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TAVI

NAVITOR™ TAVI SYSTEM

Stable delivery. Remarkable performance. Future ready.

 

The Navitor Transcatheter Aortic Valve Implantation (TAVI) System is at the cutting edge of minimally invasive heart valve replacement. Designed for stable delivery, remarkable performance, and future-ready capabilities, the Navitor TAVI System sets a new standard in the field of TAVI, which is also known as TAVR (Transcatheter Aortic Valve Replacement).

The Navitor TAVI System is intuitive, precise, and accurate, offering excellent hemodynamics and durability for TAVI procedures. Its design ensures a seamless and optimized valve replacement experience, making it a preferred choice for clinicians and patients alike.
 

0%
 

MODERATE OR SEVERE PVL

1.9%
 

ALL CAUSE
MORTALITY

1.9%
 

DISABLING
STROKE

4.2%
 

MAJOR VASCULAR
COMPLICATIONS

7.4
mm Hg

MEAN
GRADIENT

The 30-day outcomes for the Navitor TAVI System showcase its remarkable safety and effectiveness in transcatheter aortic valve implantation (TAVI) procedures.

The Navitor TAVI System offers a lifesaving treatment option for individuals with symptomatic severe aortic stenosis who are at high or greater risk for traditional open-heart surgery. This includes patients with considerations related to age, frailty, or other health conditions, making TAVI a viable and less invasive option.

Attention to every detail

The Navitor Vision Valve is engineered with meticulous attention to detail, ensuring optimal outcomes for TAVI procedures.

Navitor Valve Design Features

*Labeled as Navitor and Navitor Titan with Vision Technology

  • Controlled deployment : Ensures precise placement and deployment of the valve, critical for successful TAVI outcomes.
  • Excellent access and deliverability : The Navitor TAVI System is designed for ease of use, facilitating access to challenging anatomies and ensuring successful implantation.
Navitor FlexNav Delivery System Features

*14F and 15F equivalent

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SEE THE LATEST CLINICAL
DATA FOR NAVITOR

Clinical Data

MAT-2214014 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. Sondergaard, L. 30-day outcomes from a next generation TAVI device with an active sealing cuff. Presented at: EuroPCR conference; May 18-20, 2021.
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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