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® with SmartAssist® 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 29 days for the following indications, as well as others:

• The Impella 5.5 with SmartAssist heart pump is a cardiovascular support system for patients with acutely reduced left ventricular function, e.g. low output syndrome, cardiogenic shock after acute myocardial infarction.
• The Impella 5.5 with SmartAssist heart pump is also a temporary support system for patients in need of circulatory support due to chronically reduced left ventricular function, e.g. for bridging patients with chronic heart failure to implantable assist device, heart transplantation, or myocardial recovery / stabilization.
• The Impella 5.5 with SmartAssist heart pump may also be used as a cardiovascular support system during cardiological interventions or heart surgery (e.g. coronary bypass surgery), particularly in patients with limited preoperative ejection fraction with a high risk of postoperative low output syndrome, or in cases of difficulties to wean from heart-lung machine support.

CONTRAINDICATIONS

Impella 5.5 with SmartAssist Heart Pump is contraindicated in the following situations:
• Mechanical aortic valves, severe aortic valvular stenosis
• 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

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 vertricular perforation)
• Positioning problems causing hemolysis 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

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