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EDWARDS LIFESCIENCES PRIVACY STATEMENT

(Effective April 15, 2017 – United States)

Edwards Lifesciences Corporation, Edwards Lifesciences LLC, and their affiliated companies (collectively “Edwards Lifesciences,” “our,” or “we”) recognize the importance of online privacy and are committed to protecting the privacy and privacy choices of our online visitors and others whose Personal Information we receive. This Privacy Statement describes our policies and practices on the collection, use, and storage of information on “www.edwards.com” or any website owned, operated or controlled by us (“Sites”), and also applies to Personal Information which we obtain and process other than through the Sites (for example, personal information about our customers, end-users, vendors or service providers in the course of doing business).

Please note that our websites might offer links to other websites that are owned or controlled by third parties. This Privacy Statement applies only to Edwards Lifesciences’ Sites. We do not control or endorse the content of any third-party sites and cannot accept responsibility for the privacy practices of any websites not controlled by us. You will be notified when a link takes you to a site that is not owned or controlled by Edwards Lifesciences, and we encourage you to review the privacy policies of any third-party sites.

Click on any of the links below to visit the specific area of this Privacy Statement, or continue scrolling down to read this Privacy Statement in its entirety.

Information We Collect on Our Sites
Information Provided to us Outside the Sites
How We Use the Information We Collect
Disclosure of Information to Third Parties
Your Privacy Choices
Children’s Privacy
Our Commitment to Data Security and Protection
If You Have Concerns about Your Personal Information
Changes to Our Privacy Statement

INFORMATION WE COLLECT ON OUR SITES

We have designed our Sites so that visitors can navigate and view Site content without providing any personal information to us. This section describes information that visitors might choose to provide, as well as our practices for the automatic collection and use of non-personal information such as an IP address and a visitor’s navigation through the Sites.

Consent to Processing in the U.S. and Elsewhere

Although this Site content is intended for a U.S. audience, any information that you provide or we collect, will be available to Edwards Lifesciences affiliates and vendors around the world. This means that your information may be transmitted to a country other than your country of residence for processing or storage, and it may also be communicated to third parties hired by us to provide services such as website hosting, database management, or analytics. We have taken measures to ensure your personal information remains protected to the standards described in this policy, wherever it is processed. Your use of the Sites means you consent to these transfers.

Information You Provide

Through your use of the Sites, you may choose to provide us with personal information that identifies you or your family members. Personal information includes a person’s name, postal or email address, phone number, Social Security Number, information about your health or medical condition, or any other information that would allow Edwards Lifesciences to identify or contact you. For example, a patient who has received one of Edwards Lifesciences’ products may choose to share his or her experiences with us. A person seeking employment may choose to apply for a job online or request additional information about job opportunities. A health care professional might ask that we send information about one or more of our products, or report information about a specific patient. A charitable organization might request a donation.

In addition, some aspects of our Sites may be restricted to use only by licensed health care professionals, and access to those portions of the Sites may require personal information to facilitate registration and verification.

In these instances, in order to fulfill your request, we may ask for personal information such as your name, postal or email address, phone number, and perhaps a medical license number or other information to verify eligibility to view certain restricted content or to allow you to register for an event. In limited circumstances, such as an adverse event with one of our products, we may also be required to obtain personal information about your medical condition to enable required reporting to government regulatory agencies. Health care professionals should ensure that they have obtained their patient’s consent (where required) before submitting personal or medical information about their patients.

Information We Collect Automatically

In order to improve the online experience, we routinely collect certain non-personal information about our visitors and their use of our Sites. For example, we record the IP address of each computer/device that logs onto our Sites. This IP address does not identify you personally, but it does allow us to maintain communication with your computer/device during your visit. It also allows us to identify the country you are visiting from, so that we may direct you automatically to the content that is appropriate for your country.

We also use “cookies,” which are small text files that are placed on your computer/device. Cookies allow us to identify your navigation of the Sites and any specific pages or information that you visit. Cookies also allow us to identify your computer/device the next time you visit so that we can bring you to information on the Sites that may be of particular interest. For aspects of the Sites that require registration, cookies allow us to remember your login information. In addition, we hire third parties to provide services for us, and these third parties may also place cookies on your computer.

