A recently published cadaveric study compares the frequency and patterns of calcium fracture and medial injury based on the mechanism of action (MOA) of advanced calcified lesion preparation strategies.

17 cadaveric calcified lesions were randomized to one of three treatment arms of Intravascular Lithotripsy (IVL; Shockwave C2+), cutting balloons (CB; Wolverine™ Boston Scientific) and ultra-high pressure balloons (UHB; OPN NC SIS Medical). Frequency of calcium fracture and presence of medial injury – which potentially negatively affects long-term clinical outcomes due to increased neointimal thickness, higher inflammatory cell count and in-stent restenosis^1,2 – were identified using gold-standard techniques of micro-CT and histology.

Shockwave C2+ produced the most calcium fracture with the least amount of medial injury by lesion and across concentric and eccentric calcium arcs. Within histological sections with concentric calcium, fractures produced by Wolverine™ and OPN NC were mostly associated with medial injury. No calcium fracture was identified for UHB within eccentric calcium.

Learn more by downloading the one-page clinical summary and viewing the video below for a roundtable discussion between the study’s principal investigators, Drs. Ziad Ali and Aloke Finn, moderated by Shockwave Medical Chief Medical Officer, Dr. Nick West.

Sekimoto, T et al. Comparison of Vascular Injury From Intravascular Lithotripsy, Cutting, or Ultra-High-Pressure Balloons During Coronary Calcium Modification. J Am Coll Cardiol Intv. 2025 Sep, 18 (17) 2093-2104. Cadaveric study. May not be indicative of actual clinical use.

1: Farb A, et al., Pathology of acute and chronic coronary stenting in humans. Circulation. 1999 Jan 5-12;99(1):44-52.
2: Schwartz RS, et al., Restenosis and the proportional neointimal response to coronary artery injury: results in a porcine model. J Am Coll Cardiol. 1992 Feb;19(2):267-74.

Drs. Ziad Ali and Aloke Finn are paid consultants of Shockwave Medical. Views expressed are those of the presenters and not necessarily those of Shockwave IVL.

Shockwave IVL: In the U.S.: Rx only. Prior to use, please reference the Important Safety Information for more information on indications, contraindications, warnings, precautions and adverse events. Please contact your local Shockwave representative for specific country availability.

This case, courtesy of Dr. Maria Antonella Ruffino, Interventional Radiology, Lugano, features an ​83-year-old male patient with type 2 diabetes, dyslipidemia, and hypertension. He is suffering from Rutherford class 5 peripheral artery disease (PAD) and is presenting a heel ulcer.

Case courtesy of Dr. Maria Antonella Ruffino, Interventional Radiology, Lugano.

Dr. Maria Antonella Ruffino is a paid consultant of Shockwave Medical.

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This case, courtesy of Dr. Ashish Patel from St Thomas’, London, features a 71-year-old female patient, a smoker with hypertension Rutherford category 5 peripheral artery disease (PAD). The patient presents left hallux gangrene and severe rest pain and had no previous treatments. ​

Case courtesy of Dr. Ashish Patel, St Thomas’, London.​

Dr. Ashish Patel is a paid consultant of Shockwave Medical.

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Meet Sharon, a female patient from Oxfordshire, UK whose angina symptoms caused her to take lots of time off work from her job as a community care assistant. The unpredictability of her angina symptoms also impacted her social life and ability to walk any distance.

Cardiologist Dr. Jeremy Langrish (John Radcliffe Hospital, Oxford, UK) suggested the Shockwave Reducer as a treatment solution, and now, Sharon is back to work and spending time with friends and family.

Individual patient stories. Results may vary.

The physicians featured are paid consultants of Shockwave Medical. Views expressed are those of the authors and not necessarily those of Shockwave Medical.

Shockwave Reducer is commercially available in select European countries and has been implanted in over 3,500 patients. It is currently under clinical investigation in the U.S.

CAUTION: In the United States, Shockwave Reducer is an investigational device, limited by United States law to investigational use. Shockwave Reducer is subject of investigational testing and is being studied in the COSIRA-II trial in Canada. Shockwave Reducer is commercially available in certain countries outside the U.S. and Canada. Please contact your local representative for specific country availability. Prior to use, please reference the Instructions for Use for more information on warnings, precautions and adverse events: ifu.sw-reducer.com

Meet Kunigunde Grohmann, a 78-year-old female patient who is suffering from refractory angina despite a long history of cardiac procedures.

Kunigunde’s general practitioner referred her to Prof. Tommaso Gori (Univ. Medical Centre of Mainz, Germany), who chose Shockwave Reducer therapy to address her symptoms.

Individual patient stories. Results may vary.

Shockwave Reducer is commercially available in select European countries and has been implanted in over 3,500 patients. It is currently under clinical investigation in the U.S.

