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 Safety Information

EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE WITH THE EDWARDS COMMANDER DELIVERY SYSTEM

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: The valve and delivery systems are contraindicated in patients who cannot tolerate an anticoagulation/antiplatelet regimen or who have active bacterial endocarditis or other active infections.

Warnings: Observation of the pacing lead throughout the procedure is essential to avoid the potential risk of pacing lead perforation. There may be an increased risk of stroke in transcatheter aortic valve replacement procedures, as compared to balloon aortic valvuloplasty or other standard treatments in high or greater risk patients. The devices are designed, intended, and distributed for single use only. Do not resterilize or reuse the devices. There are no data to support the sterility, nonpyrogenicity, and functionality of the devices after reprocessing. Incorrect sizing of the valve may lead to paravalvular leak, migration, embolization, and/or annular rupture. Accelerated deterioration of the valve may occur in patients with an altered calcium metabolism. Prior to delivery, the valve must remain hydrated at all times and cannot be exposed to solutions other than its shipping storage solution and sterile physiologic rinsing solution. Valve leaflets mishandled or damaged during any part of the procedure will require replacement of the valve. Caution should be exercised in implanting a valve in patients with clinically significant coronary artery disease. Patients with pre-existing mitral valve devices should be carefully assessed prior to implantation of the valve to ensure proper valve positioning and deployment. Do not mishandle the delivery system or use it if the packaging or any components are not sterile, have been opened or are damaged (e.g., kinked or stretched), or if the expiration date has elapsed. Use of excessive contrast media may lead to renal failure. Measure the patient’s creatinine level prior to the procedure. Contrast media usage should be monitored. Patient injury could occur if the delivery system is not un-flexed prior to removal. Care should be exercised in patients with hypersensitivities to cobalt, nickel, chromium, molybdenum, titanium, manganese, silicon, and/or polymeric materials. The procedure should be conducted under fluoroscopic guidance. Some fluoroscopically guided procedures are associated with a risk of radiation injury to the skin. These injuries may be painful, disfiguring, and long-lasting. Valve recipients should be maintained on anticoagulant/antiplatelet therapy, except when contraindicated, as determined by their physician. This device has not been tested for use without anticoagulation.

Precautions: Long-term durability has not been established for the valve. Regular medical follow-up is advised to evaluate valve performance. Glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated exposure to, or breathing of, the solution. To maintain proper valve leaflet coaptation, do not overinflate the deployment balloon. Appropriate antibiotic prophylaxis is recommended post-procedure in patients at risk for prosthetic valve infection and endocarditis. Safety, effectiveness, and durability have not been established for valve-in-valve procedures. Safety and effectiveness have not been established for patients with the following characteristics/comorbidities: non-calcified aortic annulus; severe ventricular dysfunction with ejection fraction < 20%; congenital unicuspid or congenital bicuspid aortic valve; mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation > 3+); pre-existing prosthetic heart valve or prosthetic ring in any position; severe mitral annular calcification (MAC), severe (> 3+) mitral insufficiency, or Gorlin syndrome; blood dyscrasias defined as leukopenia (WBC < 3000 cells/mL), acute anemia (Hb < 9 g/dL), thrombocytopenia (platelet count < 50,000 cells/mL), or history of bleeding diathesis or coagulopathy; hypertrophic cardiomyopathy with or without obstruction (HOCM); echocardiographic evidence of intracardiac mass, thrombus, or vegetation; a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media, which cannot be adequately premedicated; significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5 cm or greater, marked tortuosity (hyperacute bend), aortic arch atheroma (especially if thick [> 5 mm], protruding, or ulcerated) or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe “unfolding” and tortuosity of the thoracic aorta; access characteristics that would preclude safe placement of 14F or 16F Edwards eSheath introducer set, such as severe obstructive calcification, severe tortuosity, or diameter less than 5.5 mm or 6 mm, respectively; or bulky calcified aortic valve leaflets in close proximity to coronary ostia.

