Vascular essential Instructions D'utilisation page 4

therapies for living
PACLITAXEL ELUTING CORONARY BALLOON DILATATION CATHETER
manometer. The balloon is inflated to predictable diameters with the pressure shown by the manometer.
Two radiopaque markers are fitted at each end of the balloon in order to mark its length and help the user to
ascertain its whereabouts while inside the patient.
At the distal end of the balloon is the tip, which is rounded and atraumatic in shape in order to avoid damag-
ing the arteries while it is being advanced.
Contents
- One rapid-exchange, Paclitaxel-releasing balloon cathether, covered by a protector over the balloon
and with a guide lumen protection stylet. All the set is introduced in a dispenser to avoid damaging the
catheter, and it is packed into a sterile bag.
- One card with the compliance curve showing the working range of pressures
- One leaflet with instructions for use
2. Indications
The Essential paclitaxel-eluting balloon catheter is indicated for the dilatation of stenosis or coronary ar-
tery or bypass grafts occlusions, including small vessels, as well as for residual stenosis after treatment
with balloon or endoprosthesis and pre- and post-dilation of coronary endovascular prosthesis, in order to
improve myocardial perfusion.
3. Contraindications
- Treatment of the left stem (first section of the left coronary artery)
- Coronary artery spasm without significant stenosis
- Patients showing angiographic evidence of the existence of thrombus.
- It must not be used in pregnant women or during lactation or in patients with known hypersensitivity
to paclitaxel.
4. Warnings
- The device must be used by physicians with experience and trained in the percutaneous transluminal
coronary angioplasty technique (PTCA).
- The coronary percutaneous intervention must be performed in hospitals equipped with the emergency
facilities to perform open surgery operations or in hospitals with easy access to other hospitals where
this surgery may be performed.
- This is a single-use product. it must not be resterilized or reused once the procedure is finished. Re-
using this product with another patient may cause cross contamination, infection or transmission of
infectious diseases from one patient to the next. Reusing the product may cause alterations thereof
and limit its effectiveness.
- The product is supplied sterile. Check the expiry date and do not use products which are past this date.
- Inspect the pack before opening it. If there are any defects or the pack is damaged, throw the product
away.
- Use aseptic techniques when the product is taken out of the primary packaging.
- Select the balloon diameter depending on the diameter of the artery to be treated. Do not insert a bal-
loon with a diameter larger than that of the artery being 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 any other 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 withdraw the catheter or the guidewire, when the balloon is inflated.
- In case a post-dilatation is necessary after use of product, it must be made with a conventional dila-
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INSTRUCTIONS FOR USE
essential