Impella CP® with SmartAssist®

Minimally invasive heart pump with intelligent technology to improve patient outcomes with peak flows up to 4.3L/min

Overview

The Impella CP with SmartAssist heart pump has been deemed safe and effective by the FDA for use in high-risk PCI procedures and for patients in cardiogenic shock.

It is a minimally invasive, temporary heart pump that uses real-time intelligence to enable better cardiac recovery

For patients with

Protected PCI

Protected PCI is a proven standard procedure in which the Impella® is used for temporary support of the heart's pumping function.

The Impella can facilitate the placement of a stent in patients at high risk of complications or with severe heart disease.

Cardiogenic Shock

Cardiogenic shock is a life-threatening situation that occurs when the heart's inability to function causes organs in the body to begin to fail. During treatment for cardiogenic shock, Impella supports the heart's pumping function, providing blood and oxygen to vital organs.

Indication and Safety Information EU

INDICATIONS FOR USE

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, 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

• 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

There are risks of complications with every procedure using a blood pump.
These include among others:
• Acute renal dysfunction
• Aortic valve injury
• Cardiogenic shock
• Cerebral Vascular Accident/Stroke
• Myocardial infarction
• Renal failure
• Thrombocytopenia
• Hemolysis
• Bleeding
• Limb ischemia
• Immune reaction
• Embolism, thrombosis
• Cardiac or vascular injury (including ventricular perforation)
• Positioning problems causing haemolysis or reduced haemodynamic support
• 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-3017