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Legal Terms

The following Terms of Use govern and apply to your use and/or reliance upon this and any website maintained by Edwards Lifesciences, LLC., including its wholly owned subsidiaries and successors (together, referred to as “Edwards”).

Access and/or use of this Edwards website are subject to all applicable laws, statutes, and/or regulations and the terms and conditions set forth herein. Edwards may revise these Terms of Use from time to time by updating this post and without additional notice. You can review the most current version of this Agreement at any time at: https://newheartvalve.com/terms-of-use. This Edwards website is intended for U.S. audiences only. Your access or use of this Edwards website indicates your acceptance of these terms, and your representation that you are at least eighteen (18) years of age or older.

Disclaimer of Warranties and Limitation of Liability

EDWARDS MAINTAINS THIS EDWARDS WEBSITE AS A SERVICE TO THE INTERNET COMMUNITY. THIS EDWARDS WEBSITE IS DESIGNED TO PROVIDE GENERAL INFORMATION ABOUT THE SUBJECT MATTER PRESENTED.

Edwards makes no warranties or representations as to the accuracy of information presented on this Edwards website and disclaims all warranties, express or implied, including any warranties of merchantability, fitness for a particular purpose, and non-infringement to the full extent permitted by applicable law. Edwards will use reasonable efforts to include accurate and up-to-date information on this Edwards website, but all information is provided “AS IS.”

Neither Edwards nor any of its agents or affiliates shall be liable for any direct, incidental, consequential, indirect, or punitive damages arising out of user’s access, use, or inability to use this Edwards website, or any errors or omissions in the content of this Edwards website.

In addition, any information presented on this Edwards website as of a particular date may only be accurate as of such date and Edwards disclaims any responsibility to update such information. Edwards shall not be held responsible for any action taken that is based on the information presented on this Edwards website, and all users of this Edwards website agree that all access and use of this Edwards website, and any and all content presented on this Edwards website, is at the user’s own risk.

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This Edwards website does not, and is not intended to, provide medical advice, nor does it provide instruction on the appropriate use of any product produced or supplied by Edwards, its affiliates, related companies, or its licensors. Information on this Edwards website regarding any product(s) approved for marketing is qualified in its entirety by reference to the FDA-approved full instructions for use information for the specific product(s). The information presented on this Edwards website should not be interpreted or construed in any way as a replacement or substitution for medical advice provided by your doctor or healthcare provider. It is important that you discuss your treatment options and any questions that you may have with your doctor or healthcare provider.

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Edwards Lifesciences LLC
Attention: General Counsel, Legal Department
One Edwards Way
Irvine, CA 92614, USA

 

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

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

Indications:
The Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System 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 appropriate for the transcatheter heart valve replacement therapy.

The Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System are indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic or mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the STS risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

Contraindications (Who should not use):
The Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System should not be used in patients who:

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

Warnings:

  • There may be an increased risk of stroke in transcatheter aortic valve replacement procedures, compared to other standard treatments for aortic stenosis in the high or greater risk population.
  • If an incorrect valve size for your anatomy is used, it may lead to heart injury, valve leakage, movement, or dislodgement.
  • Patients should talk to their doctor if they have significant heart disease, a mitral valve device or are sensitive to cobalt, nickel, chromium, molybdenum, titanium, manganese, silicon, and/or polymeric materials.
  • The SAPIEN 3 Ultra and SAPIEN 3 valves may not last as long in younger patients, or patients with a disease that results in more calcium in their blood.
  • During the procedure, your doctors should monitor the dye used in the body; if used in excess it could lead to kidney damage. X-ray guidance used during the procedure may cause injury to the skin, which may be painful, damaging, and long-lasting.
  • Patient’s creatinine level should be measured prior to the procedure.
  • Patients who have already had a valve replaced should be carefully assessed by their physician prior to receiving a new valve to ensure proper placement of the new valve.
  • Injury can occur if the delivery system is not used properly.
  • Transcatheter heart valve patients should talk to their physicians about the potential need for medications that thin the blood or prevent blood clots from forming.

Precautions:
The long-term durability of the Edwards SAPIEN 3 Ultra and SAPIEN 3 transcatheter heart valves is not known at this time. Regular medical follow-up is recommended to evaluate how well a patient’s heart valve is performing. Safety, performance, and durability of the SAPIEN 3 Ultra and SAPIEN 3 valve have not been established for placement inside a previously implanted transcatheter valve.

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

  • An aortic heart valve that is not calcified, contains only one leaflet, two leaflets in low surgical risk patients, has leaflets with large pieces of calcium that may block the vessels that supply blood to the heart or in which the main problem is that the valve leaks.
  • Previous prosthetic ring in any position.
  • Previous atrial septal occlude.
  • A heart that does not pump well, has thickening of the heart muscle, with or without blockage, unusual ultrasound images of the heart that could represent irregularities such as a blood clot, a diseased mitral valve that is calcified or leaking, or Gorlin syndrome, a condition that affects many areas of the body and increases the risk of developing various cancers and tumors.
  • Low white, red or platelet blood cell counts, or history of bleeding because the blood does not clot properly.
  • Diseased, abnormal or irregularly shaped vessels leading to the heart. Vessels which are heavily diseased or too small for associated delivery devices, or a large amount of calcification at the point of entry.
  • Allergies to blood-thinning medications or dye injected during the procedure.
  • For a valve in valve procedure, there is a risk of leakage if the previously implanted tissue valve is not securely in place or if it is damaged. There is also the possibility that a partially detached valve leaflet from the previously implanted valve could block a blood vessel.
  • Additional pre-procedure imaging will be completed to evaluate proper sizing.

Potential risks associated with the procedure include:

  • Death, stroke, paralysis (loss of muscle function), permanent disability, or severe bleeding.
  • Risks to the heart, including heart attack or heart failure, a heart that does not pump well, irregular heartbeat that may result in a need for a permanent pacemaker, chest pain, heart murmur, false aneurysm, recurring aortic stenosis (narrowing), too much fluid around the heart, injury to the structure of the heart.
  • Risks to your lungs or breathing, including difficulty breathing, fainting, buildup of fluid in or around the lungs, weakness or inability to exercise.
  • Risks involving bleeding or your blood supply, including formation of a blood clot, high or low blood pressure, limited blood supply, a decrease in red blood cells, or abnormal lab values, bleeding in the abdominal cavity, collection of blood under the skin.
  • Additional risks, including life-threatening infection, dislodgement of calcified material, air embolism (air bubbles in the blood vessels), poor kidney function or failure, nerve injury, fever, allergic reaction to anesthesia or dye, reoperation, pain, infection or bleeding at incision sites, or swelling.

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

  • Valve movement after deployment, blockage or disruption of blood flow through the heart, need for additional heart surgery and possible removal of the SAPIEN 3 Ultra or SAPIEN 3 valves, a blood clot that requires treatment, damage to the valve (e.g., wear, breakage, recurring aortic stenosis), nonstructural valve dysfunction (e.g., leakage, inappropriate sizing or positioning, blockage, excess tissue in growth, blood cell damage, etc.) or mechanical failure of the delivery system and/or accessories.

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

Important Risk Information
The Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System are indicated for relief of aortic stenosis...
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