Abiomed Impella 2.5, Instructions For Use Manual

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3.7 Impella
®
System for Use During Cardiogenic Shock 3.7
Table 3.3 Impella ® Catheter Components
Component Description
Pigtail The 6 Fr pigtail is attached to the cannula at the distal end of the inlet
area. It assists with stabilizing the Impella
®
2.5, 5.0, and Impella CP
®
Catheters in the correct position in the left ventricle.
Inlet area The inlet area, located at the distal tip of the cannula, has four
openings (windows) (five for the Impella ® 5.0 and LD) that allow blood
to be drawn into the inlet and channeled through the cannula.
Radiopaque marker The radiopaque marker on the catheter shaft of the Impella
®
2.5 and
Impella CP
®
Catheters is visible with fluoroscopy and, when properly
positioned, appears at the level of the aortic valve annulus.
Cannula The cannula (12 Fr for the Impella ® 2.5, 14 Fr for the Impella CP ® , 21
Fr for the Impella
®
5.0 and LD) has a spiral-shaped reinforced body
that is angled for the Impella ® 2.5, 5.0 and Impella CP ® Catheters
and straight for the Impella
®
LD. The cannula is made of nitinol and
covered in polyurethane.
Differential pressure
sensor
This sensor on the Impella
®
5.0 and LD Catheters measures the
pressure difference between the inside and outside of the cannula.
The pressure value is used for positioning during placement and for
monitoring flow and position during catheter operation.
Outlet area The proximal end of the cannula is attached to the outlet area where
the blood exits the cannula.
EasyGuide lumen The red loading lumen on the Impella
®
2.5 and Impella CP
®
runs from
the tip of the pigtail through the outlet area of the cannula to facilitate
loading the catheter onto the guidewire
Motor housing The motor housing (12 Fr for the Impella ® 2.5, 14 Fr for Impella CP ® ,
21 Fr for Impella
®
5.0 and LD) consists of an encapsulated motor.
Silicone plugs The two silicone plugs on the catheter shaft of the Impella
®
LD help
control bleeding during and after the Impella
®
LD Catheter insertion
process and while advancing the catheter through the Dacron
®
vascular graft.
Open pressure area The open pressure area on the Impella
®
2.5 and Impella CP
®
Catheters
is an opening located between the motor housing and the distal end of
the catheter shaft.
Catheter shaft A 9 Fr catheter shaft is located between the motor housing and the
red Impella
®
plug. The lumen of the catheter shaft contains a purge
lumen, a pressure measurement lumen (Impella
®
2.5 and Impella CP
®
),
a nitinol wire, and an electrical cable.
The catheter shaft has longitudinal and transversal marks:
• The longitudinal mark along the inner radius shows correct position
of the placement guidewire once backloaded on the Impella
®
Catheter.
• The transversal marks at 1 cm intervals with numbers every 5 cm
aid in proper positioning.
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