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Impella 2.5®

Smaller access for unloading the left ventricle

Overview

The Impella 2.5 heart pump is FDA-approved to provide hemodynamic stability during a Protected PCI procedure. It is also FDA-approved for the treatment of acute myocardial infarction (AMI) cardiogenic shock.

This left-sided device is delivered across the aortic valve, generating forward blood flow in the ascending aorta and directly unloading pressure and volume.    

  • Inserted percutaneously and unloads blood from the left ventricle into the ascending aorta
  • Maintains up to 2.5 L/min of blood flow during a procedure

Indication and Safety Information EU

INDICATIONS FOR USE 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

CONTRAINDICATIONS EU

· 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

POSSIBLE COMPLICATIONS EU

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-3062