8.
9.

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave
C2 Coronary Intravascular Lithotripsy (IVL) Catheter

10.

Instructions for Use (IFU)11.

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

12.

Device Description
The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through thecoronary arterial system of the heart to the site of an otherwise difficult to treat calcified
stenosis, including calcified stenoses that are anticipated to exhibit resistance to fullballoon dilatation or subsequent uniform coronary stent expansion. The IVL Catheter
contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse
therapy. The lithotripsy technology generates acoustic pressure pulses within the target
treatment site, disrupting calcium within the lesion allowing subsequent dilatation of acoronary artery stenosis using low balloon pressure. The system consists of the IVL
Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Coronary IVL
Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm, 3.5x12 mm, and 4.0x12mm. The Shockwave C2 is compatible with a 6F guiding catheter and extensions, has aworking length of 138 cm, and shaft depth markers at the proximal end. The catheter iscoated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during
device delivery. Refer to Figure 1 below for the Shockwave C2 Coronary IVL Catheter
components.
BalloonRX PortCatheter Shaft

Dual Port Hub

13.

Precautions
1.
This device should only be used by physicians trained in angiography andintravascular coronary procedures.
2.
For preparation, operation, warnings and precautions, and maintenance of the IVL
Generator and its accessories, refer to the IVL Generator Operator’s Manual.
3.
The catheter is intended for single (one) time use only. DO NOT re-sterilize and/or
reuse. If a second catheter of the same size is necessary, DO NOT re-use the firstcatheter. Discard it before preparing the second catheter.
4.
Use only an appropriately sized balloon for the vessel to be treated: 1:1 based on
balloon compliance chart and reference vessel diameter. The largest diameterballoon should be used if 1:1 sizing is not available (such as, using a 4.0 mm IVL
Catheter in a vessel with a reference diameter of 4.5 mm).
5.
Inflate the balloon according to the balloon compliance chart. Balloon pressure
should not exceed the rated burst pressure (RBP).
6.
Use only the recommended 50/50 contrast/saline medium to inflate the balloon toensure adequate lithotripsy delivery.
7.
If the surface of the IVL Catheter becomes dry, wetting with normal saline willreactivate the hydrophilic coating. Wetting the catheter with solvents other thansaline can compromise the coating integrity or performance.
8.
Perform all device manipulations under adequate fluoroscopic guidance.
9.
Do not advance or retract the catheter unless the balloon is fully deflated undervacuum. If resistance is met, determine the cause of the resistance before
proceeding.
10. Care must be taken when manipulating, advancing and/or withdrawing the device
past sharp objects as it may damage the hydrophilic coating.
11. Do not use or attempt to straighten a catheter if the shaft has become bent orkinked. Instead, prepare a new catheter.
12. During the procedure, appropriate antiplatelet/anticoagulant therapy must be
provided to the patient as needed. Antiplatelet/anticoagulant therapy should becontinued for a period of time to be determined by the physician after theprocedure.
13. Emitter proximity to balloon may increase incidence of balloon loss of pressure.
Ensure adequate balloon expansion prior to delivering lithotripsy and consider
anatomical restrictions that may place the emitter too close to the balloon material.
14. If the IVL Catheter appears not to deliver lithotripsy therapy, remove and replace itwith another catheter.
15. Precaution should be taken when handling the 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.
16. Precaution should be taken when treating patients with previous stenting within 5
mm of target lesion.

IVL Connector

Figure 1: Shockwave C2 Coronary IVL Catheter
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”(0.36 mm) guidewire to facilitate advancement of the catheter to and through thetarget stenosis. The system is designed as “Rapid Exchange” (Rx), so a length (190cm – 300 cm) guidewire is indicated. The emitters are positioned along the length of
the balloon working length for delivery of lithotripsy therapy. The balloon is locatednear 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.
Indications for Use
The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 Coronary
IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely
calcified, stenotic de novo coronary arteries prior to stenting.
Contraindications for Use
The Shockwave C2 Coronary IVL System is contraindicated 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.
Warnings
1. Physicians must read and understand these instructions prior to use of the device.
Failure to abide by the warnings in this labeling might result in damage to the devicehydrophilic coating.
2. Do not use a device past the expiration date on the label. Use of expired product may
result in patient injury.
3. Use the IVL Generator in accordance with recommended settings as stated in the IVL
Generator Operator’s Manual. DO NOT deviate from recommended settings as thismay cause patient injury.
4. IVL Connector Cable is non-sterile and must be enclosed in a sterile sleeve prior toand during use.
5. Inspect all product components and packaging prior to use. Do not use the device if
the device or the packaging has been damaged or if sterility has been compromised.
Damaged product could result in patient injury.
6. Do not use the device if the balloon protective sheath cannot be removed easily prior
to use. If excessive force is used, the catheter could be damaged. Damaged productcould result in patient injury.
7. Ensure that the IVL Catheter is used with a 0.014” (0.36 mm) guidewire and is inserted
through a 6F guiding catheter at least 0.068” (1.72 mm) ID. Failure to do so could
result in inadequate device performance or patient injury

LBL 63927 Rev F, Instructions for Use (May 2023)

If an inability to inflate or maintain balloon pressure occurs, remove the catheter anduse a new device.
Do not use excessive force or torque on the catheter as this could result in damage
to the device components and result in patient injury.
The risk of a dissection or perforation is increased in severely calcified lesions
undergoing percutaneous treatment, including IVL. Appropriate provisional
interventions should be readily available.
Balloon loss of pressure was observed in 6.3% of patients in the clinical trial thatwere treated with the currently marketed product and was associated with anumerical increase in dissection which was not statistically significant and was not
associated with MACE. Analysis indicates calcium length is a predictor of
dissection and balloon loss of pressure.
Treat patients per standard medication or interventional procedures in the event ofcomplications associated with the procedure or device.
IVL generates mechanical pulses which may cause atrial or ventricular capture in
bradycardic patients. In patients with implantable pacemakers and defibrillators, theasynchronous capture may interact with the sensing capabilities. Monitoring of theelectrocardiographic rhythm and continuous arterial pressure during IVL treatment
is required. In the event of clinically significant hemodynamic effects, temporarily
cease delivery of IVL therapy. In the CAD III study, there were no serious adverse
events associated with IVL-induced capture including arrhythmia.

