ivascular iVolution Instructions D'utilisation page 3

• Local haemorrhage with haematoma at the insertion site
Specifically for biliary use
• Abscess
• Additional intervention due to, but not limited to:
• Endoprothesis migration
• Bad positioning
• Partial deployment
• Biliary tract occlusion
• Perforation of biliary tract
• Cholangitis
• Pancreatitis
• Peritonitis
• Sepsis
7. How to use
7.1 Materials required
• Standard heparinised saline solution.
• Contrast medium (use contrast media indicated for intravascular use).
• Medication appropriate to the procedure.
• 0.035" Guidewire, do not use other guidewire sizes.
• Introducer with haemostasis valve in the size indicated on the label. If
a long or braided introducer sheath is used, it is recommended that a
larger French-size than the one indicated on the label be used.
• Several standard 10-20cc syringes of saline solution for flushing the
system.
• Depending on user preference, it is possible to use a guiding catheter
over the introducer, in which case it will be necessary to place a
er's luer connector, and then
hemostatic valve in the guiding cathet
continue inserting the device inside the catheter.
7.2 Preparing the System
• The diameter size of the stent has to fit to the diameter of the reference
vessel (see the product specifications table in paragraph 1. Description,
to decide the implanted stent diameter depending on the diameter of
the vessel to be treated)
• The size of the stent should coincide in length with the length of the
lesion. It is preferably slightly longer to ensure complete coverage of the
lesion.
• Remove the catheter from the protection blister. Check that the stent is
covered by the sheath. Do not remove the handle's safety system until
deployment is going to begin.
• Flush or rinse the guide lumen with sterile saline injecting it with a syringe
from the proximal connector to the handle, until it comes out the tip. Do
not dry with gauze. Avoid touching the stent area.
DANGER: if the solution does not exit trhough the tip of of the delivery
catheter, the catheter is not in good condition and must not be used.
7.3 Implantation Procedure
Preliminary steps
• Place the introducer in accordance with the manufacturer's instructions.
If you wish to use the guiding catheter, insert it through the introducer
following the manufacturer's instructions and place a haemostasis valve
on its connector.
• Flush the guidewire with sterile heparinized saline. Do not dry with gauze.
• Introduce the guidewire through the introducer's haemostasis valve
(or the guiding catheter), according to the manufacturer's instructions.
Advance the guidewire throughout the vessel toward and through the
lesion under fluoroscopic visualization.
• Before implanting a self-expanding stent, it is recommended that a
balloon predilation is performed using PTA techniques to prepare the
lesion and estimate its condition as well as the adequacy of the stent to
be implanted. For balloon dilation, follow the manufacturer's instructions
for use attached to the device.
Implantation technique
• Insert the proximal end of the guidewire in the distal tip of the delivery
iVolution
system until the guide exits through the proximal connector of the
delivery system.
• Carefully insert the system through introducer under fluoroscopic
visualization (if you are using a guiding catheter, keep the haemostasis
valve open when the system passes through it). Once the introducer
is through, make sure by fluoroscopic visualization that the sheath that
covers the stent has not moved and the stent is still compressed inside
it (movement of the sheath can be detected, if you see three radiopaque
markers instead of two in the release system under fluoroscope, one of
them could be observed on the stent, at a different height depending on
the movement of the sheath, and indicating that the stent has begun
to be released). If you notice that the stent is beginning to deploy, the
system must be removed along with the introducer as a single unit
according to the indications of the precau- tions 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.
• Advance the stent beyond the lesion and pull back to tension the system
and eliminate slacks. Preferably, the fixed sheath should be inserted
into the introducer's haemostasis valve, if this is not the case, tighten
the system with special caution. Make sure the stent is on the lesion to
be treated by checking that the lesion is between the distal radiopaque
marker of the tip aligned with the sheath marker and the radiopaque
marker proximal to the stent, contained in the delivery system. 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 according to the withdrawal procedure
indicated in the precaution section in this leaflet
• Remove the security system to unlock the handle release system.
• To release the stent can be used a slow speed and fast speed. Slow
speed is driven by the wheel while the rapid deployment occurs when
the button is pressed down and pulled back. We recommend starting
the release of the stent using the thumbwheel on low speed until this
is attached to the vessel wall. Once successful, you can use the fastest
speed to expedite the procedure.
• Hold on with one hand the proximal end of the handle with the thumb
placed on the wheel. The other hand should hold the fixed sheath
delivery system. Check that the introducer has not moved.
• Start the removal of the cover sheath stent turning the dial to the right
following the arrow. Before discovering the stent, the sheath will move
about 3 mm, from there, the stent begins to release.
• Before the stent is placed against the vessel's wall, it is possible to
slightly reposition the system. Once it has been placed, do not move
forward or backward, since the system may be damaged, or injury
caused to the patient.
• When you begin to observe that the marker of the shealth has withdrawn
backward, the release of the stent has begun. The moving marker easily
indicates the length of the released stent.
