Vascular essential Instructions D'utilisation page 7

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PACLITAXEL ELUTING CORONARY BALLOON DILATATION CATHETER
8.3 Technique for Insertion / Treatment
- Insert the introducer according to the manufacturer's instructions.
- Connect the haemostasis valve to the guiding catheter connector, keeping the valve closed. Insert
the guide catheter through the introducer, according to the manufacturer's instructions and making
sure it is located at the entrance to the coronary artery. Inject contrast liquid through the catheter
to make sure it is correctly positioned to give access to the coronary artery.
- Open the haemostasis valve to run the 0.014" guide wire through. Once the guide wire is through
the valve, seal it to avoid loss of blood. Pass the 0.014" guide wire through the lesion according to
percutaneous intervention techniques, with the aid of fluoroscopy to determine its position at all
times. Use contrast liquid infusion to ensure that the guide wire is properly positioned.
- Insert the proximal end of the guide wire into the distal end of the balloon catheter.
- Open the hemostatic valve to allow passage of the balloon tip through the valve. Once the balloon
is through, turn off the valve. If resistence is met, do not advance the dilation catheter through the
hemostatic valve. Prevent the hemostatic valve from damaging the catheter body, which may later
influece the inflation or deflation of the balloon. Take special care when passing the balloon catheter
through the hemostatic valve, so as not to alter the drug coating.
- Advance carefully the balloon catheter along the guidewire, through the guide catheter and with the
help of flouroscopy, until the area to be treated is reached. Make sure that the guidewire goes out
the insertion port of the balloon catheter guide (approximately 25 cm from the balloon catheter tip).
In case the balloon catheter chosen cannot be placed inside the lesion, choose a smaller size of a
drugless conventional balloon in order to predilate the lesion.
- Locate the balloon in the desired position for dilation.
- Apply pressure to the inflation device so that the balloon inflates. Do not exceed the rated burst
pressure (RBP) on the label and the compliance curve.
- Keep the pressure for 30-60 seconds for an optimal release of the drug. Most of the drug is released
in the first 30 seconds of inflation but, in order to optimize the dilation of the lesion, it is possible to
use longer inflation times greater than 1 minute at the operator's discretion.
- Draw the plunger on the inflation device back to deflate the balloon. Keep up the negative pressure
for between 15 and 30 seconds depending on the size of the balloon. Make sure the balloon is fully
deflated (by means of fluoroscopy) before moving the catheter.
- With negative pressure in the inflation device and with the guide wire in position, remove the cath-
eter carefully until it is pulled out through the introducer. Keep the guide wire in place across the
dilated stenosis.
- Carry out an angiography through the guiding catheter to confirm dilation.
- Keep the guide wire through the dilated stenosis for 10 minutes after angioplasty. When the angi-
ography confirms dilation, carefully withdraw the guide wire.
- Withdraw the guiding catheter through the introducer
- Leave the introducer in place until the haemodynamic profile returns to normal. Stitch in the usual way.
- Double antiplatelet therapy must be administered for a minimum of four weeks after the interven-
tion, in the case of lesions without stent. In lesions with stent, a double antiplatelet treatment for
12 weeks is recommended. However, the treatment may be prolonged at the operator's discretion.
Procedure for exchanging the dilation catheter
In case it is necessary to change the balloon, the rapid exchange dilation catheter Essential is designed
to allow one rapid exchange by only one operator. To make the exchange:
- Loosen the haemostatic valve.
- Hold the guide wire and the haemostatic valve in one hand and the balloon in the other.
- Keep the guide wire in position in the coronary artery; with the guide wire in a fixed position, with-
draw the balloon catheter from the guide catheter.
INSTRUCTIONS FOR USE
essential
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