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.

Join Dr. Nick West, Chief Medical Officer of Shockwave Medical, Professor Andrew Holder, Auckland City Hospital, New Zealand, and Dr. Raghuram Lakshminarayan, Hull Royal Infirmary, UK, as they discuss the DISRUPT BTK II acute outcomes data at CIRSE 2024.

This discussion focuses on the procedural outcomes of the DISRUPT BTK II trial which studied the treatment of Intravascular Lithotripsy (IVL) for calcified below-the-knee (BTK) arterial disease. The study, which is the largest of its kind with 250 patients, focuses on treating severely calcified lesions in a complex patient population, including a high percentage of patients with diabetes and those with renal impairment. The findings highlight IVL’s strong safety profile and efficacy, with a low rate of angiographic complications and a high success rate in achieving significant luminal gain without the need for stenting in most cases.

The experts conclude that these results validate IVL’s role in BTK interventions and may encourage its broader adoption, particularly with the introduction of new IVL catheter technologies for endovascular treatments.

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.

Professor Andrew Holder and Dr. Raghuram Lakshminarayan 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.

The SCAI Consensus Statement on the Management of Calcified Coronary Lesions aimed to create an algorithmic approach to treating calcified CAD. The purpose of the publication was to put forth an expert consensus document regarding methods to identify types of calcified coronary lesions, a central algorithm to help guide use of the various calcium modification strategies, tips for when using each treatment modality, and a look at future studies and trials for treating this challenging lesion subset. In this Q&A, we invited Dr. Deepthi Sudhakar, Sharp Memorial Hospital, San Diego, CA and the Committee Co-Chair of SCAI WIN, to share her insights on the algorithm’s recommendations and its impact on her daily practice.

Download the SCAI Algorithm

What was your algorithm before you came across the SCAI Algorithm¹?

Dr. Sudhakar: The SCAI expert consensus statement on the management of calcified coronary lesions provides valuable guidance on the management of severely calcified lesions, which are amongst the most challenging cases we encounter. With all the tools now available for plaque modification and variability in lesion types, this document distills the management of a complex subset of lesions into a streamlined algorithm. I frequently use intravascular imaging for guiding lesion preparation; however, since reviewing this algorithm, I have increased my use of imaging after modification to assess adequacy. I have also increased the use of more than one tool for lesion preparation. 

How important is it to have society guidance on things like calcium specifically? 

Dr. Sudhakar: We are seeing increasingly higher rates of complex calcified lesions and restenosis lesions, and this, coupled with the advancement of new technologies for plaque modification, has led to a lot of heterogeneity in our understanding and management of these lesions. The publication of this statement is well-timed and serves a need for a thoughtful, standardized approach to these lesions. Importantly, it highlights that not all calcified lesions are created equal, and modification is not a one-size-fits-all approach. There is a lot of emphasis placed on imaging to understand the subset of calcified lesions before deciding on a modification strategy. This is key to choosing the most appropriate modification strategy for better long-term outcomes. It is comprehensive and encompasses several types of lesions, such as bifurcation lesions and chronic total occlusions.

Is there anything you’d change or add to the current algorithm? 

Dr. Sudhakar: Expand on the subsets of lesions where you might want to combine different modalities for calcium modification. The scarcity of existing data limits some of this, so it will be very interesting to see how the results of ongoing trials like ECLIPSE (NCT03108456), ROLLING-STONE (NCT05016726), SHORT-CUT (NCT06089135), and ROLLERCOASTR (NCT04181268) add to our understanding of modification. The addition of restenosis lesions to the algorithm would also be helpful. While more tools are available for calcium modification, not all are widely available. I think that is an important aspect to keep in mind when adopting any algorithm. The setting where lesion preparation occurs and hemodynamics are also important factors to remember.

How important is imaging in your algorithmic approach to calcium? 

