Shockwave IVL for Coronary Artery Disease

A proven crack record: Shockwave coronary Intravascular Lithotripsy (IVL) is a paradigm-shifting device allowing interventional cardiologists to bridge the gap between predictably safe and consistently effective coronary calcium modification in patients suffering from calcified coronary artery disease.

Shockwave IVL Overview and MOA Shockwave C2+ Shockwave Coronary IVL Reimbursement
Shockwave C2+ device showing the generator, the connector cable, and the IVL catheter.
Shockwave C2+ device showing the generator, the connector cable, and the IVL catheter.

The Importance of Treating Coronary Artery Disease (CAD)

Coronary artery disease is a global problem that affects approximately 315 million people every year.1 In some CAD, calcified plaque limits blood flow in the larger arteries of the heart, which increases the risk of adverse side effects.  

  • Over 30% of coronary lesions have severe to moderate coronary calcification2  
  • Coronary artery calcification increases procedural complications,3, 4, 5, 6, 7 impedes stent delivery8 and prevents stent expansion2, 9 

Shockwave coronary IVL disrupts coronary calcium through its unique mechanism of action (MOA), modifying calcium in a safe, effective and intuitive manner prior to stent deployment. 

Shockwave Medical is the first-ever manufacturer of coronary IVL products — the most studied and frequently used calcium modification strategy10 in our field. Our commitment to clinical research, continuous innovation and meaningful physician collaboration has set a new standard of care that is shaping the future of treating calcified coronary artery disease. 

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 305
    Peer-reviewed journal publications
  • 7,949
    Published patient outcomes
  • 600,000+
    Patients treated

Shockwave C2+: Our Sound Solution for Coronary Artery Disease

Shockwave C2+ IVL Animation (Global)

See How Shockwave C2+ Works

The Shockwave IVL system creates pulsatile sonic pressure waves to modify coronary calcium in a low-risk manner that’s effective and intuitive.

See How Shockwave IVL Performs Across Calcium Morphologies

The Leading Solution for Treating Calcified CAD

Use of Calcium Modification During Percutaneous Coronary Intervention After Introduction of Coronary Intravascular Lithotripsy10 

Coronary IVL is now the most frequently used coronary calcium modification strategy for treatment of calcified coronary lesions. An analysis of the National Cardiovascular Data Registry CathPCI Registry demonstrates a steady, significant increase in usage since the device’s U.S. commercial launch in 2021, showcasing a previous unmet need for a safe, effective and intuitive calcified lesion preparation strategy. 

Line chart showing the usage trends of different treatment methods over time, from Q3 2020 to Q4 2022.

 

SCAI Expert Consensus Statement on the Management of Calcified Coronary Lesions11 

Coronary IVL has been included as a device consideration in a SCAI treatment algorithm for concentric, eccentric, focal and nodular coronary calcification. In a first-of-its kind expert consensus statement, the Society for Cardiovascular Angiography and Interventions (SCAI) reinforces coronary IVL’s consistent, clinically-demonstrated efficacy regardless of calcium morphology.12, 13 In addition, the experts conclude that coronary IVL can be used synergistically with atherectomy devices, especially in balloon uncrossable lesions or longer lesions with heterogeneous calcium and vessel size. 

Flowchart detailing an algorithm for treating calcified coronary lesions based on angiographic evidence and intravascular imaging criteria.

Backed By Clinical Evidence

Multiple clinical trials demonstrate coronary IVL’s safety, efficacy and intuitiveness within global patient populations.

