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Stay Informed
AORTIC STENOSIS

AORTIC VALVE
REPLACEMENT

Once aortic stenosis (AS) progresses to severe stage, one of the AS treatment options is to replace your diseased aortic valve. In some cases, your doctor may recommend aortic valve replacement even if you aren't experiencing symptoms.1 

Treating aortic stenosis

Aortic stenosis treatment depends on the severity of your condition, whether you're experiencing symptoms, and if your condition is getting worse.1 Based on your level of risk, the outcomes from your diagnostic tests, and lifestyle preference, your doctor will recommend the best treatment option for you.
 

DISCUSS ALL TREATMENT OPTIONS WITH YOUR DOCTOR
Your doctor can describe the risks and benefits and help you decide which option is right for you.

Balloon Aortic Valvuloplasty

BALLOON
AORTIC VALVULOPLASTY

In this procedure, a small balloon catheter is threaded into the heart through an artery and then inflated to open the valve.1 However, the valve will eventually narrow again, requiring additional procedures.

MEDICATION
 

Patients with mild-to-moderate aortic stenosis may be prescribed medications to help manage their symptoms or reduce the burden on their heart.1 However, medications cannot cure aortic stenosis.3

Hospitalization

AORTIC VALVE
REPLACEMENT

There are two options for replacing your aortic valve: surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement/implantation (TAVR/TAVI).

Early treatment is key to prevent progression to heart failure.1-3

Surgical Aortic Valve Replacement (SAVR)

SAVR is an open-heart procedure where your surgeon removes the damaged valve and replaces it with a mechanical valve or a bioprosthetic (tissue) valve.2  

Learn about tissue valve replacement by downloading the guide for the Epic™ aortic tissue valve .

Benifits of Aortic Valve Replacement

See how patients like Tom benefit from Surgical Aortic Valve Replacement

Tom had a life-long love of surfing, but his aortic stenosis had progressed to the point where he could no longer catch a wave. Watch Tom’s story to learn how the SAVR procedure with the Epic™ Supra Valve “rolled the clock back a decade” and enabled him to live a normal life again.

Transcatheter Aortic Valve Replacement (TAVR or TAVI)

TAVR/TAVI is a minimally invasive procedure that uses a catheter threaded through an artery to implant a new valve within your diseased aortic valve.2

The Navitor™ valve is an alternative, minimally invasive treatment option for people living with severe aortic stenosis who are not candidates for open-heart surgery due to age, frailty, or other conditions that make surgery too risky.

Learn more about Navitor, TAVR/TAVI.

Most patients can resume a healthy, active life after valve replacement.

Tissue valve replacement with Epic™ Valve therapy

The Epic™ valve is a stented bioprosthetic valve made partly with tissue from porcine (pig) or bovine (cow) hearts that functions similarly to human heart valves. Learn more about aortic tissue valve replacement with Epic valve therapy.

DOWNLOAD GUIDE

Aortic Stenosis Treatment Options for Patients
A PATIENT’S GUIDE TO TREATING AORTIC STENOSIS

Transcatheter aortic valve replacement with the Navitor™ Valve

Learn more about transcatheter aortic valve implantation (TAVI) with the Navitor™valve. 

Download Guide

The choice of proceeding with SAVR versus TAVR is based on multiple factors, including your risk score, frailty, comorbid conditions, and your personal preferences and values.4 To determine what type of valve is best for you, your doctor will take many factors into consideration, such as your age, overall health, and medication requirements.4

The information provided is not intended for medical diagnosis or treatment or as a substitute for professional advice. Consult with a physician or qualified healthcare provider for appropriate medical advice.

MAT-2305140 v5.0 | Item approved for U.S. use only.

