Legal Terms

Please Read this Terms of Use Agreement and Privacy Policy Carefully Before Using These Sites

By using these Sites, you signify your assent to these Terms of Use. If you do not agree to these Terms of Use, please do not use these Sites. This Terms of Use Agreement may be updated by us from time to time without notice to you. You can review the most current version of this Agreement at any time at: www.newheartvalve.com/hcp/legal-terms

In addition, when using particular Edwards Lifesciences services or participating in the events, you and Edwards Lifesciences shall be subject to any posted guidelines, additional terms or rules applicable to such services or events. All such guidelines or rules are hereby incorporated by reference into the Agreement.

COPYRIGHTS AND TRADEMARKS

All materials and images used on lifeisnow.com or any website owned, operated, licensed or controlled by Edwards Lifesciences (“Sites”) are owned or licensed by Edwards Lifesciences Corporation. You are hereby given permission to download and/or print a copy of information or the materials from these Sites for your non-commercial use only provided that any such copy keeps intact all copyright and other proprietary notices and any disclaimers contained therein. Except as specifically provided to the contrary in this Agreement, no material from these Sites may be copied, reproduced, republished, uploaded, posted, transmitted, mirrored, hyperlinked or distributed in any way. Modification of the materials or use for any other purpose is (i) a violation of Edwards Lifesciences’ copyright and other proprietary rights, (ii) expressly prohibited by law, and (iii) may result in civil and criminal penalties. Please be advised that Edwards Lifesciences aggressively enforces its intellectual property rights to the fullest extent of the law.

The design, layout and elements of the Sites are protected by trademark, trade dress, copyright and other laws and may not be copied or imitated in whole or in part. No logo, graphic, sound or image from the Sites may be copied or retransmitted unless expressly permitted in writing by Edwards Lifesciences. Nothing contained herein shall be construed as conferring any license or right under any Edwards Lifesciences Corporation patent, copyright or trademark.

Names, marks and logos associated with Edwards Lifesciences’ products and services are either trademarks or registered trademarks of Edwards Lifesciences Corporation. The list of Edwards Lifesciences’ trademarks, including the marks registered in the U.S. Patent and Trademark Office, may be accessed in the “Listing” link on the left navigation on this page. The use or misuse of these trademarks, except as permitted herein, is expressly prohibited and may be in violation of copyright, trademark, communications, and other state and federal laws. The list of Edwards Lifesciences’ trademarks may be updated from time to time, as appropriate.

