Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave S4 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 Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral
vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
Contents: Shockwave S4 Peripheral IVL Catheter
o The following balloon diameters are available: 2.5mm, 3.0mm, 3.5mm, 4.0mm
o Folded balloon diameters are: 0.052” (1.32mm) max for 2.5mm and 3.0mm, and 0.054” (1.37mm) max for 3.5mm and 4.0mm
o 40mm balloon lengtho 135cm catheter working lengtho 2.5 – 4.0mm balloon is 5 F introducer sheath compatible
o 0.014” (0.36mm) guidewire compatible (OTW - 300cm wire)o 5”x96” (13x244cm) Cable Sleeve
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 resterilization. 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. Storageof 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 is comprised of
an integrated balloon with an array of integrated lithotripsy emitters for the localized delivery of pulsatile mechanical energy. The system consists of an
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 S4 Peripheral IVL Catheter is compatible with a 5F sheath and has a working length of 135cm. Refer to Figure 1 below for IVL Catheter
components.

Figure 1: Shockwave S4 Peripheral IVL Catheter
The Shockwave S4 Peripheral 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” (0.36mm) guidewire tofacilitate 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 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.

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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 andConnector 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)

Shockwave S4 Peripheral IVL Catheter Balloon Compliance Chart
Pressure
atm – kPA4 – 405
5 – 5076 – 608
7 – 7098 – 811
9 – 912
10 – 1013

2.5 x 40mm
Ø (mm)*
2.41
2.42
2.44
2.45
2.46
2.47
2.49

3.0 x 40mm
Ø (mm)*
2.90
2.92
2.94
2.96
2.97
3.00
3.03

3.5 x 40mm
Ø (mm)*
3.39
3.42
3.45
3.48
3.51
3.55
3.58

4.0 x 40mm
Ø (mm)*
3.87
3.91
3.96
4.01
4.05
4.09
4.12

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 S4 Peripheral IVL System Sequence Chart
The following Shockwave S4 Peripheral IVL System pulsing sequence must be followed during treatment. Do not utilize a pulsing sequence other thanthose outlined in the IVL System Sequence Chart below. Insertion of any size IVL Catheter will automatically program the IVL Generator with thefollowing treatment sequence:
Treatment Frequency
Maximum Number of Continuous Pulses (1 cycle)
Minimum Pause Time
Maximum Total Pulses Per Catheter

1 Hz (1 Pulse per Second)
20 Pulses
10 Seconds
Displayed on generator

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 pressedagain to resume therapy. For more information, refer to the IVL Generator and Connector Cable Operator’s Manual.
If the maximum pulse count is reached as displayed on the generator, the catheter can no longer be used. If further therapy is needed, discard thiscatheter 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.
2.
3.

Unable to pass 0.014” (0.36mm) guidewire across the lesion.
This device is not intended for treatment of in-stent restenosis.
This device is not intended for use in coronary, carotid, or cerebrovascular arteries.

Warnings
1.
2.
3.
4.
5.
6.

This device is intended for single (one) time use only. DO NOT re-sterilize and/or reuse.
Do not use a device past the expiration date on the label. Use of expired product may result in patient injury.
Always insert the IVL Connector Cable into a sterile sleeve prior to use.
Use only an appropriately sized balloon for the vessel to be treated.
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 under vacuum. If resistance is met during manipulation, determine thecause of the resistance before proceeding.
7. Use the IVL Generator in accordance with recommended settings as stated in the Operator’s Manual. Do not attempt to override the lifetime pulse
limits per device as defined in the IVL System Sequence Chart.
8. This device should only be used by physicians who are familiar with interventional vascular procedures.
9. Physicians must read and understand these instructions prior to use of the device.
10. Do not use excessive force/torque when using this device as this could result in damage to the device components and patient injury.
11. 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.
12. For preparation, operation, warnings and precautions, and maintenance of the IVL Generator and its accessories refer to the IVL Generator andConnector Cable Operator’s Manual.

Precautions
1.

Perform all device manipulations under adequate fluoroscopic guidance.

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2.
3.
4.
5.
6.
7.
8.

Use only the recommended balloon inflation medium.
Appropriate anticoagulant therapy should be administered by the physician.
Decision regarding use of distal protection should be made based on physician assessment of treatment lesion morphology.
Care should be taken not to kink the catheter. If kinking occurs, remove device and prepare a new device.
If an inability to inflate or maintain pressure occurs, remove the catheter and use a new device.
If the catheter appears not to deliver lithotripsy pulsatile mechanical energy, remove and replace it with another catheter.
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 disposed of properly as per hospital protocol.

Adverse Effects
Possible adverse effects are consistent with standard angioplasty and include:
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•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
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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 lead to 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 open surgery)

Risks identified as unique to the device and its use:••

Allergic/immunologic reaction to the catheter material(s) or coating
Device malfunction or failure

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 forthe treatment of peripheral stenotic lesions (PAD I and PAD II, combined referred to as the DISRUPT PAD Program). Patients with peripheral arterial
disease of Rutherford Category 2, 3, and 4 who were candidates for percutaneous therapy and met the study criteria were enrolled and treated. Thirtyfour (34) investigators participated at seven (7) sites in Austria, New 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.
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 a low
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 theperformance goal of 89.3%. Procedural success was defined as <50% with or without adjunctive therapy was 100%.
The secondary safety endpoint, freedom from MAE at 6 months, continued to be favorable 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.

