Innovative Valve Technology
Made for You.
At Edwards Lifesciences, we design valve technology with your freedom in mind.
Through decades of research and development, we have continued to revolutionize our transcatheter aortic valve replacement (TAVR) technology to improve the lives and futures of people with SAS.
TAVR is now available to more patients with SAS. However, not all TAVR valves are created equal. With each refinement, Edwards valves were designed with your needs in mind.
Ask your doctor today about getting an Edwards valve.
Edwards is the leader in transcatheter heart valve technology. Our TAVR valves (also known as the SAPIEN family of valves) have treated more than 626,000 patients in over 70 countries around the world—making it the most widely used heart valve to date.
At Edwards, we continue to optimize our valves to support better patient outcomes, so that patients can get back to the lives they love.
The type of TAVR valve you receive can impact your heart and future.
Throughout the evolution of our SAPIEN platform, Edwards has strategically approached our valve designs with our patients in mind. We create features that differentiate our TAVR valves from the rest.
Make sure to ask your doctor about which valve is best for you.
Edwards’ transcatheter heart valves are designed to work like your native heart valve. The Edwards TAVR valves are made of the same bovine pericardial tissue (from a cow’s heart) as Edwards’ leading surgical valves. Because the Edwards TAVR valves are expanded into place with the help of a balloon, they begin working immediately when implanted.
At Edwards, we have engineered unique features that set our valves apart. The valve frame is made from cobalt chromium for strength and durability. An outer sealing skirt surrounds the bottom of the valve to help stop any possible leakage around the valve. This matters when it comes to future clinical outcomes and your ability to get back to life sooner.
We recognize the unique needs of our patients. That is why the Edwards TAVR valves are available in 4 different sizes to accommodate a variety of anatomical differences.
Our Edwards TAVR valves were created with your future in mind. Whether your TAVR Heart Team requires future coronary access, or you require another procedure to fix your failing heart valve through the valve-in-valve procedure, our Edwards valves have you covered.
As with any medical procedure, there is a possibility of risks. The most serious risk of TAVR include death, stroke, serious damage to the arteries, or serious bleeding.
Don’t settle for just any TAVR valve. Make sure you understand your options. Use our Informed Discussion Guide to help facilitate a discussion with your doctor about which valve is right for you.
Edwards continues to build upon its best-in-class design and technology for each of its successive valves. With each generation of Edwards valves comes better patient outcomes and clinical benefits when compared to surgical valves.
Explore our Edwards TAVR valves, which have lower rates of serious complications when compared to surgical valves.
The Edwards SAPIEN transcatheter heart valve was the ﬁrst TAVR valve of its kind to get FDA approval in the United States.
The Edwards SAPIEN 3 TAVR valve gave patients who were too sick to undergo open heart surgery an alternative treatment for severe aortic stenosis. As Edward’s ﬁrst transcatheter heart valve, and the ﬁrst of its kind approved in the United States, the Edwards SAPIEN 3 TAVR valve represented a major achievement in the treatment of severe aortic stenosis.
Building on the success and innovation of the Edwards SAPIEN valve, the updated design of the Edwards SAPIEN XT allowed for TAVR to be used in more patients.
The Edwards SAPIEN XT valve was FDA approved to treat severe aortic stenosis patients who were experiencing symptoms and considered to be high-risk or inoperable for open heart surgery.
Considered best in class because of its better clinical outcomes, the Edwards SAPIEN 3 transcatheter valve became available to more patients, including those who were considered low risk for open heart surgery.
The Edwards SAPIEN 3 continued to advance heart valve technology, providing additional access routes and more valve sizes to meet patients’ needs. The Edwards SAPIEN 3 TAVR continued to show success in clinical data by achieving 1% death and stroke rate for those patients who are considered low-risk, which provided patients with better clinical outcomes than open heart surgery.1
Built upon the proven SAPIEN platform, the Edwards SAPIEN 3 Ultra transcatheter heart valve was designed with patient’s future needs in mind.
Edwards’ commitment to best-in-class technology continues with the SAPIEN 3 Ultra valve. Built upon the proven SAPIEN platform, the SAPIEN 3 Ultra transcatheter heart valve was designed with patients’ future needs in mind. Its low frame height and large cell design easily facilitates future coronary access if a patient requires a procedure post-TAVR. It continues to provide alternative options for patients other than open heart surgery.
1. PARTNER 3 trial, low-risk cohort unadjusted clinical event rates, AT population.
The Edwards SAPIEN 3 and SAPIEN 3 Ultra 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 and SAPIEN 3 Ultra 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 or surgical bioprosthetic 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 Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).
Contraindications (Who should not use):
The Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System should not be used in patients who:
The long-term durability of the Edwards SAPIEN 3 Ultra 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. Long-term durability of the valve has not been established.
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.