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11. Do not use or attempt to straighten a catheter if the
shaft has become bent or kinked. 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
be continued for a period of time to be determined by
the physician after the procedure.
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 it with 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.
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
• Death
• 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 surgical
intervention
• Hematoma at the vascular access site(s)
• Hemorrhage
• Hypertension/ Hypotension
• Infection/sepsis/fever
• Myocardial Infarction
• Myocardial Ischemia or unstable angina
• Pain
• Peripheral Ischemia
LBL 64191 Rev D, Instructions for Use ( June 2023)
• 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
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.
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
Clinical Study Summary
The prospective, single arm, multi-center IDE study (Disrupt
CAD III) of the Shockwave Intravascular Lithotripsy (IVL)
System with the Shockwave C
Coronary IVL Catheter was
2
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 revasculariza-
tion (TVR). All MACE were adjudicated by an independent
Clinical Events Committee (CEC). The primary safety
endpoint was planned to be 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 Success defined 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 one-sided alpha level of 0.05.
EN
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.
Table 1. Patient Baseline Characteristics (Pivotal
Analysis Set)
Parameter
Age (years), Mean ± StdDev
Gender, % (n/N)
Male
Female
Race, % (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 Intervention
, % (n/N)
1
Prior CABG, % (n/N)
Smoking/tobacco use (current), % (n/N)
Renal insufficiency
, % (n/N)
2
Pacemaker, % (n/N)
ICD/CRT-D, % (n/N)
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.
A summary of pre-procedural angiography as determined
by the Core Lab for pivotal subjects is provided in Table 2.
Table 2. Pre-Procedural Angiography (Core Lab)
(Pivotal Analysis Set)
Parameter
Target Lesion Vessel, % (n/N)
LAD
RCA
Circumflex
Left Main
Bypass graft
RVD
(mm), Mean ± StdDev (N)
1
MLD (mm), Mean ± StdDev (N)
% Diameter Stenosis, Mean ± StdDev (N)
Lesion length (mm), Mean ± StdDev (N)
Calcification, % (n/N), severe
Pivotal
(N=384)
71.2 ± 8.6 (384)
76.6% (294/384)
23.4% (90/384)
82.8% (318/384)
3.1% (12/384)
3.4% (13/384)
0.5% (2/384)
0.3% (1/384)
9.9% (38/384)
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)
12.0% (46/384)
4.7% (18/384)
1.6% (6/384)
Pivotal
(N=384)
56.5% (217/384)
29.2% (112/384)
12.8% (49/384)
1.6% (6/384)
0.0% (0/384)
3.03 ± 0.47 (381)
1.06 ± 0.36 (381)
65.1 ± 10.8 (381)
26.09 ± 11.68 (381)
100.0% (384/384)
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