Stop? I’m just getting started

Don't let another day go by without looking into TAVR (Transcatheter Aortic Valve Replacement) for your severe aortic stenosis. The longer you wait to get treated, the harder it is to go back to the things you love to do.

Get Your Free TAVR Info Kit Now!

Get Your Free TAVR Info Kit Now!

Education on severe aortic stenosis
Information on TAVR as a treatment option
Videos of patients sharing their experiences with TAVR
Discussion guide for talking with your doctor
List of hospitals in your area that perform TAVR

The benefits of TAVR may include:

Better clinical outcomes

Less invasive with minimal scarring

Shorter hospital stay

Faster  recovery time to getting back to everyday activities

Less pain and anxiety

Improved quality of life and relief of symptoms

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

Ready for your Second Act?

See if TAVR is right for you. Get your free info kit today.

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:

 















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:
















Potential risks associated with the procedure include:













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







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

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.

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.

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.

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.




































Privacy Policy | Legal Terms | Join Email List | Do not sell my information

© 2021 Edwards Lifesciences Corporation. All Rights Reserved.

In this free info kit, you’ll get:

Education on severe aortic
stenosis

Information on TAVR as a
treatment option

Videos of patients sharing their experiences with TAVR

Discussion guide for talking
with your doctor

List of hospitals in your area
that perform TAVR

Ready for your Second Act?

Important Risk Information ⌵

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

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.

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.

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.

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.

Privacy Policy | Legal Terms | Join Email List | Do not sell my information

© 2021 Edwards Lifesciences Corporation. All Rights Reserved.


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:








Warnings:









































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:















































Potential risks associated with the procedure include:


































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


















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

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






































































































Order Free Info Kit >

In this free info kit, you’ll get:

See how Andy and Belle learned more about TAVR so they could get back to their lives sooner.

Andy, who is struggling to play a round of golf, learns about TAVR for his severe aortic stenosis

Belle learns about TAVR from an old friend who also had severe aortic stenosis

TAVR vs. Open Heart Surgery

With TAVR, you don’t need to have your chest opened. This less invasive option can result in a shorter hospital stay and faster recovery. This treatment is available to patients living with severe aortic stenosis.

Frequently Asked Questions

TAVR (also known as transcatheter aortic valve implantation or TAVI for short) is a less invasive procedure for replacing a diseased aortic valve. During the procedure, your TAVR Doctor will use a catheter to implant a new valve within your diseased valve. TAVR can be performed through multiple approaches; however, the most common is through a small incision in the leg. TAVR procedures can be performed under conscious sedation, rather than general anesthesia.
No, unlike open heart surgery, TAVR does not require stopping the heart.
With the less invasive TAVR procedure, people may return to daily activities sooner than with open heart
surgery. People who undergo TAVR report improved quality of life following the procedure. Other TAVR benefits include:shorter hospital stay (most people go home the next day), relief of symptoms, improved heart function, and reduced pain and anxiety*.
*PARTNER 3 trial, low-risk cohort unadjusted clinical event rates, AT population.
Depending on your health and the procedural approach recommended by your doctor, the average TAVR procedure lasts approximately 1 hour. In comparison, the average open heart surgery lasts approximately 4 hours*. *PARTNER 3 trial, low-risk cohort unadjusted clinical event rates, AT population.
As with any medical procedure, there is a possibility of risks. The most serious risks of TAVR include death, stroke, serious damage to the arteries, or serious bleeding. Talk to your doctor about your risks and benefits with TAVR.

Frequently Asked Questions

With TAVR, you don’t need to have
your chest opened. This less invasive option can result in a shorter hospital stay and faster recovery. This
treatment is available to patients living with severe aortic stenosis.

TAVR (also known as transcatheter aortic valve implantation or TAVI for short) is a less invasive procedure for replacing a diseased aortic valve. During the procedure, your TAVR Doctor will use a catheter to implant a new valve within your diseased valve. TAVR can be performed through multiple approaches; however, the most common is through a small incision in the leg. TAVR procedures can be performed under conscious sedation, rather than general anesthesia.
TAVR can be performed in different ways depending on each individual’s anatomy. Some approaches include:
- The transfemoral approach is the most common approach and is through an incision in the leg.
- The subclavian approach is through an incision near the shoulder.
- The transapical approach is through an incision in the chest between the ribs.
- The transaortic approach is through an incision in the upper chest.
No, unlike open heart surgery, TAVR does not require stopping the heart.
With the less invasive TAVR procedure, people may return to daily activities sooner than with open heart surgery. People who undergo TAVR report improved quality of life following the procedure. Other TAVR benefits include: shorter hospital stay, relief of symptoms, improved heart function, and reduced pain and anxiety*. *PARTNER 3 trial, low-risk cohort unadjusted clinical event rates, AT population.
Depending on your health and the procedural approach recommended by your doctor, the average TAVR procedure lasts approximately 1 hour. In comparison, the average open heart surgery lasts approximately 4 hours*. *PARTNER 3 trial, low-risk cohort unadjusted clinical event rates, AT population.