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EUROPEAN Device Guide / Transcatheter Aortic Valve Implantation

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
Boston Scientific Corporation Acurate neo Aortic Valve System S-23, M-25, L-27 48–51 Aortic annulus diameter:* 21–23, 23–25, 25–27; aortic annulus perimeter: 66–72, 72–79, 79–85 Nitinol Porcine pericardium BioFix† Acurate TF Transfemoral Delivery System, Acurate neo Transapical Delivery System Delivery catheter Phased top-down deployment Transfemoral delivery system: 18 (6 mm) with Lotus transfemoral introducer sheath (small); 14 (≥ 5.5 mm) with iSleeve expandable introducer set; Transapical delivery system: sheathless access; shaft outer diameter = 19; valve housing outer diameter = 22 Usable length transfemoral delivery system = 109; usable length transapical delivery system = 32 Yes *CT-based measurement; perimeter-derived annulus; †no clinical data are available that evaluate the long-term impact of the BioFix tissue treatment in patients
Boston Scientific Corporation Acurate neo Transapical Delivery System S-23, M-25, L-27 48–51 Aortic annulus diameter:* 21–23, 23–25, 25–27; aortic annulus perimeter: 66–72, 72–79, 79–85 Nitinol Porcine pericardium BioFix† Acurate neo Transapical Delivery System Low diameter delivery catheter Phased top-down deployment Transapical delivery system: sheathless access; shaft outer diameter = 19; valve housing outer diameter = 22 Usable length transapical delivery system = 32 Yes *CT-based measurement; perimeter-derived annulus; †no clinical data are available that evaluate the long-term impact of the BioFix tissue treatment in patients
Boston Scientific Corporation Acurate TF Transfemoral Delivery System S-23, M-25, L-27 48–51 Aortic annulus diameter:* 21–23, 23–25, 25–27; aortic annulus perimeter: 66–72, 72–79, 79–85 Nitinol Porcine pericardium BioFix† Acurate TF Transfemoral Delivery System Flexible delivery catheter Phased top-down deployment Transfemoral delivery system: 18 (6 mm) with Lotus transfemoral introducer sheath (small); 14 (≥ 5.5 mm) with iSleeve expandable introducer set Usable length transfemoral delivery system = 109 Yes *CT-based measurement; perimeter-derived annulus; †no clinical data are available that evaluate the long-term impact of the BioFix tissue treatment in patients
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 (20-F 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 (18-F OD; 23, 26, 29 mm only), 16 (20-F OD; 34 mm only) 107
Medtronic CoreValve Transcatheter Aortic Valve Implantation System 23, 26, 29, 31 45, 49, 50, 52 18–29 Nickel titanium (nitinol) Porcine pericardium Yes Accutrak Delivery System Transfemoral, subclavian, direct aortic Self expanding 18 107
Abbott Portico 23–29 49–53 19–27 Nitinol Bovine pericardium Linx anticalcification treatment Portico Delivery System Transfemoral Self expanding 18, 19 (OD) 110
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 *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 *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 Certitude Delivery System Transapical, transaortic Balloon expandable 18, 21 55 (1) Indicated for use in patients with severe, symptomatic, calcific aortic valve stenosis who are judged by a heart team, to be at intermediate or greater risk for open surgical therapy (ie, predicted risk of surgical mortality ≥ 3% at 30 days, based on the Society of Thoracic Surgeons [STS] risk score and other clinical comorbidities unmeasured by the STS risk calculator); (2) indicated for use in patients with symptomatic heart disease due to a failing aortic bioprosthetic valve or a failing mitral surgical bioprosthetic valve (stenosed, insufficient, or combined) who are judged by a heart team to be at high or greater risk for open surgical therapy (ie, predicted risk of surgical mortality ≥ 8% at 30 days, based on the 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 14, 16 105 (1) Indicated for use in patients with severe, symptomatic, calcific aortic valve stenosis who are judged by a heart team, to be at intermediate or greater risk for open surgical therapy (ie, predicted risk of surgical mortality ≥ 3% at 30 days, based on the Society of Thoracic Surgeons [STS] risk score and other clinical comorbidities unmeasured by the STS risk calculator); (2) indicated for use in patients with symptomatic heart disease due to a failing aortic bioprosthetic valve or a failing mitral surgical bioprosthetic valve (stenosed, insufficient, or combined) who are judged by a heart team to be at high or greater risk for open surgical therapy (ie, predicted risk of surgical mortality ≥ 8% at 30 days, based on the 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 XT Transcatheter Heart Valve* With Edwards Ascendra+ Delivery System 23, 26, 29 14.3, 17.2, 19.1 18–27 (diameter by TEE), 16–29 (area derived diameter) Cobalt chromium Bovine pericardium Yes Edwards Ascendra+ Delivery System Transapical/transaortic Balloon expandable 24, 26 55 *Valve and delivery systems are not available for individual sale
Edwards Lifesciences Sapien XT Transcatheter Heart Valve* With Edwards NovaFlex+ Delivery System 20, 23, 26, 29 13.5, 14.3, 17.2, 19.1 16–27 (diameter by TEE), 16–29 (area derived diameter) Cobalt chromium Bovine pericardium Yes Edwards NovaFlex+ Delivery System Transfemoral Balloon expandable 16, 18, 20 105 *Valve and delivery systems are not available for individual sale

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