Shockwave C2+ Mode D'emploi page 8

6. Fill indeflator device with 10cc of 50/50 saline/contrast
medium. Disconnect syringe and connect indeflator to
inflation port of catheter hub ensuring no air is
introduced to the system.
7. Remove the protective sheath and shipping mandrel
from the IVL Catheter.
Warning: Do not use the device if the protective
sheath or shipping mandrel are difficult to remove or
cannot be removed.
8. Flush the guidewire port with saline.
9. Wet the lithotripsy balloon and distal shaft with sterile
saline in order to activate the hydrophilic coating.
Do not wet the balloon with Isopropyl alcohol (IPA)
as this can damage the hydrophilic coating integrity.
10. Insert the IVL Connector Cable into the sterile cable
sleeve or probe cover.
11. Remove the cap from the proximal end and attach
the IVL Catheter Connector (see Fig 1) to the
IVL Connector Cable.
12. Attach the other end of the same IVL Connector Cable
to the IVL Generator.
Caution: Care must be taken to avoid applying lithotripsy
therapy, i.e. pressing the therapy button of the IVL Connector
Cable while lithotripsy balloon is dry and/or un-inflated,
as this may damage the balloon.
Delivering the Shockwave C IVL Catheter to the
2+
Treatment Site
1. Position guiding catheter proximal to the treatment site.
2. If it is anticipated that the IVL Catheter may not cross the
lesion, pre-dilatation or other vessel preparation may be
performed using standard technique based on physician
discretion.
3. Load the IVL Catheter over the exchange length
(190 – 300 cm) 0.014" guidewire and through a guiding
catheter and advance IVL Catheter to the treatment site.
4. Position the IVL balloon at the treatment site using the
marker bands to aid in positioning.
Treating the Site with Intravascular Lithotripsy
1. Once the IVL Catheter is in place, record position using
fluoroscopy.
2. If position is incorrect, adjust the lithotripsy balloon
to the correct position.
3. Inflate lithotripsy balloon, not exceeding 4.0 atm to
ensure the balloon is inflated and there is full
apposition to the vessel wall.
NOTE: Lithotripsy should not be delivered if the balloon
is inflated to >4 atm as there is no increase in sonic
output and higher pressure during treatment can
increase the risk that the balloon loses pressure.
4. Deliver IVL treatment sequence for the pre-programed
time of 10 seconds to deliver 10 pulses by pressing the
therapy button on the IVL Connector Cable.
NOTE: The IVL Generator is programmed to force
a minimum pause time of 10 seconds following every
10 pulses delivered.
LBL 64191 Rev D, Instructions for Use ( June 2023)
5. Inflate lithotripsy balloon to reference size per balloon
compliance chart and record lesion response on
fluoroscopy.
6. Deflate lithotripsy balloon and wait at least 10 seconds
to re-establish blood flow. The balloon deflation time
is up to 15 seconds, depending upon balloon volume.
7. Repeat steps 3, 4, 5, and 6 for additional treatment
cycles until the lesion has been sufficiently dilated
or if the catheter is re-positioned.
8. Additional treatments can be performed if deemed
necessary. If multiple inflations are required due to
a lesion length greater than the lithotripsy balloon
length, the recommended balloon overlap is at least
2 mm to prevent geographic miss. However, care must
be taken not to exceed 80 pulses maximum in the same
treatment segment and therefore 160 pulses in an
overlap segment.
9. Perform a completion arteriogram to assess post
intervention result.
10. Deflate the device and confirm that the balloon is fully
deflated prior to removing the IVL Catheter.
11. Remove the IVL Catheter. If there is difficulty in
removing the device through the hemostatic valve due
to the lubricity, gently grasp the IVL Catheter with
sterile gauze.
12. Inspect all components to ensure that the IVL Catheter
is intact. If a device malfunction occurs or any defects
are noted on the inspection, flush the guidewire
lumen and clean the outer surface of the catheter
with saline, store the IVL Catheter in a sealed plastic
bag, and contact Shockwave Medical, Inc.
at complaints@shockwavemedical.com for
further instructions.
Caution: IVL Catheter once pulled out of the body should
not be reinserted for additional inflation or lithotripsy
treatments. Balloon can be damaged in the process.
Patient Information
Physicians should instruct patients to seek medical
attention immediately for signs and symptoms of recurrent
ischemic heart disease. There are no known limitations to
normal daily activities. Patients should be instructed to
comply with the medication regimen as prescribed by their
physician.
Device Feedback and Return of Devices
If any portion of the Shockwave IVL System fails prior
to or during a procedure, discontinue use and contact
your local representative and/or email
complaints@shockwavemedical.com.
Patents: www.shockwavemedical.com/patents
EN 8/18