COOK Medical Zilver, Инструкция по эксплуатации

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5. Remove the inner support stylet from the hub of the delivery system’s handle.
6. Immediately before placing the delivery system into the body, use the 1 ml syringe
included in the inner package to flush the delivery system 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.
7. Place the delivery system under fluoroscopy to determine that the radiopaque markers on
the delivery system (h) are at the desired position. The stent is now ready to be deployed.
(Fig. 1)
Deployment of the Stent
1. Before deployment, it is important to straighten the proximal part of the delivery system
as much as possible and to keep the handle in a stable position.
2. The stent expansion must be performed under fluoroscopic control.
3. Hold the hub (b) on the metal cannula (g) steady. To deploy the stent, remove the red
safety lock (c). (Fig. 2)
4. Hold the hub end stationary. The stent will be deployed as you pull the handle (a) toward
the hub (b). (Fig. 3)
NOTE:
Full deployment of the stent length will occur when the distal end of the sheath
has been retracted past the proximal part of the stent.
5. As deployment occurs, continue sliding the handle (a) toward the hub (b) in a slow,
smooth and consistent fashion. (Fig. 4)
NOTE:
Once stent deployment has begun, the stent must be fully deployed.
Repositioning of the Zilver Vascular Stent is not possible since the delivery system’s
outer sheath cannot be re-advanced over the stent once deployment begins. Refer
to the Multiple Stent Placement section of these instructions for use for information
on missed lesions.
6. The stent is fully deployed when the handle (a) reaches the hub (b). (Fig. 5)
7. Remove the delivery system.
8. Perform an arterial angiogram to verify full deployment of the device.
If incomplete expansion exists within the stent at any point along the lesion, post-deployment
balloon dilatation (standard PTA) can be performed at the discretion of the physician.
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.
REFERENCES
These instructions for use are based on experience from physicians and (or) their published
literature. Refer to your local Cook sales representative for information on available literature.