Potential Adverse Events: Potential risks associated with the overall procedure including potential access complications associated with standard cardiac catheterization, balloon valvuloplasty, the potential risks of conscious sedation and/or general anesthesia, and the use of angiography: death; stroke/transient ischemic attack, clusters, or neurological deficit; paralysis; permanent disability; respiratory insufficiency or respiratory failure; hemorrhage requiring transfusion or intervention; cardiovascular injury including perforation or dissection of vessels, ventricle, myocardium, or valvular structures that may require intervention; pericardial effusion or cardiac tamponade; embolization including air, calcific valve material, or thrombus; infection including septicemia and endocarditis; heart failure; myocardial infarction; renal insufficiency or renal failure; conduction system defect which may require a permanent pacemaker; arrhythmia; retroperitoneal bleed; arteriovenous (AV) fistula or pseudoaneurysm; reoperation; ischemia or nerve injury; restenosis; pulmonary edema; pleural effusion; bleeding; anemia; abnormal lab values (including electrolyte imbalance); hypertension or hypotension; allergic reaction to anesthesia, contrast media, or device materials; hematoma; syncope; pain or changes at the access site; exercise intolerance or weakness; inflammation; angina; heart murmur; and fever. Additional potential risks associated with the use of the valve, delivery system, and/or accessories include: cardiac arrest; cardiogenic shock; emergency cardiac surgery; cardiac failure or low cardiac output; coronary flow obstruction/ transvalvular flow disturbance; device thrombosis requiring intervention; valve thrombosis; device embolization; device migration or malposition requiring intervention; valve deployment in unintended location; valve stenosis; structural valve deterioration (wear, fracture, calcification, leaflet tear/tearing from the stent posts, leaflet retraction, suture line disruption of components of a prosthetic valve, thickening, stenosis); device degeneration; paravalvular or transvalvular leak; valve regurgitation; hemolysis; device explants; nonstructural dysfunction; mechanical failure of delivery system and/or accessories; and non-emergent reoperation.

EDWARDS CRIMPER

Indications: The Edwards Crimper is indicated for use in preparing the Edwards SAPIEN 3 transcatheter heart valve for implantation.

Contraindications: There are no known contraindications.

Warnings: The devices are designed, intended, and distributed for single use only. Do not resterilize or reuse the devices. There is no data to support the sterility, nonpyrogenicity, and functionality of the devices after reprocessing.

Precautions: For special considerations associated with the use of the Edwards Crimper prior to valve implantation, refer to the Edwards SAPIEN 3 transcatheter heart valve Instructions for Use.

Potential Adverse Events: There are no known potential adverse events associated with the Edwards Crimper.

EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE WITH THE NOVAFLEX+ DELIVERY SYSTEM

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: The valve and delivery systems are contraindicated in patients who cannot tolerate an anticoagulation/antiplatelet regimen or who have active bacterial endocarditis or other active infections.

Warnings: Observation of the pacing lead throughout the procedure is essential to avoid the potential risk of pacing lead perforation. There may be an increased risk of stroke in transcatheter aortic valve replacement procedures, as compared to balloon aortic valvuloplasty or other standard treatments in high or greater risk patients. The devices are designed, intended, and distributed for single use only. Do not resterilize or reuse the devices. There are no data to support the sterility, nonpyrogenicity, and functionality of the devices after reprocessing. Care should be exercised when sizing the native annulus or surgical valve; implanting a valve that is too small may lead to paravalvular leak, migration or embolization, whereas implanting a valve that is too large may lead to residual gradient (patient-prosthesis mismatch) or annular rupture. Accelerated deterioration of the valve may occur in patients with an altered calcium metabolism. Prior to delivery, the valve must remain hydrated at all times and cannot be exposed to solutions other than its shipping storage solution and sterile physiologic rinsing solution. Valve leaflets mishandled or damaged during any part of the procedure will require replacement of the valve. Caution should be exercised in implanting a valve in patients with clinically significant coronary artery disease. Patients with pre-existing mitral valve devices should be carefully assessed prior to implantation of the valve to ensure proper valve positioning and deployment. Do not use the valve if the tamper evident seal is broken, the storage solution does not completely cover the valve, the temperature indicator has been activated, the valve is damaged, or the expiration date has elapsed. Do not mishandle the NovaFlex+ delivery system or use it if the packaging or any components are not sterile, have been opened or are damaged (e.g. kinked or stretched), or the expiration date has elapsed. Use of excessive contrast media may lead to renal failure. Measure the patient’s creatinine level prior to the procedure. Contrast media usage should be monitored. Patient injury could occur if the delivery system is not un-flexed prior to removal. Care should be exercised in patients with hypersensitivities to cobalt, nickel, chromium, molybdenum, titanium, manganese, silicon, and/or polymeric materials. The procedure should be conducted under fluoroscopic guidance. Some fluoroscopically guided procedures are associated with a risk of radiation injury to the skin. These injuries may be painful, disfiguring, and long-lasting. Valve recipients should be maintained on anticoagulant/antiplatelet therapy, except when contraindicated, as determined by their physician. This device has not been tested for use without anticoagulation. Do not add or apply antibiotics to the storage solution, rinse solutions, or to the valve.

