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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
Impella 5.5
®
with SmartAssist
Catheter and the
®
®
Circulatory Support System
IMPELLA 5.5
WITH SMARTASSIST
®
CATHETER
The Impella 5.5 with SmartAssist Catheter is an intravascular microaxial blood
pump that delivers up to 5.5 liters of blood per minute from the left ventricle
into the aorta.
PURGE CASSETTE
Do not use saline in the purge system.
The purge cassette delivers rinsing fluid to the Impella 5.5
Catheter. The purge fluid (typically 5% glucose solution with heparin
or sodium hydrogen carbonate) flows from the purge cassette through the
catheter to the microaxial blood pump to prevent blood from entering the
motor.
Purge Fluid Spike
Purge Cassette
Supply Line
®
with SmartAssist
®
Purge Disc
Purge Tubing
Proximal Yellow
Luer Connector
Distal Yellow
Luer Connector
Purge Extension
Line
®
3
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