Watch Dr. Paul Foley and Dr. Mazin Foteh for a virtual case review, moderated by Dr. Leigh Ann O’Banion, as they discuss two of their challenging below-the-knee (BTK) cases using Shockwave Intravascular Lithotripsy (IVL). The webinar showcases detailed case reviews, including the use of innovative technology such as Shockwave Javelin, highlighting its role in modifying challenging calcified lesions.

In this session, Dr. Foley presents a compelling case of an elderly male with limb-threatening ischemia, non-healing ulcers, and extensive calcified arterial disease. The discussion covers preoperative planning, including the importance of duplex ultrasound, CTA imaging, and strategic access approaches—antegrade versus pedal access—to optimize procedural success. The team emphasizes the critical role of intravascular ultrasound (IVUS) in accurately sizing vessels and characterizing plaque, which guides effective treatment choices.

Throughout the webinar, the panel explores various crossing techniques, wire escalation strategies, and the nuances of delivering energy with devices like Shockwave Javelin. They compare different atherectomy and lithotripsy tools, debating the merits of focal versus circumferential calcium modification, and discuss how these technologies can improve vessel compliance and blood flow. The importance of multidisciplinary collaboration, including insights from interventional cardiology and radiology, is also underscored as vital to advancing limb salvage efforts.

Drs. O’Banion, Foley, and Foteh 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.

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.

In this informative and in-depth session, renowned vascular specialists and interventionalists come together to explore advanced strategies for managing critical limb-threatening ischemia (CLTI) and complex tibial and pedal artery disease. Moderated by Dr. John Rollo, the discussion features expert contributions from Dr. Misty Humphreys (UC Davis), Dr. Constantino Pena (Baptist Miami), and Dr. John Corl (Cincinnati), who share their insights on techniques for challenging cases involving heavily calcified vessels and non-healing foot ulcers.

Cutting-Edge Treatment Approaches

Dr. Humphreys highlights her use of the latest balloon technology, including Shockwave E8, which facilitates treating entire tibial segments with long, subnominal inflations—often exceeding three minutes—aimed at optimizing vessel compliance. She emphasizes the importance of thorough pre-procedure planning, including sizing and physiologic assessments like pedal acceleration time, toe pressures, and transcutaneous oxygen measurements, to guide treatment decisions and improve healing outcomes.

Case-Specific Strategies

The discussion delves into case-specific strategies, particularly focusing on targeting the most promising arteries, such as the anterior tibial artery, and considering collateral flow and angiosome principles to maximize tissue perfusion. Panelists discuss when to treat multiple vessels versus a more conservative approach, stressing that treatment should be tailored based on physiologic data, wound status, and patient risk.

Shockwave Javelin

Challenging cases are examined, especially those with heavily calcified lesions where crossing may be difficult. The panel introduces Shockwave Javelin, a calcium modification tool that uses forward-shifted ultrasound energy to crack calcified plaque and facilitate successful balloon crossing. They share practical tips on crossing strategies, sheath and wire selection, and the benefits of retrograde access when antegrade approaches fail.

Dr. John Rollo, Dr. John Corl, Dr. Misty Humphries, and Dr. Constantino Pena are paid consultants of Shockwave Medical. The thoughts and views expressed are of their own opinions, and do not necessarily represent those 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.

Please contact your local Shockwave representative for specific country availability.

Join Dr. JD Corl, Interventional Cardiologist and Medical Director of the PAD/CLI Program at The Linder Center for Research and Education at the Christ Hospital, as he provides an overview of the first-of-its-kind Forward Intravascular Lithotripsy (IVL) Platform, Shockwave Javelin, and reviews three patient cases from the Forward PAD Investigational Device Exemption (IDE) Trial.

In this Shockwave Javelin case review, Dr. Vasili Lendel, Interventional Cardiologist at Arkansas Heart Hospital, Little Rock, AR, reviews a clinical case involving a patient with severe tibial peroneal (TP) trunk stenosis and anterior and posterior tibial occlusions, before diving into a Q&A discussion about Shockwave Javelin.

