Talking With Your Doctor

Understand why your first valve choice matters

If you have severe aortic stenosis and are experiencing symptoms, you now have even more choices when it comes to which transcatheter aortic valve replacement (TAVR) valve you receive. Understanding which TAVR valve you are receiving is very important, as not all TAVR valves are created equal.

SAPIEN 3 TAVR valves, the most widely used TAVR heart valves

By choosing one of the Edwards SAPIEN transcatheter heart valves, you are getting one of the most widely used TAVR valves around the world, having been implanted in over 763,000 patients around the world.*

Edwards TAVR has better outcomes than open heart surgery in low-risk patients at one year—and proven equally effective at 5 years.**

Edwards’ newest valve, the SAPIEN 3 Ultra RESILIA valve is a bovine (cow) heart tissue valve that has been treated with a special Edwards technology to block calcium build-up on the valve, potentially allowing the valve to last longer.†1

Both the SAPIEN 3 Ultra RESILIA valve and the leading surgical valves use RESILIA tissue, known to block calcium build-up on the tissue, which could potentially allow the valve to last longer.†1  Before today, the RESILIA tissue was only approved to be used on surgical heart valves.†1

The SAPIEN 3 Ultra RESILIA valve is the only TAVR valve with RESILIA tissue†1

 

The SAPIEN 3 Ultra RESILIA valve is the latest valve approved in the SAPIEN 3 TAVR family of valves

 

*Currently, does not include the SAPIEN 3 Ultra RESILIA valve.
**The PARTNER 3 Trial, SAPIEN 3 TAVR proven superior to surgery on the primary endpoint of all-cause death, all stroke, and re-hospitalization (valve-related or procedure-related and including heart failure) at one year, and multiple pre-specified secondary endpoints in low risk patients.

PARTNER 3 Trial 5-Year Results in low-risk patients – Low rates of cardiovascular mortality through five years (5.5% SAPIEN 3 TAVR to 5.1% SAVR). Low rates of all-cause mortality through five years (10.0% SAPIEN 3 TAVR vs. 8.2% with SAVR). Low rates of disabling stroke through five years (2.9% SAPIEN 3 TAVR to 2.7% SAVR). Low rates of stroke through five years (5.85% SAPIEN 3 TAVR vs. 6.4% SAVR). Lower rates of rehospitalization with SAPIEN 3 TAVR through five years (13.7% vs. 17.4%).
† RESILIA tissue has not been studied for long-term results in patients.
‡ Propensity matched analysis of intermediate risk patients using VARC3 definitions of SVD and SVD related BVF at 5 years.

Now is the time to ask for the SAPIEN 3 Ultra RESILIA valve when getting TAVR

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

Designed like your heart

  • The valves are designed to work like your native valve and begin working immediately once they are implanted.

Designed to last

  • The frame of the valves is made from cobalt chromium to help with strength and durability.
  • Edwards TAVR has better outcomes than open heart surgery in low-risk patients at one year—and proven equally effective at 5 years.***
  • An outer sealing skirt surrounds the bottom of the valve, to help stop any possible leakage around the valve.

Designed for your unique needs

  • SAPIEN 3 TAVR valves come in four unique sizes to provide a better fit for each individual patient.

Designed for your future

  • The SAPIEN 3 TAVR valves are designed purposely with a specific low frame height to facilitate future procedures, if needed.§
  • The SAPIEN 3 Ultra RESILIA valve is a bovine (cow) heart tissue that has been treated with special Edwards tehnology to block calcium build-up on the valve, potentially allowing the valve to last longer.†1
  • Up to 75% of patients who get TAVR also have coronary artery disease.3 By getting one of the SAPIEN 3 TAVR valves, your physician may have better access to your coronaries in the future, should you need another procedure, due to its unique shape and low frame height design.

Serious risks associated with the TAVR procedure, similar to those of open heart surgery, include death, stroke, serious damage to the arteries, or serious bleeding.

***The PARTNER 3 Trial, SAPIEN 3 TAVR proven superior to surgery on the primary endpoint of all-cause death, all stroke, and re-hospitalization (valve-related or procedure-related and including heart failure) at one year, and multiple pre-specified secondary endpoints in low risk patients.

PARTNER 3 Trial 5-Year Results in low-risk patients – Low rates of cardiovascular mortality through five years (5.5% SAPIEN 3 TAVR to 5.1% SAVR). Low rates of all-cause mortality through five years (10.0% SAPIEN 3 TAVR vs. 8.2% with SAVR). Low rates of disabling stroke through five years (2.9% SAPIEN 3 TAVR to 2.7% SAVR). Low rates of stroke through five years (5.85% SAPIEN 3 TAVR vs. 6.4% SAVR). Lower rates of rehospitalization with SAPIEN 3 TAVR through five years (13.7% vs. 17.4%).

