Equipment Required - ivascular luminor 14 m Instructions D'utilisation

PERIPHERAL BALLOON DILATATION CATHETER, FOR 0.014" GUIDEWIRE
ventional, drugless balloon.
- Extreme care must be exercised when the device is taken off from the pack and passed through the
hemostatic valve to make sure that the drug coating is not damaged.
- Proceed with extreme care so as not to damage the catheter while advancing it.
- The balloon must be inflated with a mixture of saline solution and contrast medium (preferably 50/50,
though the proportion of contrast medium can be reduced in large balloons, like 4mm diameter or
longer ones).
- If any resistance is noticed during advance, stop and determine its cause before continuing.
- Do not exceed the rated burst pressure (RBP) as the balloon could burst.
- If any resistance to withdrawing the catheter is noted, it is recommended that the balloon catheter,
the guide wire and introducer be removed as a single unit.
- Store in a cool, dry place away from direct sunlight.
- After use, this product may represent a biohazard. Handle and dispose it in accordance with accepted
medical practices and pertinent local, state or federal laws and regulations.
6. Possible Adverse Effects / Complications
The possible adverse effects and/or complications which might arise before, during or after the procedure
include the following:
- Death
- Ictus / embolism / thrombosis
- Haemodynamic deterioration
- Acute elastic recoil
- Arrhythmia
- Aneurysm or pseudo-aneurysm
- Infections
- Total occlusion of the artery
- Reocclusion of the treated area: restenosis
- Spasm
- Perforation or dissection of the treated area
- Arteriovenous fistula
- Local bleeding with haematoma at the access site
- Hypo/hypertension
- Allergic or immune reaction to the drug.
- Histological changes in the arterial wall.
7. Pharmacological interaction
The potential interactions of paclitaxel with the drugs administered concomitantly have not been inves-
tigated. Drug interactions at the systemic levels of paclitaxel are detailed in the product data sheet but,
considering that the amount of paclitaxel on the balloon surface corresponds approximately to a few hun-
dredths of the amount normally used in the antineoplastic treatment, it is considered very unlikely for
interactions with other drugs to occur.
Nevertheless, caution must be exercised when CYP3A4 or CYP2C8 substrates (such as terfenadine, cyclo-
sporin, lovastatin, midazolam y ondansetron)or drugs with high PPB (Plasma Protein Binding) are adminis-
tered concomitantly.
8. How to Use

8.1 Equipment Required

- Heparinized normal saline solution
- Contrast medium (use contrast media suitable for intravascular use)
- 0.014" guide wire; do not use any other size of guide wire
- Introducer with a haemostatic valve of the size specified on the label. Do not use smaller sizes as
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INSTRUCTIONS FOR USE. PACLITAXEL ELUTING
luminor 14 m