Devices Required But Not Supplied By Shockwave Medical, Inc.
•6F or 7F introducer sheath•0.014” (0.36mm) Guide Wire (300cm Length)•5”x96” minimum Sterile Sleeve

Peripheral Intravascular Lithotripsy (IVL) Catheter
Instructions for Use (IFU)

Shockwave M5 Peripheral IVL Catheter Balloon Compliance Chart
3.5 x
4.0 x
4.5 x
5.0 x
Pressure
60mm
60mm
60mm
60mm
ATM Ø (mm)*Ø (mm)*
Ø (mm)*
Ø (mm)*kPa

For use with the Shockwave Medical, Inc. IVL Generator and Connector Cable

Indication for Use
The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatationof lesions, including calcified lesions, in the peripheral vasculature, including the iliac,femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in thecoronary or cerebral vasculature.
Contents: Shockwave M5 Peripheral IVL Catheter: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 7.0mmo 60mm balloon lengtho 110cm catheter working lengtho 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 ofdamage or breach of the sterile barrier is observed as this could lead to malfunction of thedevice 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 topatient injury.

3.55

3.94

4.49

4.92

5 - 507

3.58

3.97

4.53

4.95

6 - 608

3.61

4.01

4.57

4.98

7 - 709

3.65

4.06

4.63

5.03

8 - 811

3.68

4.09

4.67

5.07

9 - 912

3.72

4.14

4.72

5.10

10 1013

3.75

4.19

4.77

5.16

Pressure
ATM kPa

5.5 x60mm

6.0 x60mm

6.5 x60mm

7.0 x60mm

Ø (mm)*

Ø (mm)*

Ø (mm)*

Ø (mm)*

4 - 405

5.39

5.92

6.39

6.77

5 - 507

5.43

5.96

6.45

6.85

6 - 608

5.48

6.02

6.59

6.91

7 - 709

5.55

6.09

6.65

6.98

8 - 811

5.61

6.15

6.72

7.05

9 - 912

5.66

6.24

6.80

7.12

5.74

6.34

6.92

7.22

10 1013

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 calcifiedstenosis. 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 ofpulsatile mechanical energy, and an integrated balloon. The system consists of an IVL
Catheter, an IVL Connector Cable and an IVL Generator. The IVL Catheter is available ineight (8) sizes: 3.5 x 60mm, 4.0 x 60mm, 4.5 x 60mm, 5.0 x 60mm, 5.5 x60mm, 6.0 x60mm, 6.5 x 60mm, and 7.0 x 60mm. The M5 IVL Peripheral Catheter is compatible witha 6 or 7Fr sheath and has a working length of 110cm. Refer to Figure 1 below for IVL
Catheter components.

Note: 4 ATM is lithotripsy treatment balloon pressure, 6ATM is nominal balloon pressure and post- treatment
angioplasty pressure and 10 ATM is RBP (Rated BurstPressure) of the balloon.

Shockwave M5 Peripheral IVL System Sequence Chart
The following Shockwave M5 Peripheral 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 automaticallyprogram the IVL Generator with the following treatment sequence:
Treatment Frequency
Maximum Number of Continuous Pulses (1cycle)
Minimum Pause Time
Maximum Total Pulses Per Catheter

1 Pulse per Second
30 Pulses
10 Seconds
300 (10 Cycles)

In the event the user attempts to deliver more than the maximum number of continuouspulses 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.

Figure 1: Shockwave M5 Peripheral IVL Catheter
The Shockwave M5 Peripheral IVL Catheter shaft contains an inflation lumen, aguidewire lumen, and the lithotripsy emitters. The inflation lumen is used for inflationand 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 andthrough 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 deliveryof pulsatile mechanical energy. The balloon is located near the distal tip of thecatheter. Two radiopaque marker bands within the balloon denote the length of theballoon to aid in positioning of the balloon during treatment. The balloon is designedto provide an expandable segment of known length and diameter at a specificpressure. 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.

