COOK Medical FORMULA 418 Gebrauchsanweisung Seite 7

PRODUCT RECOMMENDATIONS
Wire Guide Use and Selection
The Formula 418 Vascular Balloon-Expandable Stent System is compatible with 0.018 inch wire guides.
Guiding Catheter/Introducer Selection
Correct guiding catheter/sheath selection and technique are necessary for use of the stent. Ensure that the inside
lumen of the guiding catheter/sheath is of sufficient size to allow unobstructed passage of the Formula 418 Vascular
Balloon-Expandable Stent System.
NOTE: Minimum inside diameter requirements for the guiding catheter/sheath are shown in Table 1.
Standard vascular catheter curves must be selected to provide adequate guiding catheter/sheath "back-up support"
to achieve successful stent placement.
Stent Size Selection
The stent selected should have an expanded diameter approximately equal to, or slightly larger than, the estimated
reference diameter of the artery to be stented. The length of the stent should be chosen to adequately cover the
length of the lesion. A compliance card is provided with the product to facilitate the selection of an appropriate size
of stent.
INSTRUCTIONS FOR USE
The Formula 418 Vascular Balloon-Expandable Stent System is used in conjunction with equipment required for a
conventional PTA procedure including, but not limited to, a vascular access set, arterial sheath, guiding catheter, wire
guide and inflation device.
Lesion/Vessel Preparation
Stent placement must take into account proximal atherosclerotic plaque, which may inhibit advancement of the
stent, as well as atherosclerotic plaque beyond the lesion which may prevent advancement of the device across the
primary lesion. In preparing the vessel, optimal vasodilation, anticoagulant and antiplatelet therapy are essential. This
device is intended for treatment following suboptimal angioplasty.
Preparation of Balloon Catheter
1. Remove the Formula 418 Vascular Stent System from the package, remove protective sleeve from the distal tip of
the catheter and inspect the stent to ensure it has not been damaged.
2. Prepare the balloon lumen with a standard 1:1 contrast-saline mixture as follows:
WARNING: Do not attempt pre-inflation technique to purge the balloon lumen. Do not use air or any
gaseous medium to inflate the balloon.
a. Using a 20 ml syringe containing 5 ml of contrast-saline mixture, apply negative pressure for 20-30 seconds.
b. Release pressure, allowing negative pressure to draw mixture into balloon lumen.
c. Detach syringe, leaving a meniscus of mixture on the hub of the balloon lumen.
d. Prepare inflation device in standard manner and purge to remove all air from syringe and tubing.
e. Attach inflation device to balloon lumen directly, ensuring no air bubbles remain at connection.
f. Pull negative pressure on inflation device.
CAUTION: Significant amounts of air in the balloon may cause uneven expansion of the stent and
difficulty in deployment of the stent.
3. Moisten the stent with heparinized saline.
CAUTION: Do not use gauze sponges, as fibers may disrupt stent.
4. Flush the wire guide lumen of the balloon catheter in standard fashion to purge air.
5. Before inserting the Formula 418 Vascular Balloon-Expandable Stent System into the introducer or guiding
catheter, be sure that a large-bore Tuohy-Borst "Y" adapter or introducer valve is on the guiding catheter/sheath.
6. Advance a 0.018 inch wire guide of appropriate length across the target lesion.
7. Insert the appropriate guiding catheter/sheath (see Table 1).
8. Advance the pre-mounted Formula 418 Vascular Balloon-Expandable Stent System over the wire into either the
introducer valve or Tuohy-Borst "Y" adapter, making sure that the wire guide exits the wire guide port proximal to
the balloon.
a. If using an introducer with a valve, make sure the flared end of the insertion tool (provided in the package)
is loaded over the pre-mounted stent on the balloon catheter. Pass the insertion tool loaded with the
premounted stent through the introducer valve. Push the Formula 418 Vascular Balloon-Expandable Stent
System into the body of the introducer. Slide the insertion tool proximally up the catheter shaft away from the
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