Product Description - ivascular iVolution Instructions D'utilisation

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1. Product description

The self-expanding peripheral stent system from LVD Biotech SL is a self-
expanding stent made of a nickel-titanium alloy, premounted on a coaxial
delivery catheter.
The stent has a series of radiopaque markers at each end to mark its length
and identify the position and location within the artery.
The stent is a flexible prosthesis that reaches its maximum diameter when
removed from the delivery system, inside the artery. Once inside the
artery, it adapts to it by exerting a constant radial force that maintains the
vessel's permeability. The stent is made from a tube that is cut using a laser
technique and then expanded to the required final diameter. The surface is
then polished to achieve a smooth, shiny finish.
The stent's delivery system is a coaxial catheter compatible with a 0,035
guide. At the proximal end there is a handle, which when pushed, removes
the stent's outer covering sheath releasing the stent.
The handle has a slow-delivery system, to begin delivery of the stent in
an accurate manner, and a quick-delivery system which, once the stent is
placed against the vessel's wall, can be removed quickly. The handle also
contains a safety system to prevent the stent from being released or the
sheath from moving before it is removed.
The system ends in a soft, atraumatic tip to avoid damaging the artery
during its advance.
In the distal portion of the release system, there is a series of radiopaque
markers which assist in the placement of the stent on the lesion and in the
deployment stage of the same. These markers are:
• Two fixed markers which define the position of the stent, one situated
distal to the stent and the other situated proximal to the stent
• A mobile marker, situated at the extreme distal end of the retractable sheath.
Initially, this marker is aligned with the distal fixed marker, in such a way that,
under the fluoroscope, only two markers in the system are observed: the distal
and the proximal defining the stent. During the release of the stent, the marker
moves backwards with the sheath: at this time, three markers are observed:
the distal marker, the mobile marker that indicates the length of the released
stent, and the proximal fixed marker. When the stent is completely released,
the mobile marker of the retractable sheath is aligned with the proximal marker
and thus, only two markers are seen.
The system comes in two lengths: 80 cm and 140 cm.
The self-expanding stent is available in different sizes, as summarised in
the following table.
The variant selected for the procedure will depend on the diameter of the
vessel to be treated. Depending on the variant, the specifications of the
introducer and the guiding catheter to be used are defined.
Contents
• Peripheral self-expanding stent mounted on its delivery system. Packed
in a blister and bag to protect sterility.
• Implant card.
• A leaflet with instructions for use.
2. Indications
The peripheral stent system is indicated for the treatment of de novo or
restenotic atherosclerotic lesions in peripheral arteries located under the
aortic arch; that is, and for palliation of biliary tract malignant stenosis with
a nominal diameter ranging from 4.5 to 9.5 mm.
3. Contraindications
• Patients with a contraindication for anticoagulant/antiplatelet therapy.
• Patients clearly diagnosed as allergic to heavy metals. (Specifically to
nickel).
• Patients with hemorrhagic disorder.
• Presence of recent undissolved, disorganized thrombus or of embolic
material.
• Renal failure or allergy to contrast media.
• Severe ascites.
• Threat of vital lateral branch occlusion.
4. Warnings
• Stents must only be implanted in hospitals equipped with emergency
facilities and staff able to switch the operation to open surgery, or failing
iVolution
this in hospitals with such services close at hand.
• The product must only be used by physicians well trained in angioplasty
techniques, acquainted with percutaneous intervention and stent
implantation.
• This device is designed and intended for single use in only one patient.
DO NOT RESTERILIZE OR REUSE. Do not reprocess. Reutilization of the
product in another patient may cause crossed contamination, infections
or transmission of infectious diseases. Reutilization of the product in
another patient may cause alterations thereof and limit its effectiveness.
• The product is supplied sterile. Check the expiry date and do not use
products which have passed this date.
• Administer adequate medical therapy to the patient: anticoagulants,
vasodilators, etc., in accordance with the intravascular catheter insertion
protocol.
• Use aseptic techniques when removing the product from its primary
packaging.
• Do not dry with gauze.
• Do not expose the delivery system to organic solvents.
• Select the right size in diameter and length according to the size of the
lesion observed under fluoroscopy.
• Advance the product along the guidewire under fluoroscopy, until reach
the treatment area. Do not allow the product to advance without the
guidewire inside it.
• Do not superimpose stents of different compositions.
• Do not expose the product to hospital waste material.
5. Precautions
General Precautions
• Store in a dry, fresh place, away from direct sunlight.