Precautions: Long-term durability has not been established for the valve. Regular medical follow-up is advised to evaluate valve performance. Glutaraldehyde may cause irritation of the skin, eyes, nose and throat. Avoid prolonged or repeated exposure to, or breathing of, the solution. Use only with adequate ventilation. If skin contact occurs, immediately flush the affected area with water; in the event of contact with eyes, seek immediate medical attention. For more information about glutaraldehyde exposure, refer to the Material Safety Data Sheet available from Edwards Lifesciences. To maintain proper valve leaflet coaptation, do not overinflate the deployment balloon. Appropriate antibiotic prophylaxis is recommended post-procedure in patients at risk for prosthetic valve infection and endocarditis. Safety, effectiveness, and durability have not been established for transcatheter valve in transcatheter valve procedures. Safety and effectiveness have not been established for patients with the following characteristics/comorbidities: non-calcified aortic annulus, severe ventricular dysfunction with ejection fraction < 20%, congenital unicuspid or congenital bicuspid aortic valve, mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation > 3+), pre-existing prosthetic ring in any position, severe mitral annular calcification (MAC), severe (> 3+) mitral insufficiency, or Gorlin syndrome, blood dyscrasias defined as: leukopenia (WBC < 3000 cells/mL), acute anemia (Hb < 9 g/dL), thrombocytopenia (platelet count <50,000 cells/mL), or history of bleeding diathesis or coagulopathy, hypertrophic cardiomyopathy with or without obstruction (HOCM), echocardiographic evidence of intracardiac mass, thrombus, or vegetation, a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media, which cannot be adequately premedicated, significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5 cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma (especially if thick [> 5 mm], protruding, or ulcerated) or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe “unfolding” and tortuosity of the thoracic aorta, access characteristics that would preclude safe placement of 16F, 18F, or 20F Edwards expandable introducer sheath set, such as severe obstructive calcification, severe tortuosity or diameter less than 6 mm, 6.5 mm, or 7 mm, respectively, bulky calcified aortic valve leaflets in close proximity to coronary ostia, a concomitant paravalvular leak where the surgical bioprosthesis is not securely fixed in the native annulus or is not structurally intact (e.g. wireform frame fracture), and a partially detached leaflet of the surgical bioprosthesis that in the aortic position may obstruct a coronary ostium. The safety and effectiveness have not been established for implanting the transcatheter valve inside a stented bioprosthetic valve < 21 mm (labeled size) or an unstented bioprosthetic aortic valve. Residual mean gradient may be higher in a “TAV-in-SAV” configuration than that observed following implantation of the valve inside a native aortic annulus using the same size device. Patients with elevated mean gradient post procedure should be carefully followed. It is important that the manufacturer, model and size of the preexisting surgical bioprosthetic aortic valve be determined, so that the appropriate valve can be implanted and a prosthesis-patient mismatch be avoided. Additionally, pre-procedure imaging modalities must be employed to make as accurate a determination of the internal orifice as possible.

