ivascular luminor 35 Instructions D'utilisation page 2

therapies for living
PERIPHERAL BALLOON DILATATION CATHETER, FOR 0.035" GUIDEWIRE
1. Description of the Product
The Paclitaxel eluting dilatation balloon is a double lumen catheter from the connector to the tip, also called
OTW, designed for percutaneous transluminal angioplasties of peripheral arteries.
The catheter has two lumens 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 lateral port, which connects with the smallest lumen of the catheter's body, allows entry of constrast
fluid to dilate the balloon.
The straight port is the port for guidewire passage. The guidewire is intrduced in the connector's entry port
and going through the largest lumen, it goes out through the catheter's tip to take it to the lesion.
There is likewise a lumen through which the guide wire runs and a lumen through which contrast liquid
enters the balloon, directly connected to each of the ports in the luer or connector.
The maximum diameter of the guide wire must not exceed 0.89mm = 0.035 inches.
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 useful length of the catheter is 80cm or 140cm depending on the item reference.
The balloon is supplied in the following lengths and diameters:
BALLOON LENGTH
(mm)
The balloon is intended to reach different diameters at different pressures (according to the compliance
curve shown on the primary packaging).
To inflate the balloon, it is necessary to connect the connector's inflation port to a syringe that includes a
manometer. With the pressure indicated by the manometer, the balloon is inflated to predictable diameters.
At both ends of the balloon, two radiopaque markers are included so as to delimit its length, and help the
user know the place where it is when it is 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.
Contents
- A paclitaxel releasing dilatation balloon catheter OTW, covered by a protector over the balloon and
introduced in a dispenser and packed 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.
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INSTRUCTIONS FOR USE. PACLITAXEL ELUTING
20
40
60
80
120
150
BALLOON DIAMETERS (mm)
5 6
X X
X X
X X
X X
X X
X X
luminor 35
7
X
X
X
X
X