CID CRE8 Manual Del Usuario página 5

11. DRUG REGIME
Studies in clinical literature indicate the need to administer anticoagulant therapy during
the procedure and anti-platelet treatment after the procedure.
Antiplatelet treatment during the period after the procedure involves the administration of:
- Thienopyridine (ticlopidine or clopidogrel or prasugrel in the doses indicated in the
relative instruction leaflets or according to medical prescription)
- Aspirin at a minimum amount of 100 mg/day indefinitely.
12. INTERACTIONS WITH DRUGS
Although no specific clinical data are available, certain drugs, such as Tacrolimus,
which act through the same binding protein (FKBP), may interfere with the efficacy of
Sirolimus. There have been no studies on the interaction between drugs. Sirolimus is
metabolized by CYP3A4. Strong CYP3A4 inhibitors may cause greater exposure to
Sirolimus up to levels associated with systemic effects, especially in the case of multiple
implant. Systemic exposure to Sirolimus if the patient is taking concomitant systemic
immunosuppressive drugs must also be considered.
13. DIRECTIONS FOR USE
Stent + delivery catheter preparation
Before commencing the angioplasty procedure, administer heparin and check that the
patient's Activated Clotting Time (ACT) is greater than 300 seconds.
During preparation of the system, take special care not to let to any liquid come
into contact with the stent. 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 stent should be implanted in the target lesion using its delivery catheter.
After having examined the package for any damage, remove the CRE8™ device and
bring it into a sterile area.
a) Check that the delivery catheter does not present kinks, bends or other damage.
b) Carefully slide the protective cover off the stent by grasping the cover at the distal
end. Check that the stent is intact and well centred on the balloon.
Damage to the CRE8™ device may impair its performance.
c) Flush guidewire lumen with heparin/saline mixture. Caution: do not place the stent
into contact with liquids while flushing the guidewire lumen.
d) Prepare the inflation device according to the manufacturer's instructions.
e) Purge any air from the balloon the stent is mounted on as follows:
1) Fill the inflation device with 4 ml of contrast medium;
2) After connecting the inflation device to the delivery catheter Luer connector, point
the distal tip of the catheter (balloon) downwards vertically;
3) Apply negative pressure and aspirate for at least 30 seconds. Allow the pres-
sure to rise gradually back to normal as the system fills with contrast medium.
4) Without introducing air, repeat step 3 and aspirate for 10-15 seconds until air
bubbles no longer appear.
Stent insertion
The guiding catheters with a 5F diameter (inner diameter 1.47 mm) or larger are
compatible for use with the CRE8™ device.
Coronary guidewires 0.014 inches in diameter (0.356 mm) or less are compatible
for use with the CRE8™ device. The choice of guidewire stiffness and tip configu-
ration will depend on the physician's clinical experience.
a) Keep the delivery catheter the stent is crimped on at ambient pressure during inser-
tion.
b) Flush the exposed portion of the guidewire with a heparin/saline mixture to remove
traces of blood and contrast medium.
c) Ensure that the haemostasis valve is completely open before introducing the system.
d) Slowly advance the system over the guidewire to allow the blood the retrograde
filling of the guiding catheter; keep advancing the system until the stent reaches the
treatment site.
e) When advancing the delivery system into the target vessel, make sure that the stent
and the delivery balloon move as a single unit. This should be done by observing,
under fluoroscopy, the position of the balloon radiopaque markers in relation to the
stent radiopaque markers.
If resistance is encountered at any time, 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.
Stent implantation and expansion
a) Position the stent and, with the help of the balloon's radiopaque markers, make
sure it is correctly positioned in relation to the lesion to be treated and completely
covered.
b) Expand the stent by slowly inflating the balloon to the nominal diameter. Table 2 lists
the diameters of the balloon as inflation pressure varies (column I), for the seven
nominal diameter groups: 2.25 mm (column II), 2.5 mm (column III), 2.75 mm (column
IV), 3.0 mm (column V), 3.5 mm (column VI), 4.0 mm (column VII) and 4.5 mm (column
VIII). Values on dark background refer to pressures above the Rated Burst Pressure*.
The stent expands at a minimum balloon inflation pressure of about 5 atm.
c) Stent elastic recoil is between 2 and 7%* depending on stent model and expan-
sion diameter.
