CID CRE8 Manual De Instrucciones página 4

ENGLISH
CRE8™
Sirolimus eluting iCarbofilm™ coated coronary stent on rapid exchange
balloon catheter
1. DESCRIPTION
The CRE8™ device consists of a Sirolimus eluting coronary stent firmly held
on the distal end of a semicompliant balloon catheter.
The coronary stent is a flexible implantable device that can be expanded using
a PTCA catheter.
The stent is made of cobalt chromium alloy (L605) and is coated with
iCarbofilm™, a thin carbon film with a high-density turbostratic structure
substantially identical with that of the pyrolytic carbon used for mechanical
cardiac valve discs. Coating the substrate with iCarbofilm™ provides it with the
bio- and haemocompatible characteristics proper of pyrolytic carbon, without
affecting the physical and structural properties of the substrate itself.
The outer surface of the stent has dedicated grooves, fully coated with
iCarbofilm™, for containing the pharmaceutical formulation Amphilimus™,
which is composed of the drug Sirolimus and a mixture of long chain fatty acids.
The specific drug dosage for the vessel surface treated is approximately 0.9 μg/
mm², which corresponds to a minimum dose of 50 μg on the smaller stent
(2.25x8mm) and a maximum dose of 395 μg on the larger stents (4.0x38 mm
and 3.5x46 mm).
Two radio-opaque platinum markers at either end of the stent enable accurate
positioning on the lesion to be treated.
The rapid-exchange type balloon catheter provides a safe means for delivering
the coronary stent to the lesion to be treated.
The distal portion of the catheter has a hydrophilic coating and consists of
two lumens: one for balloon inflation and deflation, the other for guidewire
advancement and retraction.
Two radio-opaque markers, located outside the usable length of the balloon,
enable accurate placement across the stenosis.
The proximal portion of the catheter, a stainless steel hypotube, contains the
lumen for balloon inflation and deflation.
Two depth indicators, placed 90 and 100 cm from the distal end, indicate the
end of the balloon catheter from the guiding catheter, respectively in cases of
brachial or femoral/radial approach.
The proximal end of the catheter has a female Luer lock for attachment to an
inflation device.
The Manufacturer produces the CRE8™ device and carries out all quality
controls both during manufacture and on the finished product, in accordance to
the appropriate good manufacturing standards.
How supplied:
CRE8™ device is supplied sterile, non-pyrogenic and individually packed in a foil
pouch that must not be placed into a sterile field.
NOTE: The foil pouch is the only sterile barrier.
The manufacturer sterilization uses an ethylene oxide and CO
Sterility and chemical stability are guaranteed while the package remains intact
and correctly stored, until the expiry date printed on the packaging (EXPIRY
DATE).
Contents:
- One Cre8™ device
- One compliance table
Storage:
Store in a cool, dry place, away from sunlight, at a temperature of 25 °C; excursion
permitted to 30 °C.
2. INTENDED USE
The coronary stent is indicated for the treatment of stenotic lesions in coronary
arteries and coronary artery bypasses to maintain vessel patency.
Randomized clinical trials have shown that drug-eluting stents can significantly
reduce angiographic late loss (late lumen loss), binary restenosis and repetition
of target lesion revascularization.
3. INDICATIONS
The stent is indicated for improving coronary luminal diameter in patients with
symptomatic ischemic heart disease due to de novo and restenotic lesions of
native coronary arteries.
4. CONTRAINDICATIONS
Use of the stent is contraindicated in the following situations:
• Lesions considered untreatable with PTCA or other interventional techniques
• Disorders/allergies that limit the use of anti-platelet and/or anticoagulant
therapy
• Severe allergy to the contrast medium or drugs used during the procedure
• Lesions on a vessel with reference diameter < 2.25 mm
• Patients with known hypersensitivity or allergies to Sirolimus, fatty acids
(such as stearic acid, palmitic acid, behenic acid).
5. WARNINGS
• Evaluate the characteristics of the lesion to be treated and the specific
physiopathology of the patient with great care before making procedural
choices.
• Considering the complexity of the procedure and the specific physiopathology
of the patient, the physician should refer to updated literature for information
regarding the risks and advantages of the various procedures before choosing
the procedure to adopt.
• In patients with known hypersensitivity or allergies to metal components
of the stent, the Cre8™ stent should be used only if potential benefits
of the stent outweigh potential risks.
• There are no adequate or well-controlled studies in pregnant women for this
product. The Cre8™ stent should be used during pregnancy only if potential
benefits of the stent outweigh potential risks.
