Ventricular Assist device Impella 2.5 model 0046-3061 - Intracardiac circulatory assist axial-pump catheter

Intended purpose

‘The Impella® (intracardiac pump for supporting the left ventricle) is intended for clinical use in cardiology and in cardiac surgery for up to 5 days for the following indications, as well as others: The Impella® is a circulatory support system for patients with reduced left ventricular function, eg, postcardiotomy, low output syndrome, cardiogenic shock after acute myocardial infarction, or for myocardial protection after acute myocardial infarction. The Impella® may also be used as a cardiovascular support system during coronary bypass surgery on the beating heart, particularly in patients with limited preoperative ejection fraction with a high risk of postoperative low output syndrome. Support during high-risk percutaneous coronary intervention (PCI) Post-PCI’

Functional description

The Impella® Catheter is an intravascular microaxial blood pump that supports a patient’s circulatory system. It is inserted percutaneously through the femoral artery and into the left ventricle.When properly positioned, the Device delivers blood from the inlet area, which sits inside the left ventricle, through the cannula, to the outlet opening in the ascending aorta. Correct positioning and functioning of the Device can be monitored on the display screen of the Automated Impella® Controller.