When it comes to transcatheter aortic valve replacement (TAVR), not all valves are the same. Edwards TAVR is the only FDA approved valve that has been proven superior to surgery.*
*In the PARTNER 3 Trial, the Edwards TAVR proved superior to surgery on the primary endpoint (all-cause death, all stroke, and rehospitalization) and multiple pre-specified secondary endpoints.1
Patients who have TAVR are more likely to go directly home after their procedure compared with those who had open heart surgery. In fact, a recent study with low-risk patients† showed that open heart surgery patients were 3X more likely to require assistance at a care facility versus patients who had Edwards TAVR.
†As determined to be at low surgical risk by a Heart Team.
Life after Edwards TAVR is very different than after open heart surgery. Because it is the less invasive treatment option, there is very little scarring, as well as1:
Lower rate of serious complications
Shorter recovery time
Less pain and discomfort
Quick relief of severe aortic stenosis symptoms
Short hospital stay
(3 days vs 7 days after surgery)
1. PARTNER 3 trial, low-risk cohort unadjusted clinical event rates, AT population.
The Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System are indicated for relief of aortic stenosis...
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.