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PACLITAXEL ELUTING PERIPHERAL BALLOON DILATATION CATHETER,
1. Description of the Product
The Paclitaxel eluting dilatation balloon is a coaxial catheter (double lumen from the connector to the tip,
also called OTW), designed for percutaneous transluminal angioplasties of small peripheral arteries.
The catheter has a coaxial dual-lumen body from the connector to the tip.
On the catheter's distal part, before the tip, there is the balloon with the drug or segment inflatable at dif-
ferent pressures that dilates the artery upon inflating by means of infusion of contrast fluid inside it. The
connector is Y-shaped and it has two entry ports:
- The side port allows contrast medium passage to dilate the balloon.
- The straight port is the port for guidewire passage. The guidewire is introduced through the point of
the catheter to then exit through the entry port of the connector, in order to bring the catheter to the
lesion site. The guidewire can likewise be inserted from the coaxial luer connector and pass through
the catheter to the point.
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 0.46 mm = 0.018 inches. Optionally, a guidewire meas-
uring 0.014" = 0.36 mm can be used under medical criteria and in the cases where it is required by the lesion to be
treated.
The balloon is coated with the drug Paclitaxel, included in a physiologically inocuous matrix. The drug's dose
is 3 micrograms / mm
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 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 inflat-
ed 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.
On the distal end, there is the tip, it is rounded and atraumatic avoid damaging the arteries during advance-
ment.
Contents
- A paclitaxel-releasing dilatation balloon catheter OTW, covered by a protector over the balloon and a
guide lumen protection stylet. All the set is introduced in a dispenser to avoid damaging the catheter,
and it is packed into 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.
Variants
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:
The useful length of the catheter is 100 cm
BALLOON
DIMENSIONS
DIAMETERS
(mm)
2
FOR 0.018" GUIDEWIRE
of balloon surface and it is intended to avoid cellular proliferation, consequently
2
20
40
2,0
X
X
2,5
X
X
3,0
X
X
3,5
X
X
4,0
X
X
5,0
X
X
6,0
X
X
7,0
X
X
8,0
X
X
LENGTHS (mm)
60
80
120
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
luminor 18
150
200
X
X
X
X
X
X
X
X
X
X
X
X
X
X
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