Risks associated with the TAVR procedure include death, stroke and major bleeding
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).
The Edwards SAPIEN 3 transcatheter heart valve, model 9600TFX, and accessories 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 and delivery system should not be used in patients who:
Warnings:
Precautions:
The long-term durability of the Edwards SAPIEN 3 transcatheter heart valve 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 valve has not been established for placement inside a previously implanted transcatheter valve.
The safety and effectiveness of the transcatheter heart valve is 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 valve include:
Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, SAPIEN, and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
© 2017 Edwards Lifesciences Corporation. All rights reserved. PP--US-2507 v1.0
Edwards Lifesciences One Edwards Way, Irvine CA 92614 USA edwards.com
2221 Stockton Blvd Rm 2112
Sacramento, CA 95817
*Please verify this information when scheduling an appointment.