Page 4 of 48
LBL 61361 Rev C, Instruction for Use (May 2018)
EN
Symbol
Definition
Do not re-use
Use by date
Sterilized using irradiation
Caution
Manufacturer
Do not use if package is damaged
Keep dry
Authorized Representative in the European Community
Keep away from heat
Batch code
Catalogue number
Do not resterilize
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
2
IVL Catheter to the
Treatment Site
1. Using a guidewire and guiding catheter, position
catheter proximal of the treatment site.
2. Advance the 0.014" guidewire across the
treatment site.
3. Select a balloon catheter size that is 1:1 with the
reference vessel diameter.
4. Load the IVL Catheter over the exchange length
(190 - 300cm) 0.014" guidewire and through a guiding
catheter and advance balloon to the treatment site.
5. Position the lithotripsy 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 to 4.0 atm.
4. Deliver IVL treatment sequence per the Shockwave C
2
IVL Catheter Sequence Chart by pressing the therapy
button on the IVL Connector Cable.
5. Inflate lithotripsy balloon to reference size per balloon
compliance chart and record lesion response on
fluoroscopy.
6. Following IVL treatment, deflate lithotripsy balloon and
wait 30 seconds to re-establish blood flow.
7. Repeat steps 3, 4, 5, and 6 to complete a single
treatment of 20 pulses.
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.
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
further instructions.
Note:
IVL generates mechanical pulses and may cause
singular ectopic impulses on the electrocardiogram.
In patients with implantable pacemakers and defibrillators,
these ectopic impulses may interact with the sensing
capabilities. Monitoring of the electrocardiographic rhythm
and continuous arterial pressure during IVL treatment
is required.
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.
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
[email protected].
Patents: www.shockwavemedical.com/patents
Symbol
Definition
Non-pyrogenic
Consult instructions for use
Contains 1 unit (Contents: 1)
Recommended Guidewire
Recommended Guide Catheter
Balloon Diameter
Balloon Working Length
Catheter Working Length (Usable Length, UL)
Conformité Européenne
Patents. Refer to
www.shockwavemedical.com/patents
Intravascular Lithotripsy
PAT
UL
0086
MedPass SAS
95 bis Boulevard Pereire
75017 Paris
France
Shockwave Medical, Inc.
48501 Warm Springs Blvd., Suite 108
Fremont, CA 94539, USA
www.shockwavemedical.com
IVL
