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EUROPEAN Device Guide / Transcatheter Mitral Valve Repair

Company Name Product Name Delivery System Name Delivery Access Delivery System Size (F) Delivery System Working Length (cm) CE Mark Indications Comments
Cardiac Dimensions Europe GmbH Carillion Mitral Contour System Internal jugular vein 10
Edwards Lifesciences 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
Mitralign Mitralign System Transaortic 14
Edwards Lifesciences Sapien 3 Transcatheter Heart Valve* With Certitude Delivery System Certitude Delivery System Transapical 18, 21 55 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 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 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 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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