Join us at TCT2024 in Washington DC where Shockwave Medical and our clinical partners will bring to life long-awaited innovations that move the field of IVL FORWARD! Visit the Shockwave booth and go hands-on with the highly anticipated Shockwave Javelin catheter and our latest peripheral catheter, Shockwave E8. Join colleagues at the Shockwave Symposium on Tuesday, October 29 where a panel of experts will show how you can veto challenging calcium by backing our latest calcium contenders.

Shockwave Symposium: DISRUPTIVE DATA & TECHNOLOGY TO IMPACT YOUR PERIPHERAL PRACTICE

Tuesday October 29 – 12:30 PM to 1:30 PM | Walter E. Washington Convention Center | Lower Level | Innovation & Exhibit Hall (Halls A-C) | Presentation Theater 4

Shockwave IVL in Scientific Sessions

A day-by-day breakdown of scientific sessions involving Shockwave IVL can be found below. Sessions will be added and updated as the TCT agenda develops.

Coronary IVL

Shockwave C2 and Shockwave C2+ Safety Information

In the United States: Rx only.

Indications for Use – The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 and C2+ Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.

Contraindications – The Shockwave C2 and C2+ Coronary IVL System is contraindicated for the following: This device is not intended for stent delivery. This device is not intended for use in carotid or cerebrovascular arteries.

Warnings – Use the IVL Generator in accordance with recommended settings as stated in the Operator’s Manual. The risk of a dissection or perforation is increased in severely calcified lesions undergoing percutaneous treatment, including IVL. Appropriate provisional interventions should be readily available. Balloon loss of pressure was associated with a numerical increase in dissection which was not statistically significant and was not associated with MACE. Analysis indicates calcium length is a predictor of dissection and balloon loss of pressure. IVL generates mechanical pulses which may cause atrial or ventricular capture in bradycardic patients. In patients with implantable pacemakers and defibrillators, the asynchronous capture may interact with the sensing capabilities. Monitoring of the electrocardiographic rhythm and continuous arterial pressure during IVL treatment is required. In the event of clinically significant hemodynamic effects, temporarily cease delivery of IVL therapy.

Precautions – Only to be used by physicians trained in angiography and intravascular coronary procedures. Use only the recommended balloon inflation medium. Hydrophilic coating to be wet only with normal saline or water and care must be taken with sharp objects to avoid damage to the hydrophilic coating. Appropriate anticoagulant therapy should be administered by the physician. Precaution should be taken when treating patients with previous stenting within 5mm of target lesion.

Potential adverse effects consistent with standard based cardiac interventions include- Abrupt vessel closure – Allergic reaction to contrast medium, anticoagulant and/or antithrombotic therapy-Aneurysm-Arrhythmia-Arteriovenous fistula-Bleeding complications-Cardiac tamponade or pericardial effusion-Cardiopulmonary arrest-Cerebrovascular accident (CVA)-Coronary artery/vessel occlusion, perforation, rupture or dissection-Coronary artery spasm-Death-Emboli (air, tissue, thrombus or atherosclerotic emboli)-Emergency or nonemergency coronary artery bypass surgery-Emergency or nonemergency percutaneous coronary intervention-Entry site complications-Fracture of the guide wire or failure/malfunction of any component of the device that may or may not lead to device embolism, dissection, serious injury or surgical intervention-Hematoma at the vascular access site(s)- Hemorrhage-Hypertension/Hypotension-Infection/sepsis/fever-Myocardial Infarction-Myocardial Ischemia or unstable angina-Pain-Peripheral Ischemia-Pseudoaneurysm-Renal failure/insufficiency-Restenosis of the treated coronary artery leading to revascularization-Shock/pulmonary edema-Slow flow, no reflow, or abrupt closure of coronary artery-Stroke Thrombus-Vessel closure, abrupt-Vessel injury requiring surgical repair-Vessel dissection, perforation, rupture, or spasm.

Risks identified as related to the device and its use: Allergic/immunologic reaction to the catheter material(s) or coating-Device malfunction, failure, or balloon loss of pressure leading to device embolism, dissection, serious injury or surgical intervention-Atrial or ventricular extrasystole-Atrial or ventricular capture.

Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions and adverse events. www.shockwavemedical.com/IFU.

Peripheral IVL

Shockwave M5+, Shockwave M5, Shockwave S4, Shockwave L6 and Shockwave E8 Safety Information

In the United States: Rx only.

Indications for Use – The Shockwave Medical Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary, carotid or cerebral vasculature.

Contraindications – Do not use if unable to pass 0.014″ (M5, M5+, S4, E8) or 0.018″ (L6) guidewire across the lesion-Not intended for treatment of in-stent restenosis or in coronary, carotid, or cerebrovascular arteries.

Warnings – Only to be used by physicians who are familiar with interventional vascular procedures–Physicians must be trained prior to use of the device–Use the generator in accordance with recommended settings as stated in the Operator’s Manual.

Precautions – use only the recommended balloon inflation medium-Appropriate anticoagulant therapy should be administered by the physician-Decision regarding use of distal protection should be made based on physician assessment of treatment lesion morphology. Adverse effects-Possible adverse effects consistent with standard angioplasty include-Access site complications-Allergy to contrast or blood thinner-Arterial bypass surgery-Bleeding complications-Death-Fracture of guidewire or device-Hypertension/Hypotension-Infection/sepsis-Placement of a stent-renal failure-Shock/pulmonary edema-target vessel stenosis or occlusion-Vascular complications. Risks unique to the device and its use-Allergy to catheter material(s)-Device malfunction or failure-Excess heat at target site.

Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions and adverse events. www.shockwavemedical.com/ifu

Shockwave Javelin Peripheral IVL Catheter Safety Information

In the United States: Rx only.

