Vascular essential Instructions D'utilisation page 5

therapies for living
PACLITAXEL ELUTING CORONARY BALLOON DILATATION CATHETER
tation balloon, one without the drug, since the same vessel segment must not be dilated with more
than one balloon with drug.
- 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 recommended 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 coronary intravascular catheters.
- 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 liquid (preferably 50/50,
though the proportion of contrast liquid can be reduced in large balloons).
- If any resistance is noted 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 inserter 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 of it in accordance with ac-
cepted 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
- Acute myocardial infarction
- Unstable angina
- Ictus / embolism / thrombosis
- Haemodynamic deterioration
- Acute elastic recoil
- Arrhythmia
- Aneurysm or pseudoaneurysm
- Infections
- Total occlusion of the artery
- Reocclusion of the area treated: restenosis
- Spasm
- Perforation or dissection of the area treated
- Arteriovenous fistula
- Local haemorrhaging with haematoma at the access site
- Hypo/hypertension
- Allergic or immune reaction to the drug.
- Histological changes in the arterial wall.
INSTRUCTIONS FOR USE
essential
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