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BALLOON CATHETER FOR PERIPHERAL PREDILATION,
FOR 0.018" GUIDE WIRE, WITH HYDROPHILIC COATING
1. Description of the Product
The balloon catheter is a coaxial catheter (dual lumen from the connector to the tip, also known as OTW),
designed for percutaneous transluminal angioplasty of peripheral arteries.
The catheter has a coaxial dual-lumen body from the connector to the tip.
On the distal part of the catheter, before the tip, is located the balloon or inflatable segment, to different
pressures. The balloon dilates the artery when is inflated by means of infusion of contrast medium inside it.
The connector is Y-shaped, with two ports:
- The side port allows contrast medium passage to dilate The balloon.
- The straight port is intended for guide wire insertion. The guide wire is inserted through the tip of the
catheter and comes out by the connector port to lead the catheter to the lesion. The guidewire may also be
inserted from the coaxial luer connector and go through the catheter to the tip.
Moreover, the lumen inner of the catheter is the one through which the guide wire runs, while the outer
lumen is intended for contrast medium passage.
The maximum diameter of the guide wire must not exceed 0.46mm = 0.018". Alternatively, it can be used a
guide wire of 0.014" = 0,36mm.
The balloon is intended to reach different diameters at different pressures (according to the compliance
curve included on the primary packaging).
To inflate the balloon, the connector inflation port must be connected to an inflation device. The balloon is
inflated to predictable diameters with the pressure shown by the manometer. Two radiopaque markers are
located at each end of the balloon in order to mark its length and help the user to see the catheter while
inside the patient.
At the distal end is the tip, which is rounded and atraumatic in shape in order to avoid damaging the arteries
while it is being advanced.
The distal tube of the catheter is coated with a durable hydrophilic coating to help the catheter go through
tortuous arteries smoothly.
The useful length of the catheter is 100 cm, 140 cm or 150 cm depending on the item reference.
The balloon catheter is supplied in the following balloon diameters and lengths:
BALLOON
DIMENSIONS
Diameters (mm)
2,0
2,5
3,0
3,5
4,0
5,0
6,0
7,0
8,0
Contents
- One OTW catheter covered by protection sheath for the balloon and a stylet to protect the guide wire
lumen. This is inserted into a dispenser in a sterile bag.
- One card with the compliance curve showing the nominal inflation pressure and the recommended
maximum pressure.
- One leaflet with instructions for use.
INSTRUCTIONS FOR USE
20
40
60
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oceanus 18
Lengths (mm)
80
120
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150
200
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