Abiomed Impella 5.5 Manuel Utilisateur page 6

INTENDED USE
The Impella 5.5 with SmartAssist ®
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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
The Impella 5.5 with SmartAssist ®
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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:
• Hemolysis
• Bleeding
• Immune reaction
• Embolism, thrombosis
• Vascular injury through to angionecrotomy
• 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
2
heart pump is an intracardiac pump for
heart pump is contraindicated for the
OVERVIEW
The Impella 5.5 Catheter is an intravascular microaxial blood pump that
supports a patient's hemodynamic system. The Impella 5.5 Catheter is
inserted via axillary artery cut-down through the artery and into the left
ventricle. The Impella 5.5 Catheter may also be surgically inserted when
there is access to the ascending aorta through a sternotomy or thoracotomy.
When properly positioned, the Impella 5.5 Catheter delivers blood from
the inlet area, which sits inside the left ventricle, through the cannula, to
the outlet opening in the ascending aorta. Physicians and device operators
monitor the correct positioning and functioning of the Impella 5.5 Catheter
on the display screen of the Automated Impella Controller.
The clinical benefit of the Impella 5.5 with SmartAssist is described in the
Summary of Safety and Clinical Performance (SSCP) and can be accessed in
EUDAMED (when operational) or requested from Abiomed Europe GmbH.
This section describes the components of the Impella
Automated Impella Controller, as well as the accessory components.
REUSABLE SYSTEM COMPONENTS
The Impella 5.5 System consists of the following reusable components:
• Automated Impella Controller—provides the user interface, alarm
indications, and portable battery
• Automated Impella Controller cart—for easy transport of the Automated
Impella Controller
SINGLE-USE SYSTEM COMPONENTS
The Impella 5.5 with SmartAssist System also includes the following single-
use components:
• Impella 5.5 with SmartAssist Catheter
• Purge cassette
• 0.018 inch, 260 cm placement guidewire
• (1) Introducer
• (2) Graft locks
• Silicone Plugs
• Incision template
SYSTEM CONFIGURATION
Catheter and the
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User Manual