References
  1. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC Guideline for the management of patients with valvular heart disease. Circulation. 2014;129(23):2240-2492. doi: 10.1161/CIR.0000000000000029
  2. Satter Y, Rauf H, Bareeqa S, et al. Transcatheter aortic valve replacement versus surgical aortic valve replacement: A review of aortic stenosis management. Cureus. 2019;11(12):e6431. doi: 10.7759/cureus.6431
  3. Carita P, Coppola G, Novo G, et al. Aortic stenosis: Insights on pathogenesis and clinical implications. J Geriatr Cardiol. 2016;13:489-498. doi:10.11909/j.issn.1671-5411.2016.06.001
  4. Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC focused update of the 2014 AHA/ACC Guideline for the management of patients with valvular heart disease. Circulation. 2017;135(25):e1159-e1195. doi: 10.1161/CIR.0000000000000503
Important Safety Information
  • Navitor
  • Epic/Epic Supra

  • WHAT IS THE NAVITOR™ TAVI SYSTEM APPROVED FOR?
    Available by prescription only.

    Transcatheter Aortic Valve Implantation (TAVI) with the Navitor™ TAVI System provides an alternative, minimally invasive treatment option for people living with severe aortic stenosis, a condition where the aortic valve does not fully open or close, who are not candidates for open-heart surgery due to age, frailty, or other conditions that make surgery too risky.

    WHO SHOULD NOT RECEIVE TRANSCATHETER AORTIC VALVE IMPLANTATION WITH THE NAVITOR™ TAVI SYSTEM?

    You should not receive the Navitor valve if you have any of the following conditions: any kind of infection, including an active infection in the heart; cannot tolerate medication that thins the blood or prevents blood clots from forming; have a reaction or allergy to nitinol, an alloy of nickel and titanium.

    The Navitor™ TAVI System has not been studied in the following patient populations and therefore should not be used in patients who: have any evidence of a blood clot (thrombus), intracardiac mass or vegetation in, on or around the heart; have narrow veins or arteries with calcification that make insertion of the delivery sheath and access to the aortic valve impossible; have stenotic (narrowed) aortic valve without calcium deposits; have a heart valve defect from birth with either one or two leaflets vs. the normal three leaflets; are pregnant or breastfeeding; are age 21 or younger at the time of diagnosis or treatment; have an ejection fraction, or volume of blood fluid, less than 20%; have unstable heart function requiring mechanical assistance or drug therapy to support the normal function of the heart; are low or intermediate surgical risk; have had a previous heart valve or ring in any position in the heart; have mixed aortic valve disease (stenosis and regurgitation); have severe mitral valve disease (calcification, stenosis or inefficiency); have a medical condition that affects the cellular or plasma components of the blood; have significant coronary artery disease that requires treatment; have abnormally thick heart muscle (hypertrophic cardiomyopathy); are on dialysis, have kidney failure or inefficiency; have known allergy or sensitivity to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media/dye; have bulky calcium build up on the valve leaflets close to the coronary ostia which are the main arteries delivering blood from the heart to the rest of the body; have significant aortic disease, including abdominal aorta, thoracic aneurysm or any other folding, bending or narrowing which would make access to the aortic valve impossible.

    WHAT ARE THE POSSIBLE COMPLICATIONS ASSOCIATED WITH TRANSCATHETER AORTIC VALVE IMPLANTATION WITH THE NAVITOR™ TAVI SYSTEM?