Your Web browser allows you to disable these “cookies,” although you should be aware that some aspects of the Sites may not work efficiently without cookies.

We may also place advertisements on third parties’ websites. These third parties may track website usage information, as well as information on “click throughs” from an advertisement to our Sites. This helps us understand the effectiveness of our advertising. This information is not personally identifiable.

INFORMATION PROVIDED TO US OUTSIDE THE SITES

We recognize that we might receive Personal Information in ways other than through our websites. We collect information about our customers and potential customers for the purposes of providing our products and services – such as contact information, financial/billing information, and any other information that is provided to us during the course of doing business. For example, many physicians notify us when a specific valve has been implanted, so that we can maintain a database of the patient that received a valve with a specific serial number. Physicians also notify us of complaints or adverse events with our products, and may inadvertently include information about the patient’s health. Job applicants may submit paper applications. We maintain records of purchases by our physician customers and their attendance at educational and other events we host.

We also collect information from our vendors, suppliers, consultants, professional advisors and other third parties for the purposes of managing and operating our business. For example, we will collect business contact information, financial information and other information necessary to engage our suppliers and other business partners and to evaluate their performance.

Personal Information is given the same protection by us, whether we receive it through a website or by other means. The descriptions below apply to Personal Information collected or received by us, no matter how the information was received.

HOW WE USE THE INFORMATION WE COLLECT

If you choose to provide personal information to us, we will use that information for a range of purposes:

  • To respond to your specific inquiry or request, and to provide you with information and access to resources that you have requested from us.
  • To provide, operate and maintain the Sites;
  • To improve the navigation and content of our Sites, system administration and security;
  • To process and complete transactions;
  • To manage our customer relationships, including to respond to inquiries and comments and providing customer service and support;
  • To provide our products and services;
  • To carry out research and development to improve our products and services;
  • To assess financial, credit or insurance risks arising from any relationship or prospective relationship with a customer, supplier, distributor or business partner;
  • To carry out other legitimate business purposes, and other purposes about which we will notify our users and customers.

We will also give you an opportunity to tell us whether we may use your personal information to send you other information about Edwards Lifesciences’ products, activities, or opportunities. If at any time you wish to “unsubscribe” from these communications, you may do so by completing this form. Edwards Lifesciences does not sell or otherwise provide personal information to third parties for the third parties’ marketing purposes.

We may use the device-related and analytics information we and our partners collect (about your computer’s/device’s IP address and through the use of cookies) during your future visits. This information allows us to direct you to specific content on the Sites that may be of interest and to remember your computer/device the next time you visit. If you visit multiple Edwards Lifesciences Sites, we may aggregate the information from your visits to better understand usage of our Sites.

We may also aggregate this device-related and analytics information we collect, which helps us to improve our Sites by monitoring interest in the various Site content and understanding how our visitors navigate the Sites. This information may also help us diagnose any problems with our Sites.

If you choose to provide personal information to us, we may combine that information with the non-personal information collected through IP address recognition and cookies, to help us understand your specific interests and to deliver pertinent information to you.

DISCLOSURE OF INFORMATION TO THIRD PARTIES

Edwards Lifesciences does not routinely disclose to third parties the information collected from our Sites. We do have third parties that perform services for us, and those third parties have agreed to maintain the privacy and security of any personal information they receive from us. In addition, we may request your consent to share your personal information with a third party.

If a third party buys any of our group members or their assets, we may disclose information to that third party in connection with the sale. We will make clear to the third party that it may only use personal information it receives from us for the purposes for which it was originally intended.

In some instances, we may be required by law, subpoena, or court order to disclose information. For example, if you use a Site to report an adverse product experience, we may be required to report that information to the U.S. Food and Drug Administration (FDA) or to similar regulatory agencies in other countries.

YOUR PRIVACY CHOICES

In your use of the Sites, you will be given opportunities to make choices about the data we receive and how we use it.