Indications for Use – The Shockwave Medical IVL System with the Javelin Peripheral IVL Catheter is intended for lithotripsy-enabled modification and crossing of calcified lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries, prior to final treatment. Not for use in the coronary, carotid, cerebral, or pulmonary vasculature.

Contraindications – Do not use if unable to pass 0.014″ (0.36mm) guidewire across the treatment site-Not intended for treatment of in-stent restenosis or in coronary, carotid, cerebral or pulmonary arteries.

Warnings – Only to be used by physicians who are familiar with interventional vascular procedures-Physicians must be trained prior to use of the device-Use the generator in accordance with recommended settings as stated in the Operator’s Manual.

Precautions – Avoid applying acoustic pressure pulses while IVL window is not filled with sterile saline-Appropriate anticoagulant therapy should be administered by the physician-Decision regarding use of distal protection should be made based on physician assessment of treatment lesion morphology.

Adverse effects – Possible adverse effects consistent with standard angioplasty include-Access site complications-Allergy to contrast or blood thinner-Arterial bypass surgery-Bleeding complications-Death-Fracture of guidewire or device-Hypertension/Hypotension-Infection/sepsis-Placement of a stent-renal failure-Shock/pulmonary edema-target vessel stenosis or occlusion-Vascular complications. Risks unique to the device and its use-Allergy to catheter material(s)-Device malfunction or failure.

Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions and adverse events. www.shockwavemedical.com/ifu

During this year’s EuroPCR, Dr. Alfonso Jurado-Román (La Paz University Hospital – Madrid, Spain) presented the results of ROLLERCOASTR-EPIC22, a prospective, randomized, controlled trial that filled the gap by adding randomized evidence and confirming the importance of device selection and their complementary nature.

The study compared safety and efficacy of IVL, RA and ELCA in PCI on moderate and severe calcified lesion. The results showed similar success rate, MSA and stent expansion across all arms. Shockwave IVL proved once again its safety profile, reporting 0% severe procedural complications (includes death, perforation, flow-limiting dissection, abrupt vessel closure, ST) in the IVL arm.

Don’t miss the interview with Dr. Nick West and Dr. Alfonso Jurado-Román discussing additional insights and learnings of this trial!

Dr Alfonso Jurado-Román is a paid consultant for Shockwave Medical. See Important Safety information below.

Coronary IVL

Shockwave C2 and Shockwave C2+ Safety Information

In the United States: Rx only.

Indications for Use – The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 and C2+ Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.

Contraindications – The Shockwave C2 and C2+ Coronary IVL System is contraindicated for the following: This device is not intended for stent delivery. This device is not intended for use in carotid or cerebrovascular arteries.

Warnings – Use the IVL Generator in accordance with recommended settings as stated in the Operator’s Manual. The risk of a dissection or perforation is increased in severely calcified lesions undergoing percutaneous treatment, including IVL. Appropriate provisional interventions should be readily available. Balloon loss of pressure was associated with a numerical increase in dissection which was not statistically significant and was not associated with MACE. Analysis indicates calcium length is a predictor of dissection and balloon loss of pressure. IVL generates mechanical pulses which may cause atrial or ventricular capture in bradycardic patients. In patients with implantable pacemakers and defibrillators, the asynchronous capture may interact with the sensing capabilities. Monitoring of the electrocardiographic rhythm and continuous arterial pressure during IVL treatment is required. In the event of clinically significant hemodynamic effects, temporarily cease delivery of IVL therapy.

Precautions – Only to be used by physicians trained in angiography and intravascular coronary procedures. Use only the recommended balloon inflation medium. Hydrophilic coating to be wet only with normal saline or water and care must be taken with sharp objects to avoid damage to the hydrophilic coating. Appropriate anticoagulant therapy should be administered by the physician. Precaution should be taken when treating patients with previous stenting within 5mm of target lesion.

Potential adverse effects consistent with standard based cardiac interventions include- Abrupt vessel closure – Allergic reaction to contrast medium, anticoagulant and/or antithrombotic therapy-Aneurysm-Arrhythmia-Arteriovenous fistula-Bleeding complications-Cardiac tamponade or pericardial effusion-Cardiopulmonary arrest-Cerebrovascular accident (CVA)-Coronary artery/vessel occlusion, perforation, rupture or dissection-Coronary artery spasm-Death-Emboli (air, tissue, thrombus or atherosclerotic emboli)-Emergency or nonemergency coronary artery bypass surgery-Emergency or nonemergency percutaneous coronary intervention-Entry site complications-Fracture of the guide wire or failure/malfunction of any component of the device that may or may not lead to device embolism, dissection, serious injury or surgical intervention-Hematoma at the vascular access site(s)- Hemorrhage-Hypertension/Hypotension-Infection/sepsis/fever-Myocardial Infarction-Myocardial Ischemia or unstable angina-Pain-Peripheral Ischemia-Pseudoaneurysm-Renal failure/insufficiency-Restenosis of the treated coronary artery leading to revascularization-Shock/pulmonary edema-Slow flow, no reflow, or abrupt closure of coronary artery-Stroke Thrombus-Vessel closure, abrupt-Vessel injury requiring surgical repair-Vessel dissection, perforation, rupture, or spasm.

Risks identified as related to the device and its use: Allergic/immunologic reaction to the catheter material(s) or coating-Device malfunction, failure, or balloon loss of pressure leading to device embolism, dissection, serious injury or surgical intervention-Atrial or ventricular extrasystole-Atrial or ventricular capture.

Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions and adverse events. www.shockwavemedical.com/IFU.

The CathPCI Registry Post-Approval Study (PAS) aimed to understand the utilization and in-hospital outcomes of the Shockwave coronary intravascular lithotripsy (IVL) system in a real-world environment following its regulatory approval study. Throughout the study, a considerable number of patients with acute coronary syndrome (ACS) received IVL who were not included in the original regulatory studies, so the study investigators decided to do a post-hoc safety analysis on these patients.