TRADEMARKS INFORMATION

Edwards, Edwards Lifesciences, the stylized E logo, 1-800-4-A-Heart, 1-800-Fogarty, Advanced Venous Access, Acumen, AFM, Alterra, AMC Thromboshield, Anastaflo, Ascendra, Ascendra 2, Ascendra 3, Ascendra+, AUTHORITY, AutoIncisor, AVA 3Xi, AVA HF, AViD, Axela, BMEYE, CADENCE, CADENCE-MIS, CardiAQ, CardiAQ-Edwards, Cardioband, CardioCare, Cardiocath, Carpentier-Edwards, Carpentier-Edwards Classic, Carpentier-Edwards Physio, Carpentier-Edwards Physio II, Carpentier-Edwards S.A.V., Carpentier-McCarthy-Adams IMR ETlogix, ccNexfin, CCOmbo, CCOmbo EDV, CCOmbo V, CENTERA, Certitude, Chandler, Clarity in Every Moment, ClearSight, ClearSight IQ, COMMENCE, COM-1, COM-2, COMPASSION, COMPASSION S3, COMPASSION XT, Connected Insights, ControlCath, Corkscrew, CO-Set, CO-Set+, Cosgrove-Edwards, Cribier-Edwards, DataSphere, Dedicated to Brighter Futures, dETlogix, Dispersion, Duraflex, DualFit, Duraflo, DURAVESS, Edwards CENTERA, Edwards Commander, Edwards Critical Care System, Edwards eSheath, Edwards Essence, Edwards FloTrac, Edwards Fortis, Edwards Helio, EDWARDS INTUITY, EDWARDS INTUITY Elite, Edwards Master of Valve Therapy, Edwards MC3, Edwards NanoClip, Edwards PatientConnect, Edwards Protection Cannulae, Edwards SAPIEN, Edwards SAPIEN M3, Edwards SAPIEN XT, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, EMBOL-X, EMBOL-X Glide, Embrella, EndoClamp, EndoDirect, EndoPlege, EndoReturn, EndoVent, Enhanced Surgical Recovery Program and Design, Ergonic, eSheath, ESR, EverClip, EverGrip, Every Heartbeat Matters, EVOQUE, EV1000, EZ Glide, Fem-Flex, Fem-Flex II, FemTrak, Flex-Tip, FLOtector, FloTrac, FloTrac IQ, Fogarty, Fogarty Corkscrew, Fogarty Fortis, Fogarty Hydragrip, FORMA, Fortis, FOUNDATION, GeoForm, Heart Master, HemoSphere, Hi-Shore, HPI, Hydrajaw, Hypotension Probability Indicator, IMR ETlogix, INSPIRIS, INSPIRIS RESILIA, Intellicath, IntraClude, Intro-Flex, iProctor, Janke-Barron, KONECT, Life is Now, Magna, Magna Ease, Magna Mitral Ease, Master of Valve Therapy, MC3, MC3 Tricuspid, MDOCK, Miller, MITRAFIT, Mitris, Multi-Med, Myxo ETlogix, NanoClip, Neutralogic, newheartvalve.com, newheartvalve.com design logo, Nexfin, Nexfin CO-Trek, NovaFlex, NovaFlex+, OptiClip, OptiSite, Paceport, PARTNER, PARTNER II, PARTNER 3, PARTNER design logo, PASCAL, PatientConnect, PATRIOT, PediaSat, PERI, PERIMOUNT, PERIMOUNT Magna, PERIMOUNT Plus, PERIMOUNT Theon, PeriVue, Physio, Physio II, Physio Tricuspid, Physiocal, PORT ACCESS, PORT ACCESS MVR, PreSep, ProPlege, QPidS, Qualcrimp, QuickDraw, REF-1, REF/OX, RESILIA, Retractaguard, RetroFlex, RetroFlex II, RetroFlex 3, Retroplegia, Retroplegia II, RF3, SAPIEN, SAPIEN M3, SAPIEN XT, SAPIEN 3, SAPIEN 3 Ultra, SAT-1, SAT-2, S.A.V., Safejaw, SDA, SoftClamp, Softjaw, Starr-Edwards, SVVxtra, Swan, Swan-Ganz, Swan-Ganz IQ, S3, TAVRbyEdwards.com, Theon, ThermaFix, Thin-Flex, ThruPort, Time-in-Target, TRANSFORM, Tricentrix, Trim-Flex, TruCal, TruClip, True-Size, TRUE-SIZE, TruWave, TruWave IQ, Valtech, Valtech Cardio, ValveNet, ValvePoint, VAMP, VAMP Flex, VAMP Jr., VAMP Optima, VAMP Plus, Vantex, Vascushunt, Vascushunt II, VFem, VFit, Vigilance, Vigilance II, Vigileo, VIP, VIP+, VisuFlo II, VolumeView, and XenoLogiX are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates.

DISCLAIMERS

These Sites may contain information relating to various medical, health and fitness conditions and their treatment. This is for informational purposes only and is not meant to be a substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for diagnosing a medical, health or fitness condition or disease. You should always consult your own physician and medical advisors.

Although Edwards Lifesciences may from time to time monitor or review the Content posted in the Forums on its Sites, Edwards Lifesciences is under no obligation to do so and assumes no responsibility or liability arising from the Content contained in its Sites, or for any error, defamation, libel, slander, omission, falsehood, obscenity, pornography, profanity, danger or inaccuracy contained in any information within its Sites.