Adverse Effects
Potential adverse effects are consistent with standard catheter-based cardiac
interventions and include, but are not limited to, the following:• Abrupt vessel closure• Allergic reaction to contrast medium, anticoagulant and/or antithrombotic therapy• Aneurysm• Arrhythmia• Arteriovenous fistula• Bleeding complications• Cardiac tamponade or pericardial effusion• Cardiopulmonary arrest• Cerebrovascular accident (CVA)• Coronary artery/vessel occlusion, perforation, rupture or dissection• Coronary artery spasm• DeathEN

Page 1 of 8• Emboli (air, tissue, thrombus or atherosclerotic emboli)• Emergency or non-emergency coronary artery bypass surgery• Emergency or non-emergency percutaneous coronary intervention• Entry site complications• Fracture of the guide wire or failure/malfunction of any component of the device that
may or may not lead to device embolism, dissection, serious injury or surgicalintervention• Hematoma at the vascular access site(s)• Hemorrhage• Hypertension/ Hypotension• Infection/sepsis/fever• Myocardial Infarction• Myocardial Ischemia or unstable angina• Pain• Peripheral Ischemia• Pseudoaneurysm• Renal failure/insufficiency• Restenosis of the treated coronary artery leading to revascularization• Shock/pulmonary edema• Slow flow, no reflow, or abrupt closure of coronary artery• Stroke• Thrombus• Vessel closure, abrupt• Vessel injury requiring surgical repair• Vessel dissection, perforation, rupture, or spasm

Renal insufficiency2, % (n/N)

12.0% (46/384)

Table 2. Pre-Procedural Angiography (Core Lab) (Pivotal Analysis Set)
Pivotal(N=384)

Parameter
Target Lesion Vessel, % (n/N)
LAD
RCA
Circumflex

Clinical Study Summary
The prospective, single arm, multi-center IDE study (Disrupt CAD III) of the Shockwave
Intravascular Lithotripsy (IVL) System with the Shockwave C2 Coronary IVL Catheter was
conducted to evaluate the safety and effectiveness of the device to treat de novo, severely
calcified, stenotic coronary lesions prior to stenting. Between January 9, 2019 and March
27, 2020, a total of 431 subjects were enrolled into the Disrupt CAD III study, including 384
pivotal subjects (referred to as the Pivotal Analysis Set) and 47 roll-in subjects. Subjects
were enrolled at 47 investigational sites located in the United States and Europe. Subject
follow-up to 24 months is complete.
The primary safety endpoint for the Disrupt CAD III study was freedom from major adverse
cardiac events (MACE) at 30 days, which was a composite of cardiac death, myocardial
infarction (MI) and target vessel revascularization (TVR). All MACE were adjudicated by anindependent Clinical Events Committee (CEC). The primary safety endpoint was planned tobe compared to a performance goal (PG) of 84.4% at a one-sided alpha level of 0.05.
The primary effectiveness endpoint for the Disrupt CAD III study was Procedural Successdefined as stent delivery with a residual in-stent stenosis <50% (core laboratory assessed)
and without in-hospital MACE. All MACE were adjudicated by an independent CEC. The
primary effectiveness endpoint was planned to be compared to a PG of 83.4% at a onesided alpha level of 0.05.

56.5% (217/384)
29.2% (112/384)
12.8% (49/384)

Left Main

1.6% (6/384)

Bypass graft

0.0% (0/384)

RVD1 (mm), Mean ± StdDev (N)3.03 ± 0.47 (381)

MLD (mm), Mean ± StdDev (N)1.06 ± 0.36 (381)% Diameter Stenosis, Mean ± StdDev (N)65.1 ± 10.8 (381)

Lesion length (mm), Mean ± StdDev (N)26.09 ± 11.68 (381)

Calcification, % (n/N), severe

100.0% (384/384)

Calcification Length (mm), Mean ± StdDev (N)47.85 ± 18.81 (384)Bifurcation/Trifurcation, % (n/N)

29.9% (115/384)

LAD = left anterior descending coronary artery; RCA = right coronary artery; RVD =reference vessel diameter; MLD = minimal lumen diameter; StdDev = standard
deviation
1. Interpolated

Data collected through June 20, 2022 on the pivotal subject cohort are provided below.
A summary of baseline characteristics of pivotal subjects is provided in Table 1.

A summary of post-IVL and post-stent angiography as determined by the Core Lab for
pivotal subjects is provided in Table 3.

Table 1. Patient Baseline Characteristics (Pivotal Analysis Set)

LBL 63927 Rev F, Instructions for Use (May 2023)

4.2% (16/384)
85.9% (330/384)
9.9% (38/384)
40.1% (154/384)
89.1% (342/384)
89.1% (342/384)
7.6% (29/384)
18.0% (69/384)
46.9% (180/384)
9.4% (36/384)
12.2% (47/384)

A summary of pre-procedural angiography as determined by the Core Lab for pivotal
subjects is provided in Table 2.

Risks identified as related to the device and its use:
• Allergic/immunologic reaction to the catheter material(s) or coating• Device malfunction, failure, or balloon loss of pressure leading to device embolism,
dissection, serious injury or surgical intervention• Atrial or ventricular extrasystole• Atrial or ventricular capture

Age (years), Mean ± StdDev
Gender, % (n/N)
Male
FemaleRace, % (n/N)
White
Black and African American
Asian
American Indian or Alaska Native

Native Hawaiian or Other Pacific Islander
Not Specified
Ethnicity, % (n/N)
Hispanic or Latino
Not Hispanic or Latino
Not Specified
Diabetes Mellitus, % (n/N)
Hyperlipidemia, % (n/N)
Hypertension, % (n/N)
Prior Stroke or TIA, % (n/N)
Myocardial Infarction, % (n/N)
Prior Coronary Intervention1, % (n/N)
Prior CABG, % (n/N)
Smoking/tobacco use (current), % (n/N)

Pacemaker, % (n/N)
4.7% (18/384)
ICD/CRT-D, % (n/N)
1.6% (6/384)
TIA = transient ischemic attack; CABG = coronary artery bypass graft; ICD =implantable cardioverter defibrillator; CRT-D = cardiac resynchronization therapy
1. Percutaneous transluminal coronary angioplasty (PTCA), drug-eluting stent (DES)or atherectomy procedures.
2. An increase in serum creatinine of ≥1.0 mg/dl over previous value requiring
medical treatment but which does not require dialysis to resolve.

In addition, patients may be exposed to other risks associated with coronary interventional
procedures, including risks from conscious sedation and local anesthetic, the radiographic
contrast agents used during angiography, the drugs given to manage the subject during
the procedure, and the radiation exposure from fluoroscopy.

