Coronary Balloon Dilatation Catheter - Vascular essential Instructions D'utilisation

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PACLITAXEL ELUTING CORONARY BALLOON DILATATION CATHETER
1. Description of the product
The paclitaxel eluting coronary balloon dilatation catheter is a rapid exchange catheter, also known as RX
because it has a proximal simple lumen configuration and a distal coaxial dual lumen, intended for coronary
arteries percutaneous transluminal angioplasties.
At the distal end of the catheter, before the tip, is the balloon or segment inflatable to different pressures
which dilates the artery when inflated by means of an infusion of contrast liquid inside it. The balloon is
designed to provide an inflatable segment of known diameter and length at the pressures recommended.
The catheter ends in a cone-shaped tip.
The body of the catheter features a combination of a single lumen at the proximal end and dual lumen at
the distal end.
- The single lumen at the proximal end allows contrast liquid to pass through between the proximal
luer-lock connector and the balloon in order to inflate the balloon. This lumen is connected to the distal
contrast liquid lumen at the end of the balloon.
- The coaxial dual lumen at the distal end has two functions:
• a lumen to carry the contrast liquid used to inflate the balloon, connected to the proximal lumen
• the guide wire passes through the other lumen to facilitate and allow the passage of the catheter
towards and through the stenosis to be dilated.
There are marks in the catheter's shaft that help the operator to estimate the catheter's position in relation
to the tip of the guide catheter (the marker located closer to the catheter connector is for femoral guide
catheters and the farthest one is for brachial guide catheters
The maximum diameter of the guide wire must be no more than 0.36 mm = 0.014".
The balloon is coated with the drug Paclitaxel, included in a physiologically inocuous matrix. The drug's
dose is 3 micrograms / mm2 of balloon surface and it is intended to avoid cellular proliferation, consequently
decreasing the re-intervention rate.
The drug is released from the balloon by means of a rapid inflation in a way so that a high dose of the drug
is released in a very short period of time. For releasing the drug onto the artery wall, the inflation process
must last from 30 seconds to 1 minute, but dilation of the lesion must be optimized by using longer inflation
times at the operator's discretion.
The catheter's useful length is 142 cm.
The product has the following balloon diameters and lengths.
1,5
2,0
2,25
2,5
2,75
3,0
3,25
3,5
3,75
4,0
4,25
4,5
The balloon is preset to reach different diameters at different pressures (according to the compliance curve
shown on the primary packaging).
To inflate the balloon, the proximal luer-lock connector must be connected to a manual pump fitted with a
INSTRUCTIONS FOR USE
BALLOON LENGTH (mm)
10 15
X X
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20 25
X
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X X
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essential
30 40
X
X X
X X
X X
X X
X X
X X
X X
X X
X X
X X
X X
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