COOK Medical Zilver PTX Instrucciones De Uso página 5

Multiple Stent Placement
If placements of multiple stents are required in a patient, to cover the length
of the lesion, the following recommendations should be considered:
• In relation to the lesion site, the distal area of narrowing should be stented
first, followed by the proximal locations (i.e., a second stent should be placed
proximally to the previously placed stent).
• Stents placed in tandem must overlap to allow for complete coverage of the
lesion.
INSTRUCTIONS FOR USE
11. Determine the proper stent size after complete diagnostic evaluation.
The stent deployment must be performed under fluoroscopic control.
Measure the length of the target lesion to determine the length of the
stent required. Allow for the proximal and distal aspects of the stent to
cover the entire target area.
NOTE: The Zilver PTX Drug Eluting Peripheral Stent is designed not to shorten
upon deployment. Bench testing has shown that on average, the stent length
increases from pre-deployment to post-deployment by approximately 3%.
Measure the diameter of the reference vessel (proximal and distal to the
lesion) and use the LARGEST reference diameter as your basis for choosing the
appropriate stent size.
Reference Vessel Diameter
4.0 – 5.0 mm
5.0 – 6.0 mm
6.0 – 7.0 mm
7.0 – 8.0 mm
8.0 – 9.0 mm
12. Introduce the extra or ultra stiff 0.035 inch wire guide through the access
catheter across the distal segment of the target lesion.
13. Remove the access catheter, leaving the wire guide in place.
14. Predilatation before stent placement is optional and at the discretion of
the physician.
15. Remove the inner support stylet from the hub of the delivery system's
handle.
16. Immediately before placing the introducer catheter into the body, use the
1 ml syringe included in the inner package to flush the introducer catheter
with saline through the side-arm flushing port. Flush only until a few drops
of saline exit the distal tip, between the introducer catheter and sheath.
The time between flushing and stent deployment should be minimized, and
must be no longer than 5 minutes.
17. Place the introducer catheter under fluoroscopy to determine that the two
radiopaque marks on the delivery system ( h ) are at the desired position.
The stent is now ready to be deployed. ( Fig. 2 )
Stent Size Selection Table
h
5
unconstrained Stent Diameter
6.0 mm
7.0 mm
8.0 mm
9.0 mm
10.0 mm
Fig. 2