Find a TAVR Center
Free Info Kit
Doctor Discussion Guide

Share with friends

Close

Privacy Policy

We may modify this privacy policy at any time. If we alter our privacy policy, any changes will be posted on this web page so that you are always informed of the information we collect about you, how we use it and the circumstances under which we may disclose it. Please check back from time to time to ensure you are aware of our current privacy policy.

At Edwards Lifesciences Corporation, we are committed to protecting the privacy of our customers and the users of "NewHeartValve.com" or any website owned, operated, licensed or controlled by us ("Sites"). This Privacy Policy Statement sets out our policy on the gathering and use of information on our Sites.

Please note that although there may be links from our Sites to other websites, this Privacy Policy applies only to our Sites and not to websites of other companies or organizations to which our Sites are linked. Edwards Lifesciences does not control or endorse the content of third party websites or otherwise accept responsibility for the content or privacy policies of those sites.

Although registration is generally not required to access our Sites, you may be asked to provide us with personal information or register when you visit certain sections of our Sites or participate in certain events sponsored by us.

How does Edwards Lifesciences use information gathered about its on-line visitors?

Any consumer information gathered on our Sites may be used for aggregate research, promotional purposes, future improvement of our Sites and to better meet your needs. In particular we may use information gathered about you for the following purposes: to send to you or, where appropriate, your organization, information about us and promotional material about our products together with details of any offers we may have available from time to time; to monitor interest in our products and to assist us to tailor the content of our Sites to your needs by collecting information about your preferences through tracking patterns of page views on this site; and to create a profile relating to you in order to show you the content that might be of interest to you and to display the content according to your preferences. We may use your Internet Protocol (IP) address to help diagnose problems with our server, to administer our Sites as well as to gather broad demographic information.

If you do not want to receive email or other consumer communications from us, please let us know by filling out this form.

Disclosure of Information

Edwards Lifesciences will not disclose personal identifiable information that you provide on this Site to any third parties other than to an Edwards Lifesciences agent, except: i) in accordance with the terms of this privacy policy statement, ii) when we have your permission, or iii) to comply with valid legal requirements such as law, regulation, warrant, subpoena or court order.

Cookies

Edwards Lifesciences, in common with many website operators, may use standard technology called "cookies" on our Sites. Cookies are small data files that are downloaded onto your computer when you visit a particular website. We use cookies to store visitor preferences; record session information, such as items that consumers add to their shopping cart; record user-specific information on what pages users access; alert visitors to new areas that we think would be of interest to them; record past activity at a site in order to provide better and more personalized service when visitors return to our site; ensure that visitors are not repeatedly sent the same banner ads; customize web content on visitors' browser type or other information that visitor sends.

You can disable cookies by turning them off in your browser, however, some areas of our Sites may not function properly if you do so.

Policies for On-line Visitors Under 13 Years of Age

Edwards Lifesciences does not intend to collect personal information from children under age 13 without permission of the child's parent or legal guardian. Also, we do not provide any personal information to any third party (other than Edwards Lifesciences agents) about our on-line visitors who indicate they are under 13 years of age.

On-line visitors under 13 years of age should not submit personal information to us without the explicit permission from their parent or legal guardian. If your child has submitted personal information and you would like to request that such information be removed from our system, please fill out this form and we will use reasonable efforts to comply with your request.

Security

Our Sites incorporate safeguards using industry standard technology to heighten the security, accuracy and privacy of any personal information we have collected, and we have put in place reasonable precautions to protect information from loss and misuse. Our security and privacy policies are periodically reviewed and enhanced as may be appropriate.

Edwards Lifesciences complies with the U.S.-EU Safe Harbor Framework and the U.S.-Swiss Safe Harbor Framework as set forth by the U.S. Department of Commerce regarding the collection, use, and retention of personal information from European Union member countries and Switzerland. Edwards Lifesciences has certified that it adheres to the Safe Harbor Privacy Principles of notice, choice, onward transfer, security, data integrity, access, and enforcement. To learn more about the Safe Harbor program, and to view the company’s certification, please visit http://www.export.gov/safeharbor/

Policy Change

We may modify this privacy policy at any time. If we alter our privacy policy, any changes will be posted on this web page so that you are always informed of the information we collect about you, how we use it and the circumstances under which we may disclose it. Please check back from time to time to ensure you are aware of our current privacy policy.

Important Risk Information

Indications: The Edwards SAPIEN 3 transcatheter heart valve (THV), model 9600TFX, and accessories are indicated for relief of aortic stenosis in patients with symptomatic heart disease...