The IVL Catheter will deliver a maximum of 300 pulses or 10 cycles noted above. If thiscount 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 thesame 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/orreuse.
2.
Do not use a device past the expiration date on the label. Use of expired productmay result in patient injury.
3.
Always insert the IVL Connector Cable into a sterile sleeve prior to use.
4.
Use only an appropriately sized balloon for the vessel to be treated.

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.

LBL 62952-B, 2021-09

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EN

1/ 4

Inflate the balloon according to the balloon compliance chart. Balloon pressure
should not exceed the rated burst pressure (RBP).
Do not advance or retract the catheter unless the balloon is fully deflated undervacuum. If resistance is met during manipulation, determine the cause of theresistance before proceeding.
Use the IVL Generator in accordance with recommended settings as stated in theOperator’s Manual. Do not attempt to override the lifetime pulse limits per device as
defined in the IVL System Sequence Chart.
This device should only be used by physicians who are familiar with interventional
vascular procedures.
Physicians must read and understand these instructions prior to use of the device.
Do not use excessive force/torque when using this device as this could result indamage to the device components and patient injury.
Inspect all product components and packaging prior to use. Do not use the device if
it or the packaging has been damaged or if sterility has been compromised.
Damaged product could result in patient injury.
For preparation, operation, warnings and precautions, and maintenance of the IVL
Generator and its accessories refer to the IVL Generator and Connector Cable
Operator’s Manual.

Zealand, and Germany. A total of 95 subjects were enrolled. This clinical study summary
presents outcomes from all 95 subjects at 30 days and at 6 months.

Precautions
1. Perform all device manipulations under adequate fluoroscopic guidance.
2. Use only the recommended balloon inflation medium.
3. Appropriate anticoagulant therapy should be administered by the physician.
4. Decision regarding use of distal protection should be made based on physician
assessment of treatment lesion morphology.
5. Care should be taken not to kink the catheter. If kinking occurs, remove device andprepare a new device.
6. If an inability to inflate or maintain pressure occurs, remove the catheter and use a newdevice.
7. If the catheter appears not to deliver lithotripsy pulsatile mechanical energy, remove
and replace it with another catheter.
8. Precaution should be taken when handling device after exposure to patient e.g. contact
with blood. Used product is considered biohazardous material and should be disposedof properly as per hospital protocol.

The secondary safety endpoint, freedom from MAE at 6 months, continued to befavorable as shown in the table below. Freedom from MAE at 6 months was 96.8%. There
were no cardiovascular deaths, target limb major amputations, perforations, symptomatic
thrombus or distal embolization events.
Freedom from Major Adverse Events at 6 Months

5.
6.
7.
8.
9.
10.
11.
12.

A total of 95 subjects were enrolled in the study. Baseline characteristics were consistent
with a complex, calcified patient population. Calcium burden was significant with severe
calcification involving both sides of the arterial wall observed by the Core Lab in 54.7% of
the subjects, and an average length of calcium of 93.4 mm. Ninety-four (94) of the 95
subjects received treatment with the IVL System. The procedures were completed with alow use of adjunctive therapies including pre and post-dilatation balloons and embolic
protection filters, along with a low use of stents in this difficult to treat population.
The study met its primary safety endpoint. The lower bound of the 95% confidence
interval for freedom from Major Adverse Events (MAE) at 30 days of 97.0% was above
the performance goal of 91.3%. The freedom from MAE at 30 days was 100%.
The study also met its primary effectiveness endpoint. The lower bound of the 95%
confidence interval for procedural success of 97.0% was above the performance goal of
89.3%. Procedural success was defined as <50% with or without adjunctive therapy was
100%.