Dr. Sudhakar: Imaging is crucial in any percutaneous coronary intervention, especially with calcified lesions. As the document clearly states, multiple calcified lesions and outcomes vary despite adequate preparation in some cases, such as eruptive nodules. We must understand what we are treating specifically before choosing the right modality. This is particularly true in restenosis lesions, where understanding the mechanism is critical to lesion preparation.

Was there anything about your approach or a device that the SCAI Algorithm changed?

Dr. Sudhakar: I frequently use intravascular imaging; however, this document led me to focus on more aspects of a lesion outside of arc length, such as the type of calcified nodule and depth of calcium. I have also increased my use of imaging after lesion preparation to ensure fracture and check for dissections in eccentric lesions. In contrast, before the document, I relied more often on expansion with non-compliant balloons after modification to determine the adequacy of preparation. I have also increased my use of combining atherectomy with intravascular lithotripsy in treating these lesions. 

Are there any challenges you encounter with calcium that may not have a current treatment paradigm? 

Dr. Sudhakar: Bifurcation lesions with severe calcification and restenosis lesions with protrusion of calcified nodules remain challenging subsets to treat.

Do you follow a mental step-by-step process, and if so, when does that kick in? After imaging or upon visualization by angio? 

Dr. Sudhakar: A patient’s age and underlying comorbidities are factors I consider even before the initial angiogram in forming my pre-test probability of calcified disease. On the initial angiogram, I am focusing on calcification, tortuosity at the lesion, the presence of bifurcation lesions, and estimates of vessel size. Calcification on angiography, particularly if there are eccentric lesions, shows me that I need to assess for calcified nodules when imaging. I rely on intravascular imaging to guide my modification strategy. Still, my decision also heavily depends on the patient’s characteristics, hemodynamics, and ability to tolerate one modification tool versus another.

What data do you think are still needed to verify or support the algorithm? 

Dr. Sudhakar: We have some data to support the use of atherectomy with intravascular lithotripsy; however, there needs to be long-term data, which the ongoing trials should shed some light on. Sex differences in how we treat calcified lesions are another area where we lack data, which calls for increasing enrollment in clinical trials. In this regard, EMPOWER (NCT05755711) may be able to shed some light on this topic. 

[1] Riley, Robert F., Mitul P. Patel, J. Dawn Abbott, Sripal Bangalore, Emanouil S. Brilakis, Kevin J. Croce, Darshan Doshi, et al. “SCAI Expert Consensus Statement on the Management of Calcified Coronary Lesions.” Journal of the Society for Cardiovascular Angiography & Interventions 3, no. 2 (February 2024): 101259. https://doi.org/10.1016/j.jscai.2023.101259

Dr. Deepthi Sudhakar is a paid consultant of Shockwave Medical. 

Views expressed are those of the physician and not necessarily of Shockwave Medical. Dr. Deepthi Sudhakar is a paid consultant for Shockwave Medical. See important safety information below. 

Coronary Important Safety Information:

Please contact your local Shockwave representative for specific country availability and refer to the Shockwave C2 and Shockwave C2+ instructions for use containing 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 non-emergency coronary artery bypass surgery-Emergency or non-emergency 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 warnings, precautions and adverse events.  https://shockwavemedical.com/IFU 

Dr. Parikh is a paid consultant 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  

Kalzium ist nicht nur oberflächlich … manchmal muss man in die Tiefe!

Nach dem großen Erfolg der englischsprachigen Calcium Masterclass Webinar-Reihe und auf vielfachen Wunsch haben wir unser interaktives Fortbildungsformat nun auch auf Deutsch produziert.

In den drei neuen Folgen der Calcium Masterclass befasst sich das hochkarätige Panel von Calcium Experten aus Deutschland, Österreich und der Schweiz mit den Herausforderungen des Koronarkalks. Unter anderem werden die Vermittlung eines besseren Verständnisses für die Risiken und Therapie-Möglichkeiten bei der Kalziummodifikation, die Analyse der Datenlage zur Intravaskulären Lithotripsie und die Frage, wie IVL die Gefäßvorbereitung verbessern kann, im Fokus stehen.

