Cross section of a heart with Impella 5.0 on navy blue background

Impella 5.0®

Minimally invasive or surgically inserted heart pumps with a flow rate up to 5.0 L/min

Overview

Impella 5.0 is a temporary, minimally invasive heart pump that provides circulatory support, enabling the heart to rest and recover. The heart pump allows patients to walk around while on support to improve recovery, if inserted via the axillary artery near the shoulder. Impella 5.0 allows for the opportunity to provide longer duration of support for critically ill patients and a longer period to assess heart recovery.

 

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

Indication and Safety Information EU

INDICATIONS FOR USE

The Impella 5.0® (intracardiac pump for supporting the left ventricle) is intended for clinical use in cardiology and in cardiac surgery for up to 10 days for the following indications, as well as others:
· The Impella 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 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

There are risks of complications with every procedure using a blood pump. These include among others:
· 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:
· 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-3030