Impella 5.5® with SmartAssist®

Minimally invasive heart pump with intelligent technology to improve patient outcomes with peak flows up to 5.5 L/min

Overview

The Impella 5.5 with SmartAssist heart pump delivers full cardiac support, allowing the heart to rest and enabling the heart to achieve its natural pumping function without additional support. This heart pump is designed for long-duration support, enables patient mobility and optimizes recovery by using real-time intelligence.

For Patients Experiencing

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.

Post-Cardiotomy Cardiogenic Shock

Post-cardiotomy cardiogenic shock is a life-threatening situation that may develop after surgical procedure on the heart.

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Visit heartrecovery to access instructions for use and other clinical materials.

Indication and Safety Information EU

INDICATIONS FOR USE

The Impella 5.5 heart pump is an intracardiac pump for supporting the left ventricle. It is intended for clinical use in cardiology and in cardiac surgery for up to 30 days for the following
indications, as well as others:
• The Impella 5.5 is a cardiovascular support system for patients with reduced left ventricular function, e.g., post-cardiotomy, low output syndrome, cardiogenic shock after acute myocardial infarction.
• The Impella 5.5 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.

CONTRAINDICATIONS

Impella 5.5 with SmartAssist Heart Pump is contraindicated in the following situations:
• 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
• Ventrikelseptumdefekt (VSD) nach Myokardinfarkt
• 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:
· 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
In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices.
For more information please see the Instructions for Use Manuals.

IMP-3016