+
+
Stay Informed
TAVI

NAVITOR™ WITH FLEXNAV™ TAVI SYSTEM CLINICAL DATA

Smart Sealing. Exceptional Stability. Uncompromised Access.

EXCELLENT OUTCOMES
IN CLINICAL TRIAL RESULTS

For patients with severe aortic stenosis who are at high or greater risk for surgery

 

30-DAY1

0%

MODERATE OR
SEVERE PVL

1.9%

ALL CAUSE
MORTALITY

1.9%

DISABLING
STROKE

4.2%

MAJOR VASCULAR
COMPLICATIONS

7.4mmHg

MEAN
GRADIENT

30-DAY

30-DAYNAVITOR™1
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.

30-DAY

PVL 30-DAY
ECHO CORE
LAB DATA		NAVITOR™1
N=248
None/Trace79.8%
Mild20.2%
Moderate0.0%
Severe0.0%

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

30-DAY

30-DAY
ECHO CORE
LAB DATA

NAVITOR™1

 

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.

‡ Indicates a third-party trademark, which is property of its respective owner.

MAT-2214676 v2.0 | Item approved for U.S. use only.

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

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.

Abbott Logo

Making an everlasting
impact On human health
for 130 years

Follow Abbott

Copyright © 2023 Abbott, 3200 Lakeside Dr, Santa Clara, 95054, U.S.A.
Caution: These products are intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or at eifu.abbottvascular.com or at medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
Illustrations are artist’s representations only and should not be considered as engineering drawings or photographs. Photos on file at Abbott.
Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates.
No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

MAT-2004021 v17.0  |   Item approved for U.S. use only.

YOU ARE ABOUT TO ENTER AN ABBOTT COUNTRY OR REGION SPECIFIC WEBSITE.

Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of the product that are not approved in other countries or regions.

U.S. Health Care Professionals International Health Care Professionals

YOU ARE ABOUT TO LEAVE
www.structural­heart.abbott

You are now leaving www.structuralheart.abbott. Abbott is not responsible for any content published on the third-party website you are about to enter. Abbott has not reviewed and does not endorse any information presented on third-party websites.

OkCancel