Prof. Javier Escaned, Hospital Universitario Clínico San Carlos, Madrid, and Prof. James Spratt, St George’s University Hospital NHS Trust, London, discussed with Cardiovascular News their views about the latest data from the pooled analysis of 262 patients enrolled in OCT sub-studies from DISRUPT CAD I, II, III and IV.

“This is the study that provides, for the first time, evidence suggesting that IVL is, from a practical perspective, equally effective in eccentric and concentric plaque.”

They also share their clinical experience with Shockwave IVL in the treatment of eccentric and nodular coronary calcium.

Read the full article online here: https://cardiovascularnews.com/shockwave-ivl-advertorial-february-2022/

Prof. Javier Escaned and Prof. James Spratt are paid consultants of Shockwave Medical.

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.

Discover our PCR webinar featuring European calcium experts, Prof Emanuele Barbato, Prof Javier Escaned, Dr Margaret McEntegart, and Prof Flavio Luciano Ribichini discussing about the most recent OCT data analysis from DISRUPT CAD Trials.

This webinar includes a clinical case to illustrate the efficacy of Shockwave coronary IVL in an eccentric calcified lesion in a young female patient with coronary artery disease (CAD).

Dr. Doshi provides best practices of using Shockwave IVL with rotational atherectomy.

Dr. Darshan Doshi is a paid consultant of Shockwave Medical.

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

Dr. B. Clay Sizemore, Interventional Cardiologist at Cardiovascular Consultants of South Georgia, Thomasville, GA speaks about his experience with coronary IVL in a no surgical backup hospital, discussing his patient selection criteria, importance of same day discharge and how IVL fits well into this strategy, thereby allowing the treatment of previously undilatable calcified lesions and minimizing the risk of patient transfer and procedure staging.

Download the PDF or read The Calcium Corner online here.

This article was developed in collaboration with Cath Lab Digest to bring you the latest calcium insights from the U.S. coronary interventional experts who know it best. A new webpage on the CLD website, The Calcium Corner, contains a series of articles where operators share their perspective on the challenges and treatment of coronary artery calcium. Read about experts’ clinical experience, case studies and treatment algorithms with Coronary IVL – hope you enjoy the content.

Keep an eye out for the next Calcium Corner article coming out in early March featuring Dr. Kevin Croce on Coronary IVL in Nodular Calcified Lesions.

Dr. B. Clay Sizemore is a paid consultant for Shockwave Medical.

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.

Dr. Sandeep Nathan speaks to his real-world Shockwave IVL experience in complex coronary cases.

Dr. Price speaks on best practices to modify diffuse disease with Shockwave IVL.

Dr. Singh is a paid consultant for Shockwave Medical.

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.

DISRUPT CAD Pooled Gender Analysis is now in published in JSCAI – the new journal of the Society for Cardiovascular Angiography & Interventions. Read the JSCAI publication here: https://www.jscai.org/article/S2772-9303(21)00011-9/fulltext

“Given the strong safety profile of IVL and the known higher risks of women undergoing PCI, coronary IVL is an attractive option for optimizing outcomes in female patients,” said Alexandra Lansky, MD, FACC, FAHA, FSCAI, FESC, Professor of Medicine (Cardiology), Director of Yale Cardiovascular Clinical Research Program Yale University School of Medicine, New Haven, CT, and Editor in Chief of JSCAI. “While this is the first analysis of its kind for coronary IVL, it is highly suggestive that the technology could potentially serve as first-line therapy for women with calcified lesions, particularly if these findings can be confirmed in a larger patient cohort.”

In addition to the publication of the gender analysis in the first issue, it also included a new Expert Consensus Statement from SCAI on Sex-Specific Considerations in Myocardial Revascularization, which includes reference to the new Coronary IVL gender data and the role that IVL can play in women as a potential first-line therapy for plaque modification of calcified lesions in women. Read the SCAI Consensus Statement here: https://www.jscai.org/article/S2772-9303(21)00016-8/fulltext

Please see below for a link to the TCT data slides.

About JSCAI: JSCAI is an online only, peer-reviewed, international, Gold Open Access journal covering the broad field of cardiovascular diseases. JSCAI aims to be a highly credible and well-balanced reference highlighting practical techniques and pathways of care to deliver high impact scientific contributions from clinicians and colleagues in interventional cardiology.

More on DISRUPT CAD Pooled Gender Analysis

Download the TCT slides

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.

Dr. McEntegart is a paid consultant for Shockwave Medical.

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