Your Time Is Now.
We’re Here to Help.
Owning your future means not letting severe aortic stenosis get in your way. At Edwards, we are dedicated to supporting you throughout this journey.
Are you thinking of having transcatheter aortic valve replacement (TAVR) to treat your severe aortic stenosis? Have you already been referred for treatment? We have the resources to empower you as you plan your next steps.
This Edwards TAVR Discussion Guide will help you better understand if Edwards TAVR is the best choice for you. This guide will take your health, values, preferences, and questions into consideration, which is important when you are seeking out the valve that’s right for you. The guide can also help jump start a conversation with your doctor about your treatment options.
To get ahead of your severe aortic stenosis, take advantage of the many resources available to help you live a healthier life. We have compiled a variety of helpful websites that may provide additional education, financial resources, and other support services.
Our downloadable brochures provide detailed information on Edwards TAVR valves, so you can make informed decisions about your health.
Learn more about the TAVR procedure: how the procedure is performed and what you can expect before, during, and after TAVR.
Find information about Edwards TAVR valves, including what to expect during and after the TAVR procedure, and view our clinical data.
Our video library features in-depth animations on how the TAVR procedure is performed and the benefits of Edwards TAVR valves.
Millions of people around the globe are trying to get back to the lives they love, despite a diagnosis of severe aortic stenosis. Watch these videos as patients describe their unique journeys through diagnosis, treatment, and recovery, and how they embraced life after conquering their disease.
Through initiatives led by Edwards and our partners, we empower patients to use their experience to help themselves and others to build a community of patients who care about making a difference.
After you receive your Edwards transcatheter heart valve, you will be invited to join our TAVR Community. We are dedicated to supporting patients who want to keep in touch and stay connected, even after their procedure.
As a member, you will receive an educational valve replica and will have an opportunity to share your story with other community members. We support patients who want to keep in touch and stay connected as they take on their second acts! Watch for your invitation to join the community.
The Edwards SAPIEN 3, SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is 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, SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve, a surgical bioprosthetic mitral valve, or a native mitral valve with an annuloplasty ring 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 Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).
Contraindications (Who should not use):
The Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System should not be used in patients who:
The long-term durability of the Edwards SAPIEN 3 Ultra, SAPIEN 3 Ultra RESILIA and SAPIEN 3 transcatheter heart valves are not known at this time. Regular medical follow-up is recommended to evaluate how well a patient’s heart valve is performing. Limited clinical data are available for transcatheter aortic valve replacement in patients who are born with an aortic heart valve that has only two leaflets and who are determined to be at low risk for open heart surgery. A patient’s anatomical characteristics should be considered by their physicians when using the valve in this patient population. In addition, patient age should be considered as long-term durability of the valve has not been established. Patients who need a dental procedure should talk to their doctor about risk of infection and needing antibiotics. Patients should be treated post-procedure for heart infection as a precaution.
The safety and effectiveness of the transcatheter heart valves are also not known for patients who have:
Potential risks associated with the procedure include:
Additional potential risks specifically associated with the use of the heart valves include:
CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.