Parameter

Pivotal(N=384)
0.3% (1/384)
9.9% (38/384)

Parameter

Pivotal(N=384)71.2 ± 8.6 (384)Table 3. Post-IVL and Post-Stent Angiography (Core Lab) (Pivotal Analysis Set)
Pivotal (N=384)
Parameter

76.6% (294/384)
23.4% (90/384)
82.8% (318/384)
3.1% (12/384)
3.4% (13/384)
0.5% (2/384)

Post-IVL

Post-Stent(In-Stent)

MLD (mm), Mean ± StdDev (N)1.87 ± 0.48 (341)

2.74 ± 0.43 (381)% Diameter Stenosis, Mean ± StdDev(N)

37.2 ± 13.5 (341)

Acute Gain (mm), Mean ± StdDev (N)0.82 ± 0.48 (339)

11.9 ± 7.1 (381)1.68 ± 0.46 (378)

MLD = minimal lumen diameter; StdDev = standard deviation

EN

Page 2 of 8

Per the Disrupt CAD III protocol, all subjects required at least one stent to be placed after
IVL treatment; 99.2% of pivotal subjects (381/384) received a stent.

2. P-value is calculated based on a one-sided asymptotic Wald (normal
approximation-based) test for a binomial proportion at a 0.05 level of significance.
The standard error is calculated from the sample proportion.
3. Procedural Success defined as stent delivery with a residual in-stent stenosis <50% (corelaboratory assessed) and without in-hospital MACE (CEC adjudicated).

The Primary Safety results on the Pivotal Analysis Set are summarized in Table 4. Among 383
pivotal subjects with evaluable primary safety endpoint data, the observed 30-day MACE free rate
was 92.2% (353/383), with the corresponding one-sided lower 95% confidence limit of 89.9%, which
was higher than the PG of 84.4%. The Primary Safety Endpoint was met based on the Pivotal
Analysis Set (p<0.0001).

The components of the Primary Effectiveness Endpoint are provided in Table 7 below.
Table 7. Primary Effectiveness Endpoint Components (Pivotal Analysis Set)
Primary Effectiveness Endpoint: Procedural SuccessN (%)
Procedural Success1,2
92.4% (355/384)
Stent Delivered3
99.2% (381/384)< 50% Residual Stenosis
100.0% (381/381)
Without In-Hospital MACE
93.0% (357/384)
1.
Procedural Success defined as stent delivery with a residual in-stent stenosis <50%
(core laboratory assessed) and without in-hospital MACE (CEC adjudicated).
2.
Some subjects failed >1 component of the Procedural Success criteria; therefore, thecategories are not mutually exclusive.
3.
Three subjects did not receive a stent; two were IVL Device Delivery Failures that did
not receive any therapy on the day of the index procedure and one subject had failed
stent delivery after successful IVL.

Table 4. Primary Safety Endpoint (30-day MACE) (Pivotal Analysis Set)
% (n/N)
Primary[95% Lower
SafetyHypothesis
P value2
Conclusion
Confidence
Endpoint
1
Interval]
Freedom
92.2% (353/383)4
H0: πs ≤ 84.4%<0.0001
Performancefrom MACE3[89.9%]
HA: πs> 84.4%
Goal Met
within 30
days postprocedure
1. 95% lower confidence interval is calculated based on a one-sided asymptotic
Wald (normal approximation-based) confidence interval for a binomial proportion.
The standard error is calculated from the sample proportion.
2. P-value is calculated based on a one-sided asymptotic Wald (normal
approximation-based) test for a binomial proportion at a 0.05 level of significance.
The standard error is calculated from the sample proportion.
3. All MACE were adjudicated by an independent CEC. If full data were not available,
the event was adjudicated based on the clinical judgement of the independent
CEC. Missing data were not imputed and a sensitivity analysis was performed toassess endpoint robustness.
4. One subject was excluded from the primary safety endpoint analysis due to insufficient
follow-up (< 23 days).

Table 8 provides a summary of site-reported device and/or procedure related serious
adverse events (SAEs) observed through 24 months among pivotal subjects (by MedDRACode).
Table 8. Summary of SAEs through 24 Months (Site Reported) (Pivotal Analysis Set)
Device-Related1
Procedure-Related2
Subjects
Events Subjects Events
System Organ Class / Preferred Term
% (n/N)N% (n/N)N
Total Patients with Serious Adverse
2.9% (11/384)
11 8.1% (31/384) 44
EventsBlood and lymphatic system disorders 0.0% (0/384)
00.3% (1/384)
1
Haemorrhagic anaemia
0.0% (0/384)
00.3% (1/384)
1
Cardiac disorders
2.1% (8/384)
86.0% (23/384) 27
Coronary artery dissection
0.8% (3/384)
32.9% (11/384) 11
Myocardial infarction
0.5% (2/384)22.1% (8/384)
8
Arrhythmia
0.0% (0/384)
00.5% (2/384)
2
Angina pectoris
0.3% (1/384)
1
0.5% (2/384)
2
Cardiac arrest
0.0% (0/384)00.0% (0/384)0
Cardiac failure congestive
0.0% (0/384)00.0% (0/384)
0Coronary artery disease
0.0% (0/384)00.0% (0/384)
0Coronary artery occlusion
0.0% (0/384)00.0% (0/384)
0Coronary artery perforation
0.3% (1/384)
1
0.3% (1/384)
1
Coronary artery stenosis
0.0% (0/384)00.0% (0/384)
0Coronary artery thrombosis
0.0% (0/384)
00.3% (1/384)
1
Left ventricular failure
0.0% (0/384)00.0% (0/384)
0
Myocardial ischaemia
0.3% (1/384)
1
0.3% (1/384)
1Congenital, familial and genetic
0.0% (0/384)
00.3% (1/384)
1
disordersCongenital coronary artery
0.0% (0/384)
00.3% (1/384)
1
malformation
General disorders and administration
0.0% (0/384)00.0% (0/384)0site conditions
Pain
0.0% (0/384)00.0% (0/384)
0
Hepatobiliary disorders
0.0% (0/384)
00.3% (1/384)
1
Hepatic failure
0.0% (0/384)
00.3% (1/384)
1
Injury, poisoning and procedural
0.5% (2/384)21.0% (4/384)
4complications
Vascular access site haematoma
0.0% (0/384)
00.3% (1/384)
1
Coronary artery restenosis
0.5% (2/384)2
0.8% (3/384)
3
Investigations
0.0% (0/384)
00.5% (2/384)
2
Myocardial necrosis marker increased
0.0% (0/384)
00.5% (2/384)
2(elevated cardiac biomarker)
Nervous system disorders
0.0% (0/384)
00.3% (1/384)
1
Cerebrovascular accident
0.0% (0/384)
00.3% (1/384)
1
Dizziness
0.0% (0/384)00.0% (0/384)
0
Seizure
0.0% (0/384)00.0% (0/384)
0Renal and urinary disorders
0.0% (0/384)
00.3% (1/384)
1
Renal failure
0.0% (0/384)
00.3% (1/384)
1