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Freedom from Major Adverse Events at 6 Months
N=95
30 daysn=941

6 months
n=932

Major adverse events (MAE)

0 (0.0%)3 (3.2%)

Death (cardiovascular)

0 (0.0%)0 (0.0%)TLR

0 (0.0%)3 (3.2%)

Unplanned target limb amputation (above the ankle)

0 (0.0%)0 (0.0%)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%)

TLR

94 (100%)

90 (96.8%)

Unplanned target limb amputation (above the ankle)

94 (100%)

93 (100%)

1 One subject withdrew consent and was not available for analysis
2 Two subjects withdrew consent and were not available for analysis

Secondary effectiveness endpoints were also favorable. Procedural success defined as <50% without adjunctive therapy was achieved in 91.6% ofsubjects. In addition, procedural success defined as ≤30% with or without adjunctive therapy was achieved in 89.5%.
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=95
Patency
Target lesion patency at 30 days

91/911 (100%)

Exact Binomial Two-sided 95% CI[1]96%, 100%

Target lesion patency at 6 months

69/902 (76.7%)

Exact Binomial Two-sided 95% CI[1]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

Functional outcomes including change in ankle-brachial index (ABI), Rutherford Category and walking impairment showed a sustained and statisticallysignificant improvement from baseline 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 of stenting. Acute effectiveness results showed high procedural success and a large acute gain in vessel diameter post procedure.
Patency, TLR and functional outcomes were durable through 6 months in available patients. These results demonstrate the safety and performance of
the IVL System for the treatment of subjects with calcified, stenotic lesions.

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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.
Preparation
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.

Prepare the insertion site using standard sterile technique.
Achieve vascular access using physician’s preferred methodology and location.
Place an appropriately sized and length introducer sheath.
Select a balloon catheter size that is 1.1:1 based on Balloon Compliance Chart (above) and reference vessel diameter. The largest diameterballoon should be used if 1.1:1 sizing is not available.
Remove the IVL Catheter from the package.
Prepare the balloon using standard technique. Fill a 20cc (mL) syringe with 5cc (mL) of 50/50 saline/contrast medium. Attach syringe to inflation
port on catheter hub. Pull vacuum at least 3 times, releasing vacuum to allow the fluid to replace the air in the catheter.
Fill indeflator device with 10cc (mL) 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.
Flush the guidewire port with saline.
Remove the protection sheath from the catheter.
Wet the balloon and distal shaft with sterile saline in order to activate the hydrophilic coating.
Insert the IVL Connector Cable into a sterile sleeve or probe cover.
Remove the cap from the proximal end and attach the IVL Catheter’s connector (see Figure 1) to the IVL Connector Cable.
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 theballoon.
Delivering the IVL Catheter to the Treatment Site
1.
2.
3.

Advance the 0.014” (0.36mm) guidewire across the treatment site.
Load the IVL Catheter over the exchange length (300cm) 0.014” (0.36mm) guidewire and through the sheath and advance balloon to thetreatment site.
Position the balloon at the treatment site using the marker bands to aid in positioning.

Treating the Site with Lithotripsy
1.
2.
3.

Once the IVL Catheter is in place, record position using fluoroscopy.
If position is incorrect, adjust the IVL Catheter to the correct position.
Inflate IVL balloon, not exceeding 4.0 atm, to ensure there is full apposition to the vessel wall.
NOTE: Lithotripsy should not be delivered if the balloon is inflated to >4 atm as there is no increase in sonic output, and higher pressure during
treatment can increase the risk that the balloon loses pressure.
4. Deliver IVL treatment (up to 20 pulses) per the IVL System Sequence Chart by pressing the therapy button on the IVL Connector Cable.
5. Inflate balloon to nominal pressure per Balloon Compliance Chart (above) and record lesion response on fluoroscopy.
6. Deflate balloon and wait at least 10 seconds to re-establish blood flow.
NOTE: The IVL Generator is programmed to force a minimum pause time of 10 seconds following every 20 pulses delivered.
7. Repeat steps 3, 4, 5, and 6 for additional treatment cycles until the lesion has been sufficiently dilated or if the catheter is re-positioned.
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, the recommended balloon overlap is at least 1 cm to prevent geographic miss. However, care must be taken not to exceed 160 pulses inthe same segment.
9. Perform a completion arteriogram to assess post-IVL treatment result.
10. 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 the hemostatic valve due to the lubricity, gently grasp the catheterwith 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 theguide wire lumen and clean 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 bedamaged in the process.

Patient Information
Physicians should instruct patients to seek medical attention immediately for signs and symptoms of decreased peripheral blood flow. There are no
known limitations to normal daily activities. Patients should be instructed to comply with the medical regimen as prescribed 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.
Patents: www.shockwavemedical.com/patents

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

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Symbol

Definition
Do not re-use

Use by date

Sterilized using irradiation
Sterilized using ethylene oxide
Caution

Manufacturer
Do not use if package is damaged; If
sterile barrier is damaged, consult
instructions for use
Keep dry

Keep away from heat

Batch code
Catalogue number
Do not resterilize
Crossing profile

Non-pyrogenic

Consult instructions for use

Contains 1 unit (Contents: 1)
Quantity
Does not contain latex
Recommended Guidewire

Recommended Introducer SheathOver-the-wire
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.

PAT

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Patents. Refer towww.shockwavemedical.com/patents

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Symbol

Definition

IVL

Intravascular Lithotripsy

Indicates a carrier that contains Unique
Device Identifier information.

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PN 64556 Rev B, IFU, Shockwave S4 Peripheral IVL Catheter with Cable Sleeve (US)