Potential Adverse Events: Potential risks associated with the overall procedure including potential access complications associated with standard cardiac catheterization, balloon valvuloplasty, the potential risks of conscious sedation and/or general anesthesia, and the use of angiography: death; stroke/transient ischemic attack, clusters or neurological deficit; paralysis; permanent disability; respiratory insufficiency or respiratory failure; hemorrhage requiring transfusion or intervention; cardiovascular injury including perforation or dissection of vessels, ventricle, myocardium or valvular structures that may require intervention; pericardial effusion or cardiac tamponade; embolization including air, calcific valve material or thrombus; infection including septicemia and endocarditis; heart failure; myocardial infarction; renal insufficiency or renal failure; conduction system defect which may require a permanent pacemaker; arrhythmia; retroperitoneal bleed; Arteriovenous (AV) fistula or pseudoaneurysm; reoperation; ischemia or nerve injury; restenosis; pulmonary edema; pleural effusion; bleeding; anemia; abnormal lab values (including electrolyte imbalance); hypertension or hypotension; allergic reaction to anesthesia, contrast media, or device materials; hematoma; syncope; pain or changes at the access site; exercise intolerance or weakness; inflammation; angina; heart murmur; fever. Additional potential risks associated with the use of the valve, delivery system, and/or accessories include: cardiac arrest; cardiogenic shock; emergency cardiac surgery; cardiac failure or low cardiac output; coronary flow obstruction/transvalvular flow disturbance; device thrombosis requiring intervention; valve thrombosis; device embolization; device migration or malposition requiring intervention; valve deployment in unintended location; valve stenosis; structural valve deterioration (wear, fracture, calcification, leaflet tear/tearing from the stent posts, leaflet retraction, suture line disruption of components of a prosthetic valve, thickening, stenosis); device degeneration; paravalvular or transvalvular leak; valve regurgitation; hemolysis; device explants; nonstructural dysfunction; mechanical failure of delivery system, and/or accessories, non-emergent reoperation.

EDWARDS EXPANDABLE INTRODUCER SHEATH SET

Indications: The Edwards expandable introducer sheath is indicated for the introduction and removal of devices used with the Edwards SAPIEN XT transcatheter heart valve.

Contraindications: This product is contraindicated for tortuous or calcified vessels that would prevent safe entry of the introducer and sheath.

Warnings: The devices are designed, intended, and distributed for single use only. Do not resterilize or reuse the devices. There is no data to support the sterility, nonpyrogenicity, and functionality of the devices after reprocessing. The Edwards expandable introducer sheath set must be used with a compatible 0.035” guidewire.

Precautions: Do not use the introducer sheath set if the packaging sterile barriers and any components have been opened or damaged. The Edwards Expandable Sheath temporarily enlarges to allow the passage of devices; ensure that the vasculature can accommodate the maximum diameter of the expanded sheath. When inserting, manipulating or withdrawing a device through the expandable sheath, always maintain sheath position. When puncturing, suturing or incising the tissue near the sheath, use caution to avoid damage to the sheath.

Potential Adverse Events: Complications associated with standard catheterization and use of angiography include, but are not limited to, injury including perforation or dissection of vessels, thrombosis, and/or plaque dislodgement which may result in emboli formation, distal vessel obstruction, stroke, infection, and/or death.

EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE WITH THE Ascendra+ DELIVERY SYSTEM

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: The valve and delivery systems are contraindicated in patients who cannot tolerate an anticoagulation/antiplatelet regimen or who have active bacterial endocarditis or other active infections.

