Shockwave C2 Logo
PREDICTABLY SAFE
Establish a new standard of care for safe calcium modification by reducing the risk of perforations and other complications to make procedures more predictable and efficient
 
DISTINCTLY INTUITIVE
Optimally modify calcium from the very first case via a unique mechanism of action in an intuitive platform
 
CONSISTENTLY EFFECTIVE
Achieve excellent lumen gains and stent expansion consistently despite the calcium morphology – whether superficial or deep, concentric or eccentric, and short or long lesions
shockwave 2 emitter@2x

Shockwave C2 In-Depth

Shockwave Device

IVL Generator

  • Portable and rechargeable
  • No external connections
  • Quick & easy setup with no settings

IVL Connector Cable

  • Simple magnetic connections
  • Push-button activated

IVL Catheter

  • Standard PCI technique
  • RX System
  • 0.014" guidewire of your choice
Shockwave Device

Integrated 12mm SC Ballon

  • Facilitates energy transfer
  • IVL=4atm; Nominal=6atm; RBP=10atm

Distal and proximal marker bands

2 Emitters

  • One pulse per second (80 pulses/catheter)

Coronary IVL Clinical Evidence

DISRUPT CAD III

384
Patients at
47 sites
100%
Severe Ca++
48mm
Calcium Length
0.96mm
Average Max Calcium Thickness
98%
IVL Crossing & Therapy Delivery
2.1%
Severe Dissections
Post-IVL
0%
Abrupt Closure
Post-IVL
0%
Perforation
Post-IVL
0%
No Reflow
Post-IVL
99%
Stent Delivery
102%
Stent Expansion
6.5mm2
MSA
11.9%
Residual Stenosis
1.7mm
Acute Gain

Shockwave C2 Specifications

shockwave box
DIAMETER (mm) 2.5, 3.0, 3.5, 4.0
LENGTH (mm) 12
GUIDEWIRE COMPATIBILITY (in) 0.014
GUIDE CATHETER COMPATIBILITY 6F
WORKING LENGTH (cm) 138
CROSSING PROFILE RANGE* (in) 0.044-0.047
PULSES (max) 80

Working Lengths

Balloon working length of 12mm from inner edge of marker bands

6mm between emitters and 4mm/2mm between emitters and marker bands
12mm
4
mm
6
mm
2
mm
Diagram

Energy Profile

Acoustic pressure declines ~3mm away from the emitter

Smooth energy profile over center 12mm of ballon
12
mm
2
mm
Diagram
Diagram

Optimized Overlap

2mm overlap optimizes energy profile

Shockwave C2 Resources

Tech sheet@2x
Coronary Tech Sheet
Download
SPL 64426 Rev B Procedural Training Deck v7 2.12@2x
Coronary Step-By-Step Guide
Download
ifu portal img
Shockwave IFU Portal
Shockwave IFU PORTAL

Important Safety Information

Rx only

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— The Shockwave C2 Coronary IVL System is contraindicated for the following: This device is not intended for stent delivery. This device is not intended for use in carotid or cerebrovascular arteries.

WarningsUse the IVL Generator in accordance with recommended settings as stated in the Operator’s Manual. 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 associated with a numerical 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.  IVL generates mechanical pulses which may cause atrial or ventricular capture in bradycardic patients. In patients with implantable pacemakers and defibrillators, the asynchronous capture may interact with the sensing capabilities. Monitoring of the electrocardiographic rhythm and continuous arterial pressure during IVL treatment is required.  In the event of clinically significant hemodynamic effects, temporarily cease delivery of IVL therapy.

Precautions— Only to be used by physicians trained in angiography and intravascular coronary procedures. Use only the recommended balloon inflation medium. Hydrophilic coating to be wet only with normal saline or water and care must be taken with sharp objects to avoid damage to the hydrophilic coating. Appropriate anticoagulant therapy should be administered by the physician. Precaution should be taken when treating patients with previous stenting within 5mm of target lesion. 

Potential adverse effects consistent with standard based cardiac interventions include– 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-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.

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.

Prior to use, please reference the Instructions for Use for more information on warnings, precautions and adverse events.  www.shockwavemedical.com/IFU

Ready to Make Waves with Shockwave IVL?

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