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Transcatheter Aortic Valve Implantation
13 products
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| Compare | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NVT AG | Allegra TAVI System TF | 23, 27, 31 | 37.3, 41.3, 43 | 19–28 | Nitinol | Bovine pericardium | Yes | Allegra Delivery System TF | Transfemoral | Self expanding | Cartridge: 18; catheter shaft: 15 | 115 | Yes | – | |
| Medtronic | CoreValve Evolut Pro Transcatheter Aortic Valve Implantation System | 23, 26, 29 | 45 | 18–26 | Nickel titanium (nitinol) | Porcine pericardium | Yes | EnVeo R Delivery System | Transfemoral, subclavian, direct aortic | Self expanding | 16 F (6.7 mm OD) | 107 | – | – | |
| Medtronic | CoreValve Evolut R Transcatheter Aortic Valve Implantation System | 23, 26, 29, 34 | 45 | 18–30 | Nickel titanium (nitinol) | Porcine pericardium | Yes | EnVeo R Delivery System | Transfemoral, subclavian, direct aortic | Self expanding | 14 F (6 mm OD) for 23, 26, 29 mm; 16 F (6.7 mm OD) for 34 mm | 107 | – | – | |
| Medtronic | Evolut FX Transcatheter Aortic Valve Implantation System | 23, 26, 29, 34 | 45 | 18–30 | Nickel titanium (nitinol) | Porcine pericardium | Yes | Evolut FX delivery catheter system with InLine sheath | Transfemoral, subclavian, direct aortic, transaortic, transaxillary/subclavian, transcarotid | Self expanding | 14 F equivalent (6-mm capsule outer diameter); 18 F equivalent (7.33-mm capsule outer diameter) | 108 | – | – | |
| Medtronic | Evolut FX+ transcatheter Aortic Valve Implantation System | 23, 26, 29, 34 | 45 | 18–30 | Nickel titanium (nitinol) | Porcine pericardium | Yes | Evolut FX delivery catheter system with InLine sheath | Transfemoral, subclavian, direct aortic, transaortic, transaxillary/subclavian, transcarotid | Self expanding | 14 F equivalent (6-mm capsule outer diameter); 18 F equivalent (7.33-mm capsule outer diameter) | 108 | – | – | |
| Medtronic | Evolut Pro+ Transcatheter Aortic Valve Implantation System | 23, 26, 29, 34 | 45 | 18–30 | Nickel titanium (nitinol) | Porcine pericardium | Yes | Evolut PRO+ delivery catheter system with InLine sheath | Transfemoral, subclavian, direct aortic, transaortic, transaxillary/subclavian, transcarotid | Self expanding | 14 F equivalent (6-mm capsule outer diameter); 18 F equivalent (7.33-mm capsule outer diameter) | 107 | – | – | |
| Abbott | Navitor TAVI System | 23, 25, 27, 29 | 47–48 | 19–27 | Nitinol | Bovine pericardium | Linx AC Technology | FlexNav Delivery System | Transfemoral and subclavian/axillary | Self-expanding | 14, 15 (ID) | 107 | High/extreme | – | |
| Abbott | Portico With FlexNav TAVI System | 23, 25, 27, 29 | 47–51 | 19–27 | Nitinol | Bovine pericardium | Linx AC Technology | FlexNav Delivery System | Transfemoral and subclavian/axillary | Self-expanding | 14, 15 (ID) | 107 | High/extreme | – | |
| 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 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 | |
| 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 |
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