Navitor™ - Clinical Data

NAVITOR™
TAVI SYSTEM
CLINICAL DATA
TAVI

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)

EXCELLENT JUST GOT BETTER

30-Day Outcomes¹

MODERATE OR
SEVERE PVL

ALL-CAUSE MORTALITY

DISABLING
STROKE

MAJOR VASCULAR COMPLICATIONS

MEAN
GRADIENT

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	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 (mmHg)	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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References

Reardon, M, Chehab, B, Smith, D. et al. 30-Day Clinical Outcomes of a Self-Expanding Transcatheter Aortic Valve: The International PORTICO NG Study. J Am Coll Cardiol Intv. 2023 Mar, 16 (6) 681–689. doi.org/10.1016/j.jcin.2023.02.002.
Navitor™ TAVI System IFU.