• Once the stent has been placed against the vessel, and depending
on the user's preferences, it is possible to begin the quick-delivery
movement pressing down and moving back the release button. Avoid
abrupt movements in this action since it may cause the stent to lengthen
when the sheath is dragged on it.
• Once it is confirmed that the stent is totally deployed, which as a guide,
you can tell it is finished when the marker of the sheath is aligned with
the proximal marker of the release system, remove the delivery system
through the introducer
• Perform an angiography (or cholangiography in biliary case) to confirm
correct positioning of the stent.
• Maintain the guidewire across the dilated stenosis for 30 minutes
after the angioplasty. In case a thrombus is visualized around the
stent, administer thrombolitic agents. When the angiography confirms
dilatation, carefully withdraw the guidewire.
• Leave the introducer in situ until the haemodynamic profile is back to
normal. Suture if necessary, in the usual manner.
Further dilation of stented segments
• If the stent size with respect the vessel is insufficient, the technique of
stent post-dilation may be applied with a post-dilation balloon catheter.
To this end, a balloon catheter is inserted in the stent area (it might
be non-compliant) and the dilatation is performed according to the
manufacturer's recommendation. Do not dilate the stent beyond its
3
maximum recommended artery implantation diameter.
Withdrawing an unexpanded stent
• If the stent does not go across the lesion, it may be necessary to withdraw
it unexpanded. To this end, follow the instructions recommended in the
precautions in this leaflet and withdraw the system as a single unit.
8. Warranty
The device and all its components have been designed, manufactured,
tested and packed with a maximum level of precaution. LVD Biotech
warrants the device until its expiration date, provided the packaging is not
broken, tampered with or damaged.
CASTELLANO
1. Descripción del producto
El sistema de stent periférico autoexpandible de LVD Biotech SL, es un stent
fabricado en una aleación de Niquel Titanio de carácter autoexpandible,
que se encuentra premontado en un catéter de liberación coaxial.
El stent presenta una serie de marcadores radiopacos en los extremos que
delimitan su longitud y ayudan a conocer el posicionamiento y situación
dentro de la arteria.
El stent es una prótesis flexible que alcanza su máximo diámetro cuando
es retirado de su sistema de liberación, en el interior de la arteria. Una vez
en el interior de la arteria, se adapta a la misma ejerciendo una fuerza radial
constante que mantiene la permeabilidad del vaso. El Stent se fabrica a
partir de un tubo que se corta mediante técnicas de láser y posteriormente
se adapta al diámetro final requerido y se pule su superficie para conseguir
un acabado liso y brillante.
El sistema de liberación del stent es un catéter coaxial compatible con guía
de 0.035. En su parte más proximal tiene un mango, que al accionarlo,
retira la vaina cobertora externa del catéter liberando el stent.
El mango tiene un sistema de liberación lenta, que permite comenzar a
liberar el stent de forma precisa, y un sistema de liberación rápida con el
cual, una vez adosado el stent contra la pared del vaso, se puede terminar
de extraerlo de forma rápida. Este mango también contiene un sistema de
seguridad que evita que el stent se libere o que la vaina se mueva antes
de accionarlo.
El sistema acaba en una punta blanda y atraumática para evitar dañar la
arteria en su avance.
En la parte distal del sistema de liberación, existen una serie de marcadores
radiopacos que ayudan en la colocación del stent sobre la lesión y en la
etapa de despliegue del mismo. Dichos marcadores son:
• Dos marcadores fijos que delimitan la posición del stent, uno situado
distal al stent y otro situado proximal al stent.
• Un marcador móvil, situado en el extremo distal de la vaina cobertora
retráctil. Inicialmente, este marcador está alineado con el marcador distal
fijo, de manera que, bajo fluoroscopia, solo se observan dos marcadores
en el sistema, el distal y el proximal delimitando el stent. Durante la
liberación del stent, el marcador se mueve con la vaina cobertora hacia
atrás: en este momento, se observan tres marcadores, el marcador
distal, el marcador móvil que indica la longitud de stent liberada, y el
marcador fijo proximal. Cuando el stent está completamente liberado, el
marcador móvil de la vaina cobertora retráctil se alinea con el marcador
proximal y por tanto, volverán a verse dos marcadores.
El sistema se presenta en dos longitudes: 80 cm y 140 cm.
El stent autoexpandible puede tener diferentes tamaños. En la siguiente
tabla se resumen las variantes de presentación del stent autoexpandible.
El tipo de variante a escoger para el procedimiento, dependerá del
diámetro del vaso a tratar. En función de la variante se definen también las
especificaciones del introductor y el catéter guía a utilizar:
Contenido
• Stent periférico autoexpandible montado en su sistema de liberación.
Acondicionado en un blíster y una bolsa que protege la esterilidad.
• Una tarjeta de implantación.
• Un folleto de instrucciones de uso.
2. Indicaciones
El sistema de stent periférico autoexpandible, está indicado para el tratamiento
de lesiones ateroscleróticas de novo o restenóticas de arterias periféricas
situadas por debajo del arco aórtico, y para la paliación de las estenosis
malignas de las vías biliares con diámetro nominal entre 4.5 y 9.5 mm.
EN
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