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Transcatheter Aortic Valve Replacement
10 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) | US FDA Indicated Use | Comments |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Medtronic | Evolut FX Transcatheter Aortic Valve Replacement System | 23, 26, 29, 34 | 45 | 17/18–30 (CT derived diameters, 17 for TAV-in-SAV only) | Nickel titanium (nitinol) | Porcine pericardium | Yes | Evolut FX Delivery System | Transfemoral, direct aortic, subclavian, transcarotid | Self expanding | 14 equivalent/6 mm (23, 26, 29 mm); 18 equivalent/7.3 mm (34 mm) | 108 | 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 and for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (ie, STS predicted risk of operative mortality score ≥ 8% or at a ≥ 15% risk of mortality at 30 days) | The TAV frame contains embedded gold markers located 3 mm from the inflow and positioned under the commissures | |
| Medtronic | Evolut FX+ Transcatheter Aortic Valve Replacement System | 23, 26, 29, 34 | 45 | 17/18–30 (CT derived diameters, 17 for TAV-in-SAV only) | Nickel titanium (nitinol) | Porcine pericardium | Yes | Evolut FX Delivery Catheter System | Transfemoral, direct aortic, subclavian, transcarotid | Self expanding | 14-F equivalent/6 mm (23, 26, 29 mm); 18-F equivalent/7.3 mm (34 mm) | 108 | 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 and for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (ie, STS predicted risk of operative mortality score ≥ 8% or at a ≥ 15% risk of mortality at 30 days) | The TAV frame contains embedded gold markers located 3 mm from the inflow and positioned under the commissures; the Evolut FX+ valve is also designed with three windows that are four times larger to enable access to coronaries | |
| 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, subclavian/axillary, transaortic | Self expanding | 14, 15 (ID) | 107 | High/extreme | – | |
| 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 | 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 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 | |
| Edwards Lifesciences | Sapien 3 Ultra Transcatheter Heart Valve With Certitude Delivery System | 20, 23, 26 | 15.5, 18, 20 | 16–28 (diameter by TEE), 18.6–29.5 (area derived diameter) | Cobalt chromium | Bovine pericardium | Yes | 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 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 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 | 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 | |
| JenaValve Technology, Inc. | Trilogy Transcatheter Heart Valve System | 23, 25, 27 | 32, 34, 36 | 66–90 | Nitinol | Porcine pericardium | – | Trilogy Delivery System | Femoral | Single action | 20 (OD) | 126 | Indicated for the treatment of symptomatic, severe native tricuspid aortic valve regurgitation (not due to acute endocarditis, rheumatic heart disease, or acute aortic dissection) in patients who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for surgical aortic valve replacement (ie, 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) | Sizing provided for all sizes of the Trilogy Valve and Delivery System; the Annular Perimeter Range is listed for all valve sizes in the “Valve Annulus Size Range” field |
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