In this Q&A, we invited Dr. Dean Kereiakes, Christ Hospital Heart and Vascular Institute, to share his interpretation of the study’s conclusions and the data he presented at SCAI 2024, as well as provide insight as to how he believes the findings may impact the daily practice of physicians treating calcified lesions in these additionally complex patients.

What is the significance of coronary artery calcification for patients undergoing PCI?

Dr. Kereiakes: Moderate to severe coronary artery calcification may be present in 25 to 30%¹ of patients undergoing PCI, and it can significantly impact the outcomes by impeding optimal stent deployment through asymmetry, apposition and expansion, and coronary edge dissection. If coronary artery calcium is not adequately modified, MACE events increase peri-procedurally and throughout long term follow up (out to 10+ years).  

What prompted the analysis of the Acute Coronary Syndrome subgroup?

Dr. Kereiakes: An analysis was conducted of 18,893 PCI procedures that utilized the Shockwave C2 coronary iVL technology in a real-world environment looking at data from the ACC NCDR Cath PCI registry to better understand the utilization and in-hospital outcomes. Of the 18,893 patients, only 6% satisfied the inclusion criteria of the PAS, meaning that 94% of the cohort did not meet the inclusion/exclusion criteria for the PAS and previously conducted DISRUPT CAD studies. The acute coronary syndrome sub-group made up 36% of the non-PAS group.

How has IVL provided an opportunity for challenging patient subsets? 

Dr. Kereiakes: Intravascular lithotripsy has demonstrated safety based on the Cath PCI data, and based on the DISRUPT CAD series of trials, IVL has also demonstrated efficacy in modifying calcium. One could argue that’s a different population of patients, but the severity of calcium in DISRUPT CAD III, for example, was worse than other IDE trials, and IVL was very effective – minimum stent areas (MSAs) > 6 mm² and stent expansion > 100%, regardless of the arc of calcium, even stratified by quartiles of calcium arc up to 360 degrees.

Tell us about the patient characteristics of the ACS subgroup?

Dr. Kereiakes: These patients are complex; they include multiple lesions, acute coronary syndrome, etc. The average age was 73, 67% were male, 10% of these patients were on hemodialysis for kidney replacement, 55% had diabetes, and 93% had hypertension. The average lesion length was 32 mm. Severe calcification (site determined, not core lab adjudicated) was 57%, and almost 80% of these patients had complex lesion morphology.

What were the outcomes for the ACS patients that were treated with IVL?

Dr. Kereiakes: The most common procedure performed was IVL + stent placement (69.4%), followed by IVL + stent + atherectomy (18.1%), and with respect to intra-procedure severe angiographic complications, coronary perforation in the ACS population was observed in 0.6%, and complex coronary artery dissection was observed in 0.8%. All data were site-reported, not independently adjudicated or assessed by a core lab, and predominantly comprised of in-hospital outcomes.

How was the bedside risk score applied and why is it an important metric when evaluating the use of technology? 

Dr. Kereiakes: The bedside risk score, derived from the ACC NCDR Cath PCI database, is a validated model for predicting in-hospital mortality.² With IVL, we are seeing in-hospital mortality rates that are in line with what we would predict.

The CATH PCI data analysis includes both STEMI and NSTEMI ACS patients. How should physicians approach these groups of patients when there’s calcium present? 

Dr. Kereiakes: Anytime thrombus is present, it complicates the issue. Calcium is one thing, but calcium and thrombus makes it even more complex. It’s been my experience that the chance of slow flow and no reflow are increased, particularly if using atheroablative technologies, so having the ability to modify calcium and to optimize stent deployment without using atheroablative technologies is a benefit and is a step forward in our portfolio of tools to intervene in ACS patients.

How does the Cath PCI data inform calcium modification strategy with ACS patients?

Dr. Kereiakes: First and foremost, the Cath PCI data supports the safety of this technology. For many of these patients, it was the center’s first opportunity to utilize the technology, and the observed mortality in the PAS, Non-PAS and the ACS subsets of the Cath PCI data is in line with what would be predicted based on risk scoring. This is a complex group of patients and the safety as reflected by in-hospital mortality is in line with what would be predicted based on the complexity of any of those groups – ACS, NSTEMI, or STEMI.

How should physicians use this new data? 

Dr. Kereiakes: Physicians can use this data both for comfort and for confidence for themselves and when discussing it with patients. Based on data from a large population of patients, we know that IVL is a safe technique, and based on prior Shockwave-sponsored studies that excluded the ACS patient population, it’s been shown to very effectively modify calcium and optimize stent deployment.

What are your main takeaways from this analysis?

Dr. Kereiakes: In the real-world more complex patients with complex lesions, the safety of IVL was consistent with prior clinical trials. ACS represents over 30% of all coronary IVL cases, and the observed in-hospital mortality rates were in line with the predicted risk.

1: Genereux P et al. JACC 2014; 63:1845-1854. 

2: Castro-Dominguez Y et al. JACC 2021; 78:216-229. 

IVL efficacy in an ACS subpopulation has not been studied or proven in Shockwave sponsored studies.   

Views expressed are those of the author and not necessarily those of Shockwave Medical. Dr. Dean Kereiakes is a paid consultant for Shockwave Medical. See important safety information below. 

Coronary IVL

Shockwave C2 and Shockwave C2+ Safety Information

In the United States: Rx only.

Indications for Use – The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 and C2+ Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.

Contraindications – The Shockwave C2 and C2+ Coronary IVL System is contraindicated for the following: This device is not intended for stent delivery. This device is not intended for use in carotid or cerebrovascular arteries.