Warnings: Observation of the pacing lead throughout the procedure is essential to avoid the potential risk of pacing lead perforation. There may be an increased risk of stroke in transcatheter aortic valve replacement procedures, as compared to balloon aortic valvuloplasty or other standard treatments in high or greater risk patients. The devices are designed, intended, and distributed for single use only. Do not resterilize or reuse the devices. There are no data to support the sterility, nonpyrogenicity, and functionality of the devices after reprocessing. Care should be exercised when sizing the native annulus or surgical valve; implanting a valve that is too small may lead to paravalvular leak, migration or embolization, whereas implanting a valve that is too large may lead to residual gradient (patient-prosthesis mismatch) or annular rupture. Accelerated deterioration of the valve may occur in patients with an altered calcium metabolism. Prior to delivery, the valve must remain hydrated at all times and cannot be exposed to solutions other than its shipping storage solution and sterile physiologic rinsing solution. Valve leaflets mishandled or damaged during any part of the procedure will require replacement of the valve. Caution should be exercised in implanting a valve in patients with clinically significant coronary artery disease. Patients with pre-existing mitral valve devices should be carefully assessed prior to implantation of the valve to ensure proper valve positioning and deployment. Patients presenting with combination AV low flow, low gradient should undergo additional evaluation to establish the degree of aortic stenosis. Do not use the valve if the tamper evident seal is broken, the storage solution does not completely cover the valve, the temperature indicator has been activated, the valve is damaged, or the expiration date has elapsed. Do not mishandle the Ascendra+ delivery system or use it if the packaging or any components are not sterile, have been opened or are damaged (e.g. kinked or stretched), or the expiration date has elapsed. Care should be exercised in patients with hypersensitivities to cobalt, nickel, chromium, molybdenum, titanium, manganese, silicon, and/or polymeric materials. The procedure should be conducted under fluoroscopic guidance. Some fluoroscopically guided procedures are associated with a risk of radiation injury to the skin. These injuries may be painful, disfiguring, and long-lasting. Valve recipients should be maintained on anticoagulant/antiplatelet therapy, except when contraindicated, as determined by their physician. This device has not been tested for use without anticoagulation. Do not add or apply antibiotics to the storage solution, rinse solutions, or to the valve.

Precautions: Long-term durability has not been established for the valve. Regular medical follow-up is advised to evaluate valve performance. Glutaraldehyde may cause irritation of the skin, eyes, nose and throat. Avoid prolonged or repeated exposure to, or breathing of, the solution. Use only with adequate ventilation. If skin contact occurs, immediately flush the affected area with water; in the event of contact with eyes, seek immediate medical attention. For more information about glutaraldehyde exposure, refer to the Material Safety Data Sheet available from Edwards Lifesciences. To maintain proper valve leaflet coaptation, do not overinflate the deployment balloon. Appropriate antibiotic prophylaxis is recommended post-procedure in patients at risk for prosthetic valve infection and endocarditis. Safety, effectiveness, and durability have not been established for transcatheter valve in transcatheter valve procedures. Safety and effectiveness have not been established for patients with the following characteristics/comorbidities: Non-calcified aortic annulus, severe ventricular dysfunction with ejection fraction < 20%, congenital unicuspid or congenital bicuspid aortic valve, mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation > 3+), pre-existing prosthetic ring in any position, severe mitral annular calcification (MAC), severe (> 3+) mitral insufficiency, or Gorlin syndrome, blood dyscrasias defined as: leukopenia (WBC < 3000 cells/mL), acute anemia (Hb < 9 g/dL), thrombocytopenia (platelet count <50,000 cells/mL), or history of bleeding diathesis or coagulopathy, hypertrophic cardiomyopathy with or without obstruction (HOCM), echocardiographic evidence of intracardiac mass, thrombus, or vegetation, a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media, which cannot be adequately premedicated, excessive calcification of vessel at access site, bulky calcified aortic valve leaflets in close proximity to coronary ostia, a concomitant paravalvular leak where the surgical bioprosthesis is not securely fixed in the native annulus or is not structurally intact (e.g. wireform frame fracture), and a partially detached leaflet of the surgical bioprosthesis that in the aortic position may obstruct a coronary ostium. The safety and effectiveness have not been established for implanting the transcatheter valve inside a stented bioprosthetic valve < 21 mm (labeled size) or an unstented bioprosthetic aortic valve. Residual mean gradient may be higher in a “TAV-in-SAV” configuration than that observed following implantation of the valve inside a native aortic annulus using the same size device. Patients with elevated mean gradient post procedure should be carefully followed. It is important that the manufacturer, model and size of the preexisting surgical bioprosthetic aortic valve be determined, so that the appropriate valve can be implanted and a prosthesis-patient mismatch be avoided. Additionally, pre-procedure imaging modalities must be employed to make as accurate a determination of the internal orifice as possible.

