Impella 5.5®

with SmartAssist®
A heart pump designed for surgeons with forward flow and intelligent patient management

Overview

Impella 5.5 with SmartAssist delivers full cardiac support with maximum unloading, allowing the heart to rest and recover.

It is a microaxial, surgically implanted heart pump that unloads the left ventricle, reduces ventricular work, and provides the circulatory support necessary to allow recovery and early assessment of residual myocardial function. It is designed for long-duration support and enables ambulation to optimize recovery while using real-time SmartAssist intelligence.

Designed to Improve Outcomes with Real-Time Intelligence

 

Impella 5.5 with SmartAssist Heart Pump Axillary Insertion Animation

Learn more about the axillary insertion of the Impella 5.5 with SmartAssist heart pump.

 

Impella 5.5 with SmartAssist Heart Pump Direct Aortic Insertion

Learn more about the direct aortic insertion of the Impella 5.5 with SmartAssist heart pump.

Indications for Use EU

INDICATIONS FOR USE EU

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 EU

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 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
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-3056