DISRUPT CAD I DISRUPT CAD II DISRUPT CAD III DISRUPT CAD IV DISRUPT CAD Pooled DISRUPT CAD Pooled OCT
Study design Single arm, safety & feasibility Single arm, post-market, safety & effectiveness Single arm, IDE, safety & effectiveness Single arm, pre-market, safety & effectiveness Individual patient data (IPD) pooled analysis of the DISRUPT CAD I-IV studies Individual patient data (IPD) pooled analysis of the DISRUPT CAD I-IV OCT sub-studies
Number of patients 60 120 384 64 628 –
Number of patients in OCT sub-study 31 47 100 71 – 262
Number of sites 7 15 47 8 72 72
Regions AU, EU EU U.S., EU Japan AU, EU, U.S., Japan AU, EU, U.S., Japan
Explore All Clinical Evidence
Explore All Clinical Evidence
  • DISRUPT CAD III
    Largest and most rigorous Shockwave study showcasing safety, effectiveness and ease of use of Shockwave coronary IVL. 
    Coronary IVL
  • DISRUPT CAD Pooled
    The largest systematic assessment of Shockwave coronary Intravascular Lithotripsy (IVL) to date based on individual patient data from DISRUPT CAD I–IV.
    Coronary IVL
  • DISRUPT CAD Pooled OCT Subgroup Analysis
    Individual patient data pooled from DISRUPT CAD I-IV to see Shockwave IVL outcomes, fracture analysis and stent expansion predictors.
    Coronary IVL
Meet Calcium Crush

Game On: Calcium Crush

Our on-demand gamification of IVL allows players to virtually experience the Shockwave C2+ coronary IVL catheter in a range of calcium morphologies, all while learning best practices as it relates to pulse management and deliverability of IVL.*

Play Calcium Crush Now

*Calcium Crush is not available in all countries, please contact your local sales representative for details.

1: Stark, B., Johnson, C., & Gregory Andrew Roth. (2024). Global Prevalence of Coronary Artery Disease: An Update from The Global Burden of Disease Study. Journal of the American College of Cardiology, 83(13), 2320-2320.
2: Généreux P, et al. JACC 2014; 63(18);1845-54.
3: Madhavan MV, Tarigopula M, Mintz GS, Maehara A, Stone GW, Généreux P. Coronary artery calcification: pathogenesis and prognostic implications. J Am Coll Cardiol 2014;63:1703.
4: Chambers JW, Feldman RL, Himmelstein SI, et al. Pivotal trial to evaluate the safety and efficacy of the Orbital Atherectomy System In Treating De Novo, Severely Calcified Coronary Lesions (ORBIT II). J Am Coll Cardiol Intv 2014;7:510-8.
5: Genereux P, Lee AC, Kim CY, et al. Orbital atherectomy for treating de novo severely calcified coronary narrowing (1-year results from the pivotal ORBIT II Trial). Am J Cardiol 2015;115: 1685-90.
6: Yamamoto MH, Maehara A, Karimi Galougahi K, et al. Mechanisms of orbital versus rotational atherectomy plaque modification in severely calcified lesions assessed by optical cohérence tomography. J Am Coll Cardiol Intv 2017;10: 2584-6.
7: Kini AS, Vengrenyuk Y, Pena J, et al. Optical coherence tomography assessment of the mechanistic effects of rotational and orbital atherectomy in severely calcified coronary lesions. Catheter Cardiovasc Interv 2015;86:1024-32.
8: Ferrer Gracia MC, et al. Failure in the implantation of drug eluting stents. Frequency and related factors. Med Intensiva. 2007.
9: Mintz, G; I. J Am Coll Cardiol Imaging 2015;8(4): 461-71.
10: Neel Butala et al. “Use of Calcium Modification During Percutaneous Coronary Intervention After Introduction of Coronary Intravascular Lithotripsy” Journal of the Society for Cardiovascular Angiography & Interventions. 2024; DOI: 10.1016/j.jscai.2023.101254.
11: Robert Riley et al. “SCAI expert consensus statement on the management of calcified coronary lesions.” J Soc Cardiovasc Angiogr Interv. 2024.
12: Ziad Ali et al. “Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Calcified Nodules.” JACC Cardiovasc Interv. 2023.
13: Ziad Ali et al. “Impact of Calcium Eccentricity on the Safety and Effectiveness of Coronary Intravascular Lithotripsy: Pooled Analysis From the Disrupt CAD Studies.” Cardiovascular Interv. 2023.