Warnings – Use the IVL Generator in accordance with recommended settings as stated in the Operator’s Manual. The risk of a dissection or perforation is increased in severely calcified lesions undergoing percutaneous treatment, including IVL. Appropriate provisional interventions should be readily available. Balloon loss of pressure was associated with a numerical increase in dissection which was not statistically significant and was not associated with MACE. Analysis indicates calcium length is a predictor of dissection and balloon loss of pressure. IVL generates mechanical pulses which may cause atrial or ventricular capture in bradycardic patients. In patients with implantable pacemakers and defibrillators, the asynchronous capture may interact with the sensing capabilities. Monitoring of the electrocardiographic rhythm and continuous arterial pressure during IVL treatment is required. In the event of clinically significant hemodynamic effects, temporarily cease delivery of IVL therapy.

Precautions – Only to be used by physicians trained in angiography and intravascular coronary procedures. Use only the recommended balloon inflation medium. Hydrophilic coating to be wet only with normal saline or water and care must be taken with sharp objects to avoid damage to the hydrophilic coating. Appropriate anticoagulant therapy should be administered by the physician. Precaution should be taken when treating patients with previous stenting within 5mm of target lesion.

Potential adverse effects consistent with standard based cardiac interventions include- Abrupt vessel closure – Allergic reaction to contrast medium, anticoagulant and/or antithrombotic therapy-Aneurysm-Arrhythmia-Arteriovenous fistula-Bleeding complications-Cardiac tamponade or pericardial effusion-Cardiopulmonary arrest-Cerebrovascular accident (CVA)-Coronary artery/vessel occlusion, perforation, rupture or dissection-Coronary artery spasm-Death-Emboli (air, tissue, thrombus or atherosclerotic emboli)-Emergency or nonemergency coronary artery bypass surgery-Emergency or nonemergency percutaneous coronary intervention-Entry site complications-Fracture of the guide wire or failure/malfunction of any component of the device that may or may not lead to device embolism, dissection, serious injury or surgical intervention-Hematoma at the vascular access site(s)- Hemorrhage-Hypertension/Hypotension-Infection/sepsis/fever-Myocardial Infarction-Myocardial Ischemia or unstable angina-Pain-Peripheral Ischemia-Pseudoaneurysm-Renal failure/insufficiency-Restenosis of the treated coronary artery leading to revascularization-Shock/pulmonary edema-Slow flow, no reflow, or abrupt closure of coronary artery-Stroke Thrombus-Vessel closure, abrupt-Vessel injury requiring surgical repair-Vessel dissection, perforation, rupture, or spasm.

Risks identified as related to the device and its use: Allergic/immunologic reaction to the catheter material(s) or coating-Device malfunction, failure, or balloon loss of pressure leading to device embolism, dissection, serious injury or surgical intervention-Atrial or ventricular extrasystole-Atrial or ventricular capture.

Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions and adverse events. www.shockwavemedical.com/IFU.

Drs. Erik Stilp, Nicolas Mouawad, Elizabeth Genovese and Kumar Madassery discuss their best practices when treating patients with below-the-knee (BTK) disease. Follow along as they share case reviews and explain how Shockwave IVL plays a role in their toolbox for treating calcified BTK disease. The experts will review:

• Challenges of treating BTK disease
• Current endovascular treatment options
• How Shockwave IVL safely modifies calcium BTK
• BTK case review

Visit HMP Global Learning Network to watch the video:

The physicians featured are paid consultants of Shockwave Medical.

Peripheral IVL

Shockwave M5+, Shockwave M5, Shockwave S4, Shockwave L6 and Shockwave E8 Safety Information

In the United States: Rx only.

Indications for Use – The Shockwave Medical Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary, carotid or cerebral vasculature.

Contraindications – Do not use if unable to pass 0.014″ (M5, M5+, S4, E8) or 0.018″ (L6) guidewire across the lesion-Not intended for treatment of in-stent restenosis or in coronary, carotid, or cerebrovascular arteries.

Warnings – Only to be used by physicians who are familiar with interventional vascular procedures–Physicians must be trained prior to use of the device–Use the generator in accordance with recommended settings as stated in the Operator’s Manual.

Precautions – use only the recommended balloon inflation medium-Appropriate anticoagulant therapy should be administered by the physician-Decision regarding use of distal protection should be made based on physician assessment of treatment lesion morphology. Adverse effects-Possible adverse effects consistent with standard angioplasty include-Access site complications-Allergy to contrast or blood thinner-Arterial bypass surgery-Bleeding complications-Death-Fracture of guidewire or device-Hypertension/Hypotension-Infection/sepsis-Placement of a stent-renal failure-Shock/pulmonary edema-target vessel stenosis or occlusion-Vascular complications. Risks unique to the device and its use-Allergy to catheter material(s)-Device malfunction or failure-Excess heat at target site.

Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions and adverse events. www.shockwavemedical.com/ifu

In this Q&A, Dr. Vamsi Krishna, an Interventional and Endovascular Cardiologist and the Medical Director for Cardiac Catheterization and Cardiac Rehab at Ascension Seton Heart Institute in Austin, TX breaks down his thought process while treating a severely calcified and heavily stenosed lesion within a female patient. Watch the full case breakdown on Murmur – a new social media platform designed for and by cardiologists.

How did the patient characteristics (sex, age, etc.) influence or inform your pre-procedural strategy or thinking?

Dr. Krishna: This patient was an 80 year old female with long standing hypertension. We know that female patients present to the cath lab later in life – as is the case with this patient – with more complex disease and smaller reference vessel diameters as compared to male patients. The above may explain why female patients tend to have worse atherectomy outcomes as compared to male patients.

With this in mind I thought IVL may be an ideal upfront strategy – assuming I could cross the lesion with the device – based on the promising data from the CAD clinical program demonstrating consistent acute and long-term outcomes between male and female patients treated with IVL.

Angiographically you can appreciate a very tight calcified lesion – a near total occlusion – within the proximal RCA. Can you comment on your strategy to deliver devices (balloons, imaging, etc.) across the lesion within this case? Any reason to not try atherectomy up-front to facilitate device delivery?

