
Impella 2.5®
Therapies & Conditions
Indication and Safety Information EU
Impella 2.5®, Impella CP® , Impella CP with SmartAssist®: 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, e.g., post-cardiotomy, 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
· Mechanical aortic valves, severe aortic valvular stenosis or valvular regurgitation
· Hematological disorder causing fragility of the blood cells or hemolysis
· Hypertrophic obstructive cardiomyopathy (HOCM)
· Aneurysm or necrotomy or severe anomaly of the ascending aorta and / or the aortic arch
· Mural thrombus in the left ventricle
· Ventricular septal defect (VSD) after myocardial infarction
· Anatomic conditions precluding insertion of the pump
· Other illnesses or therapy requirements precluding use of the pump
· Severe peripheral arterial occlusion disease (PAOD) is a relative contraindication
There are risks of complications with every procedure using a blood pump. These include among others:
· Hemolysis
· Bleeding
· Immune reaction
· Embolism, thrombosis
· Vascular injury through to angionecrotomy
· Positioning problems
· Infection and septicemia
· Dislocation of the pump
· Cardiovalvular injuries due to extreme movement of the suction cannula in relation to the cardiac valve or as a result of attachment by suction of the pump to the valve system following incorrect positioning
· Endocardiac injuries as a result of attachment of the pump due to suction
· Pump failure, loss of pump components following a defect
· Patient dependency on the pump after use for support
IMP-1811