Edwards Lifesciences provides the contents of its Sites for informational purposes and for general interest and entertainment only. The materials and related graphics published on the Sites or accessed via the Sites could include technical inaccuracies or typographical errors. By using the Sites, you agree not to rely on any of the information contained herein.

THE INFORMATION ON THESE SITES IS PROVIDED “AS IS” AND EDWARDS LIFESCIENCES MAKES NO REPRESENTATIONS OR WARRANTY THAT THE INFORMATION CONTAINED ON THESE SITES WILL BE TIMELY OR ERROR-FREE. EDWARDS LIFESCIENCES AND/OR ITS RESPECTIVE SUPPLIERS MAKE NO REPRESENTATIONS OR WARRANTY ABOUT THE SUITABILITY OF THE INFORMATION CONTAINED IN THE MATERIALS AND RELATED GRAPHICS PUBLISHED, OR ANY PRODUCTS OR SERVICES OFFERED OR REFERRED TO, ON THESE SITES FOR ANY PURPOSE, INCLUDING WITHOUT LIMITATION, ANY MEDICAL, MEDICAL TESTING, HEALTH OR FITNESS PURPOSE. ALL SUCH MATERIALS, RELATED GRAPHICS, PRODUCTS OR SERVICES ARE PROVIDED “AS IS” AND WITHOUT WARRANTY OF ANY KIND.

EDWARDS LIFESCIENCES AND/OR ITS RESPECTIVE SUPPLIERS DISCLAIM ALL WARRANTIES AND CONDITIONS WITH REGARD TO SUCH INFORMATION, PRODUCTS AND SERVICES, INCLUDING ALL IMPLIED WARRANTIES AND CONDITIONS OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NON-INFRINGEMENT. IN NO EVENT SHALL EDWARDS LIFESCIENCES BE LIABLE FOR ANY SPECIAL, DIRECT, INDIRECT OR CONSEQUENTIAL DAMAGES OR ANY OTHER DAMAGES WHATSOEVER, WHETHER IN AN ACTION IN CONTRACT, TORT OR OTHER ACTION, ARISING OUT OF OR IN CONNECTION WITH THE INFORMATION, MATERIALS, PRODUCTS, OR PROVISION OF OR FAILURE TO PROVIDE SERVICES AVAILABLE ON THESE SITES.

LINKS TO THIRD PARTY SITES

The links on our Sites will allow you to leave our Sites and transfer to sites that are not under the control of Edwards Lifesciences. Edwards Lifesciences is not responsible for the contents of any linked site or any links contained in a linked site, or any changes or updates to such sites. Edwards Lifesciences is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement by Edwards Lifesciences of the site.

SUBMISSIONS

Edwards Lifesciences Corporation appreciates hearing from its customers, however, our policy does not allow us to accept or consider creative ideas, suggestions, inventions or materials other than those we have specifically requested. Accordingly, we must insist that you do not send us any such original creative materials. If, despite our request that you not send us any creative materials, you send us ideas, notes, inventions, concepts or other information (“Disclosures”), none of such Disclosures shall be subject to any obligation of confidence on the part of Edwards Lifesciences and Edwards Lifesciences shall not be liable for any use or disclosure of any Disclosures.

No confidential relationship shall be established in the event that any user of these Sites should make any oral, written or electronic response to Edwards Lifesciences Corporation (such as feedback, questions, comments, suggestions, ideas, etc.). Such response and any information submitted therewith shall be considered non-confidential and Edwards Lifesciences shall be free to reproduce, publish or otherwise use such information for any purposes, including without limitation, the research, development, manufacture, use or sale of products incorporating such information.