Case Summary

Patient background:

• 79-year-old male with a history of paroxysmal atrial fibrillation (PAF), hypertension, chronic kidney disease and type II diabetes
• Resting pain; symptoms remained refractory despite maximal medical and physical therapy
• Computed tomographic angiography (CTA) showed occluded anterior tibial (AT) artery, severe stenosis of the TP trunk with occluded posterior tibial artery (PT)
  • Renovascular disease (RVD): 2.5 – 3 mm
  • Lesion length: 120 mm

Treatment algorithm:

• 6 Fr 90 cm sheath
• 0.014″ guidewire was advanced into the distal PT
• Unable to advance 0.014 support catheter
• Shockwave Javelin was chosen to help cross and modify the calcified lesion

Treatment:

• Unable to cross the distal cap using Gaia next 3 and Astato XS 20 wires
• Shockwave Javelin was replaced for 0.018″ Crosswalk
• Retrograde access was obtained via distal PT artery using ultrasound
• Antegrade catheter was cannulated using retrograde Sion black wire
• Shockwave Javelin brought to distal cap and treated with the remaining pulses
• Subsequently, the artery was treated using 2.5 x 80 mm Shockwave E8, followed by 3 x 200 Armada balloon

Result:

• Brisk flow in the posterior tibial and medial plantar arteries without flow-limiting dissection

Dr. Lendel is a paid consultant of Shockwave Medical. The thoughts and views expressed are of their own opinions and do not necessarily represent 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.

In this video series, Dr. Karthikeshwar Kasirajan, MD, Clinical Professor of Surgery at Stanford Health Care, CA, reviews three patient cases using Shockwave Javelin, our Forward Intravascular Lithotripsy (IVL) Platform.

Case 1: Recurrent Superficial Femoral Artery (SFA) Stenosis

• Female patient
• Lesion crossing 0.014″ guidewire with Shockwave Javelin
• 30% luminal gain post-Shockwave Javelin
• Followed by Shockwave E8 5.0 mm, drug-coated balloon (DCB) and stent

Case 2: Multilevel Disease: SFA, Popliteal & Distal Posterior Tibial

• 46-year-old male with end-stage renal disease (ESRD) and gangrene of the heel and first toe
• SFA & popliteal:
  • Lesion crossing with Shockwave Javelin
  • 30% luminal gain post-Shockwave Javelin
  • Followed by Shockwave E8 6.0 mm and DCB
• Distal PT occlusion:
  • PT and medial plantar crossing with Shockwave Javelin
  • 80% luminal gain post-Shockwave Javelin
  • Followed by percutaneous transluminal angioplasty (PTA) balloon

Case 3: Anterior Tibial (AT) Occlusion

• 86-year-old male with gangrene of the heel and toe
• Shockwave Javelin followed by Shockwave E8 3.0 mm

Dr. Kasirajan is a paid consultant of Shockwave Medical. The thoughts and views expressed are of their own opinions, and do not necessarily represent those 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.

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.

Dr. Leah Raj (Interventional Cardiologist, Vanderbilt University Medical Center, TN) shares her thoughts on Intravascular Lithotripsy (IVL)’s mechanism of action (MOA) and how it modifies coronary calcium in under three minutes.

The ROLLING-STONE Registry is the largest, prospective, multi-center registry with a head-to-head comparison after propensity score matching (PSM) of Shockwave Intravascular Lithotripsy (IVL) versus rotational atherectomy (AT) in a real-world, all-comers population. The 1,005 patient registry compared the procedural success, intraprocedural complications and 30 day and 1 year MACE rates after PSM of IVL versus rotational atherectomy (RA) and orbital atherectomy (OA).

In this interview, we sat down with the lead investigator of the registry, Dr. Enrico Cerrato, San Luigi Gonzaga University Hospital and Rivoli Hospital, Italy, to discuss the outcomes of the ROLLING-STONE Registry and how he anticipates the results may impact the daily practice of interventional cardiologists.

Download the summary and watch our interview with Dr. Enrico Cerrato to learn more about the trial and to hear his perspective.

• Trial design: Prospective, multi-center, double-arm, all-comers study of 1,005 patients with moderate-severe calcification treated with atherectomy or IVL from 23 Italian institutions
• Safety endpoints: Freedom from MACE at 30 days and one year after PSM and inverse probability weighting (IPW) (core-lab adjudicated)
• Primary efficacy endpoint: Procedural success: stent delivery with residual stenosis <30% and absence of in-hospital MACE (core-lab adjudicated)

IVL demonstrates a favorable 30-day MACE and statistically significant lower 1-year MACE after PSM as compared to atherectomy

IVL demonstrates similar procedural success with favorable intraprocedural complications as compared to atherectomy

Download the summary

Cerrato, E. (2025, March). Intravascular Lithotripsy And/Or Mechanical Debulking Multicenter Registry For The Treatment Of Complex Calcified Coronary Arteries: Rolling Stone Registry. Cardiovascular Research Technologies (CRT) 2025.

Dr. Leigh Ann O’Banion (Associate Clinical Professor of Surgery Vascular Surgeon UCSF Fresno, CA) shares her thoughts on peripheral Intravascular Lithotripsy (IVL) sizing for optimal patient outcomes in under two minutes.