Equipment Required; Patient Preparation - COOK Medical Evolution Instructions For Use Manual

Mail: MedicAlert Foundation International
2323 Colorado Avenue
Turlock, CA 95382
Phone: 888-633-4298 (toll free)
209-668-3333 from outside the US
Fax: 209-669-2450
Web: www.medicalert.org
The stent is not intended to be removed and is considered a permanent implant. Attempts
to remove stent after placement may cause damage to esophageal mucosa.
Stent cannot be retrieved after the deployment threshold has been passed. Corresponding
marks on outer catheter and delivery handle indicate when threshold has been passed.

EQUIPMENT REQUIRED

Stent and delivery system
Esophageal Balloon Dilators or Bougie Dilators
.035 inch wire guide

PATIENT PREPARATION

1. Dilate stricture to a minimum size as outlined in the precautions section using Balloon
Dilators or Bougie Dilators.
2. Endoscopically locate and mark upper and lower margins of lesion with radiopaque marker.
Caution: Accurate marking of lesion borders is essential for proper stent placement.
3. Place a .035 inch wire guide, floppy tip first, through accessory channel, through stricture,
until it is fluoroscopically visualized in stomach. Leave wire guide in place and remove
endoscope.
INSTRUCTIONS FOR USE
1. Remove the protective tubing from stent.
2. Using fluoroscopic guidance, introduce and advance the introduction system in short
increments over the pre-positioned wire guide into the esophagus.
3. To ensure that stent will bridge stricture after deployment, fluoroscopically position
radiopaque markers on inner catheter beyond extremities of stricture to be crossed.
4. Confirm desired stent position fluoroscopically and deploy stent by removing red safety
guard from the handle. (See Fig. 1)
5. Continue deploying stent by squeezing trigger. Note: Each trigger squeeze will deploy stent
by an equal amount.
6. If stent repositioning is required during deployment, it is possible to recapture stent. Note: It
6
Illustrations