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Coronary
Calcium? C2 it.

Say ‘Hello’ To Your New Go 2 Calcium Modification Tool

Shockwave C2 Case Reports
c2_logo
MINIMIZE TRAUMA - Minimize trauma to soft tissue by safely selecting and fracturing intimal and medial calcium
 
OPTIMIZE OUTCOMES - Optimize stent delivery, expansion and apposition while reducing complications and cost escalation
 
SIMPLIFY PROCEDURES - Simple and intuitive system that makes complex calcified coronary procedures more predictable
 

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

100% of pts had moderate/severe calcium

Outcomes
Results
30-Day Freedom from MACE2
Death N=0; QWMI N=0; NQWMI³ N=3; TVR N=0
95%
Dissections4 (D/E/F)
3.3%5/0.0%/0.0%
Perforation4
0%
Abrupt Closure4
0%
Slow flow4
0%
No reflow4
0%
a
100%
1CAD I assessed the safety and performance of IVL in 60 subjects across 7 sites with moderate/severely calcified, de novo coronary lesions RVD 2.5–4.0 mm, stenosis ≥50%, lesion length ≤ 32 mm
2CEC adjudicated, 3NQMI defined as 3 upper limit, 4Core Lab adjudicated, 53.3% resolved with planned stent implantation

DISRUPT CAD I OCT Sub-analysis

2.1mm2
Acute Area Gain Post-IVL
5.9mm2
Mean Stent Area
A. Calcified, stenotic lesion
Treat with IVL
B. Large luminal gain with multiple calcium fractures (white arrows)
Deploy Stent
C. Stent expansion showing compliance and increased fracture size with additional increase in acute gain
A. Calcified, stenotic lesion
Treat with IVL
B. Large luminal gain with multiple calcium fractures (white arrows)
Deploy Stent
C. Stent expansion showing compliance and increased fracture size with additional increase in acute gain

Frames are co-registered to ensure cross-sections are in the same location

IVL CLINICAL EVIDENCE

Shockwave C2 Specifications

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, +/-0.002
PULSES (max) 80
*0.043" max. for 2.5mm, 0.044" max for 3.0-3.5mm and 0.046" max. for 4.0mm

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

Energy Profile

Acoustic pressure declines ~3mm away from the emitter

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

Optimized Overlap

2mm overlap optimizes energy profile

Shockwave C2 Resources

Coronary Tech Sheet
Download
Indication for Use (IFU)
Download
Coronary Step-by-Step Setup Guide
Download
IVL Generator Manual
Download

Ready to Make Waves with Shockwave IVL?

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We're excited about IVL's potential in aortic stenosis, too!

But, right now we're in the early phases of the R&D program. In the meantime, don't miss the IVL application that heart teams are embracing already — maintaining transfemoral TAVR access through heavily calcified iliacs by using IVL.

MORE ON TAVR ENABLING TRANSFEMORAL ACCESS
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Get Crackin with Shockwave IVL Today

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Wow - you're ready to start cracking, aren't you?

Too bad our coronary technology is not yet approved in the United States. Good news is that we have initiated our U.S. FDA IDE study. Learn more about the Disrupt CAD III study on our clinical research portion of the website.

About Disrupt CAD III
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