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a) Pass the guide wire through the place where Stent will be positioned with the aid of
fluoroscopy and/or endoscopy.
b) Ensure that the valve of Y-connector connecting the inner sheath and outer sheath
is locked by rotating proximal valve end in a clockwise direction to prevent
premature Stent deployment.
c) Flush the inner lumen of introducer system with the sterilized saline solution.
④ Stent Deployment Procedure
a) Under the fluoroscope and/or endoscopic guidance, position the introducer system
to the center of the target stricture.
b) Once the introducer system is in the correct position for deployment, unlock the
proximal valve of the Y-connector by turning the valve more than twice in the anti-
clockwise direction.
c) To begin Stent deployment, immobilize the hub in one hand and grasp the Y-
connector with the other. Gently slide the Y-connector back along the pusher
towards the hub.
d) When the center X-ray marker reaches the center of the target stricture, continue
pulling the Y-connector until the Stent is fully deployed. (See figure 3)
CAUTION Do not push or pull on the hub with the Stent partially deployed. The hub
must be securely immobilized. Inadvertent movement of the hub may cause
misalignment of the Stent and possible damage to urethral tissue.
⑤ After Stent Deployment
a) To confirm expansion, examine the Stent by fluoroscopy and/or endoscopy.
b) Carefully remove the introducer system, guide wire and endoscope from the
patient. If excessive resistance is felt during removal, wait for 3~5 minutes to
allow further Stent expansion. (Place the inner sheath back into the outer sheath as
the original state prior to removal.)
c) Balloon dilatation inside the Stent can be performed with the discretion of the
doctor.
d) Wash with about 50cc of warm saline solution (38~45°C) after surgery to
maximize Stent expansion.
11. Perform post-implant routine procedures
a) Assess the size and stricture of the Stent lumen. A Stent may require 1 to 3 days
to expand fully.
b) Doctor's experience and discretion can determine the appropriate drug or
procedure for each patient.
c) After implantation, patient should follow the prescription of the treating doctor.
d) Observe the patient for development of any complications.
12. Instructions for relocation and removal of Uventa
Visually examine the Stent for any tumor in-growth/over-growth into the Stent lumen or
whether the Stent is occluded. If the Stent lumen is clear, carefully remove the Stent by
using forceps and/or an appropriate device. When removing, cleansing the Stent with
cold saline solution (less than 4°C) can make the removal easier.
Grasp the retrieval string and/or collapse the proximal end of the Stent, and then
carefully retrieve the Stent. If the Stent cannot be easily withdrawn, stop removing the
Stent and make inquiry to the manufacturer or seller.
Caution: Do not use excessive force to remove the Stent as it may cause disconnect to
the retrieval string.
To relocate UventaTM Urethral Stent immediately after deployment, use forceps or an
appropriate device to grasp the retrieval string and gently adjust to the correct placement.
Adjustment should be made only toward the external urethral orifice.
The timing of the removal should be determined by the doctor at his/her discretion.
Figure 2
Figure 3
TM
Urethral Stent
