Coronary
Calcium? C2 it.
Say ‘Hello’ To Your New Go 2 Calcium Modification Tool
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
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
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%
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
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
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
mm
6
mm
mm
2
mm
mm
Energy Profile
Acoustic pressure declines ~3mm away from the emitter
Smooth energy profile over center 12mm of ballon
12
mm
mm
2
mm
mm
Optimized Overlap
2mm overlap optimizes energy profile
Shockwave C2 Resources
Coronary Tech Sheet
Download
Instructions for Use (IFU)
Download
Coronary Step-by-Step Setup Guide
Download
IVL Generator Manual
Download
Using the Sterile Sleeve for Shockwave IVL
Watch Video
Ready to Make Waves with Shockwave IVL?
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.
Get Crackin with Shockwave IVL Today
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.