Talking With Your Doctor

At Edwards Lifesciences, we design valve technology with your freedom in mind.

Through decades of research and development, we have continued to revolutionize our transcatheter aortic valve replacement (TAVR) technology to improve the lives and futures of people with SAS.

TAVR is now available to more patients with SAS. However, not all TAVR valves are created equal. With each refinement, Edwards valves were designed with your needs in mind.

Ask your doctor today about getting an Edwards valve.

Edwards TAVR Valves, the Most Widely Used Transcatheter Heart Valves

Edwards is the leader in transcatheter heart valve technology. Our TAVR valves (also known as the SAPIEN family of valves) have treated more than 626,000 patients in over 70 countries around the world—making it the most widely used heart valve to date.

At Edwards, we continue to optimize our valves to support better patient outcomes, so that patients can get back to the lives they love.

TAVR Procedure Animation

Watch this animation to learn more about Edwards TAVR valves and then ask your doctor for a TAVR evaluation.

Watch the TAVR Procedure Animation

Valve Features That Matter to You

The type of TAVR valve you receive can impact your heart and future.

Throughout the evolution of our SAPIEN platform, Edwards has strategically approached our valve designs with our patients in mind. We create features that differentiate our TAVR valves from the rest.

Make sure to ask your doctor about which valve is best for you.

Designed Like Your Heart

Edwards’ transcatheter heart valves are designed to work like your native heart valve. The Edwards TAVR valves are made of the same bovine pericardial tissue (from a cow’s heart) as Edwards’ leading surgical valves. Because the Edwards TAVR valves are expanded into place with the help of a balloon, they begin working immediately when implanted.

Designed for Stability

At Edwards, we have engineered unique features that set our valves apart. The valve frame is made from cobalt chromium for strength and durability. An outer sealing skirt surrounds the bottom of the valve to help stop any possible leakage around the valve. This matters when it comes to future clinical outcomes and your ability to get back to life sooner.

Designed for Your Unique Needs

We recognize the unique needs of our patients. That is why the Edwards TAVR valves are available in 4 different sizes to accommodate a variety of anatomical differences.

Designed for Your Future

Our Edwards TAVR valves were created with your future in mind. Whether your TAVR Heart Team requires future coronary access, or you require another procedure to fix your failing heart valve through the valve-in-valve procedure, our Edwards valves have you covered.

As with any medical procedure, there is a possibility of risks. The most serious risk of TAVR include death, stroke, serious damage to the arteries, or serious bleeding.

Don’t settle for just any TAVR valve. Make sure you understand your options. Use our Informed Discussion Guide to help facilitate a discussion with your doctor about which valve is right for you.

TAVR Valves Built on Decades of Success

Edwards continues to build upon its best-in-class design and technology for each of its successive valves. With each generation of Edwards valves comes better patient outcomes and clinical benefits when compared to surgical valves.

Explore our Edwards TAVR valves, which have lower rates of serious complications when compared to surgical valves.

FDA Approved 2011

Edwards SAPIEN Transcatheter Heart Valve

The Edwards SAPIEN transcatheter heart valve was the first TAVR valve of its kind to get FDA approval in the United States.

The Edwards SAPIEN 3 TAVR valve gave patients who were too sick to undergo open heart surgery an alternative treatment for severe aortic stenosis. As Edward’s first transcatheter heart valve, and the first of its kind approved in the United States, the Edwards SAPIEN 3 TAVR valve represented a major achievement in the treatment of severe aortic stenosis.

FDA Approved 2014

Edwards SAPIEN XT Transcatheter Heart Valve

Building on the success and innovation of the Edwards SAPIEN valve, the updated design of the Edwards SAPIEN XT allowed for TAVR to be used in more patients.

The Edwards SAPIEN XT valve was FDA approved to treat severe aortic stenosis patients who were experiencing symptoms and considered to be high-risk or inoperable for open heart surgery.

FDA Approved 2015

Edwards SAPIEN 3 Transcatheter Heart Valve

Considered best in class because of its better clinical outcomes, the Edwards SAPIEN 3 transcatheter valve became available to more patients, including those who were considered low risk for open heart surgery.

The Edwards SAPIEN 3 continued to advance heart valve technology, providing additional access routes and more valve sizes to meet patients’ needs. The Edwards SAPIEN 3 TAVR continued to show success in clinical data by achieving 1% death and stroke rate for those patients who are considered low-risk, which provided patients with better clinical outcomes than open heart surgery.1

FDA Approved 2018

Edwards SAPIEN 3 ULTRA Transcatheter Heart Valve

Built upon the proven SAPIEN platform, the Edwards SAPIEN 3 Ultra transcatheter heart valve was designed with patient’s future needs in mind.

Edwards’ commitment to best-in-class technology continues with the SAPIEN 3 Ultra valve. Built upon the proven SAPIEN platform, the SAPIEN 3 Ultra transcatheter heart valve was designed with patients’ future needs in mind. Its low frame height and large cell design easily facilitates future coronary access if a patient requires a procedure post-TAVR. It continues to provide alternative options for patients other than open heart surgery.

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  • 2014
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  • 2018

Next Page: Know the Clinical Difference

Learn about the benefits of Edwards valves and what that means for getting back to the life you love.

