Impella CP with SmartAssist 2000640 - Intracardiac circulatory assist axial-pump catheter

Intended purpose

Impella CP with SmartAssist is an 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 the following indications, as well as others: • Circulatory support system for patients with reduced left ventricular function, eg, post-cardiotomy, low output syndrome, cardiogenic shock after acute myocardial infarction, or for myocardial protection after acute myocardial infarction • Cardiovascular support system during coronary bypass surgery on the beating heart, particularly in patients with limited pre-operative ejection fraction with a high-risk of post-operative low output syndrome • Support during high-risk percutaneous coronary intervention (PCI) • Post-PCI

Functional description

Impella CP with SmartAssist is an intravascular microaxial blood pump that supports a patient’s circulatory system. It is inserted percutaneously through the femoral or axillary artery into the left ventricle. It draws blood from the inflow area in the left ventricle, through the cannula, to the outflow area in the ascending aorta. The pump reduces the workload of the heart via direct unloading of the left ventricle.