  • Important Risk Information for Patients

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    Indications: The Edwards SAPIEN 3 transcatheter heart valve, model 9600TFX, and accessories are 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 at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 3% 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 and delivery 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 allergic to chromium, nickel, molybdenum, manganese, copper, silicon, and/or polymeric materials.
    • The SAPIEN 3 valve may not last as long in patients whose bodies do not process calcium normally.
    • 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.
    • Transcatheter aortic heart valve patients should take medications that thin the blood or prevent blood clots from forming, except when likely to have an adverse reaction, as determined by their physician. The Edwards SAPIEN 3 transcatheter heart valve has not been tested for use without medications that thin the blood or prevent blood clots from forming.

    Precautions: The long-term durability of the Edwards SAPIEN 3 transcatheter heart valve is not known, at this time. Regular medical follow-up is recommended to evaluate how well a patient’s heart valve is performing. For patients who have previously had aortic valve replacement, the safety, effectiveness, and durability of putting a transcatheter valve in an already implanted artificial valve are not known at this time.

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

    • An aortic heart valve that is not calcified, contains only one or two leaflets, 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 heart valve replacement or repair
    • 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 or irregularly shaped vessels leading to the heart. Vessels in the legs which are heavily diseased or too small for associated delivery devices, or a large amount of calcification at the point of entry to the heart
    • Allergies to blood-thinning medications or dye injected during the procedure

    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
    • 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 valve include:

    • Valve movement after deployment, blockage or disruption of blood flow through the heart, need for additional heart surgery and possible removal of the SAPIEN 3 valve, 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
  • EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    Indications: The Edwards SAPIEN XT transcatheter heart valve, model 9300TFX, and accessories are 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 at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 3% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

    The Edwards SAPIEN XT transcatheter heart valve and accessories are also indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic 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., STS operative risk score ≥8% or at a ≥15% risk of mortality at 30 days).

    Contraindications (Who should not use): The Edwards SAPIEN XT transcatheter heart valve and delivery systems 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 is a higher risk of stroke in transcatheter aortic valve replacement procedures, compared to balloon aortic valvuloplasty and other standard treatments for aortic stenosis in the high or greater risk population.
    • Implanting a valve that is too small may cause blood leakage and valve movement. Implanting a valve that is too large can cause a buildup of pressure in the valve or a rupture of blood vessels in or around your heart. Your Heart Team will do tests to determine the best valve size for you.
    • The SAPIEN XT valve may not last as long in patients whose bodies do not process calcium normally.
    • Patients should talk to their doctor if they have significant heart disease, a mitral valve device or are allergic to chromium, nickel, molybdenum, manganese, copper, silicon, and/or polymeric materials.
    • 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.
    • Transcatheter aortic heart valve patients should take medications that thin the blood or prevent blood clots from forming, except when likely to have an adverse reaction, as determined by their physician. The Edwards SAPIEN XT transcatheter heart valve has not been tested for use without medications that thin the blood or prevent blood clots from forming.

    Precautions: The long-term durability of the Edwards SAPIEN XT transcatheter heart valve is not known, at this time. Regular medical follow-up is recommended to evaluate how well a patient’s heart valve is performing.

    The safety and effectiveness of implanting:

    • A transcatheter valve inside a transcatheter valve is not known
    • A transcatheter valve inside a surgical tissue valve is not known in the intermediate-risk population

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

    • An aortic heart valve that is not calcified, contains only one or two leaflets, 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 heart valve replacement or repair
    • 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 or irregularly shaped vessels leading to the heart. Vessels in the legs which are heavily diseased or too small for associated delivery devices, or a large amount of calcification at the point of entry to the heart, depending on delivery method
    • Allergies to blood-thinning medications or dye injected during the procedure

    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 pace maker, chest pain, heart murmur, false aneurysm, recurring aortic stenosis(narrowing), too much fluid around 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
    • 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. The safety and effectiveness of the transcatheter heart valve has not been determined when the valve is implanted:
      • Inside a stented previously implanted valve smaller than 21 mm
      • Inside an unstented previously implanted aortic tissue valve
    • Your Heart Team will do tests to determine the exact size of the new valve you should receive and communicate what to expect.

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

    • Valve movement after deployment, blockage or disruption of blood flow through the heart, sudden loss of heart function, heart failure, need for additional heart surgery and possible removal of the SAPIEN XT valve, 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 ingrowth, blood cell damage, etc.) or mechanical failure of the delivery system and/or accessories

    Be sure to ask your Heart Team to explain your treatment options and the possible benefits and risks of the procedure.

    CAUTION: Federal law (USA) restricts these devices to sale by or on the order of a physician. This information is not a substitute for talking with your doctor.

    Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN XT, Edwards SAPIEN 3, NewHeartValve.com, NewHeartValve.com design logo, SAPIEN, SAPIEN XT, and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

    © 2016 Edwards Lifesciences Corporation. All rights reserved.