Impella 2.5®

Minimally invasive heart pump with a flow rate up to 2.5 L/min

Overview

The Impella 2.5 heart pump temporarily maintains blood flow during high-risk PCI procedures or cardiogenic shock. It allows the heart to rest and pumps blood to vital organs while the physician treats the underlining disease.

Therapies & Conditions

Protected PCI

Protected PCI, or protected stenting, is a proven and widely accepted procedure using Impella®, the world’s smallest heart pump, to temporarily assist the pumping function of the heart. Impella may enable placement of a stent for patients who are at high risk for complications or have severe heart disease.

Cardiogenic Shock

Cardiogenic shock is a life-threatening situation that occurs when the heart is unable to efficiently pump blood to the organs causing the body to begin to fail. During cardiogenic shock, Impella supports the heart’s pumping function, providing blood and oxygen to vital organs during treatment.

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-1811