• The device is intended for single use only. Do not reuse, reprocess
or re-sterilize. This could compromise device performance and cause
contamination risks of the device and infections to the patient, inflammation
and patient-to-patient transmission of infective diseases.
• The CRE8™ device should be carefully handled so as to avoid any contact
with metallic or abrasive instruments that could damage the highly polished
surfaces or produce alterations.
• The stent should not be touched. This is most important during catheter
removal from packaging, placement over the guide wire, and advancement
through the rotating hemostatic valve adapter and guiding catheter hub.
• The CRE8™ device is designed to perform as a system. Do not use its
components separately.
• The CRE8™ device is indicated for use in combination with PTCA. The
delivery catheter is not a coronary dilatation catheter; it should be used for
stent deployment only.
• Do not use the CRE8™ device if its packaging has been opened or damaged,
incorrectly stored, or if the stated "Expiry date" has passed. In such cases
product performances and sterility are not guaranteed.
• Do not use the CRE8™ if the shaft of the catheter has kinks or bends; in
such cases do not try to straighten the catheter.
• The stent should not come into contact with liquids prior to preparation and
positioning. However, if it is absolutely necessary to flush the stent with
sterile/isotonic saline solution, the contact time should be limited (maximum
one minute).
• A heart surgery team should be available for a possible intervention.
• Follow the manufacturer's instructions when using accessories (guiding
catheter, guidewire, haemostatic valve).
• The CRE8™ device should be guided under fluoroscopy and monitored with
the use of radiographic equipment that produces high-quality images.
• The traditional procedure for stent deployment requires pre-dilatation of the
lesion.
• Recent scientific literature describes procedures performed without pre-
dilatation.
• The stent should be implanted in the target lesion using its delivery catheter.
• If resistance is encountered at any time during the insertion procedure, do
not force the system: withdraw the CRE8™ device and the guiding catheter
as a single unit. Applying excessive force and/or incorrectly handling the
system may lead to stent deployment or damage to the delivery catheter.
• If the patient has multiple lesions in a single vessel, it is advisable to treat
first the distal lesion, then the proximal lesions. This order will reduce the
need to cross the proximal stent during implantation of the distal stent and
therefore reduces the risk of displacing the proximal stent.
• Implantation of a coronary stent may cause dissection of the vessel distal
and/or proximal to implantation site and may also cause acute occlusion
mixture.
of the vessel, making an additional intervention necessary (CABG, further
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dilatation, placement of additional stents, or other procedures).
• Do not pressurise the system until the stent is positioned across the lesion
to be treated.
• Never use air or any other gas to inflate the balloon.
• During catheter inflation do not exceed the Rated Burst Pressure.
• Do not retract the catheter at the end of the procedure until its balloon is
fully deflated.
• Do not attempt to reposition a partially expanded stent. Attempted
repositioning may cause severe vessel damage.
• If the stent is lost in the coronary vessel, recovery procedures can be initiated.
The procedures can, however, cause injury to coronary vessels and/or to
the vessel access site.
• Do not attempt to clean or re-sterilize devices that have been in contact with
blood and organic tissues. Used devices are to be disposed of as dangerous
medical waste with risk of infection.
6. PRECAUTIONS
• Before the angioplasty procedure, examine the catheter to check that it
operates correctly (no kinks, bends or other damage) and ensure that the
dimensions are correct for the specific procedure in which it is to be used.
• Use of a gauged inflation device is strongly recommended.
• The Cre8™ device should be used only by physicians trained specifically
to perform percutaneous transluminal coronary angioplasty (PTCA) and
coronary stent implantation.
• In cases of acute myocardial infarction, implantation of the stent should be
carefully assessed by the operator due to the risk of acute thrombosis.
• Where vessels are excessively tortuous and there is also proximal
atherosclerosis, the catheter may be difficult to advance. In such cases
incorrect handling could lead to dissection or rupture of the coronary vessel.
• Placement of a stent has the potential to compromise side branch patency.
• An unexpanded stent may be retracted into the guiding catheter one time
only. An unexpanded stent should not be reintroduced into the artery once
it has been pulled back into the guiding catheter.
• To avoid damaging the stent, use extreme care whenever passing the
guidewire or the balloon catheter across a stent that has just been expanded.
7. MRI SAFETY INFORMATION
Non-clinical testing has demonstrated that CoCr stent product lines are MR
Conditional. A patient with these devices can be safely scanned in an MR
system meeting the following conditions:
• Static magnetic field of 1.5-Tesla (1.5 T) or 3-Tesla (3 T).
• Maximum spatial field gradient of 2,890 G/cm (28.90 T/m)
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