Implantation Procedure; Preliminary Steps; Implantation Technique - Vascular Restorer CoCr Instructions D'utilisation

therapies for living
pressure, it may be a clear indication that the balloon catheter has leaks, is broken or the syringe-
three-way stopcock are not airtight. If after checking the connections, bubbles continue to appear,
do not use. Return the device to the manufacturer or distributor for inspection.
• Return the plunger to its initial position allowing the contrast fluid to enter the balloon lumen.
DANGER: do not apply positive pressure since this action may lead to balloon dilation and early stent
expansion.
• Repeat the process again. Once it is finished, close the three-way stopcock to close the air pas-
sage through the balloon.
- Connect the inflation pump (if it had not been connected), with a 1/3 mixture of contrast fluid- saline
1:1 (duly purged), to the three-way stopcock and the extension. Do not apply pressure since it may
dislodge the stent.

7.3 Implantation Procedure

Preliminary steps

- Place the introducer in accordance with the manufacturer's instructions.
- Flush the guidewire with sterile heparinized saline. Do not dry with gauze.
- Introduce the guidewire through the introducer's haemostasis valve, according to the manufac-
turer's instructions. Advance the guidewire throughout the vessel toward and through the lesion
under fluoroscopic visualization.

Implantation technique

If the lesion to be dilated is so small in diameter, is calcified or so tortuous that it may compromise stent
access, pre-dilation with a dilation balloon catheter must be considered. In order to pre-dilate the lesion,
follow the instructions of the balloon catheter's manufacturer. After pre-dilatation of the lesion, proceed
to stent implantation.
- Insert the proximal end of the guidewire in the distal tip of the delivery system until the guide exits
through the straight port of the delivery system luer hub.
- Carefully insert the system through introducer under fluoroscopic visualization. Once the introducer
is through, make sure by fluoroscopic visualization that the stent has not moved from between the
balloon's radiopaque markers. If this happens, the system must be removed along with the intro-
ducer as a single unit according to the indications of the precautions section in this leaflet.
- Carefully advance the stent system on the guidewire, with the help of fluoroscopy, until the area to
be treated is reached. Make sure that the guidewire goes out through the tip of the delivery system.
- Position the stent through the lesion; to this end, place the radiopaque markers on either side of the
lesion. Before expanding the stent, check by means of high resolution fluoroscopy that it has not
been damaged or moved during advancement, otherwise, proceed to withdraw the system accor-
ding to the withdrawal procedure indicated in the precaution section in this leaflet.
- Slowly inflate at low pressure the stent's delivery system applying pressure with the inflation
device. Maintain the pressure until you observe that the balloon inflates in the stent's proximal and
distal ends. Continue to apply pressure until the nominal pressure indicated in the compliance curve
is reached. Do not exceed recommended maximum pressure (RBP), indicated on the label and the
compliance curve.
- For optimum expansion the stent must be in contact with the artery, otherwise the stent could
move when the balloon is removed. The balloon diameter must be a little more than the diameter of
the vessel to prevent for elastic recoil of the stent once the balloon is deflated. Refer to the compli-
ance table for the correct expansion, as if it is too big it may also cause arterial dissection.
- Withdraw the plunger in the inflation device to deflate the balloon. Keep up the negative pressure
from 15 to 30 seconds depending on the balloon size. Make sure the balloon is fully deflated (using
fluoroscopy) before moving the catheter.
INSTRUCTIONS FOR USE
PERIPHERAL STENT SYSTEM CoCr
restorer
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