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TAVI

NAVITOR™ TAVI SYSTEM

Stable delivery. Remarkable performance. Future ready.

 

Your work demands a safe, intuitive and future ready TAVI system that achieves excellent outcomes, every time. Our Navitor™ TAVI System is intuitive, precise and accurate — with excellent hemodynamics and durability. There are Navitor Vision* Valve sizes for a wide range of anatomies.

0%

moderate or
severe PVL

1.9%

all-cause
 mortality

1.9%

disabling
 stroke

4.2%

major vascular
complications

7.4mm Hg

mean
 gradient

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.

Discover how Nancy benefited from a TAVR/TAVI procedure

Nancy faced the challenges associated with aortic stenosis. Her heart team treated her with the Navitor TAVI system, which offers excellent hemodynamic performance and a low-profile design, enabling precise placement and reducing paravalvular leak risk and ultimately improving patient outcomes and procedural confidence for physicians.

Attention to every detail

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

Navitor Vision features

*Labeled as Navitor and Navitor Titan with Vision Technology

Low-profile, highly flexible catheter enables excellent access and deliverability.

Navitor-Flexnav

**14 F and 15 F equivalent

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Physician Near Me

Use this tool to refer a patient or consult with a certified implanting physician near you.

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See the latest clinical data for Navitor

Clinical Data

MAT-2214014 v7.0 | 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; Paris, France.  
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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