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Edwards Lifesciences
One Edwards Way, Irvine, CA 92614
PHONE: (949) 250-2500 | FAX: (949) 756-4656
Valves / Transcatheter Aortic Valve Implantation
View Chart| Company Name | Product Name | Valve Diameter (mm) | Valve Height (mm) | Valve Annulus Size Range (mm) | Valve Frame Material | Valve Leaflet Material | Valve Anticalcification Process | Delivery System Name | Delivery Access | Delivery System Deployment Type | Delivery System Size (F) | Delivery System Working Length (cm) | CE Mark Indications | Comments |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Edwards Lifesciences | Sapien 3 Transcatheter Heart Valve* With Edwards Certitude Delivery System | 20, 23, 26, 29 | 15.5, 18, 20, 22.5 | 16–28 (diameter by TEE), 18.6–29.5 (area derived diameter) | Cobalt chromium | Bovine pericardium | Yes | Edwards Certitude Delivery System | Transapical/transaortic | Balloon expandable | 18, 21 | 55 | Sapien 3, Sapien 3 Ultra, and Sapien 3 Ultra Resilia transcatheter heart valve system is indicated for use in patients with asymptomatic or symptomatic heart disease due to native calcific aortic stenosis at any or all levels of surgical risk for open heart surgery; indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of an aortic transcatheter bioprosthetic or surgical aortic or mitral bioprosthetic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (ie, predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator) | *Valve and delivery systems are not available for individual sale |
| Edwards Lifesciences | Sapien 3 Transcatheter Heart Valve* With Edwards Commander Delivery System | 20, 23, 26, 29 | 15.5, 18, 20, 22.5 | 16–28 (diameter by TEE), 18.6–29.5 (area derived diameter) | Cobalt chromium | Bovine pericardium | Yes | Edwards Commander Delivery System | Transfemoral | Balloon expandable | 14, 16 | 105 | The Edwards Sapien 3, Sapien 3 Ultra, and Sapien 3 Ultra Resilia transcatheter heart valve system is indicated for use in patients with asymptomatic or symptomatic heart disease due to native calcific aortic stenosis at any or all levels of surgical risk for open heart surgery; indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of an aortic transcatheter bioprosthetic or surgical aortic or mitral bioprosthetic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (ie, predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator) | *Valve and delivery systems are not available for individual sale |
| Edwards Lifesciences | Sapien 3 Ultra Transcatheter Heart Valve* With Certitude Delivery System | 20, 23, 26 | 15.5, 18, 20 | 16–25 (diameter by TEE), 18.6–26.4 (area derived diameter) | Cobalt chromium | Bovine pericardium | Yes | Edwards Certitude Delivery System | Transapical/transaortic | Balloon expandable | 18, 21 | 55 | The Edwards Sapien 3, Sapien 3 Ultra, and Sapien 3 Ultra Resilia transcatheter heart valve system is indicated for use in patients with asymptomatic or symptomatic heart disease due to native calcific aortic stenosis at any or all levels of surgical risk for open heart surgery; indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of an aortic transcatheter bioprosthetic or surgical aortic or mitral bioprosthetic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (ie, predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator) | *Valve and delivery systems are not available for individual sale |
| Edwards Lifesciences | Sapien 3 Ultra Transcatheter Heart Valve* With Commander Delivery System | 20, 23, 26 | 15.5, 18, 20 | 16–25 (diameter by TTE), 18.6–26.4 (area derived diameter) | Cobalt chromium | Bovine pericardium | Yes | Edwards Commander Delivery System | Transfemoral | Balloon expandable | 14, 16 | 105 | The Edwards Sapien 3, Sapien 3 Ultra, and Sapien 3 Ultra Resilia transcatheter heart valve system is indicated for use in patients with asymptomatic or symptomatic heart disease due to native calcific aortic stenosis at any or all levels of surgical risk for open heart surgery; indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of an aortic transcatheter bioprosthetic or surgical aortic or mitral bioprosthetic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (ie, predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator) | *Valve and delivery systems are not available for individual sale |
