MitraClip Percutaneous Mitral Valve* Repair System
Steerable Guide Catheter
Transfemoral
Septal crossing diameter: 22 (OD: 24)
80
Indicated for the percutaneous reduction of significant symptomatic MR (≥ 3+) due to primary abnormality of the mitral apparatus (degenerative MR) in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the MR; the Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum; for more information, including important safety information, please visit http://www.abbottvascular.com/static/cms_workspace/pdf/ifu/structural_heart/eIFU_MitraClip.pdf; also indicated for heart failure (HF) patients who have moderate-to-severe functional mitral regurgitation (MR) despite treatment with optimal medical therapy
*Valve and delivery systems are not available for individual sale
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
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