CID CRE8 Manual Del Usuario página 4

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 pyrolitic carbon used for mechanical cardiac valve discs. Coating the substrate
with iCarbofilm™ provides it with the bio- and haemocompatible characteristics of py-
rolytic 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/mm
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 stent (4.0x38 mm - 3.5x46 mm).
Two radio-opaque platinum markers at either end of the stent enable accurate position-
ing 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 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 indicators placed at a depth of 90 and 100 cm from the distal end, signal the end
of the balloon catheter from the guiding catheter, respectively in cases of brachial or
femoral approach.
The proximal end of the catheter has a female Luer lock for attachment to an inflation
device.
The Manufacturer directly manufactures the CRE8™ device and carries out all quality
controls both during production and on the finished product, according to the norms of
Good Manufacturing Practice.
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 sympto-
matic 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
• Patients who do not qualify for coronary artery bypass surgery
• Women who are pregnant
• 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
• Stenosis of an unprotected vessel
• Ejection fractions < 30%
• Diffuse distal coronary artery disease
• Lesions in an area involving a major side branch. A major side branch is defined
as a vessel that would be bypassed if it was occluded
• Lesions on a vessel with reference diameter < 2.25 mm
• Lesions distal to stenosis > 50% non dilatable
• Patients with known hypersensitivity or allergies to Sirolimus, fatty acids (such as
stearic acid, palmitic acid, behenic acid) or the metal components of the stent
5. MODEL
Each CRE8™ device is identified by a model code and a lot number; available product
codes are listed in Table 1. The code is composed of the letters IC, followed by two let-
ters identifying the type of device, two or three digits indicating the nominal diameter of
expansion of the stent and a further two digits indicating the length of the stent.
The batch number allows traceability of all information regarding device manufacture
and system control in the Quality Assurance archives of the Manufacturer.
To facilitate traceability of the device at the user end, the product code is printed on
the adhesive labels included on each box; these labels can be attached to the implant
patient's medical chart.
6. HOW SUPPLIED
The CRE8™ device is supplied sterile in a foil pouch that must not be brought into a
sterile area.
NOTE: The foil pouch is the only sterile barrier.
The manufacture sterilisation uses an ethylene oxide and CO2 mixture.
Sterility and chemical stability are guaranteed while the package remains intact and
correctly stored, until the expiry date printed on the packaging (USE BEFORE DATE).
7. STORAGE
Store in a cool, dry place at a temperature of 25°C; excursions permitted to 30°C.
8. WARNINGS
• The device is intended for single use only. Do not reuse, reprocess or resterilise.
This could 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 with bare hands.
• 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).
• 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, incor-
rectly stored, or if it is past the stated expiry date. In such cases product sterility is
,
2
not guaranteed.
• Do not use the CRE8™ if, during handling, due to torsion or resistance to insertion,
the proximal portion of the catheter has kinks or bends; in such cases do not try to
straighten the catheter.
• The CRE8™ device should be used only by physicians trained specifically to per-
form percutaneous transluminal coronary angioplasty (PTCA) and coronary stent
implantation.
• A heart surgery team must be available for a possible intervention.
• 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.
• Evaluate the characteristics of the lesion to be treated and the specific physiopathol-
ogy 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.
• The stent should be implanted in the target lesion using its delivery catheter.
• Do not pressurise the system until the stent is positioned across the lesion to be
treated.
• Do not retract the catheter at the end of the procedure until its balloon is fully de-
flated.
• Do not attempt to reposition a partially expanded stent. Attempted repositioning may
cause severe vessel damage.
• Do not attempt to clean or re-sterilise 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.
• Follow the manufacturer's instructions when using accessories (guiding catheter,
guidewire, haemostatic valve).
• 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 first treat 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 of the vessel,
making an additional intervention necessary (CABG, further dilatation, placement of
additional stents, or other procedures).
• 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 ac-
cess site.
• During catheter inflation do not exceed the Rated Burst Pressure.
• Never use air or any other gas to inflate the balloon.
9. PRECAUTIONS
• Use of a gauged inflation device is strongly recommended.
• 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.
• To avoid damaging the stent, use extreme care whenever passing the guidewire or
the balloon catheter across a stent that has just been expanded.
10. 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 fol-
lowing 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)
Under the scan conditions defined below, CoCr stent product lines in a single stent
configuration are expected to produce a maximum temperature rise of less than 2.4 °C
in a 1.5 T MRI system and 2.9 °C in a 3 T MRI system.
MR system reported, whole body averaged SAR
Calorimetry measured values, whole body averaged SAR
Highest temperature change
In non-clinical testing, the image artifact caused by the device extends approximately
1.0 cm from CoCr stents when imaged with a gradient-echo pulse sequence in a 3 T
MRI system.
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1.5 T 3 T
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2.9 W/kg 2.9 W/kg
2.1 W/kg 2.7 W/kg
2.4 °C 2.9 °C