The components of the Primary Safety Endpoint are provided in Table 5 below.
Table 5. Primary Safety Endpoint Components (Pivotal Analysis Set)
In-Hospital
30-Day Follow-up
Cumulative MACE Rates
N=384
N=3831
MACE2,3
7.0% (27/384)
7.8% (30/383)
Cardiac Death
0.3% (1/384)
0.5% (2/383)
Non-Q-wave MI4
5.7% (22/384)
6.0% (23/383)
Q-wave MI
1.0% (4/384)
1.6% (6/383)
Target Vessel Revascularization
0.5% (2/384)
1.6% (6/383)
1. One subject was excluded from the primary safety endpoint analysis due to insufficient
follow-up (< 23 days).
2. All MACE were adjudicated by an independent CEC. If full data were not available, theevent was adjudicated based on the clinical judgement of the independent CEC. Missing
data were not imputed and a sensitivity analysis was performed to assess endpointrobustness.
3. Some subjects failed >1 component of the MACE criteria; therefore, the categories are
not mutually exclusive.
4. Myocardial Infarction (MI) is defined as CK-MB level > 3 times the upper limit of lab
normal (ULN) value with or without new pathologic Q wave at discharge (periproceduralMI) and using the Fourth Universal Definition of Myocardial Infarction beyond discharge(spontaneous MI).
The Primary Effectiveness results on the Pivotal Analysis Set are summarized in Table 6. No
pivotal subjects were missing data required to define Procedural Success (data related to stentdelivery or final residual stenosis) and therefore all pivotal subjects were included in the primaryeffectiveness analysis (n=384). The observed procedural success rate was 92.4%(355/384), with the corresponding one-sided lower 95% confidence limit of 90.2%, which was
higher than the PG of 83.4%. Therefore, the Primary Effectiveness Endpoint was met based on
the Pivotal Analysis Set (p<0.0001).

Table 6. Primary Effectiveness Endpoint (Pivotal Analysis Set)
% (n/N)
Primary[95% Lower
EffectivenessHypothesis
P value2
Conclusion
Confidence
Endpoint
1
Interval]
Procedural
92.4%
H0: πs ≤ 83.4% <0.0001
Performance
Success3(355/384)
HA: πs> 83.4%
Goal Met[90.2%]
1. 95% lower confidence interval is calculated based on a one-sided asymptotic
Wald (normal approximation-based) confidence interval for a binomial proportion.
The standard error is calculated from the sample proportion.

LBL 63927 Rev F, Instructions for Use (May 2023)

EN

Page 3 of 8

Device-Related1
Procedure-Related2
Subjects
Events Subjects Events% (n/N)N% (n/N)N
0.0% (0/384)
00.3% (1/384)
1

Table 10. MACE through 24 Months (Pivotal Analysis Set)

System Organ Class / Preferred Term
Respiratory, thoracic and mediastinal
disorders
Respiratory failure
0.0% (0/384)
00.3% (1/384)
1
Vascular disorders
0.3% (1/384)
11.3% (5/384)
5
Hypertension
0.0% (0/384)00.0% (0/384)0Hypotension
0.3% (1/384)
1
0.5% (2/384)2
Shock0.0% (0/384)
00.3% (1/384)
1
Embolism
0.0% (0/384)
00.3% (1/384)
1
Peripheral ischaemia
0.0% (0/384)
00.3% (1/384)
1
Note: A subject experiencing multiple occurrences of an adverse event was counted, at most,once per system organ class and preferred term. Adverse events are coded using MedDRA
version 21.1.
1. Includes events reported with device relatedness as possible, probable ordefinite.
2. Includes events reported with procedure relatedness as possible, probable ordefinite.

Number of Subjects with Completed Follow-up
Visits12 Months

24 Months

373

367

346

MACE1,2
10.2%
13.6%
18.9%
Cardiac Death
0.8%
1.1%
2.7%
Non-Q-wave Myocardial Infarction3
7.8%
9.2%
11.3%
Q-wave Myocardial Infarction
1.6%
1.6%
1.6%
Target Vessel Revascularization
2.9%
5.8%
8.5%
Note: MACE rates were calculated as Kaplan-Meier estimates event rates with the number of events.
1. All MACE were adjudicated by an independent CEC.
2. Some subjects failed >1 component of the MACE criteria; therefore, the categories are notmutually exclusive.
3. Myocardial Infarction (MI) is defined as CK-MB level > 3 times the upper limit of lab normal(ULN) value with or without new pathologic Q wave at discharge (periprocedural MI) andusing the Fourth Universal Definition of Myocardial Infarction beyond discharge(spontaneous MI).
Target Lesion Revascularization (TLR) Kaplan-Meier (K-M) estimates at 6,12, and 24
months are 2.4%, 4.3%, and 6.4%, respectively.

The angiographic complications as identified by core laboratory assessment for pivotal
subjects are provided in Table 9 below.

The effect of IVL on hemodynamics during the index procedure was assessed.