Go to the Clinical Difference Page

Reference

1. PARTNER 3 trial, low-risk cohort unadjusted clinical event rates, AT population.

Important Risk Information

Edwards SAPIEN 3 THV System and Edwards SAPIEN 3 Ultra THV System

Indications:

The Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve 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 appropriate for the transcatheter heart valve replacement therapy.

The Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve system is indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve or surgical bioprosthetic mitral valve who are judged by a heart team, including a cardiac surgeon, to be at 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 co-morbidities unmeasured by the STS risk calculator).

Contraindications (Who should not use):

The Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System should not be used in patients who:

  • Cannot tolerate medications that thin the blood or prevent blood clots from forming.
  • Have an active infection in the heart or elsewhere.

Warnings:

  • There may be an increased risk of stroke in transcatheter aortic valve replacement procedures, compared to other standard treatments for aortic stenosis in the high or greater risk population.
  • If an incorrect valve size for your anatomy is used, it may lead to heart injury, valve leakage, movement, or dislodgement.
  • Patients should talk to their doctor if they have significant heart disease, a mitral valve device or are sensitive to cobalt, nickel, chromium, molybdenum, titanium, manganese, silicon, and/or polymeric materials.
  • The Edwards SAPIEN 3 Ultra and SAPIEN 3 valves may not last as long in younger patients, or patients with a disease that results in more calcium in their blood.
  • During the procedure, your doctors should monitor the dye used in the body; if used in excess it could lead to kidney damage. X-ray guidance used during the procedure may cause injury to the skin, which may be painful, damaging, and long-lasting.
  • Patient’s creatinine level should be measured prior to the procedure.
  • Patients who have already had a valve replaced should be carefully assessed by their physician prior to receiving a new valve to ensure proper placement of the new valve.
  • Injury can occur if the delivery system is not used properly.
  • Transcatheter heart valve patients should talk to their physicians about the potential need for medications that thin the blood or prevent blood clots from forming.

Precautions:

The long-term durability of the Edwards SAPIEN 3 Ultra and SAPIEN 3 transcatheter heart valves are not known at this time. Regular medical follow-up is recommended to evaluate how well a patient’s heart valve is performing. Limited clinical data are available for transcatheter aortic valve replacement in patients who are born with an aortic heart valve that has only two leaflets and who are determined to be at low risk for open heart surgery. Long-term durability of the valve has not been established.

The safety and effectiveness of the transcatheter heart valves are also not known for patients who have:

  • An aortic heart valve that is not calcified, contains only one leaflet, has leaflets with large pieces of calcium that may block the vessels that supply blood to the heart or in which the main problem is that the valve leaks.
  • Previous prosthetic ring in any position.
  • Previous atrial septal occlude.
  • A heart that does not pump well, has thickening of the heart muscle, with or without blockage, unusual ultrasound images of the heart that could represent irregularities such as a blood clot, a diseased mitral valve that is calcified or leaking, or Gorlin syndrome, a condition that affects many areas of the body and increases the risk of developing various cancers and tumors.
  • Low white, red or platelet blood cell counts, or history of bleeding because the blood does not clot properly.
  • Diseased, abnormal or irregularly shaped vessels leading to the heart. Vessels which are heavily diseased or too small for associated delivery devices, or a large amount of calcification at the point of entry.
  • Allergies to blood-thinning medications or dye injected during the procedure.
  • For a valve in valve procedure, there is a risk of leakage if the previously implanted tissue valve is not securely in place or if it is damaged. There is also the possibility that a partially detached valve leaflet from the previously implanted valve could block a blood vessel.
  • Additional pre-procedure imaging will be completed to evaluate proper sizing.

Potential risks associated with the procedure include:

  • Death, stroke, paralysis (loss of muscle function), permanent disability, or severe bleeding.
  • Risks to the heart, including heart attack or heart failure, a heart that does not pump well, irregular heartbeat that may result in a need for a permanent pacemaker, chest pain, heart murmur, false aneurysm, recurring aortic stenosis (narrowing), too much fluid around the heart, injury to the structure of the heart.
  • Risks to your lungs or breathing, including difficulty breathing, fainting, buildup of fluid in or around the lungs, weakness or inability to exercise.
  • Risks involving bleeding or your blood supply, including formation of a blood clot, high or low blood pressure, limited blood supply, a decrease in red blood cells, or abnormal lab values, bleeding in the abdominal cavity, collection of blood under the skin.
  • Additional risks, including life-threatening infection, dislodgement of calcified material, air embolism (air bubbles in the blood vessels), poor kidney function or failure, nerve injury, fever, allergic reaction to anesthesia or dye, reoperation, pain, infection or bleeding at incision sites, or swelling.

Additional potential risks specifically associated with the use of the heart valves include:

  • Valve movement after deployment, blockage or disruption of blood flow through the heart, need for additional heart surgery and possible removal of the Edwards SAPIEN 3 Ultra and SAPIEN 3 valves, a blood clot that requires treatment, damage to the valve (e.g., wear, breakage, recurring aortic stenosis), nonstructural valve dysfunction (e.g., leakage, inappropriate sizing or positioning, blockage, excess tissue in growth, blood cell damage, etc.) or mechanical failure of the delivery system and/or accessories.

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