CAUTION: In the United States, Shockwave Reducer is an investigational device, limited by United States law to investigational use. Shockwave Reducer is subject of investigational testing and is being studied in the COSIRA-II trial in Canada. Shockwave Reducer is commercially available in certain countries outside the U.S. and Canada. Please contact your local representative for specific country availability. Prior to use, please reference the Instructions for Use for more information on warnings, precautions and adverse events: ifu.sw-reducer.com

At EuroPCR 2025, anchorperson James Spratt, spokesperson Felix Woitek and discussants Ranil de Silva, Mariusz Tomaniak and Tommaso Gori took the stage to present “Road to Relief: Effective Treatment of Refractory Angina Patients with Shockwave Reducer.”

Incidence & Impact of Refractory Angina

Watch this video in which Dr. de Silva (Royal Brompton Hospital, London) provides an overview of the definition, prevalence, challenges and impact of refractory angina on patients’ lives. Why is angina a problem? Why is angina misunderstood? These are just some of the questions Dr. de Silva tackles before exploring a real-world patient case.

Mechanism of Action (MOA)

Tune in to watch Prof. Spratt (St George’s Hospital, London) review the hypothesized MOA of the Shockwave Reducer device, first exploring how flow is maintained in a healthy heart versus a diseased heart, before diving into how Shockwave Reducer works to redistribute flow. Additionally, Dr. Spratt touches on the ORBITA-COSMIC clinical study, which provides further insights into Reducer’s MOA.

Reducer Implanting Procedure & Patient Follow Up

Join Prof. Tomaniak (Medical University of Warsaw, Poland) as he explores a real-world patient case example to demonstrate the four simple steps to implant the Shockwave Reducer – prepare, assess, deploy and retract. To conclude, Prof. Tomaniak emphasizes the importance to develop a successful referral network to increase the patient inflow to a Reducer program.

Clinical Data & Real-Life Results

Watch this video to see Prof. Gori (University Medical Centre of Mainz, Germany) review the comprehensive and compelling clinical data on Reducer and watch a patient testimonial from one of his patients to learn about the real-life impact of the Reducer.

Unique Randomized Controlled Trial (RCT) Design Relevant for Clinical Practice

The BALI study is the first randomized study that examines the potential advantages of a routine Intravascular Lithotripsy (IVL) strategy versus conventional lesion preparation strategies in a rigorous, intracoronary imaging-guided, all-comers population with severely calcified lesions representative of real-world clinical practice.

• Recognizing that many calcium tools are complementary and atherectomy is a critical tool to be able to cross lesions, BALI compared 99 patients treated with IVL, 101 patients undergoing conventional balloon-based lesion preparation strategies, including cutting, scoring, ultra-high pressure balloons, and non-compliant (NC) balloons, but not IVL, across nine sites in Denmark, Norway, Estonia and Belgium.
• Rotational atherectomy was utilized in 31% of patients in the IVL arm and 42% of patients in the conventional lesion preparation arm only to facilitate balloon crossing.

Watch the BALI Trial Summary to learn why this study is important and for details on the study design and results.

Routine use of IVL Strategy Found Superior to Conventional Approaches

• 2/3 of patients with routine IVL were free of the primary endpoint, compared with approximately 1/2 of patients with conventional treatment arm, leading the BALI investigators to determine that at one year, a routine IVL strategy was the superior calcium modification strategy.
  • The primary endpoint of procedural failure (stent implantation with a residual area stenosis of ≥20%) or target vessel failure (CD, TVMI CD-TLR) at one year occurred in 35% of IVL patients and in 52% of conventional preparation patients (p_superiority = 0.02). 

Watch Dr. Niels Thue Olsen, MD, PhD, Clinical Associate Professor at the University of Copenhagen, and Chief Medical Officer at Shockwave Medical, Nick West, discuss more about the BALI study.

Key Takeaway

In patients undergoing percutaneous coronary intervention (PCI) for severely calcified coronary lesions, the use of lithotripsy before stent implantation reduced the incidence of procedural failure or target vessel failure at one year, without an increased risk of adverse events.

Dr. Niels Thue Olsen is a paid consultant of Shockwave Medical.

Views expressed are those of the authors and not necessarily those of Shockwave Medical.

In this video series, Drs. Suzanne Baron, Kevin Croce and Nieves Gonzalo share their experiences with the Shockwave C2+ coronary Intravascular Lithotripsy (IVL) catheter in treating female patients with calcified coronary artery disease (CAD).

EMPOWER CAD is a prospective, multi-center, single-arm, female-only, all-comers study to generate real-world clinical evidence associated with coronary IVL.

Complex PCI in Women

Dr. Suzanne Baron outlines the growing need to EMPOWER, highlighting the studies that detail the discrepancies in percutaneous coronary interventions (PCI) between females and males.