Table 9. Angiographic Complications (Core Lab) (Pivotal Analysis Set)
After Final
PostPre-Dil
Post OCTFinal1
Post-IVL
Stent
BeforeIVUS
Stent
Any Serious
2.6%
1.6%
0.8%
0.0%
0.5%
Angiographic(9/341)(1/64)(3/357)(0/122)(2/384)Complication2
Dissection3
0.3%
0.0%
0.0%
0.0%
0.3%
A
(1/341)(0/64)(0/357)(0/122)(1/384)
10.6%
3.1%
2.2%
0.0%
1.6%
B
(36/341)(2/64)(8/357)(0/122)(6/384)
4.7%
1.6%
0.0%
0.0%
0.3%
C
(16/341)(1/64)(0/357)(0/122)(1/384)
Severe Dissection(Type D to F)
1.5%
0.0%
0.0%
0.0%
0.0%
D
(5/341)(0/64)(0/357)(0/122)(0/384)
0.6%
0.0%
0.0%
0.0%
0.0%
E
(2/341)(0/64)(0/357)(0/122)(0/384)
0.0%
1.6%
0.0%
0.0%
0.3%
F
(0/341)(1/64)(0/357)(0/122)(1/384)
Perforation4
0.0%
0.0%
0.6%
0.0%
0.3%
Any
(0/341)(0/64)(2/357)(0/122)(1/384)
0.0%
0.0%
0.0%
0.0%
0.0%
I
(0/341)(0/64)(0/357)(0/122)(0/384)
0.0%
0.0%
0.3%
0.0%
0.3%
II
(0/341)(0/64)(1/357)(0/122)(1/384)
0.0%
0.0%
0.3%
0.0%
0.0%
III
(0/341)(0/64)(1/357)(0/122)(0/384)
0.0%
1.6%
0.0%
0.0%
0.3%
Abrupt Closure(0/341)(1/64)(0/357)(0/122)(1/384)
0.6%
0.0%
0.3%
0.0%
0.0%
Slow Flow(2/341)(0/64)(1/357)(0/122)(0/384)
0.0%
0.0%
0.0%
0.0%
0.0%
No Reflow(0/341)(0/64)(0/357)(0/122)(0/384)
1. The final image is the one chosen by the core lab analyst based on optimal
projection, image quality, etc. from the post-procedural images obtained after all
devices have been removed and the procedure has been completed.
2. Serious angiographic complications include severe dissection (Type D to F),
perforation, abrupt closure, persistent slow flow and no flow.
3. Dissections were categorized per the NHLBI classification system.
4. Perforations were categorized per the Ellis classification for coronary perforation

Table 11 summarizes the hemodynamic data for those subjects with IVL-induced capture(n=171) and those without (n=245). There were no instances of sustained ventriculararrhythmias in the group with IVL-induced capture, and there was no difference in themagnitude of BP drop between the two groups.
Table 11. Hemodynamic Effects of IVL-Induced Capture During Index Procedure (Safety
Set)
Subjects without
IVL-induced
capture(n=245)

Subjects with
IVL-induced
capture(n=171)p-value

Pre-Procedure Heart Rate (bpm)69.0 ± 11.9

65.9 ± 11.4

0.0094

Heart Rate ≤ 60 bpm

20.8% (51/245)

37.4% (64/171)

0.0002

Drop in Systolic BP during IVL
Procedure

24.5% (58/237)

40.5% (66/163)

0.0007

Clinically Significant Drop in Systolic
BP1

3.4% (2/58)2,3

1.5% (1/66)4

0.5988Magnitude of Systolic BP Drop

23.5 ± 15.0

18.9 ± 14.2

0.0670

Sustained Ventricular Arrhythmia
During or After IVL Procedure

0.4% (1/245)2

0% (0/171)

1.0000Parameter

1. Clinical significance determined by the investigator.
2. One subject experienced a drop in BP (23 mmHg) secondary to ventricular tachycardia
which occurred during pre-dilatation prior to IVL and the procedure continued without
further complication.
3. One subject experienced a drop in BP (50 mmHg) following two unsuccessful attempts
to deliver a stent post-IVL, loss of guidewire position, difficulty placing a new guidewire,and subsequent PTCA.
4. One subject experienced a drop in BP (36 mmHg) after becoming transiently
bradycardic and hypotensive following IVL; after treatment, the procedure continued
without further complication.
An additional analysis by pooling individual patient-level data from the Disrupt CAD studies(CAD I-IV) based on uniform study inclusion/exclusion criteria and endpoint definitions, aswell as the use of an independent angiographic core lab and Clinical Events Committee
adjudication, was conducted. Across the four studies, a total of 683 subjects were enrolledfrom December 2015 to April 2020 at 72 sites from 12 countries including Australia,
Europe, U.S. and Japan. The Safety Set population from CAD III and IV was used for thisanalysis.
A total of 42 subjects in the pooled safety set (6.1%, 42/683) had a prior PPM/ICD. Table
12 summarizes relevant adverse events in this subset including PPM/ICD-related adverse
events (e.g., inappropriate shock, transient pacing inhibition), arrhythmias andhemodynamic events (including hypotension, cardiogenic shock and hemodynamic
instability). In the pooled safety set, there were no PPM/ICD-related events and nohemodynamic adverse events. Three (3) subjects (7.1%, 3/42) with a PPM/ICD

Supplemental Clinical Information
An analysis of long-term MACE (through 24 months) was conducted for pivotal subjects on
the complete data set.
All MACE were adjudicated by the CEC, and of the events that occurred beyond 30 days,
none were adjudicated by the CEC as being definitely or probably device-related.
LBL 63927 Rev F, Instructions for Use (May 2023)

6 Months

EN

Page 4 of 8

experienced an arrhythmia > 30 days following the index procedure; however, none wererelated to the study device (IVL) or the index procedure. All three subjects were enrolled in
the Disrupt CAD III study; all had a medical history of arrhythmia; and all arrhythmia-related
AEs occurred > 30 days following the index procedure.
In conclusion, the pooled safety analysis demonstrates there is no association between
PPM/ICD adverse events and coronary IVL and support the conclusion that coronary IVL issafe in patients with an implanted PPM/ICD device.
Table 12. Summary of PPM/ICD Events (CAD I-IV Pooled Safety Set)
CAD I1CAD II2 CAD III3

CAD
IV4

Pooled

6.3%
1.4%
6.1%
Prior PPM/ICD(27/431(1/72) (42/683))
AEs Relevant to Potential
0.0%
0.0%
11.1%
0.0%
7.1%
PPM/ICD Interaction
(0/7)
(0/7)
(3/27)(0/1)(3/42)
0.0%
0.0%
0.0%
0.0%
0.0%
PPM/ICD Events5
(0/7)
(0/7)
(0/27)(0/1)(0/42)
0.0%
0.0%
11.1%
0.0%
7.1%
Arrhythmia
(0/7)
(0/7)
(3/27)6(0/1)(3/42)
0.0%
0.0%
0.0%
0.0%
0.0%
Hemodynamic Events7
(0/7)
(0/7)
(0/27)(0/1)(0/42)
IVL-related AEs Relevant to
0.0%
0.0%
0.0%
0.0%
0.0%
Potential PPM/ICD Interaction
(0/7)
(0/7)
(0/27)(0/1)(0/42)
0.0%
0.0%
0.0%
0.0%
0.0%
Adverse pacing/ICD5
(0/7)
(0/7)
(0/27)(0/1)(0/42)
0.0%
0.0%
0.0%
0.0%
0.0%
Arrhythmia
(0/7)
(0/7)
(0/27)(0/1)(0/42)
0.0%
0.0%
0.0%
0.0%
0.0%
Hemodynamic events7
(0/7)
(0/7)
(0/27)(0/1)(0/42)
1. CAD I includes all AEs reported during the study follow-up period (180 days).
2. CAD II includes all AEs reported during the study follow-up period (30 days).
3. CAD III includes all AEs reported as of June 28, 2020 during the study follow-up
period (24 months).
4. CAD IV includes all AEs reported as of August 6, 2020 during the study follow-up
period (24 months).
5. Inappropriate ICD shock, transient pacing inhibition
6. All 3 subjects had medical history of arrhythmia; no events were device-related
and all occurred > 30 days after index procedure.
7. Hypotension, cardiogenic shock, hemodynamic instability
11.7%(7/60)