Dr. Krishna: I preferred to avoid atherectomy to facilitate device delivery within this female patient for the reasons stated above. Fortunately, with some difficulty, I was able to cross the lesion with a Pilot 200 guidewire and a microcatheter. I then swapped the existing guidewire with a Wiggle wire which is my workhorse wire for calcified lesions and was ultimately able pre-dilate the lesion with a 1.25 mm balloon. This ultimately facilitated delivery of an OCT imaging catheter that allowed me to confirm the severity of calcium present within the lesion.

Knowing that the crossing profile of the OCT catheter is similar to Coronary IVL, I was confident I would be able to deliver IVL across the lesion for calcium modification.

What was your rationale for using IVL upfront in this case? Why not try another strategy (scoring/cutting balloon, atherectomy) first within this lesion?

Dr. Krishna: Using intravascular imaging every case allows for me to determine disease morphology, treatment length and vessel size. The calcium presentation within the lesion is of great interest since it changes the modification strategy. The OCT image demonstrated circumferential, deep and lengthy calcified disease satisfying the “rule of 5’s” which made it clear to advanced lesion prep was needed.

Given the calcium arc, depth and length of the calcium present along the treatment lesion I simply didn’t think cutting balloons would, for a lack of a better phrase, cut it. In general, I am not keen on using scoring / cutting balloons for calcium given the challenges associated with deliverability. So given my confidence that IVL would cross combined with my desire to avoid atherectomy for the reasons stated above positioned Coronary IVL as an ideal upfront strategy for this case.

How were the additional pulses found in Shockwave C2+ (120 pulses per catheter) utilized in this case? How would this case look differently if you only had the prior generation of Coronary IVL (80 pulses per catheter)?

Dr. Krishna: In general, the 120 pulses found in Shockwave C2+ allow me to better modify longer and more challenging calcium as compared to the previous version. The additional pulses pairs nicely with the known mechanistic benefits and clinically demonstrated consistency of IVL across calcium morphologies. Notably, I have found that Minimal Stent Area (MSA) on OCT improves when I use all 120 pulses on eccentric, deep calcium patients as demonstrated by this patient’s post PCI OCT image. So, to answer the question, the additional pulses found in Shockwave C2+ allowed me to better address the challenging calcium within this lesion as compared to the prior version.

Any final thoughts or key takeaways to share regarding this case?

Dr. Krishna: This case reinforces why IVL is a promising therapy option for female patients with balloon crossable, calcified lesions given its safety profile and effectiveness within severe calcium. I’m looking forward to seeing the results of the EMPOWER CAD which is designed to prospectively study IVL outcomes within female patients. I suspect the results of EMPOWER CAD will confirm the existing, positive results from the retrospective analysis.

Secondly, IVL device delivery is possible within very tight, near sub-total occlusions by utilizing sound delivery strategies such as the use of supportive wires (i.e Wiggle), pre-dilatation with NC balloons, and/or unsheathing techniques with guide extensions.

In short, IVL’s mechanism of action is uniquely designed to safely, effectively and intuitively modify severe calcium — this case is another example of why IVL continues to be my preferred, up-front strategy for balloon crossable calcified lesions.

Coronary IVL

Shockwave C2 and Shockwave C2+ Safety Information

In the United States: Rx only.

Indications for Use – The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 and C2+ Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.

Contraindications – The Shockwave C2 and C2+ Coronary IVL System is contraindicated for the following: This device is not intended for stent delivery. This device is not intended for use in carotid or cerebrovascular arteries.

Warnings – Use the IVL Generator in accordance with recommended settings as stated in the Operator’s Manual. The risk of a dissection or perforation is increased in severely calcified lesions undergoing percutaneous treatment, including IVL. Appropriate provisional interventions should be readily available. Balloon loss of pressure was associated with a numerical increase in dissection which was not statistically significant and was not associated with MACE. Analysis indicates calcium length is a predictor of dissection and balloon loss of pressure. IVL generates mechanical pulses which may cause atrial or ventricular capture in bradycardic patients. In patients with implantable pacemakers and defibrillators, the asynchronous capture may interact with the sensing capabilities. Monitoring of the electrocardiographic rhythm and continuous arterial pressure during IVL treatment is required. In the event of clinically significant hemodynamic effects, temporarily cease delivery of IVL therapy.

Precautions – Only to be used by physicians trained in angiography and intravascular coronary procedures. Use only the recommended balloon inflation medium. Hydrophilic coating to be wet only with normal saline or water and care must be taken with sharp objects to avoid damage to the hydrophilic coating. Appropriate anticoagulant therapy should be administered by the physician. Precaution should be taken when treating patients with previous stenting within 5mm of target lesion.

Potential adverse effects consistent with standard based cardiac interventions include- Abrupt vessel closure – Allergic reaction to contrast medium, anticoagulant and/or antithrombotic therapy-Aneurysm-Arrhythmia-Arteriovenous fistula-Bleeding complications-Cardiac tamponade or pericardial effusion-Cardiopulmonary arrest-Cerebrovascular accident (CVA)-Coronary artery/vessel occlusion, perforation, rupture or dissection-Coronary artery spasm-Death-Emboli (air, tissue, thrombus or atherosclerotic emboli)-Emergency or nonemergency coronary artery bypass surgery-Emergency or nonemergency percutaneous coronary intervention-Entry site complications-Fracture of the guide wire or failure/malfunction of any component of the device that may or may not lead to device embolism, dissection, serious injury or surgical intervention-Hematoma at the vascular access site(s)- Hemorrhage-Hypertension/Hypotension-Infection/sepsis/fever-Myocardial Infarction-Myocardial Ischemia or unstable angina-Pain-Peripheral Ischemia-Pseudoaneurysm-Renal failure/insufficiency-Restenosis of the treated coronary artery leading to revascularization-Shock/pulmonary edema-Slow flow, no reflow, or abrupt closure of coronary artery-Stroke Thrombus-Vessel closure, abrupt-Vessel injury requiring surgical repair-Vessel dissection, perforation, rupture, or spasm.