Do Not Track Signals/Online Tracking. Some Web browsers may be set to send a “Do Not Track” (DNT) signal to the websites you visit. This signal instructs the website to not collect information about your activities across different websites. We currently do not respond to DNT signals.

However, Edwards Lifesciences does not track your activities on any third-party websites or applications (except for monitoring of your interaction with any of our advertisements on third-party sites), and we do not select content based on your activities on third party sites or applications. However, if you visit more than one Edwards Site, we do track your activities on all Edwards-run websites, so that we can improve your overall experience with Edwards.

Receive information about Edwards. If you provide personal information to us, you may be asked whether you wish to “opt in” to future communications. If you choose to “opt in,” we may from time to time send you information about products or services. Even if you permit Edwards to send you additional information, you may change your mind at any time by completing this form or by following the instructions in any email communication we send you.

Cookies. As noted, your Web browser settings allow you to reject all cookies. Please be aware that the Site functions may not work well if you choose to do so.

Correcting or Changing Your Personal Information. If you wish to update or correct the personal information you have previously given us, please complete this form.

Removing Your Personal Information. You may request that Edwards Lifesciences delete your personal information by completing this form. Edwards Lifesciences will use commercially reasonable efforts to identify and delete your personal information, unless we are prohibited by law from doing so. Please be aware that, because information may be stored in multiple locations, it may not always be possible to identify every location where your information is stored, and in some instances it may appear in a non-erasable format.

CHILDREN’S PRIVACY

Edwards Lifesciences does not intend to collect personal information from children under age 13, without consent from the child’s parent or legal guardian. We do not share personal information of anyone under 13 years of age with anyone outside of Edwards (except where required by law, and to our agents who have committed to maintain data privacy).

Children under 13 years of age should not submit any personal information to us without the express permission of their parent or legal guardian. If you believe that your child has submitted personal information and you would like to request that their information be removed from our systems, please complete this form. We will make reasonable efforts to comply with your request.

OUR COMMITMENT TO DATA SECURITY AND PROTECTION

Edwards Lifesciences understands that the security of your personal information is of the utmost importance, and we work to maintain your trust. We use industry-standard technologies to protect the security of the information that we collect and that which you provide to us.

We also comply with the U.S.-EU and Swiss-US Privacy Shield Frameworks, as set forth by the U.S. Department of Commerce, regarding the collection, use, and retention of personal information from European Union member countries (including the United Kingdom) and from Switzerland, respectively. To learn more about the Privacy Shield, please visit https://www.privacyshield.gov.

If you have any questions or concerns regarding our Privacy Shield certifications, you can contact us using the contact information below and we will attempt to resolve your question or concern. We will also cooperate and comply with any investigation, decision or advice made or given by competent EU or Swiss data protection authorities regarding personal information we receive pursuant to the Privacy Shield.

Despite these reasonable efforts to safeguard personal information from loss, theft, alteration, or other types of misuse, we cannot guarantee that such loss will never occur. There is always a risk that a third party, without our authorization, might unlawfully access our systems or otherwise access personal information.

IF YOU HAVE CONCERNS ABOUT YOUR PERSONAL INFORMATION

If you have any questions about this Privacy Statement or about your personal information, you may contact us through this form or at the below address:

Privacy Office
Edwards Lifesciences
One Edwards Way
Irvine, California 92614
Email: privacy@edwards.com

If you wish to receive a response by email, please be sure to include your name, postal address, and email address. If we do not receive an email address, we will respond by postal mail.

CHANGES TO OUR PRIVACY STATEMENT

From time to time, we may revise our Privacy Statement. When we do so, the changes will be prominently posted on this section of our Sites, along with the date the changes were made.

Our intention is to use personal information in accordance with the Privacy Statement in place at the time the information was collected. If we change the way in which we use or share personal information, you will be given an opportunity to choose whether to allow us to use your information in those new or different ways.

Revised April 15, 2017, to replace references to the Swiss-US Safe Harbor Program with references to the Swiss-US Privacy Shield Framework.

Important Risk Information

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.