5.8%(7/120)29.0% (5,475/18,893)

27.2% (330/1,212)

Male

71.0% (13,418/18,893)

72.8% (882/1,212)

0.2% (2/1,170)

0.2% (39/18,243)

0.0% (0/1,170)

Hispanic Origin

5.9% (1,103/18,734)

5.6% (67/1,200)

Prior Percutaneous Coronary Intervention(PCI)

52.6% (9,933/18,893)

38.9% (471/1,212)

Prior Myocardial Infarction

34.7% (6,558/18,893)

20.6% (250/1,212)

MI within 30 Days

3.8% (721/18,893)

0.0% (0/1,212)

Prior Coronary Artery Bypass Graft

20.5% (3,880/18,893)

16.6% (201/1,212)

Diabetes Mellitus

51.8% (9,784/18,893)

44.3% (537/1,212)

Currently on Dialysis

7.5% (1,412/18,893)

0.0% (0/1,212)

Cerebrovascular Disease

21.7% (4,109/18,893)

17.3% (210/1,212)

Heart Failure

42.1% (7,960/18,893)

24.3% (295/1,212)

PCI Indication: STEMI

3.2% (611/18,881)

0.0% (0/1,212)

PCI Indication: NSTEMI-ACS

32.8% (6,200/18,881)

0.0% (0/1,212)

PCI Status: Emergency or Salvage

4.3% (815/18,889)

0.0% (0/1,212)

Cath Lab Visit Indication: Acute Coronary
Syndrome (ACS)

38.1% (7195/18,893)

0.0% (0/1,212)

Other Indication of Cardiac Arrest or
Instability

1.6% (301/18,893)

0.0% (0/1,212)

Death at Discharge

Coronary Artery Perforation
Coronary Artery Dissection (C andabove)IVL Auxiliary Forms Completed
Safety Endpoint: IVL-Related Ventricular
Arrhythmia
Sustained Ventricular Arrhythmia (during IVL
device utilization)

87.4% (15,953/18,243)

90.7% (1,061/1,170)

7.5% (1,376/18,243)

5.9% (69/1,170)

Asian

2.0% (373/18,243)

1.3% (15/1,170)

7.7% (1,458/18,893)

2.9% (35/1,212)

0.7% (129/18,893)

0.6% (7/1,212)

0.9% (169/18,893)

0.4% (5/1,212)

Cardiac Arrest

11.1% (2,077/18,776)

12.6% (153/1,212)

0.2% (5/2,077)

0.0% (0/153)

0.1% (3/2,077)

0.0% (0/153)

1.2% (24/2,077)

1.3% (2/153)

0.0% (1/2,077)

0.0% (0/153)

6.9% (143/2,077)

7.8% (12/153)

32.9% (47/143)

50.0% (6/12)

67.1% (96/143)

50.0% (6/12)

0.0% (0/143)

0.0% (0/12)

Safety Endpoint: IVL Balloon Loss of
Pressure and Related Serious Dissections
Balloon Loss of Pressure/Rupture
Serious Coronary Dissection following
Balloon Loss of Pressure/Rupture
Safety Endpoint: Safety of IVL in Patientswith PPM/ICD
Total Patients with Cardiac Implantable
Electronic Device (CIED) (PPM or ICD)
Permanent Pacemaker (PPM)Black/African American

0.2% (3/1,212)

Table 15. Safety Endpoint: IVL-Specific Data Points (from IVL Auxiliary Data Collection
Form)
CathPCI Cohort
PAS Cohort
Measure% (n/N)% (n/N)Race, % (n/N)
White

2.2% (423/18,893)

A summary of IVL-specific data points for the CathPCI and PAS Cohorts is shown in Table
15. There were no instances of adverse device interaction (inhibition of pacing,
inappropriate shock, required device reprogramming) reported in PPM/ICD patients.

GenderLBL 63927 Rev F, Instructions for Use (May 2023)

0.6% (101/18,243)

Native Hawaiian/Pacific Islander

Procedure-Related Adverse Events(AEs)
Any Procedure-Related AE

Table 13: Patient Baseline Characteristics of CathPCI Cohort and PAS Cohort
CathPCI Cohort
PAS Cohort
Measure
(N=18,893)(N=1,212)

FemaleAmerican Indian/Alaskan Native

All-Cause Death

Patients were enrolled in the CathPCI Registry who were confirmed to have a lesion treated with a
Shockwave C2 Coronary IVL Catheter (hereafter referred to as the “CathPCI Cohort”). Of theprocedures in the CathPCI Cohort, 1,212 (6.4%) met the following eligibility criteria: severely
calcified, stenotic de novo coronary artery lesions presenting with stable, unstable, or silent ischemia
that are suitable for percutaneous coronary intervention (PCI) and had clinical characteristics similar
to the Disrupt CAD III IDE study. This group is referred to as the “PAS Cohort” and is considered theenrolled population. Demographics for the PAS Cohort and overall CathPCI Cohort are summarizedin Table 13.

73.4 ± 9.0

PAS Cohort(N=1,212)

Table 14. Summary of Safety Data for the CathPCI Cohort and PAS Cohort
CathPCI Cohort
PAS Cohort
Safety Endpoint% (n/N)% (n/N)The safety endpoints for the Disrupt CAD III PAS are based on site-reported data and include allcause death, procedure-related adverse events, and IVL-specific data points. The IVL-specific data
points were IVL-related ventricular arrhythmia, IVL balloon loss of pressure and related serious
dissections, and safety of IVL in patients with PPM/ICD.

