Impella 5.5 with SmartAssist Set - Intracardiac circulatory assist axial-pump catheter

Intended purpose

The Set provides the Impella 5.5® with SmartAssist® heart pump and devices for inserting, placing and rinsing the pump. The Impella 5.5 with SmartAssist 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 30 days for supporting the heart in patients with reduced left ventricular function.

Functional description

The Impella 5.5 Catheter is an intravascular microaxial blood pump that supports a patient’s hemodynamic system. When properly positioned, the Impella 5.5 Catheter delivers blood from the inlet area, which sits inside the left ventricle, through the cannula, to the outlet opening in the ascending aorta. Physicians and device operators monitor the correct positioning and functioning of the Impella 5.5 Catheter on the display screen of the Automated Impella Controller.