Risks identified as related to the device and its use: Allergic/immunologic reaction to the catheter material(s) or coating-Device malfunction, failure, or balloon loss of pressure leading to device embolism, dissection, serious injury or surgical intervention-Atrial or ventricular extrasystole-Atrial or ventricular capture.

Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions and adverse events. www.shockwavemedical.com/IFU.

Get your wetsuits ready because Shockwave’s SCAI 2024 lineup will cause some serious waves in Long Beach. Take a look at the hot topics Shockwave has in store for you this year including:

Cracking Open the Discussion on the Clinical Experience with Coronary IVL in ACS

Friday, May 3 12:20pm – 1:20pm PST

Imaging Guided Approach to Coronary Calcium: Application of the SCAI Consensus Document*

Thursday, May 2 8:15am – 9:15am PST

Preview the discussion by reading the SCAI Consensus Statement

OR02-9 Characteristics, Trends, and Outcomes of IVL-Assisted Transfemoral Transcatheter Aortic Valve Replacement in the United States: A Nationwide Analysis from the Vizient Clinical Database*

Saturday, May 2 12:30pm – 1:30pm PST

OR04-1 In-hospital Results with IVL in the Real-World: Outcomes from the ACC NCDR CathPCI Registry*

Thursday, May 2 3:40pm – 3:45pm PST

*Views expressed during the scientific sessions are those of the speakers, and necessarily of Shockwave Medical.

See the full IVL lineup in the eFlyer below:

To download the full eFlyer, click here.

Ein aufregendes Jahr 2023 liegt hinter uns mit drei großen Highlights: Verbesserung der Erstattungslage für die koronare IVL in Deutschland, Launch des neuen koronaren IVL C2+ Katheters und die Integration des REDUCERs in die Shockwave Produktpalette!

Was hält Shockwave in 2024 für Sie bereit? Soviel sei gesagt, es wird bestimmt nicht langweilig mit uns!

Gemeinsam wird bei uns 2024 großgeschrieben: Besuchen Sie uns auf der DGK Jahrestagung am gemeinsamen IVL & REDUCER Stand #211 in der 1. Etage auf einen Coffee-Shock und ein gutes Gespräch!

Lernen Sie, wie die Anwender-Teams im IVL Symposium unter der Leitung von Prof. Dr. Alexander Ghanem und PD Dr. Luise Gaede gemeinsam die Herausforderungen von verschiedenen komplexen koronaren Verkalkungen bewältigen.

Wir freuen uns insbesondere auf Dr. Ziad Ali als International Keynote Speaker! Läuten Sie mit uns gemeinsam den Freitagabend ein! Die Mannheim Team-Besprechung mit Snacks und Getränken.

Shockwave C2+

Vor der Anwendung lesen Sie bitte die Gebrauchsanweisung für weitere Informationen über Indikationen, Kontraindikationen, Warnhinweise, Vorsichtsmaßnahmen und unerwünschte Ereignisse: www.shockwavemedical.com/IFU 

Bitte wenden Sie sich an Ihren Shockwave-Vertreter vor Ort, um die länderspezifische Verfügbarkeit zu erfahren. 

Shockwave Reducer

Vor der Anwendung lesen Sie bitte die Gebrauchsanweisung für weitere Informationen über Indikationen, Kontraindikationen, Warnhinweise, Vorsichtsmaßnahmen und unerwünschte Ereignisse: ifu.neovasc.com

Bitte wenden Sie sich an Ihren örtlichen Shockwave-Vertreter, um Informationen zur spezifischen Länderverfügbarkeit zu erhalten.

Though sizing 1:1 to the healthy RVD may be a customary approach seen in other devices like traditional balloon angioplasty, peripheral IVL is an exception to the rule. It’s recommended to oversize peripheral IVL by 10% (a ratio of 1.1:1) to the healthy RVD because it achieves better and sustained wall apposition, which leads to more efficient energy transfer from the IVL device.^{1, 2, 3}

Under-sizing often happens with peripheral IVL (and other endovascular devices) due to concerns over safety and the limitations of angiography, which can result in undertreatment. However, it’s important to remember that IVL operates at ultra-low pressures and is different from traditional angioplasty in that it relies on sonic pressure waves to do the calcium cracking, not mechanical force from the balloon itself. In addition, the DISRUPT PAD clinical program shows very low complication rates with IVL across peripheral vessel beds, even when the device is oversized by 10% or greater.

Undersized peripheral IVL leads to:

• Energy loss, associated with less fracturing¹

Optimally Sized Peripheral IVL (oversizing by 10%) leads to:

• Efficient energy transfer, associated with enhanced fracturing, improved stenosis reduction and better patency rates^{1, 2, 3}

Clinical Evidence for Oversizing

Evidence from the DISRUPT PAD clinical program (DISRUPT PAD II and DISRUPT PAD III Observational Study) shows that oversizing results in improved outcomes in terms of stenosis reduction and patency, all achieved with ultra-low treatment pressures (2-4 atm) and minimal complications, without compromising outcomes.

Improved Stenosis Reduction

• The DISRUPT PAD III Observational Study of 1,373 patients represents the largest prospective ‘real-world’ evidence for the treatment of heavily calcified peripheral arterial disease.
• Per a multivariable analysis, oversizing by 10% or greater was an independent predictor of improved stenosis reduction across multiple peripheral vessel beds but not a predictor of complications.²

Check out the DISRUPT PAD III Observational Study to learn more.

Improved Patency

• The DISRUPT PAD II trial was a multi-center study prospectively enrolling heavily calcified, stenotic, femoropopliteal arteries with a 12-month follow-up.
• In DISRUPT PAD II, the optimal IVL technique* (including oversizing by 10% vs. the healthy reference vessel diameter) was associated with 15% improved primary patency & rate of CD-TLR in PAD II.³
• This technique was performed in the absence of drug, using only IVL and no drug-eluting technology.

