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Shockwave Intravascular Lithotripsy (IVL) System with
the Shockwave C
Coronary Intravascular Lithotripsy
2+
(IVL) Catheter
Instructions for Use (IFU)
Rx only
For use with the Shockwave Medical, Inc.
IVL Generator and Connector Cable
Device Description
The Shockwave C
Coronary IVL Catheter is a proprietary
2+
lithotripsy device delivered through the coronary arterial
system of the heart to the site of an otherwise difficult
to treat calcified stenosis, including calcified stenoses
that are anticipated to exhibit resistance to full balloon
dilatation or subsequent uniform coronary stent expansion.
The IVL Catheter contains integrated lithotripsy emitters for
the localized delivery of acoustic pressure pulse therapy.
The lithotripsy technology generates acoustic pressure
pulses within the target treatment site, disrupting calcium
within the lesion allowing subsequent dilatation of
a coronary artery stenosis using low balloon pressure.
The system consists of the IVL Catheter, IVL Connector
Cable and IVL Generator. The Shockwave C
Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm,
3.5x12 mm, and 4.0x12 mm. The Shockwave C
with a 5F guiding catheter and extensions, has a working
length of 138 cm, and shaft depth markers at the proximal
end. The catheter is coated with hydrophilic coating to
22.75 cm from the distal tip to reduce friction during device
delivery. The IVL Catheter Rx port is located at 27 cm from
the distal tip. Refer to Figure 1 below for the Shockwave C
Coronary IVL Catheter components.
Dual Port Hub
Catheter Shaft
Balloon
RX Port
Figure 1: Shockwave C
IVL Catheter
2+
The catheter shaft contains an inflation lumen, a guidewire
lumen, and the lithotripsy emitters. The inflation lumen is
used for inflation and deflation of the balloon with 50/50
saline/contrast medium. The guidewire lumen enables
the use of a 0.014" (0.36 mm) guidewire to facilitate
advancement of the catheter to and through the target
stenosis. The system is designed as "Rapid Exchange" (Rx),
so a length 190 cm – 300 cm guidewire is indicated. The
emitters are positioned along the length of the balloon
working length for delivery of lithotripsy therapy.
The balloon is located near the distal tip of the catheter.
Two radiopaque marker bands within the balloon denote
the working length of the balloon to aid in positioning of
the balloon during treatment. The balloon is designed to
provide an expandable segment of known length and
diameter at a specific pressure. The proximal hub has two
ports: one for inflation/deflation of the balloon and one
for the connection to the IVL Connector Cable.
LBL 64191 Rev D, Instructions for Use ( June 2023)
Indications for Use
The Shockwave Intravascular Lithotripsy (IVL) System with
the Shockwave C
2+
lithotripsy-enabled, low-pressure balloon dilatation of
severely calcified, stenotic de novo coronary arteries prior
to stenting.
Contraindications for Use
The Shockwave C
2+
for the following:
1. This device is not intended for stent delivery.
2. This device is not intended for use in carotid or
cerebrovascular arteries.
Warnings
1. Physicians must read and understand these instructions
prior to use of the device. Failure to abide by the
warnings in this labeling might result in damage to
the device hydrophilic coating.
2. Do not use a device past the expiration date on the label.
Use of expired product may result in patient injury.
3. Use the IVL Generator in accordance with recommended
settings as stated in the IVL Generator Operator's
Manual. DO NOT deviate from recommended settings
as this may cause patient injury.
Coronary IVL
4. IVL Connector Cable is non-sterile and must be enclosed
2+
in a sterile cable sleeve prior to and during use.
is compatible
5. Inspect all product components and packaging prior
2+
to use. Do not use the device if the device or the
packaging has been damaged or if sterility has been
compromised. Damaged product could result in
patient injury.
6. Do not use the device if the balloon protective sheath
cannot be removed easily prior to use. If excessive force
2+
is used, the catheter could be damaged. Damaged
product could result in patient injury.
IVL Connector
7. Ensure that the IVL Catheter is used with a 0.014"
(0.36 mm) guidewire and is inserted through a 5F
guiding catheter at least 0.066" (1.67 mm) ID. Failure
to do so could result in inadequate device performance
or patient injury.
8. If an inability to inflate or maintain balloon pressure
occurs, remove the catheter and use a new device.
9. Do not use excessive force or torque on the catheter as
this could result in damage to the device components
and result in patient injury.
10. The risk of a dissection or perforation is increased in
severely calcified lesions undergoing percutaneous
treatment, including IVL. Appropriate provisional
interventions should be readily available.
11. Balloon loss of pressure was observed in 6.3% of
patients in the clinical trial that were treated with the
currently marketed product and was associated with
a numerical increase in dissection which was not
statistically significant and was not associated with
MACE. Analysis indicates calcium length is a predictor
of dissection and balloon loss of pressure.
12. Treat patients per standard medication or interventional
procedures in the event of complications associated
with the procedure or device.
Coronary IVL Catheter is indicated for
Coronary IVL System is contraindicated
EN
13. IVL generates mechanical pulses which may cause
atrial or ventricular capture in bradycardic patients.
In patients with implantable pacemakers and
defibrillators, the asynchronous capture may interact
with the sensing capabilities. Monitoring of the
electrocardiographic rhythm and continuous arterial
pressure during IVL treatment is required. In the
event of clinically significant hemodynamic effects,
temporarily cease delivery of IVL therapy. In the CAD III
study, there were no serious adverse events associated
with IVL-induced capture including arrhythmia.
14. Do not exceed 80 pulses in the same treatment
segment. If the lesion length is greater than the
lithotripsy balloon length and requires multiple IVL
treatments, care should be taken to not exceed
80 pulses in the same treatment segment and
therefore 160 pulses in an overlap segment. If more
than 120 pulses are needed for further therapy,
then additional catheters will be needed.
Precautions
1. This device should only be used by physicians trained
in angiography and intravascular coronary procedures.
2. For preparation, operation, warnings and precautions,
and maintenance of the IVL Generator and its accessories,
refer to the IVL Generator Operator's Manual.
3. The catheter is intended for single (one) time use only.
DO NOT re-sterilize and/or reuse. If a second catheter
of the same size is necessary, DO NOT re-use the first
catheter. Discard it before preparing the second
catheter.
4. Use only an appropriately sized balloon for the vessel to
be treated: 1:1 based on balloon compliance chart and
reference vessel diameter. The largest diameter balloon
should be used if 1:1 sizing is not available (such as,
using a 4.0 mm IVL Catheter in a vessel with a reference
diameter of 4.5 mm).
5. Inflate the balloon according to the balloon compliance
chart. Balloon pressure should not exceed the rated
burst pressure (RBP).
6. Use only the recommended 50/50 contrast/saline
medium to inflate the balloon to ensure adequate
lithotripsy delivery.
7. If the surface of the IVL Catheter becomes dry, wetting
with normal saline will reactivate the hydrophilic
coating. Wetting the catheter with solvents other than
saline can compromise the coating integrity or
performance.
8. Perform all device manipulations under adequate
fluoroscopic guidance.
9. Do not advance or retract the catheter unless the
balloon is fully deflated under vacuum. If resistance
is met, determine the cause of the resistance before
proceeding.
10. Care must be taken when manipulating, advancing
and/or withdrawing the device past sharp objects as
it may damage the hydrophilic coating.
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