In der umfassenden Analyse von zwei spannenden Live-Fällen wird die Theorie der Intravaskulären Lithotripsie in der praktischen Anwendung diskutiert – Seien Sie ab 13. Sept. 2023 mit dabei!

Nehmen Sie an diesem Webinar teil, wenn Sie:

• die Herausforderungen von koronarem Kalk und ihre Auswirkungen auf die PCI-Ergebnisse verstehen wollen
• den Wirkmechanismus der intravaskulären Lithotripsie bei verkalkten Läsionen kennenlernen möchten
• verstehen möchten, wie Komplikationen bei der Behandlung von Koronarkalk minimiert werden können

am 13. Sept. 17:00 Uhr LIVE, anschließend on demand.

Folge 1 Ansehen

IVL IM KLINISCHEN ALLTAG & KALZIUM-ALGORITHMEN

Nehmen Sie an diesem Webinar teil, wenn Sie:

• die Rolle der intravaskulären Lithotripsie im Behandlungs-Algorithmus verkalkter Stenosen kennenlernen möchten.
• die neuesten Daten zur intravaskulären Lithotripsie aus dem DISRUPT-CAD-Datenpool kennenlernen möchten.
• einen komplexen Fall einer linken Hauptstemm-Bifurkation verfolgen möchten.

am 27. Sept. 17:00 Uhr LIVE, anschließend on demand.

Folge 2 Ansehen

DIE MÖGLICHKEITEN DER IVL UND WANN EINE THERAPIE-KOMBINATION SINNVOLL IST

Nehmen Sie an diesem Webinar teil, wenn Sie

• anhand klinischer Best Practice Beispiele mehr über die Behandlung schwieriger kalzifizierter Läsionen lernen möchten
• die Wirksamkeit der IVL bei exzentrischen und nodulären Verkalkungen verstehen möchten
• erfahren möchten, wann es sinnvoll ist, die IVL zur Behandlung nicht passierbarer Läsionen zu kombinieren

am 18. Okt. 17:00 Uhr LIVE, anschließend on demand.

Folge 3 Ansehen

SIND SIE GERMANY’S NEXT CALCIUM MASTER?

Finden Sie es heraus bei unserem Live-Quiz am 06. Okt. 2023 um 19:00 Uhr in der Piano Bar des GOP-Varieté Theaters, Bonn (direkt neben dem World Conference Center).

Kämpfen Sie mit unserem Experten-Team um Dr. Luise Gaede, Dr. Stefan Harb, Dr. Christina Brinkmann und Dr. Milad Golabkesh um den Sieger-Titel Germany’s Next Calcium Master!

Weitere Informationen zur Location und dem Experten-Team finden Sie im Veranstaltungsflyer hinter dem Link im Bild.

Moderiert vom Master of Ceremony Erik Rafflenbeul.

Achtung: auf 50 Teilnehmer limitiert, deshalb möglichst früh vor Ort sein.

Save the Date

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 non-emergency coronary artery bypass surgery-Emergency or non-emergency 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 warnings, precautions and adverse events.  https://shockwavemedical.com/IFU

Please contact your local Shockwave representative for specific country availability and refer to the Shockwave C2 instructions for use containing important safety information.

Get an up-close and detailed look at how Shockwave intravascular lithotripsy (IVL) simplifies the treatment of calcium via a unique mechanism of action (MOA) on an intuitive platform that’s predictably safe and consistently effective.

Please contact your local Shockwave representative for specific country availability and refer to the Shockwave C2, Shockwave C2+, Shockwave S4, Shockwave M5, Shockwave M5+, Shockwave L6, Shockwave E8, Shockwave Javelin and Shockwave Reducer instructions for use containing important safety information.

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

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.