How Supplied; Recommended Materials; Operational Instructions; Patient Preparation - Boston Scientific Epic Mode D'emploi

HOw SUPPlIED

Handling and Storage
Store in a cool, dry dark place and do not exceed 55°C.
Do not use if package is opened or damaged.

rECOMMEnDED MaTErIalS

• Micropuncture kit
• 0.035 in (0.89 mm) guidewire of appropriate length
• Introducer sheath of appropriate size and length and equipped with a
hemostatic valve
• Syringe (10 ml (cc) for prepping the stent delivery system)

OPEraTIOnal InSTrUCTIOnS

Patient Preparation

The percutaneous placement of a vascular self-expanding stent in a peripheral
vascular stenotic or obstructed artery should be done in an angiography
procedure room equipped with the appropriate imaging equipment. Patient
preparation and sterile precautions should be the same as for any angioplasty
procedure. Angiography should be performed to map out the extent of the lesion(s)
and the collateral flow. Access vessels must be sufficiently patent, or sufficiently
recanalized, to proceed with further intervention. If thrombus is present or
suspected, thrombolysis should precede stent deployment using standard
acceptable practice.

Inject Contrast Media

Perform angiogram using standard technique.

Evaluate and Mark the Stenosis

Observe fluoroscopically the most distal view of the stenotic or obstructed artery.

Select Proper Stent System

1. Measure the diameter of the reference vessel (proximal and distal to the
lesion or obstruction). Select a stent per the table below to achieve a secure
placement:
reference Vessel Diameter
(mm)
.0
.0-5.0
5.0-6.0
6.0-7.0
7.0-8.0
8.0-9.0
9.0-11.0
11.0-13.0
. Measure the entire length of the actual lesion and select the proper length
of the stent(s) to be deployed. To help ensure adequate apposition, it is
recommended that the length of the stent be chosen so that the ends of the
stent extend at least 5mm beyond both ends of the lesion into healthy tissue.
Should more than one stent be required to cover the lesion, place the distal
stent first followed by the proximal stent(s), allowing for at least 5 mm of stent
overlap.
Self Expanding Stent Diameter
(mm)
5.0
6.0
7.0
8.0
9.0
10.0
1.0
1.0
3. Estimate the distance between the lesion and the entry site to select the
proper stent delivery system length.

Preparation of Stent Delivery System

1. Open the outer box to reveal the pouch containing the stent delivery system.
. Check the temperature exposure indicator on the pouch label to confirm that
the product has not been compromised. See Warnings section.
3. After careful inspection of the pouch looking for damage to the sterile barrier,
carefully peel open the pouch and extract the stent delivery system tray.
. Open the door on the tray that contains the handle.
5. Carefully withdraw the stent delivery system from the tray by grasping the
handle of the delivery system.
6. Examine the device for any damage. If it is suspected that the sterility or
performance of the device has been compromised, the device should not be
used.
7. If the safety lock (Reference Figure 1) is not attached to the device, verify
③
that the stent is fully constrained in the delivery system and place safety lock
in position as shown in Figure 1.
8. Attach a 10 ml (cc) syringe filled with saline to the luer
on the handle. Apply positive pressure. Continue to flush until saline appears at
the distal end of both the guidewire lumen and the sheath–tip junction. Note:
If the luer is not present when received, the device may require greater than
10cc to flush entire device.
9. Remove the flushing luer .
⑦
MARKER
6 4 PULL GRIP
BAND
2
RADIOPAQUE
1
MARKERS ON STENT
RADIOPAQUE
MARKERS ON STENT
figure 1.

Delivery Procedures

1. Gain arterial access utilizing a 6F (.1mm) sheath with a hemostatic valve.
Precaution: Always use an introducer or guide sheath for the implant
procedure, to protect the access site. An introducer sheath of a 6F or larger
size is recommended.
. Pass a 0.035 in (0.89 mm) guidewire of appropriate length across the target
lesion or obstruction.
3. Pre-dilate the lesion as necessary with a balloon dilatation catheter using
conventional technique.
5
(Reference Figure 1)
⑦
SAFETY
3
LOCK
7 LUER
THUMB
5
WHEEL