* NOTE: These values are obtained from the results of in-vitro testing
d) Deflate the balloon and check angiographically that the stent has fully expand-
ed. If necessary, re-inflate the balloon for optimal implantation.
e) Before withdrawing the delivery catheter, maintain negative pressure for a minimum
of 30 seconds, as per routine PTCA procedure.
f) If post-dilatation of the stent is required, a PTCA balloon can be used. Use extreme
care:
not to expand the 2.25 mm nominal diameter stent over 2.55 mm.
not to expand the 2.50 mm nominal diameter stent over 3.05 mm.
not to expand the 2.75 mm nominal diameter stent over 3.05 mm.
not to expand the 3.00 mm nominal diameter stent over 3.85 mm.
not to expand the 3.50 mm nominal diameter stent over 3.85 mm.
not to expand the 4.00 mm nominal diameter stent over 5.05 mm.
not to expand the 4.50 mm nominal diameter stent over 5.05 mm.
Optimal expansion requires the stent to be in full contact with the arterial wall,
so that the stent diameter equals the diameter of the reference vessel.
ENSURE THAT THE STENT IS FULLY EXPANDED.
14. ADVERSE EVENTS
Coronary stent implantation may give rise to the following complications:
• Access site haematoma
• Acute myocardial infarction
• Allergic reaction (to contrast medium, drugs used during the procedure or the materi-
als composing the stent)
• Arterial spasm
• Artery aneurysm or pseudoaneurysm
• Cardiac arrhythmia
• Death
• Dissection, perforation, rupture of the artery
• Distal embolism
• Haemorrhage
• Infection and pain at the access site
• Restenosis of the vessel
• Stent embolization
• Stent occlusion
• Thrombosis (acute, subacute or late)
• Unstable angina
• Ventricular fibrillation
• Vessel occlusion
15. LIABILITY AND WARRANTY
The Manufacturer guarantees that this device has been designed, manufactured and
packaged with the greatest care, using the most appropriate procedures the current
state of technology allows. The safety standards integrated into the design and man-
ufacture of the product guarantee its safe use under the aforestated conditions and
for its intended purposes in observation of the precautions listed above. These safety
standards are meant to reduce as far as possible, but not eliminate completely, the risks
related to the use of the product.
The product must be used only under a specialist physician's care, while taking into
account any risks or side effects and complications that might arise from its intended
use, as mentioned in other sections of this instructions booklet.
Given the technical complexity, the critical nature of treatment choices and the methods
used to apply the device, the Manufacturer cannot be held responsible, either explicitly
or implicitly, for the quality of end results subsequent to the use of the device or its ef-
fectiveness in resolving a patient's state of infirmity. The end results, in terms of both the
clinical status of the patient and the functionality and the lifetime of the device, depend
on many factors outside the manufacturer's control, among which are the patient's con-
ditions, the surgical procedure of implantation and application, and the handling of the
device after being removed from its package.
In light of these factors, therefore, the Manufacturer is solely responsible for the re-
placement of any device which, upon delivery, is found to have manufacturing defects.
Under such circumstances, the customer shall deliver the device to The Manufacturer,
which reserves the right to examine the allegedly faulty device and establish whether
it actually presents manufacturing defects. The warranty consists exclusively in the
replacement of the defective device with another device of the same type or equivalent,
from the same Manufacturer.
The warranty applies under the condition that the device is returned correctly packed
to the Manufacturer, and that it is accompanied by a written, detailed report describing
the defects claimed, and, if the device has been implanted, stating the reasons for its
removal from the patient.
On replacement of the device, the Manufacturer shall reimburse the buyer the expens-
es incurred for return of the defective device.
The Manufacturer declines any responsibility for cases of negligence to observe the
methods of use and the precautions stated in this instructions booklet and for cases of
use of the device after the use before date printed on the package.
Furthermore, the Manufacturer declines any responsibility related to the consequences
arising from the treatment choices and the methods of use or the application of the
device; the Manufacturer shall, therefore, not be liable for any damage of any nature,
material, biological or moral, subsequent to the application of the device, or the choice
of implantation technique used by the operator.
The agents and the representatives of the Manufacturer are not authorized to modify
any of the conditions of this warranty or to assume any further obligations or to offer any
guarantees related to this product beyond the terms stated above.
3