• Inspect the pack before opening it. If it is found to be damaged, do not
use the product.
• The minimum size of the introducer with which the system may be
used is indicated on the product's label. Do not use introducers that are
smaller than the size indicated. In addition, in case of long and/or braided
introducer sheaths, a larger French-size than indicated on the label may
be necessary to ensure success of the procedure.
• After use, this product may be a biological hazard. Handle and dispose
of it in accordance with accepted medical practice and relevant local,
state or federal laws and regulations
Precautions when preparing the product
• Inspect the product before use to make sure it is in good condition, and
discard any device which does not inspire confidence. If you notice that
the stent has begun to deploy or that the sheaths do not cover the stent,
discard the device.
• The stent's length must coincide with the length of the lesion. Preferably,
it should be a little longer so as to ensure that the lesion is totally covered.
• Do not attempt to remove the stent from its delivery system.
• Do not use the system if the safety device has moved or the deplacement
button has moved from its initial point.
• Do not unlock the handle before the stent has been placed in the precise
location, because if it is unlocked before, the stent may be delivered in
the wrong position.
Precautions during advance-positioning-de-
ployment-withdrawal of the product
• Always advance the device under fluoroscopic visualization. If any
resistance is met while advancing, stop and determine the cause
before continuing. If the stent can not reach or pass through the lesion,
withdraw the whole system as a single unit, including the introducer and
the guidewire.
• If any resistance is met while advancing, stop and determine the cause
before continuing.
• Before stent deployment, apply tension to the delivery system in order to
avoid that the stent be implanted in an incorrect place.
• Once expansion of the stent has begun, the system cannot be
withdrawn or moved.
• Do not handle, advance or withdraw neither the catheter nor the
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guidewire while the stent has started its deployment.
• The stent is not designed to be reintroduced in the sheath once
deployment has started.
• Once the stent has been placed against the vessel's wall, do not try
to reposition or move the stent as it may drag and damage the artery.
• If resistance of any kind is noted while accessing the lesion, while
extracting the deployment system or while removing a stent which could
not be implanted, the whole system should be withdrawn as a single
unit.
• Do not retract the delivery system inside the introducer or the guiding
catheter since the stent may be released into the vasculature.
• Advance the guidewire forward in the anatomy, as far as possible.
• Withdraw and extract the introducer (or the guiding catheter) and the
stent system together, as a single unit
• Finally, withdraw the guidewire, or in the event that you wish to begin
implantation again keep the guidewire in place and place further
devices.
• Positioning the stent in an important bifurcation may obstruct or hamper
future access to lateral branches.
• For treatment of multiple lesions, start by the most distal lesions and
continue onto the proximal ones.
• Immediately after an implant, if it is necessary to re-cross the stent, great
care must be taken not to push it with the guides or balloons so as not
to dislodge it.
• Corrosion by friction of superimposed prosthesis has not been
demonstrated.
Precautions: MRI Safety[1]:
Thorough non-clinical testing security was proved by magnetic resonance (MR)
imaging of nickel titanium alloy stents under certain conditions (MR conditional).
The conditions of the MR test used to assess these devices were the following:
for magnetic field interactions, a static magnetic field strength of 3.0 Tesla, with
a maximum spatial gradient of 3,3 T/m; for MR-related heating, a maximum
whole body averaged specific absorption rate (SAR) of 2,0W/kg for 15 minutes.
No clinical or non-clinical testing has been conducted to rule out the
possibility of stent migration at field strengths of over 3.0 Tesla
MR imaging quality may be affected if the area of interest is adjacent or very
close to the stent place.
6. Possible adverse effects/complications
Possible adverse effects and/or complications which could arise before,
during or after the procedure include the following:
• Death
• Infarction/angina
• Stroke / embolism / thrombosis
• Emergency bypass surgery
• Endocarditis
• Total occlusion of the artery / thrombosis / stent embolisation
• Perforation or dissection of the segment treated
• Air embolism
• Arteriovenous fistula
• Renal failure
• Migration of endoprothesis / bad positioning / partial deployment
• Allergic reaction to the metals or contrast media
• Reocclusion of the segment treated: restenosis
• Arterial spasm
• Haemodynamic deterioration
• Arrhythmias
• Aneurysm or pseudoaneurysm
• Infections
• Hypotension/hypertension
[1] This data has been obtained bibliographically, searching for currently
approved stents of equal composition. It is recommended that MRI is not
performed unless strictly necessary for the patient. If the patient can wait,
it is better to perform the MRI when the stent has endothelialized, around
four weeks after implantation.