How Supplied; Device Description - Shockwave S4 Manual De Istrucciones

Instructions for Use (IFU)
For use with the Shockwave Medical, Inc. IVL
Generator and Connector Cable
Indication for Use
The Shockwave S Peripheral IVL System is indicated for
4
lithotripsy-enhanced, low-pressure balloon dilatation of
calcified, stenotic peripheral arteries in patients who are
candidates for percutaneous therapy.
Contents: Shockwave S Peripheral IVL Catheter
4
o The following balloon diameters are available:
2.5mm, 3.0mm, 3.5mm, 4.0mm
o Folded balloon diameters are: 0.052" max for 2.5mm
and 3.0mm, and 0.054" max for 3.5mm and 4.0mm
o 40mm balloon length
o 135cm catheter working length
o 2.5 – 4.0mm balloon is 5 Fr. introducer sheath
compatible
o 0.014" (0.36mm) guidewire compatible (OTW -
300cm wire)

How Supplied

The IVL Catheter is supplied sterile via e-beam sterilization.
The IVL Catheter is intended for single use only and is not
intended for reuse or re-sterilization. Carefully inspect all
packaging for damage or defects prior to use. Do not use
the device if any sign of damage or breach of the sterile
barrier is observed as this could lead to malfunction of the
device and/or injury to the patient. Store the IVL Catheter
in a cool, dark, dry place. Storage of the device in extreme
conditions may affect device performance and lead to
patient injury.

Device Description

The IVL Catheter is a proprietary lithotripsy device delivered
through the peripheral arterial system of the lower
extremities to the site of an otherwise difficult to treat
calcified stenosis. Energizing the lithotripsy device will
generate pulsatile mechanical energy within the target
treatment site, disrupting calcium within the lesion and
allowing subsequent dilation of a peripheral artery stenosis
using low balloon pressure. The IVL Catheter comprises
an array of integrated lithotripsy emitters for the localized
delivery of pulsatile mechanical energy and an integrated
balloon. The system consists of the IVL Catheter, an IVL
Connector Cable and an IVL Generator. The IVL Catheter
is available in four (4) sizes: 2.5 x 40mm, 3.0 x 40mm, 3.5
x 40mm, and 4.0 x 40mm. The IVL Catheter is compatible
with a 5Fr sheath and has a working length of 135cm. Refer
to Figure 1 below for IVL Catheter components.
LBL 61333-D, (2019-03)
IVL Connector Cable
IVL Balloon Inflation Port
Catheter Shaft Catheter Hub
Guidewire Exit Port
Figure 1: Shockwave S Peripheral IVL Catheter
4
The IVL 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" guidewire to facilitate
advancement of the catheter to and through the target
stenosis. The system is designed as 'Over-the-wire'
(OTW) with 135cm shaft working length, so an exchange
length (300cm) guidewire is indicated. The emitters are
positioned along the length of the balloon working length
for delivery of pulsatile mechanical energy. The balloon is
located near the distal tip of the catheter and contains a
hydrophilic coating designed to increase lubricity during
advancement of the catheter to the treatment site. Two
radiopaque marker bands within the balloon denote the
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 three ports: one for
inflation/deflation of the balloon, one for guidewire lumen,
and one for connection to the IVL Connector Cable.
Required Devices for the IVL Procedure
The IVL Catheter is to be used exclusively with the IVL
Generator and its accessories. Refer to the Shockwave Medical,
Inc. IVL Generator and Connector Cable Operator's Manual for
preparation, operation, warnings and precautions, and
maintenance of the IVL Generator and IVL Connector Cable.
Devices Required But Not Supplied By Shockwave
Medical, Inc.
• 5F introducer sheath
• 0.014" (0.36mm) Guide Wire (300cm Length)
• 5"x96" (13x244 cm) minimum Sterile Sleeve
Shockwave S Peripheral IVL Catheter Balloon
4
Compliance Chart
Pressure 2.5 x 40mm 3.0 x 40mm 3.5 x 40mm
ATM - kPa Ø (mm)* Ø (mm)*
4 - 405 2.42 2.93
5 - 507 2.44 2.96
6 - 608 2.45 3.00
7 - 709 2.47 3.03
8 - 811 2.50 3.06
9 - 912 2.52 3.09
10 - 1013 2.54 3.11
Note: 4 ATM is lithotripsy treatment balloon pressure, 6 ATM is nominal
balloon pressure and post-treatment angioplasty pressure and 10 ATM is RBP
(Rated Burst Pressure) of the balloon.
EN
Shockwave S
The following IVL System pulsing sequence must be
followed during treatment. Do not utilize a pulsing
sequence other than those outlined in the IVL System
Sequence Chart below. Insertion of any size IVL Catheter
will automatically program the IVL Generator with the
following treatment sequence:
Treatment Frequency
Maximum Number of Continuous
Pulses (1 cycle)
Minimum Pause Time
Maximum Total Pulses Per Catheter
In the event the user attempts to deliver more than
the maximum number of continuous pulses allowed,
the IVL Generator is designed to stop automatically. To
resume pulsing, wait at least the minimum pause time
before resuming therapy. The therapy button must be
released and pressed again to resume therapy. For more
information, refer to the IVL Generator and Connector Cable
Operator's Manual.
The IVL Catheter will deliver a maximum of 160 pulses or
8 cycles noted above. If this count is reached, the catheter
shall not be used any further. If further therapy is needed,
discard this catheter and obtain a new one. Caution:
Do not exceed 160 pulses in the same treatment
segment.
Contraindications for Use
The IVL System is contraindicated for the following:
1. Unable to pass 0.014" guidewire across the lesion.
2. This device is not intended for treatment of in-stent
restenosis.
3. This device is not intended for use in coronary, carotid,
or cerebrovascular arteries.
Warnings
1. This device is intended for single (one) time use only.
DO NOT re-sterilize and/or reuse.
2. Do not use a device past the expiration date on the
label. Use of expired product may result in patient
injury.
3. Always insert the IVL Connector Cable into a sterile
4.0 x 40mm
sleeve prior to use.
Ø (mm)* Ø (mm)*
4. Use only an appropriately sized balloon for the vessel
3.38 3.87
to be treated.
3.41 3.91
5. Inflate the balloon according to the balloon compliance
3.45 3.96
chart. Balloon pressure should not exceed the rated
3.50 4.01
burst pressure (RBP).
3.54 4.05
6. Do not advance or retract the catheter unless the
3.57 4.09
balloon is fully deflated under vacuum. If resistance is
3.60 4.12
met during manipulation, determine the cause of the
resistance before proceeding.
Page 2 of 48
Peripheral IVL Catheter Sequence Chart
4
1 Pulse per Second
20 Pulses
10 Seconds
160 (8 Cycles)