ivascular luminor 18 Instructions D'utilisation page 4

PACLITAXEL ELUTING PERIPHERAL BALLOON DILATATION CATHETER,
- Drug eluting stents must not be implanted in the same segment that has been previously treated with
the balloon with drug, since it is possible for overdose or interaction among the active principles to
occur.
- Published in vitro and in vivo studies prove the mutagenic effect of Paclitaxel. The carcinogenesis risk
potential has not been studied. The published in vivo studies prove the teratogenic effect, therefore it
is not ecommended for pregnant women to use this product.
5. Precautions
- Administer suitable medical therapy to the patient: anticoagulants, vasodilators, etc., in accordance
with the procedure for inserting intravascular catheters.
- Use with standard 0.018-inch guide wires (secondarily 0.014") and standard introducers. If the intro-
ducer length goes above 25 cm or the braided type is used, it may be necessary to increase its size to
avoid catheter friction.
- Before use, check the size and suitability of the catheter for its intended use.
- Use the product with precautions in complex lesions, since the abrasive nature of said lesions may
alter the drug coating. In these cases it is recommended to predilate the lesion previously with a con-
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).
- Do not exceed the rated burst pressure (RBP) as the balloon could burst.
- If any resistance is noticed during advance, stop and determine its cause before continuing.
- 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 investigat-
ed. Drug interactions at the systemic levels of paclitaxel are detailed in the product data sheet but, consider-
ing that the amount of paclitaxel on the balloon surface corresponds approximately to a few hundredths
of the amount normally used in the antineoplastic treatment, it is considered very unlikely for interactions
with other drugs to occur.
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FOR 0.018" GUIDEWIRE
luminor 18