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TAVI

NAVITOR™ TAVI SYSTEM

Stable delivery. Remarkable performance. Future ready.

Clinical Data

EXCELLENT JUST GOT BETTER

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.

30-day outcomes¹:

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

PATIENTS WHO BENEFIT

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.

NAVITOR VISION VALVE

Attention to every detail

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

*Labeled as Navitor and Navitor Titan with Vision Technology

FLEXNAV™ DELIVERY SYSTEM:
THE CONFIDENCE OF CONTROLLED DEPLOYMENT

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

**14 F and 15 F equivalent

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Find a Navitor TAVI Certified
Physician Near Me

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

SEE THE LATEST CLINICAL
DATA FOR NAVITOR

MAT-2214014 v5.0 | Item approved for U.S. use only.

Important Safety Information

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.