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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)

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-DAYNAVITOR™2
N=260
All-Cause Mortality1.9%
Disabling Stroke1.9%
Life-Threatening Bleeding3.8%
Acute Kidney Injury Stage 2/31.9%
Major Vascular Complications4.2%*

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

PVL 30-DAY
ECHO CORE
LAB DATA		NAVITOR™2
N=248
None/Trace79.8%
Mild20.2%
Moderate0.0%
Severe0.0%

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

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-2214676 v4.0 | Item approved for U.S. use only.

References
  1. 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.
  2. Navitor™ TAVI System IFU.
Important Safety Information

Rx Only

NAVITOR™ TRANSCATHETER AORTIC VALVE IMPLANTATION SYSTEM

INDICATIONS

The Navitor™ Transcatheter Aortic Valve Implantation System is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator).

CONTRAINDICATIONS  

The valve is contraindicated for patients with inability to tolerate antiplatelet/anticoagulant therapy or nitinol alloy (nickel and titanium), or who have active infections, including endocarditis.

POTENTIAL ADVERSE EVENTS  

Adverse events potentially associated with the use of transcatheter bioprosthetic heart valves include but are not limited to: access site complications (e.g., pain, bleeding, infection, hematoma, pseudoaneurysm, etc.); acute coronary obstruction; acute myocardial infarction; allergic reaction to antiplatelet agents, contrast medium, or valve components; aortic rupture; ascending aorta trauma; atrio-ventricular node block; cardiac arrhythmias; conduction system injury; conversion to open surgical procedure; death; dissection; embolism; emergent balloon valvuloplasty; emergent percutaneous coronary intervention (PCI); emergent surgery (i.e., coronary artery bypass, heart valve replacement); endocarditis; explantation; heart failure; hemodynamic compromise; hemolysis; hemolytic anemia; hemorrhage; hypotension or hypertension; infection; myocardial ischemia; mitral valve insufficiency; multi-organ failure; non-structural dysfunction (i.e., entrapment by pannus, paravalvular leak, inappropriate sizing or positioning); pannus; pericardial effusion; perforation of the myocardium, ventricle, or a blood vessel; permanent disability; permanent pacemaker; regurgitation; renal insufficiency or renal failure; reoperation; respiratory failure; sepsis; stroke; structural deterioration (i.e., calcification, leaflet tear); thrombosis; tamponade; transfusion; valve embolization or migration; vessel dissection or spasm.

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