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January 17, 2026

Cardiac Lithotripsy: A Modern Approach to Coronary Artery Calcification

Introduction:

In September 2025, a multi-jurisdictional evidentiary Contractor Advisory Committee (CAC) convened to review the clinical evidence and expert perspectives on coronary intravascular lithotripsy (IVL). The meeting highlighted IVL's growing role in managing heavily calcified coronary lesions, its safety profile, and its potential to improve outcomes compared to traditional calcium modification techniques. This discussion reinforced IVL as an important tool for vessel preparation prior to stent placement in complex PCI cases. Additionally, CAC members contributed valuable insights from real-world practice, providing context for the growing adoption of IVL in the management of coronary artery disease.

Clinical Background:

Calcified coronary lesions remain a major challenge during percutaneous coronary intervention (PCI). Extensive calcification may prevent adequate balloon expansion, hinder stent delivery, and increase the risk of suboptimal stent apposition and restenosis.

Technology Overview:

Intravascular lithotripsy (IVL), also known as cardiac lithotripsy, is a catheter-based technology developed to modify calcified plaque in coronary arteries prior to stent placement. The device delivers pulsatile sonic pressure waves that fracture both intimal and medial calcium, improving vessel compliance and facilitating optimal stent expansion during percutaneous coronary intervention (PCI).

Coding Guidance:

CPT Code: 92972 Percutaneous transluminal coronary lithotripsy (List separately in addition to code for primary procedure)

Regulatory Status:

The Shockwave Intravascular Lithotripsy (IVL) System with C2 Coronary IVL Catheter (Shockwave Medical Inc.) received FDA Premarket Approval (PMA P200039) on February 12, 2021.

FDA Approval and Indications

The Shockwave Coronary Intravascular Lithotripsy (IVL) System received FDA approval for the treatment of de novo, severely calcified coronary artery lesions to enhance vessel preparation prior to stent deployment.

Any use of intravascular lithotripsy outside of this approved indication, such as for in-stent restenosis, non-coronary applications, or use in carotid, cerebrovascular, peripheral or other vascular territories, are considered off-label.

Documentation Requirements:

Providers must ensure all services align with FDA approved indications. The documentation outlined below should be maintained in the medical record and provided upon request.

Requirements outlined in the FDA label have been met.

Include the following in the operative note:

Description of severity of vessel calcification confirmed by imaging.
Rationale for IVL use.
Lesion location, device used, and number of pulses delivered.
Post-lithotripsy results and stent placement details.

References:

FDA. Summary of Safety and Effectiveness Data (SSED). Published 2021. Updated February 12, 2021. Accessed February 27, 2025.
Saito S, Yamazaki S, Takahashi A, et al. Intravascular lithotripsy for vessel preparation in calcified coronary arteries prior to stent placement – Japanese Disrupt CAD IV study 2-year results. Circ Rep. 2023;5(12):437-441.
Saito S, Yamazaki S, Takahashi A, et al. Intravascular lithotripsy for vessel preparation in severely calcified coronary arteries prior to stent placement—primary outcomes from the Japanese Disrupt CAD IV study. Circ J. 2021;85(6):826-833.
Kereiakes DJ, Di Mario C, Riley RF, et al. Intravascular lithotripsy for treatment of calcified coronary lesions: patient-level pooled analysis of the Disrupt CAD studies. JACC Cardiovasc Interv. 2021;14(12):1337-1348.
Kereiakes DJ, Ali ZA, Riley RF, et al. Intravascular lithotripsy for treatment of calcified coronary artery disease. Interv Cardiol Clin. 2022;11(4):393-404.
Kereiakes DJ, Hill JM, Shlofmitz RA, et al. The Disrupt CAD III Post-Approval Study: real-world safety and effectiveness of coronary intravascular lithotripsy from the ACC NCDR CathPCI registry. J Soc Cardiovasc Angiography Interv. 2023;2(3).
Hill JM, Kereiakes DJ, Shlofmitz RA, et al. Intravascular lithotripsy for treatment of severely calcified coronary artery disease. J Am Coll Cardiol. 2020;76(22):2635-2646.
Ali ZA, Nef H, Escaned J, et al. Safety and effectiveness of coronary intravascular lithotripsy for treatment of severely calcified coronary stenoses: the Disrupt CAD II study. Circ Cardiovasc Interv. 2019;12(10):e008434.
Brinton TJ, Ali ZA, Hill JM, et al. Feasibility of shockwave coronary intravascular lithotripsy for the treatment of calcified coronary stenoses: first description. Circulation. 2019;139(6):834-836.
Sattar Y, Ullah W, Mir T, et al. Safety and efficacy of coronary intravascular lithotripsy for calcified coronary arteries—a systematic review and meta-analysis. Expert Rev Cardiovasc Ther. 2021;19(1):89-98.
Mousa MAA, Bingen BO, Al Amri I, et al. Efficacy and safety of intravascular lithotripsy versus rotational atherectomy in balloon-crossable heavily calcified coronary lesions. Cardiovasc Revasc Med. 2023;48:1-6.
Carvalho PEP, Strepkos D, Alexandrou M, et al. Intravascular lithotripsy versus rotational atherectomy in coronary chronic total occlusions: analysis from the prospective global registry for the study of chronic total occlusion intervention registry. Am J Cardiol. 2025;235:37-43.
Aksoy A, Tiyerili V, Jansen N, et al. Propensity-score-matched comparison of safety, efficacy, and outcome of intravascular lithotripsy versus high-pressure PTCA in coronary calcified lesions. Int J Cardiol Heart Vasc. 2021;37:100900.
Gallinoro E, Monizzi G, Sonck J, et al. Physiological and angiographic outcomes of PCI in calcified lesions after rotational atherectomy or intravascular lithotripsy. Int J Cardiol. 2022;352:27-32.
Wong B, Kam KK, So CY, et al. Synergistic coronary artery calcium modification with combined atherectomy and intravascular lithotripsy. J Invasive Cardiol. 2023;35(3):E128-E135.
Hesse K, Shahid F, Ahmed R, et al. Early experience of intravascular lithotripsy in unprotected calcified left main coronary artery disease. Cardiovasc Revasc Med. 2023;55:33-41.
Oomens T, Vos NS, van der Schaaf RJ, et al. Expansion of stents after intravascular lithotripsy versus conventional predilatation in calcified coronary arteries. Int J Cardiol. 2023;386:24-29.
Sandesara PB, Elhage Hassan M, Shekiladze N, et al. Intravascular lithotripsy compared to rotational atherectomy for the treatment of calcified distal left main coronary artery disease: a single center experience. Catheter Cardiovasc Interv. 2023;102(6):997-1003.
Sukul D, Seth M, Madder RD, et al. Contemporary trends and outcomes of intravascular lithotripsy in percutaneous coronary intervention: insights from BMC2. JACC Cardiovasc Interv. 2024;17(15):1811-1821.
Grines CL, Box LC, Mamas MA, et al. SCAI Expert Consensus Statement on percutaneous coronary intervention without on-site surgical backup. J Soc Cardiovasc Angiography Interv. 2023;2(2).
Oliveri F, van Oort MJH, Phagu AAS, et al. Intravascular lithotripsy in calcified left main coronary artery: procedural success and 1-year clinical outcomes. Int J Cardiol. 2025;423:132996.
Gibbs S, Wiens EJ, Minhas K. One-year outcomes in patients who underwent coronary intravascular shockwave lithotripsy for highly-calcified coronary lesions. Indian Heart J. 2022;74(6):524-526.
Mhanna M, Beran A, Nazir S, et al. Efficacy and safety of intravascular lithotripsy in calcified coronary lesions: a systematic review and meta-analysis. Cardiovasc Revasc Med. 2022;36:73-82.
Wong JJ, Umapathy S, Keh YS, et al. Coronary intravascular lithotripsy versus rotational atherectomy in an Asian population: clinical outcomes in real-world patients. Korean Circ J. 2022;52(4):288-300.
Blachutzik F, Meier S, Weissner M, et al. Comparison of coronary intravascular lithotripsy and rotational atherectomy in the modification of severely calcified stenoses. Am J Cardiol. 2023;197:93-100.
Gupta A, Shrivastava A, Chhikara S, et al. Safety, efficacy, and optical coherence tomography insights into intravascular lithotripsy for the modification of non-eruptive calcified nodules: a prospective observational study. Catheter Cardiovasc Interv. 2024;104(4):688-696.
Frizzell J, Kereiakes DJ. Calcified plaque modification during percutaneous coronary revascularization. Prog Cardiovasc Dis. 2024.
Blachutzik F, Meier S, Weissner M, et al. Coronary intravascular lithotripsy and rotational atherectomy for severely calcified stenosis: results from the ROTA.shock trial. Catheter Cardiovasc Interv. 2023;102(5):823-833.
van Oort MJH, Al Amri I, Bingen BO, et al. Procedural and clinical impact of intravascular lithotripsy for the treatment of peri-stent calcification. Cardiovasc Revasc Med. 2024;61:16-23.
van Oort MJH, Al Amri I, Bingen BO, et al. Evolving use and clinical outcomes of coronary intravascular lithotripsy: insights from an international, multicentre registry. Heart. 2024;111(2):62-68.
McInerney A, Travieso A, Jeronimo Baza A, et al. Impact of coronary calcium morphology on intravascular lithotripsy. EuroIntervention. 2024;20(10):e656-e668.
Rola P, Furtan L, Wlodarczak S, et al. Safety and efficacy of a novel calcified plaque modification technique – Shockwave Intravascular Lithotripsy – in patients with coronary artery disease: mid-term outcomes. Kardiol Pol. 2023;81(9):878-885.
Huisman J, van der Heijden LC, Kok MM, et al. Two-year outcome after treatment of severely calcified lesions with newer-generation drug-eluting stents in acute coronary syndromes: a patient-level pooled analysis from TWENTE and DUTCH PEERS. J Cardiol. 2017;69(4):660-665.
Rola P, Furtan L, Wlodarczak S, et al. Rota-lithotripsy as a novel bail-out strategy for highly calcified coronary lesions in acute coronary syndrome. Biomedicines. 2022;10(11).
Shlofmitz E, Ali ZA, Maehara A, et al. Intravascular imaging guided percutaneous coronary intervention: a universal approach for optimization of stent implantation. Circ Cardiovasc Interv. 2020;13:e008686. doi:10.1161/CIRCINTERVENTIONS.120.008686
Fujino A, Mintz GS, Matsumura M, et al. A new optical coherence tomography based calcium scoring system to predict stent underexpansion. EuroIntervention. 2018;13(18):e2182-e2189. doi:10.4244/EIJ-D-17-00962
Sandoval Y, Leipsic J, Collet C, et al. Coronary computed tomography angiography to guide percutaneous coronary intervention: expert opinion from a SCAI and SCCT roundtable. Catheter Cardiovasc Interv. 2023;102(5):992-1007. doi:10.1002/ccd.30577