FORWARD LOOKING STATEMENTS

Certain portions of these Sites may include forward-looking statements that involve risks and uncertainties that could cause actual results or experience to differ materially from historical results or those anticipated. Actual future results may differ materially depending on a variety of factors, including technological advances in the medical field, foreign currency exchange rates, product demand and market acceptance, the impact of competitive products and pricing, the effect of economic conditions, and other risks detailed in Edwards Lifesciences’ filings with the Securities and Exchange Commission. All forward-looking statements are based on estimates and assumptions made by management of the company as of the date of publication.

APPLICABLE LAWS

These Sites are controlled and operated from the United States of America and Edwards Lifesciences makes no representations that materials in the Sites are appropriate or available for use in other locations. These Sites contain information about products which may or may not be available in any particular country, may be available under different trademarks or names and, if applicable, may have received approval or market clearance by a governmental regulatory body for sale or use with different indications and restrictions in different countries. Each country has specific laws, regulations and medical practices governing the communication of medical information and information about medical products on Internet. You should not construe anything on these Sites as a promotion or solicitation for any product or for the use of any product that is not authorized by the laws and regulations of the country where you are located.

These Sites may link to other sites produced by Edwards Lifesciences’ various operating divisions and subsidiaries. Those sites may have information that is appropriate only to the particular originating country or region where the site is based.

ACTIONS IN RESPONSE TO INTELLECTUAL PROPERTY INFRINGEMENT

It is the policy of Edwards Lifesciences to respect intellectual property rights of others. Edwards Lifesciences will process and investigate notices of alleged infringement and will take appropriate actions under the Digital Millennium Copyright Act, Title 17, United States Code, Section 512(c)(2) (“DMCA”) and other applicable intellectual property laws.

Pursuant to the DMCA, notifications of claimed copyright infringement should be sent to a Service Provider’s Designated Agent. Notification must be submitted to the following Designated Agent for these sites:

Service Provider(s): Edwards Lifesciences Corporation

NAME OF AGENT DESIGNATED TO RECEIVE NOTIFICATION OF CLAIMED INFRINGEMENT: NOLAN TAIRA

FULL ADDRESS OF DESIGNATED AGENT TO WHICH NOTIFICATION SHOULD BE SENT:

Attn: Nolan Taira
Edwards Lifesciences Corporation
One Edwards Way
Irvine, CA 92614

Telephone Number of Designated Agent:
949-250-2500

Facsimile Number of Designated Agent:
949-250-2733

E-mail Address of Designated Agent:
nolan_taira@edwards.com

TO BE EFFECTIVE, THE NOTIFICATION MUST BE A WRITTEN COMMUNICATION THAT INCLUDES THE FOLLOWING:

A physical or electronic signature of a person authorized to act on behalf of the owner of an exclusive right that is allegedly infringed

Identification of the copyrighted work claimed to have been infringed, or, if multiple copyrighted works at a single online site are covered by a single notification, a representative list of such works at that site

Identification of the material that is claimed to be infringing or to be the subject of infringing activity and that is to be removed or access to which is to be disabled, and information reasonably sufficient to permit the service provider to locate the material

Information reasonably sufficient to permit the service provider to contact the complaining party, such as an address, telephone number, and, if available, an electronic mail address at which the complaining party may be contacted

A statement that the complaining party has a good-faith belief that use of the material in the manner complained of is not authorized by the copyright owner, its agent, or the law

CONTENT POSTED TO EDWARDS LIFESCIENCES’ SITES

Certain areas on our Sites may enable you to access on-line forums or message boards where you can post messages and read messages posted by other users (“Forums”). Edwards Lifesciences is not responsible for and does not endorse any information, data, text, software, music, sound, photographs, graphics or other materials, including without limitation any information relating to procedures or applications which are not approved by the Food and Drug Administration (i.e. off-label uses) (“Content”) submitted to us or posted on such Forums by Site users. By posting Content on the Sites, however, you grant Edwards Lifesciences a world-wide, royalty free, non-exclusive and fully sublicenseable right and license to reproduce, modify, publish, translate and otherwise use such Content for any purpose Edwards Lifesciences chooses, commercial, public or otherwise without compensation whatsoever.

