Shockwave C2 Manual Del Usuario página 2

Coronary Intravascular Lithotripsy (IVL) System
Instructions for Use (IFU)
For use with the Shockwave Medical, Inc.
IVL Generator and Connector Cable
Indication for Use
The Shockwave C Coronary IVL System is indicated for
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lithotripsy-enhanced, low-pressure balloon dilatation
of calcified, stenotic de novo coronary arteries prior
to stenting.
Contents: Shockwave C Coronary IVL Catheter (1)
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o The following balloon diameters are available:
2.5mm, 2.75mm, 3.0mm, 3.25mm, 3.5mm,
3.75mm, 4.0mm
o Folded Balloon Diameters are: 0.043" max. for
2.5mm to 2.75mm, 0.044" max for 3.0mm to 3.5mm
and 0.046" max. for 3.75mm to 4.0mm
o 12mm balloon working length
o 138cm catheter working length
o 6F guide catheter compatible
o 0.014" (0.36mm) guidewire compatible,
(Rx 190cm - 300cm)
How Supplied
The IVL Catheter is supplied sterile via e-beam sterilization
and is intended for single use only. Do not re-sterilize as
this could damage the device and lead to patient injury.
Do not reuse the device as this could result in cross-
contamination that could result in patient injury. Carefully
inspect all packaging for damage or defects prior to use.
Do not use the device if there is any sign of breach of the
sterile barrier, as this could indicate loss of sterility that
could result in patient injury. Do not use the device if
there is damage to the package, as this could lead to
device malfunction and result in patient injury. Store the
IVL Catheter in a cool, dark, dry place. Storage of the device
in extreme conditions may damage the device and/or affect
device performance that could lead to patient injury.
Device Description
The IVL Catheter is a proprietary lithotripsy device delivered
through the coronary arterial system of the heart to the site
of an otherwise difficult to treat calcified stenosis, including
calcified stenosis that are anticipated to exhibit resistance
to full balloon dilation or subsequent uniform coronary
stent expansion. Energizing the lithotripsy device will
generate intermittent sound waves within the target
treatment site, disrupting calcium within the lesion and
allowing subsequent dilation of a coronary artery stenosis
using low balloon pressure. The IVL Catheter comprises
integrated lithotripsy emitters for the localized delivery
LBL 61361 Rev C, Instruction for Use (May 2018)
of intermittent sound wave therapy. The system consists
of the IVL Catheter, IVL Connector Cable and IVL Generator.
The Shockwave C IVL Catheter is available in seven (7)
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sizes: 2.5x12mm, 2.75x12mm, 3.0x12mm, 3.25x12mm,
3.5x12mm, 3.75x12mm, and 4.0x12mm. The Shockwave C
IVL Catheter is compatible with a 6F guiding catheter, has
a working length of 138cm, with hydrophilic coating at the
distal end, and shaft depth markers at the proximal end.
Refer to Figure 1 below for Shockwave C IVL Catheter
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components.
Dual Port Hub
Rx Port
Lithotripsy Balloon
Catheter Shaft
Figure 1: Shockwave C IVL Catheter
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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" guidewire to facilitate
advancement of the catheter to and through the target
stenosis. The system is designed as 'Rapid Exchange' (Rx),
so a length (190cm - 300cm) 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.
Required Devices for the Coronary IVL Procedure
The IVL Catheter is to be used exclusively with the
IVL Generator, IVL Connector Cable and its accessories.
The IVL Connector Cable is a remote actuator which connects
the IVL Generator to the IVL Catheter and is used to activate
the lithotripsy therapy from the IVL Generator. Refer to the
IVL Generator and IVL 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.
• 6F guide catheter
• 0.014" (0.36mm) Guide Wire (190cm - 300cm Length)
• 5"x96" (13x244 cm) minimum Sterile Sleeve
EN
Shockwave C Coronary IVL Catheter Balloon
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Compliance Chart
2.5x 2.75x 3.0x
Pressure
12mm 12mm 12mm
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ATM - KPa Ø (mm)* Ø (mm)* Ø (mm)* Ø (mm)* Ø (mm)* Ø (mm)* Ø (mm)*
4* - 405 2.4 2.6 2.9
5 - 507 2.4 2.7 2.9
6* - 608 2.5 2.7 2.9
7 - 709 2.5 2.7 3.0
8 - 811 2.5 2.7 3.0
9 - 912 2.5 2.8 3.1
Connector
10* - 1013 2.5 2.8 3.1
Note: *Ø (mm) is ± 0.10 mm; 4 ATM is IVL treatment
balloon pressure, 6 ATM is nominal balloon pressure and
post-treatment pressure and 10 ATM is RBP (Rated Burst
Pressure) of the balloon.
Shockwave C Coronary IVL System Sequence Chart
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The following 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 Shockwave C
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 80 Pulses (8 Cycles)
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 IVL Connector Cable
Operator's Manual.
The Shockwave C Coronary IVL Catheter will deliver
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a maximum of 80 pulses or 8 cycles as 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 80 pulses
in the same treatment segment.
Contraindications for Use
The Shockwave C Coronary IVL System is contraindicated
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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.
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3.25x 3.5x 3.75x 4.0x
12mm 12mm 12mm 12mm
3.2 3.4 3.7 3.8
3.2 3.4 3.7 3.8
3.2 3.4 3.7 3.9
3.3 3.5 3.8 3.9
3.3 3.5 3.8 4.0
3.3 3.5 3.9 4.1
3.4 3.6 3.9 4.1
IVL Catheter will
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1 Pulse per 1 Second
10 Pulses
10 Seconds