Potential Adverse Events: Potential risks associated with the overall procedure including potential access complications associated with standard cardiac catheterization, balloon valvuloplasty, the potential risks of conscious sedation and/or general anesthesia, and the use of angiography: death; stroke/transient ischemic attack, clusters or neurological deficit; paralysis; permanent disability; respiratory insufficiency or respiratory failure; hemorrhage requiring transfusion or intervention; cardiovascular injury including perforation or dissection of vessels, ventricle, myocardium or valvular structures that may require intervention; pericardial effusion or cardiac tamponade; embolization including air, calcific valve material or thrombus; infection including septicemia and endocarditis; heart failure; myocardial infarction; renal insufficiency or renal failure; conduction system defect which may require a permanent pacemaker; arrhythmia; retroperitoneal bleed; Arteriovenous (AV) fistula or pseudoaneurysm; reoperation; ischemia or nerve injury; restenosis; pulmonary edema; pleural effusion; bleeding; anemia; abnormal lab values (including electrolyte imbalance); hypertension or hypotension; allergic reaction to anesthesia, contrast media, or device materials; hematoma; syncope; pain or changes at the access site; exercise intolerance or weakness; inflammation; angina; heart murmur; fever. Additional potential risks associated with the use of the valve, delivery system, and/or accessories include: cardiac arrest; cardiogenic shock; emergency cardiac surgery; cardiac failure or low cardiac output; coronary flow obstruction/transvalvular flow disturbance; device thrombosis requiring intervention; valve thrombosis; device embolization; device migration or malposition requiring intervention; valve deployment in unintended location; valve stenosis; structural valve deterioration (wear, fracture, calcification, leaflet tear/tearing from the stent posts, leaflet retraction, suture line disruption of components of a prosthetic valve, thickening, stenosis); device degeneration; paravalvular or transvalvular leak; valve regurgitation; hemolysis; device explants; nonstructural dysfunction; mechanical failure of delivery system, and/or accessories; non-emergent reoperation.

Ascendra+ INTRODUCER SHEATH SET

Indications: The Ascendra+ introducer sheath set is indicated for the introduction and removal of devices used with the Edwards SAPIEN XT transcatheter heart valve.

Contraindications: No known contraindications.

Warnings: The devices are designed, intended, and distributed for single use only. Do not resterilize or reuse the devices. There are no data to support the sterility, nonpyrogenicity, and functionality of the devices after reprocessing. Do not mishandle the device or use it if the packaging or any components are not sterile, have been opened or are damaged (e.g. kinked or stretched), or the expiration date has elapsed. Should not be used in patients with left ventricular aneurysm. The Ascendra+ introducer sheath set must be used with a 0.035” guidewire.

Precautions: No known precautions.

Potential Adverse Events: Complications associated with cardiac surgical intervention and use of angiography include, but are not limited to, allergic reaction to anesthesia or to contrast media, injury including myocardial injury, thrombus formation, and plaque dislodgement which may result in myocardial infarction, arrhythmia, stroke, and/or death. Reference the Edwards SAPIEN XT transcatheter heart valve with the Ascendra+ delivery system Instructions for Use for a full list of potential adverse events.

EDWARDS CRIMPER

Indications: The Edwards crimper is indicated for use in preparing the Edwards SAPIEN XT transcatheter heart valve for implantation.

Contraindications: No known contraindications.

Warnings: The device is designed, intended, and distributed for single use only. Do not resterilize or reuse the device. There are no data to support the sterility, nonpyrogenicity, and functionality of the device after reprocessing. Do not mishandle the device. Do not use the device if the packaging or any components are not sterile, have been opened or are damaged, or the expiration date has elapsed.

Precautions: For special considerations associated with the use of this device prior to valve implantation, refer to the SAPIEN XT transcatheter heart valve Instructions for Use.

Potential Adverse Events: No known potential adverse events.

CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.