You agree to be fully responsible for your own postings and agree to access and use the Forums at your own risk on an as-is basis. While Edwards Lifesciences has no obligation to monitor the Forums, it may, from time to time, monitor the Forums to determine whether postings comply with this Agreement, to guide the discussion on the Forums, or for other reasons. Edwards Lifesciences cannot and does not guarantee that it will post or continue to post every message or other Content that you or others submit to the Forums. Edwards Lifesciences reserves the right to edit or abridge postings for any reason and to disclose any information as necessary to satisfy any applicable law, regulation, legal process or government request, or to edit, refuse to post or to remove any information or materials, in whole or part, in Edwards Lifesciences’ sole discretion.

YOU MUST ABIDE BY THE FOLLOWING RULES IN CONNECTION WITH YOUR USE OF THE FORUMS:

You agree to post only messages that relate to the subject matter of the Forum.

You agree not to defame, abuse, harass, stalk, threaten or otherwise violate the legal rights of others. You agree not to impersonate any person or entity, including, for example, an Edwards Lifesciences employee or officer, a Forum leader, or falsely state or otherwise misrepresent your affiliation with a person or entity.

You agree not to post messages that contain material that is inappropriate, profane, pornographic, threatening, defamatory, inflammatory, infringing, obscene, or indecent or that could constitute or encourage conduct that would be considered a criminal offense, give rise to civil liability, or would otherwise violate the law. This includes any Content that infringes any patent, trademark, trade secret, copyright or other proprietary rights of any third party.

You agree to give attribution to others when you quote or paraphrase materials owned by others, and to limit your quotations to no more than 50 words.

You agree not to upload files, or cause others to upload files, that contain viruses, corrupted files, or any other similar software or programs that may adversely affect the operation of another’s computer.

You agree not to advertise or promote any goods or services in the Forums. This includes, among other things, “contests,” “junk mail”, “spam”, “chain letters”, and “pyramid schemes.”

You agree to indemnify and hold Edwards Lifesciences harmless from and against any claim or demand, including reasonable attorneys’ fees, made by any third party due to or arising out of Content you submit, post or transmit through Edwards Lifesciences’ sites, your use of the Sites, or your violation of any rights of another.

TREATMENT CENTER NOTICE

This directory is compiled from a variety of sources, including self-reported information provided by health care providers. Edwards also lists treatment centers that have aquired the relevant technologies, but Edwards recommends that you verify that the technology has been deployed and is being used clinically at a given treatment center, and that the treatment modality of interest is applicable to your diagnosis. Please contact the health care providers directly to obtain this information. Although Edwards undertakes reasonable efforts to keep the information contained in the directory listing accurate, Edwards does not warrant the accuracy, completeness, timeliness, merchantability or fitness for a particular purpose of the information contained in the directory listing. Edwards does not in any way endorse the health care providers or centers described in the directory listing, nor does Edwards verify medical qualifications, licenses, practice areas or suitability of the listed health care centers in order to provide this directory listing. To ensure that the information provided is accurate, call the provider. Patients should also ask whether the provider accepts their insurance and should contact their insurance providers to determine whether coverage is available before pursuing treatment. Edwards makes no representations about insurance coverage. To determine whether a treatment described herein is right for you, contact your medical professional. In no event shall Edward be liable to you or anyone else for any decision made or action taken by you in reliance on such information provided herein. Any damages or expenses of any kind, for any reason, shall be limited to the amount paid to access this directory listing.

MISCELLANEOUS

This agreement shall be governed by and construed in accordance with the laws of the State of California, without giving effect to any principles of conflicts of law. If any provision of this agreement shall be deemed unlawful, void, or for any reason unenforceable, then that provision shall be deemed severable from this agreement and shall not affect the validity and enforceability of any remaining provisions.

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.