N=9530 days
n=941
0 (0.0%)0 (0.0%)0 (0.0%)0 (0.0%)Major adverse events (MAE)
Death (cardiovascular)
TLR
Unplanned target limb amputation (above theankle)
Freedom from Major adverse events (MAE)
94 (100%)
90 (96.8%)
Exact Binomial one-sided lower 95% CI[1]97%92%Death (cardiovascular)
94 (100%)
93 (100%)
TLR94 (100%)90 (96.8%)
Unplanned target limb amputation (above the94 (100%)
93 (100%)
ankle)
1One subject withdrew consent and was not available for analysis
2 Two subjects withdrew consent and were not available for analysis

Adverse Effects
Possible adverse effects are consistent with standard angioplasty and include:•
Access site pain•
Allergic reaction to contrast medium, anticoagulant and/or antithrombotic therapy•
Arterial dissection•
Arterial perforation or rupture•
Arterial spasm•
Arteriovenous fistula•
Bleeding complications•Death•Emboli (air, tissue, thrombus or atherosclerotic emboli)•
Emergency or non-emergency arterial bypass surgery•
Entry site complications•
Fracture of the guide wire or any component of the device that may or may not leadto device embolism, serious injury or surgical intervention•
Hematoma at the vascular access site(s)•Hemorrhage•
Hypertension/Hypotension•
Infection/sepsis•
Ischemia•
Placement of a stent•
Pseudoaneurysm•
Renal failure•
Restenosis of the treated segment•
Shock/pulmonary edema•
Total occlusion of the peripheral artery•
Vascular complications which may require surgical repair (conversion to opensurgery)

Secondary effectiveness endpoints were also favorable. Procedural success defined as<50% without adjunctive therapy was achieved in 91.6% of subjects. In addition,
procedural success defined as ≤30% with or without adjunctive therapy was achieved in89.5%.
Target lesion patency assessed by duplex ultrasound at 30 days and 6 months was 100%
and 76.7% respectively as shown in the table below. Freedom from target lesion
revascularizations (TLR) at 6 months was 96.8% for a true rate of 3.2%.
Patency at 6 Months
N=95Patency
Target lesion patency at 30 days
Exact Binomial Two-sided 95% CI[1]91/911 (100%)96%, 100%

Target lesion patency at 6 months
Exact Binomial Two-sided 95% CI[1]69/902 (76.7%)
67%, 85%

Freedom from TLR at 6 months
90/933 (96.8%)
Exact Binomial Two-sided 95% CI[1]91%, 99%
1 Two subjects withdrew consent and data for an additional 2 subjects was
not available at 30 days
2 Two subjects withdrew consent and data for an additional 3 subjects was
not available at 6 months
3 Two subjects withdrew consent and data was not available for analysis

Risks identified as unique to the device and its use:
•Allergic/immunologic reaction to the catheter material(s)•Device malfunction or failure•
Excess heat at target site due to malfunction of IVL Generator
Summary of Clinical Studies
To evaluate the safety and performance of the IVL System, Shockwave Medical, Inc.
conducted a two-phased, non-randomized, multi-center study for the treatment ofperipheral stenotic lesions (PAD I and PAD II, combined referred to as the DISRUPT PADProgram). Patients with peripheral arterial disease of Rutherford Category 2, 3, and 4
who were candidates for percutaneous therapy and met the study criteria were enrolledand treated. Thirty-four (34) investigators participated at seven (7) sites in Austria, New
LBL 62952-B, 2021-09

6 monthsn=932
3 (3.2%)0 (0.0%)3 (3.2%)0 (0.0%)Functional outcomes including change in ankle-brachial index (ABI), Rutherford Categoryand walking impairment showed a sustained and statistically significant improvement frombaseline and data available at 30 days and 6 months.
In conclusion, the DISRUPT PAD program met the study success criteria. The IVL
System demonstrated compelling safety with minimal vessel injury, and minimal use ofstenting. Acute effectiveness results showed high procedural success and a large acuteEN2/ 4

Patents: www.shockwavemedical.com/patents

gain in vessel diameter post procedure. Patency, TLR and functional outcomes weredurable through 6 months in available patients. These results demonstrate the safety
and performance of the IVL System for the treatment of subjects with calcified, stenoticlesions.