Check out DISRUPT PAD II to learn more.

As mentioned above, Shockwave IVL works at ultra-low treatment pressures. Our data shows IVL maintains its exceptional safety profile and efficacy as a calcium modification tool even when oversized by 10%. When combined, these pillars allow you to confidently employ optimal sizing techniques in your treatment approach.

Using RVD vs. MLD for Sizing: Pre-FEVAR

By Dr. Mazin Foteh

Dr. Foteh is a paid consultant of Shockwave Medical.

As you can see, while Dr. Foteh measured the minimum lumen diameter (MLD) to be 4.5 mm, the healthy reference vessel diameter (RVD) measured to 9.5 mm. To optimize his treatment with IVL, Dr. Foteh used a 10.0 mm Shockwave L6.

Read the article, “Adding 8-12mm diameter devices to the Shockwave Peripheral Intravascular Lithotripsy toolkit,” to learn more.

Size for Success with Peripheral IVL – Interview & Case Review with Dr. Paul Foley

In this sizing discussion and case review, Dr. Paul Foley elaborates on his journey using Shockwave IVL and what led him to oversize peripheral IVL by 10% to receive optimized results.

Dr. Foley further shares his experience through reviewing three cases:

• Case 1: Calcified Bilateral Common Iliac Artery Stenoses
• Case 2: Calcified Left Popliteal Stenosis
• Case 3: BTK Intervention for CLTI

Size for Success Video Series

In this 3-part video series, Dr. Eric Secemsky (Interventional Cardiologist, Beth Israel Deaconess in Boston, MA) and Dr. Michael Siah (Vascular Surgeon, UT Southwestern Medical Center in Dallas, TX) discuss appropriate peripheral intravascular lithotripsy (IVL) sizing — the what, why and how — for optimal clinical results.

• Part 1: Why We Undersize Our Endovascular Tools & the Importance of IVUS
• Part 2: Peripheral IVL Sizing for Optimal Results
• Part 3: Putting Optimal Peripheral IVL Sizing Into Action – Case Review

Check out the video series on HMP Global Learning Network.

Peer-to-Peer Articles

In the latest Endovascular Today article on Sizing for Success, Drs. Sasanka Jayasuriya and Paul J. Foley discuss:

• How they size their endovascular tools
• Their experience oversizing Peripheral IVL by 10%
• Their preferred imaging modalities
• Multiple case examples highlighting their sizing approach

Now in Journal of Vascular and Interventional Radiology, Drs. Patrick Harty and Varshana Gurusamy share their experience oversizing with peripheral IVL and share two case reviews:

• Popliteal Disease in CLTI patient
• Below the Knee Disease in CLTI patient

The physicians featured are paid consultants for Shockwave Medical.

1: Kereiakes et. al. J Am Coll Cardiol Intv 2021.

2: Data on file at Shockwave Medical.

3: Brodmann et al. Catheter Cardiovascular Interv. 2018; 1-8.

4: Tepe et al, J Am Coll Cardiol Intv 2021.

5: Armstrong E, VIVA Late Breaking Clinical Trial 2022.

Important Safety Information

In the United States: Rx only.

Indications for Use—The Shockwave Medical Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary, carotid or cerebral vasculature.

Contraindications—Do not use if unable to pass 0.014″ (M5, M5+, S4, E8) or 0.018″ (L6) guidewire across the lesion-Not intended for treatment of in-stent restenosis or in coronary, carotid, or cerebrovascular arteries.

Warnings—Only to be used by physicians who are familiar with interventional vascular procedures—Physicians must be trained prior to use of the device—Use the generator in accordance with recommended settings as stated in the Operator’s Manual.

Precautions—use only the recommended balloon inflation medium—Appropriate anticoagulant therapy should be administered by the physician—Decision regarding use of distal protection should be made based on physician assessment of treatment lesion morphology.

Adverse effects–Possible adverse effects consistent with standard angioplasty include–Access site complications–Allergy to contrast or blood thinner–Arterial bypass surgery—Bleeding complications—Death—Fracture of guidewire or device—Hypertension/Hypotension—Infection/sepsis—Placement of a stent—renal failure—Shock/pulmonary edema—target vessel stenosis or occlusion—Vascular complications. Risks unique to the device and its use—Allergy to catheter material(s)— Device malfunction or failure—Excess heat at target site.

Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions and adverse events. https://discover.shockwavemedical.com/ifu

Please contact your local Shockwave representative for specific country availability.

As one of the biggest calcium publications of 2023, JACC: Cardiovascular Interventions’ inclusion of the “Direct Comparison of Rotational vs Orbital Atherectomy for Calcified Lesions Guided by Optical Coherence Tomography” study, also known as DIRO, was notable as the first prospective randomized trial comparing rotational atherectomy (RA) and orbital atherectomy (OA). In the below Q&A, we invited its lead author Dr. Naotaka Okamoto of Osaka Rosai Hospital in Osaka, Japan to share his interpretation of the findings, how the results may impact the role of RA and OA in the cath lab, and the possibility of future research on the topic.

What makes the DIRO study unique?

Dr. Okamoto: The DIRO study is the first prospective randomized trial to compare the OCT findings and clinical outcomes in patients treated with rotational atherectomy (RA) versus orbital atherectomy (OA). All procedures were performed under OCT guidance in this study. While there are several previous studies comparing OCT findings and clinical outcomes after RA and OA, they were retrospective, and not all PCIs were performed with OCT. Therefore, the “prospective” and “OCT-guided” aspects of the DIRO study are unique points.

What were the key findings of the DIRO study and what key factors do you think led to them?

