications	0.8%^††	10.0%	3.3%	4.2%
New Permanent Pacemaker Implantation	15.0%	11.8%	16.1%	14.5%

1-YEAR

1-YEAR	NAVITOR™^1,2 N=120	EVOLUT^‡ PRO⁶ N=60	ACURATE NEO2^‡4 N=120	SAPIEN^‡ 3⁷ N=96*
All-Cause Mortality	4.2%	11.8%	11.9%	8.4%
Disabling Stroke	0.8%	1.7%	1.7%	1.1%
Life-Threatening Bleeding	5.0%	NR	8.5%	NR
Acute Kidney Injury Stage 2/3	1.7%	NR	0.8%	NR
Major Vascular Complications	0.8%	NR	3.3%	NR
Naive Pacemaker Implantation	16.8%^**	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 CORE	NAVITOR™^1,2 N=118	EVOLUT^‡ PRO³ N=58	ACURATE NEO2^‡4 N=100	SAPIEN^‡ 3⁵ N=113*
None/Trace	79.7%	72.4%	35.0%	74.3%
Mild	20.3%	27.6%	62.0%	22.1%
Moderate	0.0%	0.0%	3.0%	3.5%
Severe	0.0%	0.0%	0.0%	0.0%

1-YEAR

PVL 1-YEAR ECHO CORE LAB DATA	NAVITOR™^1,2 N=104	EVOLUT^‡ PRO⁶ N=46	ACURATE NEO2^‡4 N=81	SAPIEN^‡ 3⁷ N=100*
None/Trace	70.2%	89.1%	60.5%	84.0%
Mild	28.8%	10.9%	37.0%	14.0%
Moderate	1.0%	0.0%	2.5%	2.0%
Severe	0.0%	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™^1,2	EVOLUT^‡ PRO³	ACURATE NEO2^‡4	SAPIEN^‡ 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™⁶	EVOLUT^‡ PRO⁶	ACURATE NEO2^‡4	SAPIEN^‡ 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.

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References

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.
Smith, D. One-year clinical trial results with a next-generation aortic transcatheter heart valve. Presented at: EuroPCR conference; May 17–20, 2022.
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.
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.
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.
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.
Webb, J. 1-year outcomes from the Sapien^‡ 3 Trial. Presented at: EuroPCR conference; May 19–22, 2015.