Shockwave C2 Aero Fly

Our latest upgrade in Coronary Shockwave Intravascular Lithotripsy (IVL) is ready for takeoff with 2X-faster pulsing that boosts treatment efficiency and elevates patient care.

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Hero image of the Shockwave generator and Shockwave C2 Aero Intravascular Lithotripsy catheter
Hero image of the Shockwave generator and Shockwave C2 Aero Intravascular Lithotripsy catheter

Delivers elevated efficiency

Shockwave C2 Aero Fly combines the impressive deliverability and crossability of Shockwave C2 Aero with increased efficiency you’ll appreciate clinically and operationally.

  • 2X-faster pulsing

    Improve procedural flow and support cath lab efficiency with upgraded pulsing speed.

  • Best-in-class deliverability

    Reach difficult anatomy using fewer exchanges with optimized profile and trackability.*

  • Patient-focused innovation

    Minimize ischemic times1 with reduced periods of prolonged balloon inflation and shorter treatment duration.

*Based on simulated use bench testing. Based on feedback from physicians who participated in the Limited Market Release Survey

 

Shockwave C2 Aero Fly | Johnson & Johnson Circulatory Restoration

Taking Coronary IVL further, faster

Discover how Shockwave C2 Aero Fly enhances coronary IVL with faster pulsing and shorter treatment times to support procedural efficiency.

Taking Coronary Shockwave IVL further faster

You asked for quicker Coronary IVL — Shockwave C2 Aero Fly delivers. Reduced pause time between cycles paired with 2 Hz pulsing capabilities (two pulses per second) increases procedural efficiency and reduces overall ischemic time for the patient during the procedure.1

Shockwave C2 Aero Fly specifications 

Catalog number Diameter Length Pulses Guidewire Guide cath Length Tip profile Max crossing profile
C2AFIVL2512 2.5 mm 12 mm 120 0.014 in 6 Fr 138 cm 0.022 in 0.044 in
C2AFIVL3012 3.0 mm 12 mm 120 0.014 in 6 Fr 138 cm 0.022 in 0.045 in
C2AFIVL3512 3.5 mm 12 mm 120 0.014 in 6 Fr 138 cm 0.022 in 0.045 in
C2AFIVL4012 4.0 mm 12 mm 120 0.014 in 6 Fr 138 cm 0.022 in 0.047 in

 

DISRUPT CAD DUO: demonstrated safety with elevated efficiency

Shockwave C2 Aero Fly’s 2Hz pulsing has the same safety profile as 1Hz rate in the coronaries.3,4

Accordion Section

The Disrupt CAD Duo IDE study is a prospective, multicenter, single-arm study designed to evaluate the safety and effectiveness of the novel 2-Hz IVL platform. The study enrolled 145 patients with single, de novo severely calcified lesions. Both primary study endpoints were evaluated for noninferiority compared with a propensity score–matched cohort from the Disrupt CAD III.

Primary Endpoints Disrupt CAD Duo
(N=144)		 Disrupt CAD III
(N=288)		 Difference
[95% Lower CI]		 P-value
(non-inferiority)
Safety: Freedom from 30-day MACE 98.6% (142/144) 96.2% (277/288) 2.43% [-1.90%] 0.00025
Cardiac death 0.0% (0/144) 0.7% (2/288)
Periprocedural MI
(SCAl definition)		 0.7% (1/144) 2.8% (8/288)
Spontaneous MI beyond discharge (4th Universal) 0.0% (0/144) 1.4% (4/288)
TVR 0.7% (1/144) 1.7% (5/288)
Effectiveness: Procedural Success 97.9% (140/143) 96.5% (278/288) 1.37% [-2.92%] 0.00075
Stent delivery 98.6% (141/143) 99.3% (286/288)
Residual stenosis ≤30% 98.6% (141/143) 99.0% (285/288)
Without in-hospital MACE 99.3% (142/143) 96.9% (279/288)

 

The Disrupt CAD Duo study device was the Shockwave C2+ 2Hz Coronary IVL Catheter with Shockwave Intravascular Lithotripsy (IVL) System.

Parameter Post-IVL
(N=115)		 Final
(N=144)
Any serious angiographic complication6 0.9% (1/115) 0.0% (0/144)
Major dissection (D-F)7 0.9% (1/115) 0.0% (0/144)
Perforation (any)8 0.0% (0/115) 0.0% (0/144)
Abrupt closure 0.0% (0/115) 0.0% (0/144)
Slow flow 0.0% (0/115) 0.0% (0/144)
No reflow 0.0% (0/115) 0.0% (0/144)

 

Parameter Disrupt CAD DUO
(N=144)		 Disrupt CAD III
(N=290)
Capture during IVL therapy 66.0% (95/144) 43.7% (124/284)*
Single Beat 22.1% (21/95) 13.9% (24/122)
2 or More Consecutive Beats 77.9% (74/95) 86.1% (105/122)
Clinically significant systolic BP reduction9 0.7% (1/144)10 0.1% (2/176)11
Sustained ventricular arrhythmia (>30 seconds) 0.0% (0/144) 0.4% (1/285)12

 

*p<0.0001

Shockwave C2 Aero Fly resources

1: A shorter inflation time exposes the patient to less ischemic time compared to prior Shockwave devices.
2: Treatment time includes pulsing time and pause time. Pause time may vary by patient need.
3: Davies RE, Shlofmitz RA, Kim M, Schmidt TR, Roberts J, Oseni AO, et al. Safety and Effectiveness of a Novel 2-Hz Coronary Intravascular Lithotripsy System: The Disrupt CAD Duo IDE Study. JACC Cardiovasc Interv. 2026 Jul 27;19(14):1963–5. doi:10.1016/j.jcin.2026.02.018 PMID: 41804720.
4: Price M. Safety and Effectiveness of a Novel 2Hz Coronary Intravascular Lithotripsy System… CRT. Washington D.C., US; 2026.
5: Both primary endpoints were non-inferior to the propensity score-matched comparator cohort.
6: Serious angiographic complications include severe dissection (Type D to F), perforation, abrupt closure, persistent slow flow and no flow.
7: Dissections were categorized per the NHLBI classification system.
8: Perforations were categorized per the Ellis classification for coronary perforation.
9: Clinical significance determined by investigator.
10: Patient experienced BP drop prior to IVL.
11: Includes 2 patients with BP drop not during IVL portion of procedure.
12: Arrhythmia detected in patient without capture.