    There are risks with any heart valve implantation procedure. The most serious risks are: death, stroke, serious damage to the arteries and serious bleeding. Additional risks include, but are not limited to: access site complications (e.g., pain, bleeding, infection, blood vessel damage); buildup of deposits (plaque) in and on the walls of coronary arteries; heart attack - blockage of blood flow to the heart muscle; allergic reaction to medication or products/devices used during the procedure (medication to prevent blood clotting, x-ray die, components of the valve delivery process); tear or burst of the aorta; irregular heart rate; disruption or injury of electrical system in your heart leading to the need for a permenant pacemaker implant; tear or separation of the layers of the wall of an artery; obstruction of an artery, typically by a clot of blood or an air bubble; inflammation of the lining of your heart; failure of your heart to pump enough blood to the body’s organs; unstable blood flow; rupture or destruction of blood cells; blood cell damage; low red blood cell count; bleeding, infection, clotting in or on the valve or tissue of the valve; loose clots in the bloodstream that may block an artery in your arms, legs, or brain; escape of blood from a ruptured blood vessel; blood pressure changes above or below the normal levels; infection; reduced blood flow to your heart, preventing the heart muscle from receiving enough oxygen; changes to the Mitral valve where it doesn’t close tightly; multi-organ failure - inflammation from a severe infection or injury causes dysfunction in two or more organ systems; wrong sizing or positioning of the implanted valve; collection of fluid or blood around your heart; perforation or tear of the heart muscle, ventricle or blood vessel; formation of scar tissue that may cover or block the valve from functioning normally; leakage of blood around the edge of the valve; valves in your heart don’t close tightly, allowing blood to flow backward in your heart; kidneys lose the ability to remove waste and balance fluids; blood doesn’t have enough oxygen or has too much carbon dioxide; sepsis; structural deterioration of the implanted valve (i.e., calcification, leaflet tear); having an abnormal particle (air or blood clots) floating in the bloodstream or attached to an object, including the valve; when extra fluid builds up in the space around the heart; when the transcatheter valve moves or is dislodged from the deployment position/location; permanent disability; the need for additional medical procedures to include blood transfusions, operation to remove the valve, use of a balloon to adjust the valve (valvuloplasty), and catheter insertion into coronary arteries to treat blockages.

  • WHAT ARE THE EPIC™ VALVE AND EPIC™ SUPRA VALVE APPROVED FOR?
    Available by prescription only.

    The Epic™ valve is for use in replacement of a native (natural) aortic and/or mitral heart valve that is diseased, damaged, or does not function properly. It may also be used to replace a previously implanted prosthetic aortic and/or mitral heart valve.

    The Epic™ Supra valve is for use in replacement of a native (natural) aortic heart valve that is diseased, damaged, or does not function properly. It may also be used to replace a previously implanted prosthetic aortic heart valve.

    WHO SHOULD NOT RECEIVE THE EPIC VALVE OR EPIC™ SUPRA VALVE?

    There are no known contraindications with the use of the Epic™ valve or Epic™ Supra valve.

    WHAT ARE THE POSSIBLE COMPLICATION ASSOCIATED WITH THE EPIC™ VALVE OR EPIC™ SUPRA VALVE?

    Potential adverse events that may occur during or after implantation of the Epic™ valve or Epic™ Supra valve include, but are not limited to: chest pain; loss of regular heart rhythm; infection or inflammation in the heart; failure of the heart to pump enough blood for the body’s needs; destruction of red blood cells; anemia caused by excessive destruction of red blood cells; excessive bleeding related to use of blood thinners; leak near the valve; heart attack; nonstructural destruction of the valve; valve unable to close completely, thus allowing blood to flow backward through the valve; stroke; structural deterioration (calcification, leaflet tear, perforation, or other); blood clot that blocks a vessel; formation of a blood clot near or attached to the valve.

    It is possible that these complications could lead to reoperation, surgical removal of the valve, permanent disability, or death.

    WHAT ARE THE WARNINGS ASSOCIATED WITH THE EPIC™ VALVE OR EPIC™ SUPRA VALVE?

    Faster deterioration of the Epic™ valve and Epic™ Supra valve may occur in children, adolescents, or young adults; patients with a disease that results in more calcium in the blood (e.g., hyperparathyroidism or chronic renal failure); or individuals requiring hemodialysis.

    Talk to your doctor to learn more about the risks associated with use of the Epic™ valve or Epic™ Supra valve.

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MAT-2302755 v6.0  |   Item approved for U.S. use only.

Step 1

To implant the device, your doctor inserts a narrow tube into a vein in your upper leg.

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