72.8 ± 9.8

CathPCI Cohort(N=18,893)

The Primary Safety results for the PAS and CathPCI Cohort are summarized in Table 14.

Post-Approval Study Summary
Shockwave Medical conducted a PMA Post Approval Study (PAS) to assess the utilization,
safety, and effectiveness of the Shockwave Coronary IVL System in a “real-world” setting.
The Disrupt CAD III PAS was a prospective, multicenter, observational, single-arm postapproval study using data collected from the National Cardiovascular Data Registry(NCDR®) CathPCI Registry®.

Age (yrs), Mean ± StdDev

MeasureImplantable Cardioverter Defibrillator(ICD)
Inappropriate Inhibition of Pacing during IVL
Device Utilization (PPM or ICD)
EN

Page 5 of 8

Measure
Device Reprogramming Required During or
After PCI Procedure (PPM or ICD)
Inappropriate ICD Shocks Delivered during
IVL Device Utilization (for those with ICD)

CathPCI Cohort% (n/N)PAS Cohort% (n/N)

0.0% (0/143)

0.0% (0/12)

0.0% (0/47)

0.0% (0/6)

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.
Required Devices for the Coronary IVL Procedure
The IVL Catheter is to be used exclusively with the IVL Generator, IVL Connector Cableand 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.

The data collected from the CathPCI Registry provide important information on clinicaloutcomes in a ‘’real-world’’ population; more than 1700 institutions currently participate in the
CathPCI Registry, representing over 95% of US centers performing PCI procedures. All datain the registry are site-reported; there is no independent adjudication of adverse events orcore lab assessment of angiographic characteristics. The registry data are comprised
predominantly of in-hospital outcomes.

Devices Required But Not Supplied By Shockwave Medical, Inc.
• 6F guide catheter and extension(s)• 0.014” (0.36 mm) Guide Wire (190 cm – 300 cm Length)• 5”x96” (13x244 cm) minimum Sterile Sleeve• Indeflator

The Shockwave IVL System with Shockwave C2 Coronary IVL Catheter continues to demonstratesafety with a low incidence of procedure-related adverse events including all-cause death,
supporting the absence of unreasonable risk of illness or injury associated with the use of the device
for its intended uses and conditions of use. These results confirm the overall safety profile of the
Shockwave Medical Coronary IVL System for the treatment of subjects with highly calcified lesions
in coronary arteries prior to stent placement.

Folded Balloon Diameters:• 0.044” max. for 2.5 mm• 0.045” max. for 3.0 mm and 3.5 mm• 0.047” max. for 4.0 mm
Shockwave C2 Coronary IVL Catheter Balloon Compliance Chart

Supplemental Clinical Information
The overall CathPCI Cohort consisted of both the PAS Cohort and patients who were indicated for
PCI but did not have the same characteristics as the Disrupt CAD III IDE study. Demographics forthe overall CathPCI and PAS Cohorts were similar; however, the CathPCI Cohort had a higher
prevalence of cardiovascular risk factors including prior PCI, prior MI, prior CABG, diabetes, dialysis,
cerebrovascular disease and heart failure. The CathPCI Cohort also included patients with a highdegree of procedural urgency or cardiovascular instability which are correlated with poor outcomes
including: MI within 30 days; PCI indication of STEMI or NSTEMI; PCI status of emergency orsalvage; patients in cardiogenic shock or with acute heart failure symptoms; those presenting withacute coronary syndrome (ACS); and those with another indication of cardiac arrest or instability.
These factors were exclusionary for the PAS Cohort.

Pressure
ATM -KPa
4 *– 405
5 -507
6** – 608
7 – 709
8 -811
9 – 912
10***-1013

Observed
In-Hospital
Mortality
2.24%
0.25%
3.55%

Predicted
In-Hospital
Mortality1
2.24%
0.31%
3.79%

RR (95% CI)2

Treatment Frequency
Maximum Number of Continuous Pulses (1 cycle)
Minimum Pause Time
Maximum Total Pulses Per Catheter

4.0x12 mm
Ø (mm)*

1 Pulse per 1 Second
10 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 pressed again to resume therapy. For more information, refer to the IVL
Generator and IVL Connector Cable Operator’s Manual.

PvalueCathPCI Cohort
18,8931.00 (0.91 – 1.10)
NS
PAS Cohort
1,212
0.79 (0.15 - 1.93)
NS
NSTE-ACS
6,200
0.94 (0.82 - 1.07)
NS
NSTE-ACS
without
Cardiogenic
5,886
2.34%
2.40%
0.98 (0.82 - 1.15)
NS
Shock orCardiac Arrest
STEMI
611
11.29%
11.63%
0.97 (0.76 - 1.21)
NS
STEMI without
Cardiogenic
490
4.90%
6.20%
0.79 (0.51 - 1.14)
NS
Shock orCardiac Arrest
NS = non-significant
1 Castro -Dominguez YS, et al. Predicting In-Hospital Mortality in Patients Undergoing PercutaneousCoronary Intervention. J Am Coll Cardiol. 2021 Jul 20;78(3):216-229. doi:
10.1016/j.jacc.2021.04.067. Epub 2021 May 3. PMID: 33957239.
2 Vandenbroucke JP. A Shortcut Method For Calculating The 95 Percent Confidence Interval of theStandardized Mortality Ratio. (Letter). Am J Epidemiol. 1982 Feb; 115(2):303-4. doi:
10.1093/oxfordjournals.aje.a113306.

If the maximum pulse count is reached as displayed on the generator, the catheter shallnot 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.
Procedural Steps
Caution: 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.
Preparation1.
Prepare the insertion site using standard sterile technique.
2.
Achieve preferred vascular access and place a guidewire and guide catheter.
3.
Select a lithotripsy balloon catheter size that is 1:1 based on balloon compliancechart (above) and reference vessel diameter. The largest diameter balloon should
be used if 1:1 sizing is not available (such as using a 4.0 mm IVL Catheter in a
vessel with a reference diameter of 4.5 mm).
4.
Remove the IVL Catheter from the package.
5.
Prepare the lithotripsy balloon using standard technique. Fill a 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.

