NuMED CP STENT Instrucciones De Utilizacion página 4

I
NSTRUCTIONS FOR
Select Stent Size
1. Measure the length of the target stricture to determine the length of stent required. Size the
stent length to extend slightly proximal and distal to the stricture.
2. The appropriate stent length should be selected based on covering the entire obstructed
segment with a single stent.
Note: Should more than one stent be required, place the stent most distal from the puncture
site first, followed by placement of the proximal stent in tandem.
3. Measure the diameter of the reference stricture and vessel proximal and distal to the target
lesion to determine the appropriate size stent and delivery system.
Preparation of Stent
• Remove the stent and rinse in sterile saline.
Preparation of Stent Delivery Catheter
• See instruction for use provided with the recommended balloon catheter.
Preparation of Stent Delivery System
1. Always place an appropriate sized guidewire through the balloon catheter lumen while
prepping the balloon and crimping the stent.
2. Remove the balloon protector and visually inspect the balloon being used to insure that it is
properly folded to its lowest profile in preparation for the stent. "Dry Prepping" the balloon
delivery catheter by using negative pressure is highly recommended.
3. Slide the stent over the distal end of the balloon, maintaining the balloon fold, until the
radiopaque markers are equal distance from the ends of the stent. Check the stent position
under the fluoroscope before crimping.
4. Gently crimp (see insert IFU-CPCE) the stent on the balloon by using finger pressure and a
"rolling action" to exert equal pressure on all sides of the stent. Only crimp until no
movement is felt on the catheter. Platinum is very malleable and should be easily crimped.
Place a small amount of undiluted contrast to "coat" the stent and improve adherence to the
balloon. (AVOID BENDING OR TWISTING THE STENT).
5. Visually inspection the balloon/stent assembly to assure proper placement of the stent (MAY
BE CONFIRMED BY FLUOROSCOPY).
Stent Deployment
1. The assembly is advanced through the long delivery sheath and over the stiff guidewire into
the desired location for implant.
2. After correct positioning of the stent, pull back on the sheath to expose the stent. Confirm
proper stent position by a small injection of contrast through the sidearm of sheath or through
a second catheter. Expand the stent by inflating the balloon catheter to the recommended
inflation pressure. Do not exceed the balloon manufacturer's rated burst pressure.
Delivery System Withdrawal
1. Once the stent is expanded, deflate the balloon and rotate to insure the stent is free and
properly deployed.
2. Remove the balloon catheter and confirm the result with angiography.
NOTE: Diameter of the stent may be increased after placement by expanding with a larger
diameter balloon. Do not exceed the maximum recommended expanded stent diameter.
R E
ETURN OF XPLANTED
NuMED, Inc. is interested in obtaining recovered CP Stents. Place the explanted device in a
container or vial immediately after excision. For further instructions on the return of an explanted
device, contact RA Manager, NuMED, Inc. 2880 Main Street, Hopkinton, New York, 12965. Phone
number: 315-328-4491.
W :
ARNING
NuMED stents are placed in the extremely hostile environment of the human body. Stents
may fail to function for a variety of causes including, but not limited to, medical complications
or failure of stent by fracture and embolization. In addition, despite the exercise of all due
U
SE
D :
EVICE
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