How Supplied; Device Description - Shockwave M5 Gebrauchsanleitung

Peripheral Intravascular Lithotripsy (IVL) Catheter
Instructions for Use (IFU)
For use with the Shockwave Medical, Inc. IVL
Generator and Connector Cable
Indication for Use
The Shockwave M Peripheral IVL System is indicated for
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lithotripsy-enhanced, low-pressure balloon dilatation of
calcified, stenotic peripheral arteries in patients who are
candidates for percutaneous therapy.
Contents: Shockwave M Peripheral IVL Catheter (1)
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o The following balloon diameters are available:
3.5mm, 4.0mm, 4.5mm, 5.0mm, 5.5mm, 6.0mm,
6.5mm and 7.0mm
o Folded balloon diameters are: 0.064" max. for 3.5 to
6.0mm and 0.072" max. for 6.5 and 7.0mm
o 60mm balloon length
o 110cm catheter working length
o 3.5 – 6.0mm balloon is 6 Fr. introducer sheath
compatible; 6.5 - 7.0mm balloon is 7 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 eight (8) sizes: 3.5 x 60mm, 4.0 x 60mm,
4.5 x 60mm, 5.0 x 60mm, 5.5 x60mm, 6.0 x 60mm, 6.5 x
60mm, and 7.0 x 60mm. The M Peripheral IVL Catheter
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is compatible with a 6 or 7Fr sheath and has a working
length of 110cm. Refer to Figure 1 below for IVL Catheter
components.
LBL 62859-B, 2019-03
IVL Connector Cable
IVL Balloon Inflation Port
Catheter Hub
Catheter Shaft
Guidewire Exit Port
Figure 1: Shockwave M Peripheral IVL Catheter
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The Shockwave M Peripheral IVL Catheter shaft contains
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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 110cm 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. 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.
• 6F or 7F introducer sheath
• 0.014" (0.36mm) Guide Wire (300cm Length)
• 5"x96" (13x244 cm) minimum Sterile Sleeve
EN
Shockwave M Peripheral IVL Catheter Balloon
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Compliance Chart
Pressure 3.5 x 60mm 4.0 x 60mm 4.5 x 60mm
ATM - kPa Ø (mm)* Ø (mm)* Ø (mm)*
4 - 405 3.55 3.94
5 - 507 3.58 3.97
6 - 608 3.61 4.01
7 - 709 3.65 4.06
8 - 811 3.68 4.09
9 - 912 3.72 4.14
10 - 1013 3.75 4.19
Pressure 5.5 x 60mm 6.0 x 60mm 6.5 x 60mm
ATM - kPa Ø (mm)* Ø (mm)* Ø (mm)*
4 - 405 5.39 5.92
5 - 507 5.43 5.96
6 - 608 5.48 6.02
7 - 709 5.55 6.09
8 - 811 5.61 6.15
9 - 912 5.66 6.24
10 - 1013 5.74 6.34
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.
Shockwave M Peripheral IVL System Sequence Chart
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The following Shockwave M Peripheral IVL System pulsing
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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 300 pulses or
10 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 180 pulses in the same treatment
segment.
2/76
5.0 x 60mm
Ø (mm)*
4.49 4.92
4.53 4.95
4.57 4.98
4.63 5.03
4.67 5.07
4.72 5.10
4.77 5.16
7.0 x 60mm
Ø (mm)*
6.39 6.77
6.45 6.85
6.59 6.91
6.65 6.98
6.72 7.05
6.80 7.12
6.92 7.22
1 Pulse per Second
30 Pulses
10 Seconds
300 (10 Cycles)