Device Dossier

Ventricular assist device - Impella 5.0 Model 004680 - Intracardiac circulatory assist axial-pump catheter

Device Dossier for Ventricular assist device - Impella 5.0 Model 004680 - Intracardiac circulatory assist axial-pump catheter (Intracardiac circulatory…

Intended purpose

The Impella 5.0 heart pump is an intracardiac pump for supporting the left ventricle;it is intended for clinical use in cardiology and cardiac surgery for up to 10 days for supporting the heart in patients with reduced left ventricular function.

Functional description

The Impella 5.0 is an intravascular microaxial blood pump that supports a patient's circulatory system. The Impella 5.0 is inserted via femoral or axillary artery cut-down through the artery and into the left ventricle(LV). The Impella 5.0 delivers blood from the inlet area,which sits inside the LV,through the cannula,to the outlet opening in the ascending aorta.The Impella 5.0 pump reduces the workload of the heart as it continuously draws blood from the LV.

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