Edwards Cardioband Mitral Valve Reconstruction System
Transseptal Steerable Sheath
Transseptal
25.5
82
Indicated for the reconstruction and/or remodeling of pathological mitral valves
Implant and delivery system are not available for individual sale
Edwards Lifesciences
Edwards Pascal Transcatheter Valve Repair System
Pascal Delivery System
Transfemoral
22 (septal crossing OD)
79
–
–
Abbott
MitraClip Percutaneous Mitral Valve* Repair System
Steerable Guide Catheter
Transfemoral
22 (septal crossing diameter), 24 (OD)
80
–
*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 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 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 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; is 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
Advertisement
Advertisement
We value keeping the Device Guide up to date.
If you want to add or update your company’s device listings, please let us know!