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Contraindications; Mri Information - Cook Medical Zilver Flex 35 Mode D'emploi

Endoprothèse vasculaire
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  • FRANÇAIS, page 42
• Arteriosclerotic stenosis
• Total occlusions that have been recanalized
The product provides mechanical support to maintain constant blood flow of the vessel.
The product is intended for use by physicians trained and experienced in diagnostic and
interventional techniques.
Placement of the stent requires advanced skills in interventional procedures. The following
instructions will give technical guidance but do not obviate formal training in the use of the
device.
Standard techniques for placement of an arterial access sheath and wire guide should be
employed during use of the vascular stent.

CONTRAINDICATIONS

Patients with bleeding diathesis or other disorder, e.g. peptic ulceration or recent
cerebrovascular accident, limiting the use of antiplatelet and anticoagulant therapy.
Patients with total arterial occlusion.
Coronary use is not recommended.
WARNINGS
• Possible allergic reactions should be avoided.
PRECAUTIONS
• Manipulation of the product requires high-resolution fluoroscopic control.
• The lesion and vessel can be predilated before placement of the stent.
• Do not try to remove the stent from the introducer system before use.
• Ensure that the safety lock is not inadvertently removed prior to stent release.

MRI INFORMATION

Non-clinical testing has demonstrated that the ZILVER FLEX™35 Vascular Stent is MR
conditional. A patient with this stent can be scanned safely after placement under the
following conditions.
Static Magnetic Field
• Static magnetic field of 3-Tesla or less
• Highest spatial magnetic gradient of 720-gauss/cm
Non-clinical evaluation was conducted in a 3-Tesla MR system with a maximum spatial
magnetic gradient field of 720 Gauss/cm as measured with a gauss meter in the position of
the static magnetic field pertinent to the patient (i.e., outside of scanner covering, accessible
to a patient or individual) and resulted in a deflection angle of 3 degrees. An implant that
displays a deflection angle of ≤ 45 degrees is considered to pose no harm to a patient or
individual.
MRI-Related Heating
1.5 and 3.0 Tesla Systems
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