COOK Medical Evolution Gebrauchsanweisung Seite 8

• a maximum whole body average specific absorption rate (SAR) of 3.8 W/kg (corresponding
to a calorimetry measured value of 3.1 W/kg) for 15 minutes of MR scanning in a 1.5 Tesla
Magnetom (Siemens Medical Solutions, Malvern, PA, Software Numaris/4) MR scanner.
• a maximum whole body average specific absorption rate (SAR) of 3.0 W/kg (corresponding
to a calorimetry measured value of 2.8 W/kg) for 15 minutes of MR scanning in a 3.0 Tesla
Excite (GE Electric Healthcare, Milwaukee, WI, Software G3.0-052B) MR scanner.
MR image quality may be compromised if the area of interest is within the lumen of the
Evolution Stent or within approximately 7 mm of the position of the Evolution Stent as found
during non-clinical testing using the sequences: T1-weighted, spin echo pulse sequence
and Gradient echo pulse sequence in a 3.0 Tesla Excite (GE Electric Healthcare, Milwaukee,
WI, Software G3.0-052B) MR system with body radiofrequency coil. Therefore, it may be
necessary to optimize MR imaging parameters for the presence of this metallic implant.
The safety of MR imaging using a local transmit/receive RF coil in areas immediately
adjacent or directly involving the implant has not been established and is therefore not
recommended.
The safety of performing MRI imaging in patients with overlapping stents or other device(s)
in the esophagus has not been established and is therefore not recommended.
PRECAUTIONS
• A complete diagnostic evaluation must be performed prior to use to determine proper stent
size.
• The Evolution Esophageal Stent – Fully Covered should be used with caution and only after
careful consideration in patients with:
• Significant preexisting pulmonary or cardiac disease
• Conditions where esophageal stenting may cause a secondary tracheal stenosis.
• Prior gastric pull up operations resulting in altered anatomy.
• Stent should be placed using fluoroscopic monitoring.
• Prior to advancing the system, physician discretion should be used to determine if dilation
is required. If required, dilate area to be stented to a diameter that is at least equal to the
diameter of the delivery system and a maximum of 11 mm.
• The migration rate may be increased by absence of a tumor abutment in benign esophageal
stenoses, esophageal fistula without stenoses, incorrect sizing of the stent, or in cases of
malignant stenoses where radiotherapy and/or chemotherapy is employed.
• Long-term patency of this device has not been established. Periodic evaluation is advised.
• After stent placement, patients should be instructed to chew food well or eat soft or pureed
food.
• This device shortens upon deployment. With proximal strictures near the upper esophageal
sphincter, deployment should be performed under fluoroscopic visualization as this may
enhance placement accuracy.
• For Malignant use, alternate methods of therapy should be investigated prior to placement.
After stent placement, alternative methods of treatment such as chemotherapy and
radiation should not be administered as this may increase risk of stent migration due to
tumor shrinkage, stent erosion, and/or mucosal bleeding.
• The stent should only be placed with the Cook delivery system, which is provided with each
stent.
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