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 notreuse 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 thedevice if there is any sign of breach of the sterile barrier, as this could indicate loss ofsterility that could result in patient injury. Do not use the device if there is damage to the
LBL 63927 Rev F, Instructions for Use (May 2023)

3.5x12 mm
Ø (mm)*

Shockwave C2 Coronary IVL System Sequence Chart
The following pulsing sequence must be followed during treatment. Do not utilize apulsing sequence other than those outlined in the IVL System Sequence Chart below.
Insertion of any size Shockwave C2 IVL Catheter will automatically program the IVL
Generator with the following treatment sequence:

Table 16. Observed vs Predicted In-Hospital Mortality (based on CathPCI Bedside Risk
Score)
N

3.0x12 mm
Ø (mm)*

2.4
2.9
3.4
3.9
2.4
2.9
3.5
3.9
2.5
3.0
3.5
4.0
2.5
3.0
3.6
4.0
2.5
3.0
3.6
4.1
2.5
3.0
3.6
4.1
2.5
3.1
3.7
4.1
Note: *Ø (mm) is ± 0.10 mm; 4 atm is IVL treatment balloon pressure** 6 atm is nominal balloon pressure and post- treatment pressure*** 10 atm is RBP (Rated Burst Pressure) of the balloon

An additional analysis confirmed the observed in-hospital mortality rate in both cohorts(CathPCI Cohort and PAS Cohort) is consistent with the predicted mortality rate generated
from an established CathPCI model (Table 16). Using this model and associated bedside risk
score, the observed in-hospital mortality rate for the PAS Cohort was 0.25% vs. 0.31%
predicted (p=Non-Significant [NS]); the observed rate for the CathPCI Cohort was 2.24% vs2.24% predicted (p=NS). The overall CathPCI Cohort was further stratified to show that theobserved mortality rates for the highest risk patients with ACS are also consistent with thepredicted rates, including those with a PCI indication of non-ST-elevation MI (NSTE-ACS)
and ST-elevation MI (STEMI). As previously noted, patients with these characteristics were
excluded from the PAS Cohort.

Cohort2.5x12 mm
Ø (mm)*

EN

Page 6 of 8

7.
8.
9.
10.
11.
12.

Remove the protective sheath and shipping mandrel from the IVL Catheter.
Warning: Do not use the device if the protective sheath or shipping mandrel are
difficult to remove or cannot be removed.
Flush the guidewire port with saline.
Wet the lithotripsy balloon and distal shaft with sterile saline in order to activate thehydrophilic coating. Do not wet the balloon with Isopropyl alcohol (IPA) as this candamage the hydrophilic coating integrity.
Insert the IVL Connector Cable into the sterile sleeve or probe cover.
Remove the cap from the proximal end and attach the IVL Catheter Connector (seeFig 1) to the IVL Connector Cable.
Attach the other end of the same IVL Connector Cable to the IVL Generator.

Shockwave Medical, Inc.
5403 Betsy Ross Drive
Santa Clara, CA 95054 USA
www.shockwavemedical.com
SymbolDefinition
Do not re-use

Caution: Care must be taken to avoid applying lithotripsy therapy, i.e. pressing thetherapy button of the IVL Connector Cable while lithotripsy balloon is dry and/or uninflated, as this may damage the balloon.

Use by date
Sterilized using irradiation

Delivering the Shockwave C2 IVL Catheter to the Treatment Site
1.
Position guiding catheter proximal to the treatment site.
2.
If it is anticipated that the IVL Catheter may not cross the lesion, pre-dilatation orother vessel preparation may be performed using standard technique based on
physician discretion.
3.
Load the IVL Catheter over the exchange length (190 – 300 cm) 0.014” guidewire
and through a guiding catheter and advance IVL Catheter to the treatment site.
4.
Position the IVL balloon at the treatment site using the marker bands to aid in
positioning.

Caution
Manufacturer
Do not use if package is damaged

Treating the Site with Intravascular Lithotripsy
1.
Once the IVL Catheter is in place, record position using fluoroscopy.
2.
If position is incorrect, adjust the lithotripsy balloon to the correct position.
3.
Inflate lithotripsy balloon, not exceeding 4.0 atm to ensure the balloon is inflated
and 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 canincrease the risk that the balloon loses pressure.
4.
Deliver IVL treatment sequence for the pre-programed time of 10 seconds todeliver 10 pulses by pressing the therapy button on the IVL Connector Cable.
NOTE: The IVL Generator is programmed to force a minimum pause time of 10
seconds following every 10 pulses delivered.
5.
Inflate lithotripsy balloon to reference size per balloon compliance chart and record
lesion response on fluoroscopy.
6.
Deflate lithotripsy balloon and wait at least 10 seconds to re-establish blood flow.
The balloon deflation time is up to 15 seconds, depending upon balloon volume.
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 lithotripsy balloon length, therecommended balloon overlap is at least 2 mm to prevent geographic miss.
However, care must be taken not to exceed 80 pulses maximum in the same
treatment segment and therefore 160 pulses in an overlap 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 IVL Catheter with sterilegauze.
12. Inspect all components to ensure that the IVL Catheter is intact. If a device
malfunction occurs or any defects are noted on the inspection, flush the guidewire
lumen and clean the outer surface of the catheter with saline, store the IVL
Catheter in a sealed plastic bag, and contact Shockwave Medical, Inc. atcomplaints@shockwavemedical.com for further instructions.

Keep dry
Keep away from heat
Batch code
Catalogue number
Rapid Exchange Catheter
Do not resterilize
Non-pyrogenic
Consult instructions for use
Contains 1 unit (Contents: 1)
Recommended Guidewire
Recommended Guide Catheter
Crossing Profile

Caution: IVL Catheter once pulled out of the body should not be reinserted for additional
inflation or lithotripsy treatments. Balloon can be damaged in the process.

Balloon Diameter

Patient Information
Physicians should instruct patients to seek medical attention immediately for signs andsymptoms of recurrent ischemic heart disease. There are no known limitations to normal
daily activities. Patients should be instructed to comply with the medication regimen asprescribed by their physician.

Balloon Working Length
Catheter Working Length(Usable Length, UL)

Return of Devices

PAT
IVL

If any portion of the Shockwave IVL System fails prior to or during a procedure,
discontinue use and contact your local representative and/or email
complaints@shockwavemedical.com.
Patents: www.shockwavemedical.com/patents

Patents. Refer towww.shockwavemedical.com/patents
Intravascular Lithotripsy
Caution: Federal (USA) Law restricts
this device to sale by or on the orderof a physician.

LBL 63927 Rev F, Instructions for Use (May 2023)

EN

Page 7 of 8

Symbol

Definition
Indicates a carrier that contains
Unique Device Identifier information.

LBL 63927 Rev F, Instructions for Use (May 2023)

EN

Page 8 of 8

PN 62185 Rev F