Dr. Okamoto: In this study, we analyzed both pre- and post-atherectomy OCT images to evaluate accurate and pure tissue modification resulting from atherectomy devices, and we observed greater tissue modification after RA compared to OA. Interventional cardiologists familiar with IVUS or OCT might have the impression that RA can achieve larger tissue modification than OA. However, not many interventional cardiologists are familiar with intracoronary imaging. For them, the result can be surprising. Furthermore, the finding that greater stent expansion resulted in larger tissue modification after RA than OA was surprising to me.

Do the study results align with what you personally experience in clinical practice?

Dr. Okamoto: As I mentioned above, I have the impression that RA can achieve larger tissue modification than OA and the DIRO study confirmed my impression. Furthermore, the finding that a bigger burr of RA can create a bigger tissue modification aligns with my experience.

Has DIRO generated any follow-on research ideas?

Dr. Okamoto: Yes, we are considering substudies of the DIRO study. For example, exploring the risk factors of slow-flow phenomenon and relevant factors of stent under-expansion after adequate tissue modification could be interesting. Additionally, comparison OCT findings after IVL, RA and OA is also intriguing, and we are currently prospectively collecting OCT images after IVL.

Given the findings of the study, are there certain clinical situations that you would still advocate for the use of OA over RA despite its decreased tissue modification ability?

Dr. Okamoto: Rotational atherectomy (RA) and orbital atherectomy (OA) are approaches to reduce calcium volume, and the DIRO study demonstrated that RA can eliminate more calcium. RA is favorable according to this result, but the DIRO study also demonstrated that RA tended to cause slow or no flow immediately after atherectomy compared with OA. This is probably explained by 3 reasons: 1) the amount of ablated plaque was small with OA; 2) OA is not likely to lead to burr wedge during atherectomy, because of its small burr size; and 3) OA can modify only target calcified lesions, whereas RA with large burr occasionally modifies not only target calcified lesions but proximal diseased lesions, even when they contain elastic tissue. Therefore, there is a stage at which OA plays an active role, especially for patients with a low ejection fractions or the last remaining coronary artery after old myocardial infarction, in whom slow or no flow can be critical even if it is transient.

Okamoto, N., Egami, Y., Nohara, H., Kawanami, S., Sugae, H., Kawamura, A., Ukita, K., Matsuhiro, Y., Nakamura, H., Yasumoto, K., Tsuda, M., Matsunaga-Lee, Y., Yano, M., Nishino, M., & Tanouchi, J. (2023). Direct comparison of rotational vs orbital atherectomy for calcified lesions guided by optical coherence tomography. JACC: Cardiovascular Interventions, 16(17), 2125–2136. https://doi.org/10.1016/j.jcin.2023.06.016

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

Dr. Naotaka Okamoto is a paid consultant for Shockwave Medical. See Important Safety information below.

Coronary Important Safety Information:

In the United States: Rx only 

Indications for Use— The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2+ Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.

Contraindications— The Shockwave C2+ Coronary IVL System is contraindicated for the following: This device is not intended for stent delivery. This device is not intended for use in carotid or cerebrovascular arteries.

Warnings—Use the IVL Generator in accordance with recommended settings as stated in the Operator’s Manual. The risk of a dissection or perforation is increased in severely calcified lesions undergoing percutaneous treatment, including IVL. Appropriate provisional interventions should be readily available. Balloon loss of pressure was associated with a numerical increase in dissection which was not statistically significant and was not associated with MACE. Analysis indicates calcium length is a predictor of dissection and balloon loss of pressure. IVL generates mechanical pulses which may cause atrial or ventricular capture in bradycardic patients. In patients with implantable pacemakers and defibrillators, the asynchronous capture may interact with the sensing capabilities. Monitoring of the electrocardiographic rhythm and continuous arterial pressure during IVL treatment is required. In the event of clinically significant hemodynamic effects, temporarily cease delivery of IVL therapy.

Precautions— Only to be used by physicians trained in angiography and intravascular coronary procedures. Use only the recommended balloon inflation medium. Hydrophilic coating to be wet only with normal saline or water and care must be taken with sharp objects to avoid damage to the hydrophilic coating. Appropriate anticoagulant therapy should be administered by the physician. Precaution should be taken when treating patients with previous stenting within 5mm of target lesion.

Potential adverse effects consistent with standard based cardiac interventions include– Abrupt vessel closure – Allergic reaction to contrast medium, anticoagulant and/or antithrombotic therapy-Aneurysm-Arrhythmia-Arteriovenous fistula-Bleeding complications-Cardiac tamponade or pericardial effusion-Cardiopulmonary arrest-Cerebrovascular accident (CVA)-Coronary artery/vessel occlusion, perforation, rupture or dissection-Coronary artery spasm-Death-Emboli (air, tissue, thrombus or atherosclerotic emboli)-Emergency or nonemergency coronary artery bypass surgery-Emergency or nonemergency percutaneous coronary intervention-Entry site complications-Fracture of the guide wire or failure/malfunction of any component of the device that may or may not lead to device embolism, dissection, serious injury or surgical intervention-Hematoma at the vascular access site(s)- Hemorrhage-Hypertension/Hypotension-Infection/sepsis/fever-Myocardial Infarction-Myocardial Ischemia or unstable angina-Pain-Peripheral Ischemia-Pseudoaneurysm-Renal failure/insufficiency-Restenosis of the treated coronary artery leading to revascularization-Shock/pulmonary edema-Slow flow, no reflow, or abrupt closure of coronary artery-Stroke Thrombus-Vessel closure, abrupt-Vessel injury requiring surgical repair-Vessel dissection, perforation, rupture, or spasm.

Risks identified as related to the device and its use: Allergic/immunologic reaction to the catheter material(s) or coating-Device malfunction, failure, or balloon loss of pressure leading to device embolism, dissection, serious injury or surgical intervention-Atrial or ventricular extra systole-Atrial or ventricular capture.

Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions and adverse events. https://shockwavemedical.com/IFU