Instructions For Use. Paclitaxel Eluting Peripheral Balloon Dilatation Catheter, For 0.014" Guidewire - ivascular luminor 14 m Instructions D'utilisation

PERIPHERAL BALLOON DILATATION CATHETER, FOR 0.014" GUIDEWIRE
2. Indications
The device is indicated to dilate stenosis in femoral, popliteal and infra-popliteal arteries, with a reference
diameter balloon from 1.5 and 4.0 mm and lengths from 40 up to 200 mm.
3. Contraindications
Inability to cross lesion with guide-wire
It must not be used in pregnant women or during lactation or in patients with known hypersensitivity to
paclitaxel.
4. Warnings
- The device should only be used by experienced doctors familiar in the percutaneous transluminal
angioplasty (PTA) technique.
- The percutaneous procedure must be carried out in hospitals equipped with emergency facilities to
conduct open heart surgery or hospitals with easy access to other hospitals where this type of opera-
tion can be performed.
- The product is for single use. It must not be re-sterilised or re-used once the procedure has been com-
pleted. Re-using the product in another patient may lead to cross contamination, infection or trans-
mission of infectious diseases from one patient to another. Re-use of the product may cause altera-
tions to it and affect its effectiveness.
- The product is supplied sterile. Check the expiry date and do not use products which are past this date.
- Inspect the packaging before opening it. If there are any defects or the packaging is damaged, do not
use the product.
- Use aseptic techniques when the product is taken out of the primary packaging.
- Select the balloon diameter according to the diameter of the artery to be treated. Do not insert a bal-
loon with a diameter larger than the artery to be treated.
- Do not touch the balloon directly or dry it with gauze, since doing so may cause the drug coating to
come off.
- Do not expose the product to organic solvents such as alcohol, or to constrast media not indicated for
intravascular use.
- Do not use air or gaseous media to inflate the balloon.
- Advance the product on the guide wire using fluoroscopy. Do not allow the product to advance without
the guide wire inside it.
- Do not manipulate, advance or retract either the catheter or the wire guide while the balloon is inflated.
- In case a post-dilatation is necessary after use of product, it must be made with a conventional dila-
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 intravascular catheters.
- Use with standard 0.014-inch guide wires and standard introducers. If the introducer length goes above
25cm 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-
INSTRUCTIONS FOR USE. PACLITAXEL ELUTING
luminor 14 m
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