| Edwards Lifesciences | Sapien 3 Ultra RESILIA Heart Valve* With Commander Delivery System | 20, 23, 26, 29 | 15.5, 18, 20, 22.5 | 16–28 (diameter by TEE), 18.6–29.5 (area derived diameter) | Cobalt chromium | Bovine pericardium | Yes | Commander Delivery System | Transfemoral | Balloon expandable | Sheath size is 14 and 16 | 105 | The Edwards Sapien 3, Sapien 3 Ultra, and Sapien 3 Ultra Resilia transcatheter heart valve system is indicated for use in patients with asymptomatic or symptomatic heart disease due to native calcific aortic stenosis at any or all levels of surgical risk for open heart surgery; indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of an aortic transcatheter bioprosthetic or surgical aortic or mitral bioprosthetic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (ie, predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator) | *Valve and delivery systems are not available for individual sale |
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Valves / Transcatheter Mitral Valve Repair
View Chart| Company Name | Product Name | Delivery System Name | Delivery Access | Delivery System Size (F) | Delivery System Working Length (cm) | CE Mark Indications | Comments |
|---|---|---|---|---|---|---|---|
| Edwards Lifesciences | Edwards Cardioband Mitral Valve Reconstruction System | Transseptal Steerable Sheath | Transseptal | 25.5 | 82 | Indicated for the reconstruction and/or remodeling of pathological mitral valves | Implant and delivery system are not available for individual sale |
| Edwards Lifesciences | Edwards Pascal Transcatheter Valve Repair System | Pascal Delivery System | Transfemoral | 22 (septal crossing OD) | 79 | – | – |
| Edwards Lifesciences | Sapien 3 Transcatheter Heart Valve* With Certitude Delivery System | Certitude Delivery System | Transapical | 18, 21 | 55 | The Edwards Sapien 3, Sapien 3 Ultra, and Sapien 3 Ultra Resilia transcatheter heart valve system is indicated for use in patients with asymptomatic or symptomatic heart disease due to native calcific aortic stenosis at any or all levels of surgical risk for open heart surgery; indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of an aortic transcatheter bioprosthetic or surgical aortic or mitral bioprosthetic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (ie, predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator) | *Valve and delivery systems are not available for individual sale |
| Edwards Lifesciences | Sapien 3 Transcatheter Heart Valve* With Commander Delivery System | Commander Delivery System | Transfemoral | 14, 16 | 105 | The Edwards Sapien 3, Sapien 3 Ultra, and Sapien 3 Ultra Resilia transcatheter heart valve system is indicated for use in patients with asymptomatic or symptomatic heart disease due to native calcific aortic stenosis at any or all levels of surgical risk for open heart surgery; is indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of an aortic transcatheter bioprosthetic or surgical aortic or mitral bioprosthetic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (ie, predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator) | *Valve and delivery systems are not available for individual sale |
Valves / Transcatheter Pulmonary Valve Repair
View Chart| Company Name | Product Name | Valve Diameter (mm) | Valve Height (mm) | Valve Annulus Size Range (mm) | Valve Frame Material | Valve Leaflet Material | Valve Anticalcification Process | Delivery System Name | Delivery Access | Delivery System Deployment Type | Delivery System Size (F) | Delivery System Working Length (cm) | CE Mark Indications | Comments |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Edwards Lifesciences | Sapien 3 Transcatheter Heart Valve | 20, 23, 26, 29 | 15.5, 18, 20, 22.5 | 16.5–29 | Cobalt chromium | Bovine pericardium | Yes | Commander Delivery System | Venous access | Balloon expandable | 14, 16 including provided sheath | 105 | Indicated for patients with dysfunctional, previously repaired or replaced noncompliant right ventricular outflow tract/pulmonary valve (RVOT/PV) or previously implanted valve in the pulmonic position | – |
| Edwards Lifesciences | Sapien 3 Transcatheter Heart Valve With the Alterra Adaptive Prestent | 29 | 49 | 27–38 | Nitinol for the Alterra Adaptive Prestent and cobalt chromium for the valve | Bovine pericardium | Yes | Alterra Delivery System for the Alterra adaptive prestent followed by the Pulmonic Delivery System for the Sapien 3 valve | Venous | Self expanding followed by balloon expandable | 16 for the Alterra Delivery System and 28 for the Pulmonic Delivery system including inline sheath | 105 for the Alterra Delivery System and 112 for the Pulmonic Delivery System | Indicated for use in the management of pediatric and adult patients with severe pulmonary regurgitation as measured by echocardiography who have a native or surgically repaired right ventricular outflow tract and are clinically indicated for pulmonary valve replacement | – |
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