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US Device Guide / Transcatheter Aortic Valve Repair

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 CoreValve Evolut Pro Transcatheter Aortic Valve Replacement System 23, 26, 29 45 17/18–26 (CT derived diameters, 17 for TAV-in-SAV only) Nickel titanium (nitinol) Porcine pericardium Yes EnVeo Delivery System Long and short access (eg, transfemoral, direct aortic, subclavian) Self expanding 16 equivalent 107 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 at intermediate or greater risk for open surgical therapy (ie, predicted risk of surgical mortality at a ≥ 3% at 30 days, based on the STS risk score and other clinical comorbidities unmeasured by the STS risk calculator) 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)
Medtronic CoreValve Evolut R 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 EnVeo Delivery System Long and short access (eg, transfemoral, direct aortic, subclavian) Self expanding 14 equivalent (23, 26, 29 mm); 16 equivalent (34 mm) 107 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 at intermediate or greater risk for open surgical therapy (ie, predicted risk of surgical mortality at a ≥ 3% at 30 days, based on the STS risk score and other clinical comorbidities unmeasured by the STS risk calculator) 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)
Medtronic Evolut Pro+ 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 Pro+ Delivery System Long and short access (eg, transfemoral, direct aortic, subclavian) Self expanding 14 equivalent (23, 26, 29 mm); 18 equivalent (34 mm) 107 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)
Boston Scientific Corporation Lotus Edge Aortic Valve System 23, 25, 27 19 20–27 Braided nitinol Bovine pericardium Yes Lotus Edge Aortic Valve System* Transfemoral and transaortic Controlled expansion 21 (with Lotus Introducer Set [LIS]); 15 (with iSleeve Expandable Introducer Set†) 114 (23 mm, 25 mm); 115 (27 mm) Indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area [AVA] of ≤ 1.0 cm² or index of ≤ 0.6 cm²/m²) who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (ie, predicated risk of surgical mortality ≥ 8% at 30 d, 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; †iSleeve is an Investigational Device, not available for sale
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 (1) 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; (2) indicated for 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, 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 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 (1) 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 to be appropriate for the transcatheter heart valve replacement therapy; (2) indicated for 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, 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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