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TAVI

NAVITOR™ WITH FLEXNAV™ TAVI SYSTEM CLINICAL DATA

Smart Sealing. Exceptional Stability. Uncompromised Access.

EXCELLENT OUTCOMES
IN CLINICAL TRIAL RESULTS

 

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		EVOLUT‡ PRO2
N=60		SAPIEN‡ 33
N=583
All-Cause Mortality1.9%1.7%2.2%
Disabling Stroke1.9%1.7%0.9%
Life-Threatening Bleeding3.8%11.7%10.2%
Acute Kidney Injury Stage 2/31.9%1.7%1.7%
Major Vascular Complications4.2%*10.0%5.1%

NOTE: Data not from head-to-head studies. Data provided for informational purposes only.

NOTE: Referenced data reflect results from prospective, multicenter clinical studies with contemporary valves in pre-market approval studies for comparable patient populations.

*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		EVOLUT‡ PRO2
N=58

SAPIEN‡ 33

N=1597*

None/Trace79.8%72.4%55.9%
Mild20.2%27.6%40.7%
Moderate0.0%0.0%3.4%
Severe0.0%0.0%0.0%

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

NOTE: Data not from head-to-head studies. Data provided for informational purposes only.

NOTE: Referenced data reflect results from prospective, multicenter clinical studies with contemporary valves in pre-market approval studies for comparable patient populations (except Sapien‡ 3 study cohort includes mixed high and intermediate risk patients).

*Echocardiographic findings among patients with 30-day assessments (combined high-risk/inoperable and intermediate cohorts).

30-DAY

30-DAY
ECHO CORE
LAB DATA

NAVITOR™4

 

EVOLUT‡ PRO2
 

SAPIEN‡ 33

 

Mean Gradient (mmHg)7.4
(N=249)		6.4
(N=55)		10.6
(N=1583*)
EOA (cm2)2.0
(N=215)		2.0
(N=47)		1.5
(N=1457*)

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

NOTE: Data not from head-to-head studies. Data provided for informational purposes only.

NOTE: Referenced data reflect results from prospective, multicenter clinical studies with contemporary valves in pre-market approval studies for comparable patient populations (except Sapien‡ 3 study cohort includes mixed high and intermediate risk patients).

*Echocardiographic findings among patients with 30-day assessments (combined high-risk/inoperable and intermediate cohorts).

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

MAT-2214676 v1.0 | Item approved for U.S. use only.

References
  1. Navitor™ TAVI System IFU.
  2. Forrest, JK. Early outcomes with the Evolut PRO repositionable self-expanding transcatheter aortic valve with pericardial wrap.JACC Cardiovasc Interv. 2018 11(2):160-168.
  3. Kodali S, et al. Early clinical and echocardiographic outcomes after SAPIEN‡3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis. European Heart Journal (2016) 37, 2252–2262; doi:10.1093/eurheartj/ehw112.
  4. Abbott data on file CL1019595.
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.

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