Shockwave Medical, Inc.
5403 Betsy Ross Drive
Santa Clara, CA 95054 USA
www.shockwavemedical.com

Procedural Steps
Caution: Refer to the IVL Generator and Connector Cable Operator’s Manual for
preparation, operation, warnings and precautions, and maintenance of the IVL Generator
and IVL Connector Cable.
Preparation1.
Prepare the insertion site using standard sterile technique.
2.
Achieve vascular access and place an introducer sheath.
3.
Select a balloon catheter size that is 1.1:1 based on balloon compliance chart(above) and reference vessel diameter.
4.
Remove the IVL Catheter from the package.
5.
Prepare the balloon using standard technique. Fill a 20cc syringe with 5cc of 50/50
saline/contrast medium. Attach syringe to inflation port on catheter hub. Pullvacuum at least 3 times, releasing vacuum to allow the fluid to replace the air in thecatheter.
6.
Fill indeflator device with 10cc of 50/50 saline/contrast medium. Disconnect
syringe and connect indeflator to inflation port of catheter hub ensuring no air is
introduced to the system.
7.
Flush the guidewire port with saline.
8.
Remove the protection sheath from the catheter.
9.
Wet the balloon with sterile saline.
10. Insert the IVL Connector Cable into a sterile sleeve or probe cover.
11. Remove the cap from the proximal end and attach the IVL Catheter’s connector(see Fig 1) to the IVL Connector Cable.
12. Attach the other side of same IVL Connector Cable to the IVL Generator.
Caution: Do not press the therapy button unless the balloon is filled with 50%
saline/ 50% contrast medium because this may damage the balloon.
Delivering the IVL Catheter to the Treatment Site
1.
Advance the 0.014” guidewire across the treatment site.
2.
Load the IVL Catheter over the exchange length (300cm) 0.014” guidewire andthrough the sheath and advance balloon to the treatment site.
3.
Position the balloon at the treatment site using the marker bands to aid inpositioning.
Treating the Site with Lithotripsy
1.
Once the IVL Catheter is in place, record position using fluoroscopy.
2.
If position is incorrect, adjust the IVL balloon to the correct position.
3.
Inflate IVL Balloon to 4.0 atm.
4.
Deliver IVL System treatment sequence per the IVL System Sequence Chart.
5.
Inflate balloon per balloon compliance chart (above) and record lesion response onfluoroscopy.
6.
Following lithotripsy treatment, deflate balloon and wait 30 seconds to re-establish
blood flow.
7.
Repeat steps 3, 4, 5, 6 to complete a single treatment with 60 pulses.
8.
Additional treatments can be performed if deemed necessary. If multiple inflations
are required due to a lesion length greater than the IVL balloon length, therecommended balloon overlap is at least 1 cm to prevent geographic miss.
Caution: Care must be taken not to exceed 180 pulses in the same 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 thehemostatic valve due to the lubricity, gently grasp the catheter with sterile gauze.
12. Inspect all components to ensure that the catheter is intact. If a device malfunction
occurs or any defects are noted on the inspection, flush the guide wire lumen andclean the outer surface of the catheter with saline, store the catheter in a sealed
plastic bag, and contact Shockwave Medical, Inc. for further instructions.
Caution: IVL Catheter once pulled out of the body should not be reinserted for
additional inflation or lithotripsy treatments. Balloon can be damaged in theprocess.
Patient Information
Physicians should instruct patients to seek medical attention immediately for signs andsymptoms of decreased peripheral blood flow. There are no known limitations to normal
daily activities. Patients should be instructed to comply with the medical regimen asprescribed by their physician.
Return of Devices
If any portion of the Shockwave Medical IVL System fails prior to or during a procedure,
discontinue use and contact local representative and/or email
complaints@shockwavemedical.com.
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EN3/ 4

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 theEuropean Community

Keep away from heat
Batch code
Catalogue number
Do not resterilize

Non-pyrogenic

Consult instructions for use

Contains 1 unit (Contents: 1)

Recommended Guidewire
Recommended Introducer Sheath
Balloon Diameter
Balloon Working Length
Catheter Working Length(Usable Length, UL)
Caution: Federal (USA) Law restricts
this device to sale by or on the orderof a physician.
Conformité Européene
PATIVLLBL 62952-B, 2021-09

Patents. Refer towww.shockwavemedical.com/patents
Intravascular Lithotripsy
Indicates a carrier that contains Unique
Device Identifier information.
EN4/ 4PN 62944 Rev B