Ask which TAVR valve you are getting today

Understand why your first transcatheter valve choice matters. Know the different types of valves available to you. Don’t settle for just any TAVR valve. Make sure you understand your options.

Edwards SAPIEN 3 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. New research confirms the short and long-term effectiveness of TAVR by Edwards, as compared to open heart surgery in low-risk patients. TAVR was proven superior at one year—and equally as effective at 5 years.**

FDA Approved 2022

Edwards SAPIEN 3 Ultra RESILIA transcatheter heart valve

The Edwards SAPIEN 3 Ultra RESILIA valve builds upon the best-in-class and proven SAPIEN valve platform, while also using the tissue from the leading Edwards surgical valves.

Edwards’ commitment to technology continues with the SAPIEN 3 Ultra RESILIA valve. Built using the proven SAPIEN 3 valve, the SAPIEN 3 Ultra RESILIA transcatheter heart valve is made with RESILIA tissue (previously only used on Edwards surgical valves) and designed to reduce calcium build up on the valve tissue, potentially allowing the valve to last longer.*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.

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 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 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.

expand_less expand_more
  • 2022
  • 2018
  • 2015
  • 2014
  • 2011

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

References

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.

2. Pibarot 2020 (S-13919) describes 5-yr PII S3i trial outcomes similar between S3 and SAVR, based on VARC3 definition.

*Currently, does not include the SAPIEN 3 Ultra RESILIA valve.
**The PARTNER 3 Trial, SAPIEN 3 TAVR proven superior to surgery on the primary endpoint of all-cause death, all stroke, and re-hospitalization (valve-related or procedure-related and including heart failure) at one year, and multiple pre-specified secondary endpoints in low risk patients.

PARTNER 3 Trial 5-Year Results in low-risk patients – Low rates of cardiovascular mortality through five years (5.5% SAPIEN 3 TAVR to 5.1% SAVR). Low rates of all-cause mortality through five years (10.0% SAPIEN 3 TAVR vs. 8.2% with SAVR). Low rates of disabling stroke through five years (2.9% SAPIEN 3 TAVR to 2.7% SAVR). Low rates of stroke through five years (5.85% SAPIEN 3 TAVR vs. 6.4% SAVR). Lower rates of rehospitalization with SAPIEN 3 TAVR through five years (13.7% vs. 17.4%).

†RESILIA tissue has not been studied for long-term results in patients.

§Indication for aortic THV-in-THV with demonstrated future coronary access (68/68 patients).

The PARTNER 3 Trial, SAPIEN 3 TAVR proven superior to surgery on the primary endpoint of all-cause death, all stroke, and re-hospitalization (valve-related or procedure-related and including heart failure) at one year, and multiple pre-specified secondary endpoints in low risk patients.

Important Risk Information

Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, and Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System

Indications:
The Edwards SAPIEN 3, SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA 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, SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA 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, a surgical bioprosthetic mitral valve, or a native mitral valve with an annuloplasty ring 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, Edwards SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA 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.
  • Have a mitral ring that is damaged and can no longer support the valve.

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 anesthesia, contrast media, cobalt, nickel, chromium, molybdenum, titanium, manganese, silicon, and/or plastics.
  • The Edwards SAPIEN 3 Ultra, SAPIEN 3 Ultra RESILIA 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. Patients who do not may be at increased risk of a stroke. Blood-thinning medication may increase the risk of bleeding in the brain (stroke).
  • Transcatheter valve replacement is not recommended in previous mitral valve rings that are damaged or have become too rigid.

Precautions:
The long-term durability of the Edwards SAPIEN 3 Ultra, SAPIEN 3 Ultra RESILIA 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. A patient’s anatomical characteristics should be considered by their physicians when using the valve in this patient population. In addition, patient age should be considered as long-term durability of the valve has not been established. Patients who need a dental procedure should talk to their doctor about risk of infection and needing antibiotics. Patients should be treated post-procedure for heart infection as a precaution.

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.
  • Who have a prosthetic ring in the tricuspid position.
  • 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 the delivery devices, or a large amount of calcification at the point of entry.
  • Allergies to blood-thinning medications or dye injected during the procedure.
  • Whose previously implanted artificial valve or ring is not securely in place or is damaged that could cause it to leak.
  • Whose previously implanted valve or ring could block a blood vessel caused from the leaflet partially detaching.

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, sudden loss of heart function, 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, dizziness, 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, serious damage to the arteries, severe bleeding in the heart or in the body that could require a transfusion or surgery.
  • 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 or emergency heart surgery and possible removal of the Edwards SAPIEN 3 Ultra, SAPIEN 3 Ultra RESILIA and SAPIEN 3 valves, a blood clot that requires treatment, damage to the valve (e.g., wear, breakage, recurring aortic stenosis), valve issues not related to structure (e.g., leakage, inappropriate sizing or positioning, blockage, excess tissue in growth, blood cell damage) 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.