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TAVI

NAVITOR™ TAVI SYSTEM CLINICAL DATA

Explore the latest TAVI clinical data for Navitor valves: 0% moderate or severe PVL, low mortality and stroke rates, and excellent hemodynamics.

PIONEERING CLINICAL EXCELLENCE
IN HEART VALVE REPLACEMENT

The Navitor TAVI* System demonstrates exceptional clinical trial results in transcatheter aortic valve implantation. Engineered for patients with severe aortic stenosis considered high-risk for traditional surgery, the Navitor TAVI System represents a significant advancement in minimally invasive heart valve replacement.

*TAVI is also referred to as TAVR (Transcatheter Aortic Valve Replacement)

Acute Outcomes for Navitor TAVI

The 30-day clinical outcomes of the Navitor TAVI System highlight its advanced design and its role in providing a safe, effective treatment option for those at high or greater risk for traditional surgery, emphasizing its precision and the minimized risk of complications associated with the procedure.
 

30-DAY

NAVITOR™2
N=260

All-Cause Mortality

1.9%

Disabling Stroke

1.9%

Life-Threatening Bleeding

3.8%

Acute Kidney Injury Stage 2/3

1.9%

Major Vascular Complications

4.2%*

*3.1% access site-related, and 1.2% non-access site-related.

0% Moderate or Severe PVL

PVL 30-DAY
ECHO CORE
LAB DATA

NAVITOR™2
N=248

None/Trace

79.8%

Mild

20.2%

Moderate

0.0%

Severe

0.0%

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

Excellent Hemodynamics in TAVI With Navitor Valves

The Navitor valves feature a unique cylindrical stent and intra-annular leaflets that open fully to maximize orifice area and achieve single digit mean gradients.
 

30-DAY
ECHO CORE
LAB DATA

NAVITOR™2

 

Mean Gradient (mm Hg)

7.4
(N=249)

EOA (cm2)

2.0
(N=215)

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

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MAT-2506546 v1.0 | Item approved for OUS use only.

References
  1. Smith, D. One-year clinical trial results with a next-generation aortic transcatheter heart valve. Presented at: EuroPCR conference; May 17-20, 2022.
  2. Forrest JK, Mangi AA, Popma JJ, et al. Early outcomes with the Evolut PRO repositionable self-expanding transcatheter aortic valve with pericardial wrap.
    J Am Coll Cardiol Intv. 2018;11:160-168.
  3. 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.
  4. Webb J, Gerosa G, Lefèvre T, et al. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol. 2014;64:2235-43.
  5. 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.
  6. Webb, J. 1-year outcomes from the Sapien 3 Trial. Presented at: EuroPCR conference; May 19-22, 2015.
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