Need surgical aortic valve replacement?

You have options

Evaluate the differences between mechanical and tissue valves – and find out if the INSPIRIS RESILIA aortic valve could be right for you

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INSPIRIS RESILIA tissue valve

To find a surgeon with experience with the INSPIRIS RESILIA aortic valve, start your search here

What are your surgical
aortic valve options?

There are two types of heart valves used to replace diseased valves:

Mechanical valve

Made from man-made material

Tissue valves

Made mostly from animal tissue, such as bovine (cow) heart tissue (the tough sac around the heart), porcine (pig) tissue, or human valves from cadavers

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Discuss with your doctor the different types of valve options and which might be best for you.

For more information on valve disease, visit www.edwards.com/patients

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Tissue valve

Mechanical valve

The difference between tissue and mechanical valves

A key selection criteria for patients going through the valve selection process is durability. The more durable a valve is, the less chance a re-operation will be required.

Tissue valves, typically do not require the use of blood thinners and typically last between 10 to 20 years depending on the type of valve, patient characteristics and other factors.

Mechanical valves are designed with durable materials that may last longer. However, patients with mechanical valves require a lifelong treatment of anticoagulants (blood thinners) to avoid clots on the valve.

Here are some additional considerations when
comparing tissue and mechanical valves:

Tissue Valves Mechanical Valves
Long-term blood thinner required No Yes
Daily blood thinner medication and regular blood tests for rest of life
Valve longevity

10 to over 20 years, depending on type of valve, patient characteristics, and other factors

RESILIA tissue has been shown in animal studies to have less calcium build-up, potentially allowing the valve to last longer.1*

Over 20 years, in general
Lifestyle and dietary considerations Yes
May need to reduce calcium intake
Yes
Limits active lifestyle and foods high in vitamin K (such as leafy greens) from diet
Noticeable sounds from valve No Yes
Clicking sound as valve opens and closes
Pregnancy considerations No
No known pregnancy complication risk
Yes
High pregnancy complication risks due to use of blood thinners

Reference:

1. Flameng et al. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardiovasc Surg. 2015;149:340–5.
*RESILIA tissue has not been studied for long term results in patients.

Is the INSPIRIS RESILIA aortic valve right for you?

The INSPIRIS RESILIA aortic valve is made of RESILIA tissue, a bovine (cow) heart tissue that has been preserved with a special Edwards technology designed to reduce calcium build-up on the valve tissue and allow the valve to be stored dry.1

The special technology used in the RESILIA tissue on the INSPIRIS valve blocks the calcium from depositing on the tissue. Less calcium build-up could potentially allow the valve to last longer.

Diagram of INSPIRIS RESILIA aortic valve

It also has a first of its kind expandable valve frame designed for potential valve-in-valve procedures*^

The INSPIRIS valve is built on the proven Carpentier-Edwards Perimount valve design – which has helped over one million patients worldwide.

Additionally, the INSPIRIS valve typically will not require you to take blood thinners for the long-term – unless you have other risk factors or medical conditions that would require it. Your doctors will decide if the INSPIRIS valve is right for you.

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Reference:

*RESILIA tissue has not been studied for long term results in patients.
^This device is not approved by the FDA to have another valve placed inside it. This approach has not been studied in a clinical trial.

There are a few aspects of the INSPIRIS RESILIA aortic valve that are important.

Reduces Calcium Build-up

The INSPIRIS valve uses RESILIA tissue, a bovine (cow) tissue with a special technology that reduces calcium build-up on the valve.

Reducing calcium build-up is important because calcium build-up is the main cause of tissue valve failure. RESILIA tissue has demonstrated significantly less calcium build-up in animal studies.1*

1. Flameng et al. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardiovasc Surg. 2015;149:340–5.

*RESILIA tissue tested against commercially-available bovine pericardial tissue from Edwards in a juvenile sheep model.

RESILIA tissue valve

RESILIA tissue valve

Control tissue valve

Control tissue valve

Explanted valves from an animal study showing less calcium build-up in the valve with RESILIA tissue compared to the valve with regular tissue.1

Expandable Valve Frame

The INSPIRIS valve comes with VFit technology that provides the first-of-its-kind expandable frame specifically designed for potential future TAVR valve-in-valve procedures.^

^This device is not approved by the FDA to have another valve placed inside it. This approach has not been studied in a clinical trial.

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Additionally, the INSPIRIS valve typically will not require you to take blood thinners for the long-term – unless you have other risk factors or medical conditions that would require it. Your doctors will work with you to decide if the INSPIRIS valve is right for you.

Encouraging INSPIRIS RESILIA valve results for patients

Dr. Svensson, the Co-Principal Investigator for the COMMENCE trial that evaluated the RESILIA tissue technology had this to say about the INSPIRIS RESILIA valve results*. “Almost 700 patients were enrolled in the FDA trial, known as the COMMENCE aortic trial, which supported the approval of the INSPIRIS valve,” Dr. Svensson stated. “There have been no structural failures of the study valve during the trial out to 3 years which we reported at the recent American Association for Thoracic Surgery Conference, and hence we did not have any re-operations due to structural valve failures. This is obviously an encouraging result for a breakthrough technology.”

Doctor and patient

Reference:

*RESILIA tissue tested against commercially-available bovine pericardial tissue from Edwards in a juvenile sheep model.

Download Patient Brochure

For more information about the INSPIRIS RESILIA aortic valve please download our patient brochure

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Find an INSPIRIS valve surgeon

Use our interactive tool to assist you in finding a facility or surgeon that can evaluate you for all your treatment options, including the INSPIRIS RESILIA aortic valve. You can search for hospitals which use the INSPIRIS valve by zip code, city/state, or by hospital name. Once you find a hospital, you may click on the provider to view listing details.

    Important Risk Information: INSPIRIS RESILIA Aortic Valve keyboard_arrow_up

    INSPIRIS RESILIA Aortic Valve Indications: For use in replacement of native or prosthetic aortic heart valves.

    Contraindications (Who should not use): There are no known contraindications with the use of the INSPIRIS RESILIA aortic valve.

    Complications and Side Effects: The risks with the INSPIRIS RESILIA aortic valve are similar to risks with other heart valves, and include the following:

    • Heart failure
    • Leaking from the valve or areas around the valve
    • Improper opening and closing of the valve
    • Damage to red blood cells that can result in low red blood cell count
    • Heart lining inflammation
    • Heart infection
    • Abnormal bleeding or bleeding problems from using blood thinners
    • Clots from around the valve or other areas of the heart entering the bloodstream and blocking blood flow
    • Heart attack
    • Heart rhythm problems that may lead to the need for implanting a permanent pacemaker, a device that helps your heart beat in regular rhythm

    These could lead to the need for reoperation to replace the valve, permanent disability, or death. This is not a complete list of all the risks that can occur with heart valve surgery. Your doctor can give you more information about these and other risks. This information is not a substitute for talking with your doctor.

    Warning: This device is not approved by the FDA to have another valve placed inside it. This approach has not been studied in a clinical trial.

    CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.