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EUROPEAN Device Guide / Catheter-Based Cardiac Assist Devices

Company Name Product Name Max Flow Rate (L/m) Catheter Size (F) Pump Size (F) Surface Across Valve Insertion Method Duration of Support CE Mark Indications
Abiomed, Inc. Impella 2.5 2.5 9 12 Smooth Percutaneous via femoral artery ≤ 5 days or as needed for patient Circulatory support for patients with reduced left ventricular function; cardiovascular support during or after high-risk PCI; cardiovascular support during coronary bypass surgery
Abiomed, Inc. Impella 5.0 5 9 21 Smooth Peripheral via arterial cut-down ≤ 10 days or as needed for patient Cardiovascular support for patients with reduced left ventricular function; cardiovascular support during coronary bypass surgery
Abiomed, Inc. Impella 5.5 with SmartAssist > 6 9 21 Cannula Axillary and direct aortic insertion 30 days Clinical use in cardiology and cardiac surgery for patients with reduced left ventricular function; postcardiotomy, low output syndrome, and cardiogenic shock after acute myocardial infarction
Abiomed, Inc. Impella CP 4.3 9 14 Smooth Percutaneous via femoral artery ≤ 5 days or as needed for patient Circulatory support for patients with reduced left ventricular function; cardiovascular support during or after high-risk PCI; cardiovascular support during coronary bypass surgery
Abiomed, Inc. Impella LD 5 9 21 Smooth Direct, surgical insertion ≤ 10 days or as needed for patient Cardiovascular support for patients with reduced left ventricular function; cardiovascular support during coronary bypass surgery
Abiomed, Inc. Impella RP 4 11 22 Smooth Percutaneous via femoral vein ≤ 14 days or as needed for patient Reduced right ventricular function; cardiogenic shock after posterior MI with RV failure; right heart support during coronary bypass surgery
Terumo Europe iVAC2L - pVAD (PulseCath B.V.) 2 17 Extracorporeal membrane pump 45 cc Smooth nitinol braided catheter shaft Percutaneous via femoral artery through Solopath Recollapsible Balloon-Expandable Access System 24 hours Intended for use in patients with impaired left ventricular function that requires left ventricular mechanical circulatory support

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