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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
 
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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 1

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
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A. Calcified, stenotic lesion
chart1
Treat with IVL
B. Large luminal gain with multiple calcium fractures (white arrows)
chart2
Deploy Stent
C. Stent expansion showing compliance and increased fracture size with additional increase in acute gain
chart3

Shockwave C2 Specifications

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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
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

Optimized Overlap

2mm overlap optimizes energy profile

Shockwave C2 Resources

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

Ready to Make Waves with Shockwave IVL?

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