Consistency Across the Sexes: IVL is Safe & Effective in Modifying Nodular Calcium in Men & Women¹

Case courtesy of Dr. Kevin Croce, Brigham and Women’s Hospital

Nodular calcium poses a big clinical problem that is predominantly represented in female patients. Calcified nodules have worse long-term outcomes than any other presentation of calcium. Shockwave IVL’s unique mechanism of action has proven to have a safer, more effective outcome when modifying nodular calcium compared to other atherectomy devices.²

Dr. Kevin Croce’s patient presented with a challenging tortuous nodular calcified lesion in the right coronary artery. After being unsuccessful in passing equipment through the lesion, a 1.5 Rota burr passed through the lesion. A post-atherectomy IVUS showed that rotational atherectomy supplied minimal benefit in modifying the calcium. A Shockwave IVL catheter was used and proved on IVUS to have a significant impact on the nodular calcium. Once the right coronary artery was fixed the left circumflex artery showed signs of nodular calcium on OCT. A Shockwave C2+ IVL catheter was used to successfully treat the nodular calcium safely and effectively. IVL has shown consistent MSA and stent expansion despite the presence of nodular calcium.

Consistent Results Regardless of Complex Anatomy

Case courtesy of Dr. Nieves Gonzalo, Clinico San Carlos University Hospital in Madrid

The main challenges for calcific lesion treatment in women are related with vessel size and tortuosity.³ Dr. Nieves Gonzalo’s patient presented with both challenges in the left anterior descending artery and the circumflex artery. After visualizing how severe the calcium was in both arteries, a 2.5 Shockwave C2+ catheter was used to modify the calcium. IVL has proven to be impactful and safe for the treatment of calcific coronary disease in females.

The physicians featured are paid consultants for Shockwave Medical.

1: Hill, J, Kereiakes, D, Shlofmitz, R. et al. Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease. JACC. 2020 Dec, 76 (22) 2635-2646. https://doi.org/10.1016/j.jacc.2020.09.603.
2: Ali ZA, Shin D, Singh M, Malik S, Sakai K, Honton B, Kereiakes DJ, Hill JM, Saito S, Mario CD, Gonzalo N, Riley RF, Maehara A, Matsumura M, Hokama J, West NEJ, Stone GW, Shlofmitz RA. Outcomes of coronary intravascular lithotripsy for the treatment of calcified nodules: a pooled analysis of the Disrupt CAD studies. EuroIntervention. 2024 Dec 2;20(23):e1454-e1464. doi: 10.4244/EIJ-D-24-00282. PMID: 39618263; PMCID: PMC11586657.
3: Equity in Modifying Plaque of Women With Undertreated Calcified Coronary Artery Disease: Design and Rationale of EMPOWER CAD study McEntegart, Margaret et al. Journal of the Society for Cardiovascular Angiography & Interventions, Volume 3, Issue 11, 102289.

Shockwave IVL: In the U.S.: Rx only. Prior to use, please reference the Important Safety Information for more information on indications, contraindications, warnings, precautions and adverse events.

55-year-old male patient with insulin-dependent diabetes presents with gangrene affecting the second and third toes of the left foot. He exhibits absent foot pulses, while the popliteal pulse is palpable. The patient is scheduled for a hybrid procedure that includes the amputation of both toes and revascularization. His past medical history is significant for hypertension and hyperlipidemia. Currently, he is unable to work due to chronic limb-threatening ischemia (CLTI).

Case courtesy of Dr. Ash Patel – Guy’s & St Thomas’ NHS Foundation Trust, London.

Dr. Ash Patel is a paid consultant of Shockwave Medical.

In this VIVA 2024 interview, Dr. Nick West, Chief Medical Officer of Shockwave Medical, moderates a discussion on the DISRUPT BTK II acute and 30-day outcomes with the two co-principal investigators of the study, Dr. Armstrong, Interventional Cardiologist and Medical Director at Adventist Heart & Vascular Institute, and Dr. Venita Chandra, Vascular Surgeon and Clinical Professor at Stanford Health Care.

Watch now to learn more about the study’s significance, particularly in addressing an understudied area—below-the-knee (BTK) disease in patients with critical limb-threatening ischemia (CLTI). The study includes high-risk patients with heavy calcification who are often excluded from similar trials.

The 30-day results show promising outcomes, with low Major Adverse Limb Events (MALEs) and no mortality. A majority of patients experienced a substantial reduction in stenosis, with more than 90% achieving less than 50% residual stenosis and approximately 75% reaching less than 30% residual stenosis—all with a low stent rate (less than 5%) and low angiographic complications (1.0% at Final). Additionally, early wound healing signals were observed, and a mean improvement in Vascular Quality of Life scores within 30 days. The investigators are particularly excited about the upcoming six-month and one-year data, which will provide more insight into long-term wound healing and vessel patency.

Chandra V, Lansky AJ, Sayfo S, et al. Thirty-Day Outcomes from the Disrupt PAD BTK II Study of the Shockwave Intravascular Lithotripsy System for Treatment of Calcified Below-the-Knee Peripheral Arterial Disease. Journal of Vascular Surgery. Published online November 12, 2024. doi:10.1016/j.jvs.2024.11.003.

Dr. Armstrong and Dr. Venita Chandra are paid consultants of Shockwave Medical.

Shockwave IVL: In the U.S.: Rx only. Prior to use, please reference the Important Safety Information for more information on indications, contraindications, warnings, precautions and adverse events.