ivascular BTK Instructions D'utilisation page 2

ENGLISH
EN
1. Description of the Product
The LVD Biotech SL angiolite BTK Sirolimus-eluting peripheral stent is a
stent made of a Chromium cobalt alloy named L605, to which a coating
made of a mixture of sirolimus and polymers has been applied. The stent is
supplied pre-mounted on a delivery system which will expand it, by means
of the distal balloon, in the artery to be treated.
The stent is intended to fit with different artery diameters by adjusting
its open-cell design with alternated connecting bridges. The stent is
manufactured means of laser cuttings in metallic tubes. Afterwards, it
is submitted to several treatments in order to give a smooth and sleek
finishing to the surface.
The content of a stent drug is approximately 1.4 µg/mm
larger (4.50x39 mm), which has the maximum drug amount, 339 µg.
The stent delivery system consists on a rapid-exchange balloon catheter.
The catheter comprises an inflatable balloon at the distal part. The
balloon has different diameters and lengths to fit with the different stent
configurations. When the balloon is inflated, it dilates the stent and deploys
it against the artery. Afterwards, the balloon is deflated and removed, and
the stent remains permanently implanted.
There are markers on the catheter shaft to help the user to calculate the
position of the catheter as it is advanced through the guiding catheter
without fluoroscopy, so that, when the last mark disappears, the catheter is
already near to the tip of the guiding catheter and about to enter the artery.
The marker located nearest to the catheter adapter is for femoral guiding
catheters and the one furthest away is for brachial guiding catheters.
The distal part of the catheter is covered in a durable hydrophilic coating to
lubricate the catheter so that it can navigate through arteries.
The maximum guidewire passage diameter must not exceed 0.36 mm =
0.014".
Useful length of the catheter is 142 cm, while the total length is 150 cm.
The stent is supplied in the following stent lengths and diameters: (pg. 31).
To expand the stent, the proximal luer-lock hub is needed to be connected
to an inflation device with a manometer. The balloon is inflated with the
pressure shown by the manometer to expand the stent to predictable
diameters. One radiopaque marker is located at each end of the balloon
in order to mark its length and help the user to know its position while it
is inside the patient.
Contents
• One sirolimus-eluting peripheral stent system comprising the coated
stent pre-mounted on its delivery system (balloon catheter). The stent is
protected by a sheath and a stylet inserted at the guide insertion lumen,
and it is inserted into a dispenser and in a sterile bag. In turn, the bag
with sterile contents is inserted into a second foil bag.
• One card with the compliance curve showing the working pressure range
• One implant card
• One leaflet with instructions for use
2. Indications
The device is indicated for treating chronic and acute arterial lesions in the
lower limbs below the knee (BTK), as well as popliteal and infrapopliteal
lesions with reference vessel diameters of between ≥2 mm and ≤4.50
mm, with the aim of increasing the internal diameter of an artery and
consequently improving blood flow in the following cases:
• Severe claudication
• Critical limb ischaemia
3. Contraindications
• Antiplatelet and/or anticoagulation therapy is contraindicated.
• Patients with clear diagnosed heavy metal allergy.
• Patients with lesions that prevent complete angioplasty balloon inflation
or proper stenting.
• Patients with hypersensitivity or an allergy to Sirolimus or its by-products
and to acrylate polymers.
4. Warnings
• Stent implantation must be carried out in hospitals equipped with
emergency facilities to conduct open heart surgery or, in its absence, in
hospitals with easy access to other hospitals where this type of operation
can be performed.
• The product should only be used by experienced physicians in
hemodynamic and familiar with the percutaneous peripheral intervention
and stent implantation.
• The device is designed for single use in a single patient. DO NOT
RE-STERILIZE OR RE-USE IT, REPROCESSING IS FORBIDDEN. Re-
using the product in another patient may lead to cross contamination,
infection or transmission of infectious diseases from one patient to
another. Re-use of the product may cause alterations to it and affect
its effectiveness.
• The product is supplied sterile. Check its expiry date and do not use
products which are past this date.
with the stent being
2
• Administer suitable medical therapy to the patient: anticoagulants,
vasodilators, etc., according to the protocol of peripheral intravascular
catheter insertion.
• Use aseptic techniques when the product is taken out of its primary
packaging.
• Do not dry with gauze.
• Do not expose the delivery device to organic solvents.
• Do not use oily or high viscous contrast media unsuitable for
intravascular use.
• Do not use air or gaseous media to inflate the balloon, it must be inflated
with a mixture of saline solution and contrast liquid (preferably 1:1).
• Select the suitable product size, in terms of diameter and length,
according to the size of the lesion fluoroscopically observed.
• Advance the product on the guidewire by means of fluoroscopy imaging.
Do not allow product advance without the guidewire inside it.
• Do not overlap stents with different compositions.
• The possible interaction of the product with other drug-eluting stents has
not been evaluated, and therefore, they should be avoided whenever
possible.
