ON THE +PLUS SIDE.
+ PULSES

Additional pulses needed for eccentric and nodular calcium
along the treatment lesion+ EFFICIENCY

Single-cather modification of longer calcified lesions+ PRACTICALITY

A sterile sleeve for the connector cable is now packaged witheach catheter

Shockwave C2+: More Energy Where it Counts
Shockwave C2+
keeps things safe,
simple and efficient
within longer
calcified lesions
Case Courtesy of Dr. Nikos WernerKrankenhaus der Barmherzigen BrüderTrier, GermanyBaseline

Guide extension-facilitateddelivery of IVL

120 pulses delivered distally to proximally with single 3.0mm
Shockwave C2+ catheter treating ~100mm of the lesion

Shockwave C2+
demonstrates
efficacy andefficiency withinbifurcated,
eccentric lesions

Final result after DES

60 Pulses

Case Courtesy of Dr. Peter O’Kane
Royal Bournemouth Hospital
Bournemouth, UK
60 Pulses

Baseline

Single 3.5mm Shockwave C2+ catheter delivers 120
pulses for vessel preparation within LCX and LAD

Final result after stenting via
Culotte technique with 3.5x15mm
Synergy and 3.5x24mm MegatronIVL GENERATOR AND CONNECTOR CABLE SPECS
Power90-240VAC; 50-60Hz; Single Phase, 15A service

Size11" (28.0 cm) high x 6" (15.2 cm) wide x 11.5" (29.2 cm) deep

Weight

6 pounds (2.7 kg)

Output

Proprietary pulse delivery system. Output voltage 3000 volts peak, pulse frequency 1Hz

Mobility

Product is designed to be mounted to an IV pole

Length5 ft (1.53m)

Compatibility

Proprietary male key distally designed to connect only to catheter

Operation

Lithotripsy pulsing is activated by pushing a button on the Connector Cable

UseRe-usable

IVL Generator
CATALOG NUMBER:
IVLGCCDX(FOR U.S. CUSTOMERS)IVLGCCD(FOR NON-U.S. CUSTOMERS)IVL Connector Cable
CATALOG NUMBER:IVLCC

SHOCKWAVE C2+ CATHETER SPECS
Catalog
NumberPulses(Max*)

SterileSleeveDiameter(mm)

Length(mm)

Guidewire
Compat.
(in)

Guide
CatheterCompat.

Working
Length(cm)

Crossing
ProfileRange(in)

C2KIVL2512

120

Includedin Kit2.5120.014”

5F

138.044 max

C2KIVL3012

120

Includedin Kit3.0

120.014”5F

138.045 max

C2KIVL3512

120

Includedin Kit3.5120.014”

5F

138.045 max

C2KIVL4012

120

Includedin Kit

4.0120.014”

5F138.047 max

Barcode*C2KIVL2512**C2KIVL3012**C2KIVL3512**C2KIVL4012*

GTIN

00195451000423

00195451000430

00195451000447

00195451000454* Do not exceed 80 pulses in a 12 mm segment

Visit ShockwaveIVL.com for more information.
Coronary Safety Information
In the United States: Rx onlyIndications 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.
Warnings—Use 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 indicatescalcium 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, theasynchronous 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 betaken 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 fistulaBleeding 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 nonemergency coronary artery bypass surgery-Emergency or nonemergency 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 InfarctionMyocardial 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 ofcoronary 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 surgicalintervention-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
Please contact your local Shockwave representative for specific country availability and refer to the Shockwave C2+ instructions for use containing important safety information.						© 2023 Shockwave Medical Inc., All rights reserved. SPL-66116 Rev C