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Edwards Lifesciences
One Edwards Way, Irvine, CA 92614
PHONE: (949) 250-2500 | FAX: (949) 756-4656
Valves / Transcatheter Aortic Valve Replacement
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) | US FDA Indicated Use | Comments |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Edwards Lifesciences | Sapien 3 Transcatheter Heart Valve* With 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 | Certitude Delivery System | Transapical | Balloon expandable | 18, 21 | 55 | The Edwards Sapien 3, Sapien 3 Ultra, and Sapien 3 Ultra Resilia Transcatheter Heart Valve system is indicated to reduce the risks associated with progression from asymptomatic to symptomatic severe native calcific aortic stenosis in patients who are judged by a heart team to be appropriate for transcatheter heart valve replacement therapy; 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; indicated for patients with symptomatic heart disease due to a failing (stenosed, insufficient, or combined) surgical or transcatheter bioprosthetic aortic 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 (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); indicated for patients with symptomatic heart disease due to a failing (stenosed, insufficient, or combined) surgical bioprosthetic mitral valve who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (ie, predicted risk of surgical mortality ≥ 4% 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 | 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 | 14, 16 | 105 | The Edwards Sapien 3, Sapien 3 Ultra, and Sapien 3 Ultra Resilia Transcatheter Heart Valve system is indicated to reduce the risks associated with progression from asymptomatic to symptomatic severe native calcific aortic stenosis in patients who are judged by a heart team to be appropriate for transcatheter heart valve replacement therapy; 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; indicated for patients with symptomatic heart disease due to a failing (stenosed, insufficient, or combined) surgical or transcatheter bioprosthetic aortic 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 (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); indicated for patients with symptomatic heart disease due to a failing (stenosed, insufficient, or combined) surgical bioprosthetic mitral valve who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (ie. predicted risk of surgical mortality ≥ 4% 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 to reduce the risks associated with progression from asymptomatic to symptomatic severe native calcific aortic stenosis in patients who are judged by a heart team to be appropriate for transcatheter heart valve replacement therapy; 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; indicated for patients with symptomatic heart disease due to a failing (stenosed, insufficient, or combined) surgical or transcatheter bioprosthetic aortic 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 (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); indicated for patients with symptomatic heart disease due to a failing (stenosed, insufficient, or combined) surgical bioprosthetic mitral valve who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (ie, predicted risk of surgical mortality ≥ 4% 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) | US FDA Indicated Use | Comments |
|---|---|---|---|---|---|---|---|
| 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 to reduce the risks associated with progression from asymptomatic to symptomatic severe native calcific aortic stenosis in patients who are judged by a heart team to be appropriate for transcatheter heart valve replacement therapy; 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; indicated for patients with symptomatic heart disease due to a failing (stenosed, insufficient, or combined) surgical or transcatheter bioprosthetic aortic 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 (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); indicated for patients with symptomatic heart disease due to a failing (stenosed, insufficient, or combined) surgical bioprosthetic mitral valve who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (ie, predicted risk of surgical mortality ≥ 4% 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 to reduce the risks associated with progression from asymptomatic to symptomatic severe native calcific aortic stenosis in patients who are judged by a heart team to be appropriate for transcatheter heart valve replacement therapy; 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; indicated for patients with symptomatic heart disease due to a failing (stenosed, insufficient, or combined) surgical or transcatheter bioprosthetic aortic 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 (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); indicated for patients with symptomatic heart disease due to a failing (stenosed, insufficient, or combined) surgical bioprosthetic mitral valve who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (ie, predicted risk of surgical mortality ≥ 4% 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) | US FDA Indicated Use |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Edwards Lifesciences | Sapien 3 Transcatheter Heart Valve | 20, 23, 26, 29 | 15.5, 18, 20, 22.5 | 16.5–29 (by diameter) | Cobalt chromium | Bovine pericardium | Yes | Commander Delivery System | Venous access | Balloon expandable | 14, 16 including provided sheath | 105 | The Edwards Sapien 3, Sapien 3 Ultra, and Sapien 3 Ultra Resilia Transcatheter Heart Valve system is indicated to reduce the risks associated with progression from asymptomatic to symptomatic severe native calcific aortic stenosis in patients who are judged by a heart team to be appropriate for transcatheter heart valve replacement therapy; 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; indicated for patients with symptomatic heart disease due to a failing (stenosed, insufficient, or combined) surgical or transcatheter bioprosthetic aortic 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 (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); indicated for patients with symptomatic heart disease due to a failing (stenosed, insufficient, or combined) surgical bioprosthetic mitral valve who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (ie, predicted risk of surgical mortality ≥ 4% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator) |
| 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 |
Valves / Transcatheter Tricuspid Valve Interventions
View Chart| Company Name | Product Name | Valve Size Options (mm) | Valve Height/Profile (mm) | Annulus Size Range (mm) | Frame Material | Leaflet Material | Leaflet Treatment | Delivery System | Access Route(s) | Deployment Mechanism | Delivery System Size (F) | Working Length (cm) | US FDA Indicated Use |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Edwards Lifesciences | Evoque | 44, 48, 52 | 18–22 | 36–52 | Nitinol | Bovine pericardium | Anti-calcification coating | Evoque DS | Transfemoral, transjugular | Self-expanding, repositionable | 28 | 105 | – |
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