• Do not expose the product to hospital waste material.
• Studies in pregnant or breastfeeding women or in men who wish to have
children have not been conducted with this product. Fertility studies
in animals demonstrated reproductive toxicity. The use of the product
in women who are trying to become pregnant or who are pregnant or
breastfeeding is not recommended.
5.Precautions
5.1 General precautions
• It is recommended to be stored in a cool, dry place (15º -30º C), away
from direct sunlight.
• Inspect the packaging. If it is damaged, do not use the product.
• After its use, this product may be a biological hazard. Handle and
dispose it of according to the accepted medical practices, and the
pertinent local, state or federal laws and standards.
• The foil bag is not sterile. The sterile protective barrier is the plastic bag.
• Safety and efficacy of the product in patients whose lesion has been
previously treated with brachytherapy have not yet been established.
• The use of drug-eluting stents in patients and lesions not included in the
instructions for use may mean a higher risk of adverse reactions, such as
stent thrombosis, myocardial infarction or death.
• The use of drug-eluting stents in patients and lesions not listed in the
instructions for use may lead to an increased risk of adverse reactions.
5.2 Precautions during product preparation
• Inspect the product before using it to ensure it is in perfect conditions,
and discard any device not showing proper confidence.
• Do not prepare or pre-inflate the delivery system before starting the
procedure or deploying the stent at the lesion.
• Do not handle the stent with the fingers, due to this action may dislodge
the stent from the balloon and damage the coating.
• Do not attempt to separate the stent from its delivery system; if any stent
movement or unsuitable stent place or crimping is noticed, do not use it.
angiolite BTK
• Do not attempt to straighten a kinked hypotube (proximal part of the
delivery system), it may get broken.
5.3 Precautions
withdrawal
• In case of multiple lesions treatment, begin with the most distal lesions,
followed by the proximal ones.
• Always advance the device with fluoroscopic imaging. If any resistance
is noted, do not continue until determining its cause. If the stent is not
able to cross or reach the lesion, remove the whole system (including the
guiding catheter and the guidewire) as a single unit.
• If any resistance is noticed during advance, stop the advance and
determine its cause before continuing.
• Once stent expansion is started, do not intent to remove it or change
its position.
• Do not manipulate, advance or retract, either the catheter or the
guidewire, while the balloon is inflated.
• Do not exceed the maximum recommended pressure indicated on the
label and the attached compliance curve.
• If any resistance is noted during lesion access, delivery system
withdrawal or withdrawal of a stent which could not be implanted, the
whole system should be removed as a single unit:
• Do not withdraw the delivery system into the guiding catheter or long
introducer:
- Place the proximal balloon marker distally to the tip of the guiding
catheter or long introducer
- Advance the guidewire towards into the anatomy as far as safely possible
- Tighten the haemostatic valve so it properly grabs the guiding catheter
or long introducer and the balloon
- Remove the guiding catheter or long introducer and the balloon
catheter together, as a single unit
- Finally, remove the guidewire, or in case an implantation is wished to
begin again, maintain the guidewire and placed the rest of the devices.
• Great care must be exercised immediately after implantation and if it was
needed to re-cross it, not to push the stent with guidewires or balloons
not to destructure it.
6. Precautions: MRI[1] Safety:
Chromium-cobalt drug-eluting stents have shown in pre-clinical trials,
individually and in super-posed configurations, that they are safe for
magnetic resonance under certain conditions:
• Static magnetic field with intensity equal to or less than 3 Tesla strength
• Maximum spatial gradient of 720 gauss/cm
• Whole-body specific absorption rate (SAR) with a maximum average of
3.0 W/Kg over 15 minutes of magnetic resonance exploration.
In non-clinical tests with static magnetic resonance of 3.0 Tesla strength
and a whole-body maximum specific absorption rate of 2.0 W/Kg over 15
minutes of magnetic resonance exploration, the increase in temperature
for a single stent was a little more than 1ºC, while for an overlapping pair,
it was less than 2ºC.
No clinical or non-clinical trials have been conducted to rule out the
possibility of stent migration at an over 3.0 Tesla strength field. It is not
recommended to perform MR tests with over 3.0 Tesla strength.
MR imaging quality may be affected if the area of interest is adjacent or very
close to the stent place.
7. Drug interaction
Although specific clinical information is not available, drugs that act through
the same binding protein (FKBP) as sirolimus may interfere with its efficacy.
In turn, potent CYP3A4 inhibitors (such as ketoconazole) may cause an
increase in exposure of sirolimus up to levels associated with systemic
effects, especially when multiple stents are implanted. One should also
keep in mind the systemic presence of sirolimus when treating a patient
concomitantly with immunosuppressant therapy.
8. Possible Adverse Effects / Complications
Possible associated adverse effects and/or complications that may arise
before, during or after the procedure include the following:
[1] These data were obtained bibliographically, by searching for marketed
stents with the same composition. Drug interaction
2
during product advance-positioning-stenting-