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US Device Guide / Transcatheter Mitral Valve Repair

Company Name Product Name Delivery System Name Delivery Access Delivery System Size (F) Delivery System Working Length (cm) US FDA Indicated Use Comments
Abbott 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 Indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic mitral 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 STS risk score and other clinical comorbidities unmeasured by the Society of Thoracic Surgeons [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 patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic mitral 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 STS risk score and other clinical comorbidities unmeasured by the Society of Thoracic Surgeons [STS] risk calculator) *Valve and delivery systems are not available for individual sale

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