Device Dossier

Impella CP with SmartAssist Set - Intracardiac circulatory assist axial-pump catheter

Device Dossier for Impella CP with SmartAssist Set - Intracardiac circulatory assist axial-pump catheter (Intracardiac circulatory assist axial-pump…

Intended purpose

The Set provides the Impella CP® with SmartAssist heart pump and devices for inserting, placing and rinsing the pump. The Impella CP® with SmartAssist pump is a intracardiac pump for supporting the left ventricle; it is intended for clinical use in cardiology and in cardiac surgery for up to 5 days for supporting the native heart in patients with reduced left ventricular function.

Functional description

The set consists of 1 Impella CP with SmartAssist heart pump, 1 introducer Kit for femoral access, 1 guidewire to place the pump and 1 purge cassette to rinse the pump after it has been properly placed and connected to the Controller (not included)

TGA Public Summary