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 Reducer Safety Information
Caution: In the United States, Shockwave Reducer is an investigational device, limited by United States law to investigational use.
The Reducer is subject of Investigational testing and is being studied in the COSIRA-II trial in Canada.
The Reducer is commercially available in certain countries outside the U.S. and Canada. Please contact your local representative for specific country availability.
Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions and adverse events: ifu.neovasc.com
Important Safety Information
Indications/Intended Use— The Reducer System is indicated for use in patients with refractory angina pectoris and objective evidence of reversible myocardial ischemia, who have limited treatment options and are thus referred to as ‘no-option’ patients. These patients are either not amenable to, or are high risk for, revascularization by coronary artery bypass grafting (CABG) or by percutaneous coronary intervention (PCI).
Contraindications— For a full list, refer to the product Instructions for Use (IFU) at ifu.neovasc.com. The Reducer is contraindicated for use in patients with recent (within 3 months) acute coronary syndrome, recent (within 6 months) PCI revascularization by stent or CABG, recent (within 30 days) unsuccessful PCI, unstable angina (recent onset angina, crescendo angina, or rest angina with ECG changes) during the last 30 days, decompensated congestive heart failure (CHF) or hospitalization due to CHF during the last 3 months, left ventricular ejection fraction of less than 30%.
Warnings and precautions— For a full list, refer to the product Instructions for Use (IFU) at ifu.neovasc.com. FOR SINGLE USE ONLY. Do not reuse, reprocess, or resterilize. Reuse, reprocessing, and/or resterilization creates a risk of contamination of the device and/or failure which could cause patient injury, illness or death. Note product “Use By” date. Sterilized with ethylene oxide gas. Placement of the Neovasc Reducer should only be attempted at a location in the proximal segment of the CS, 2-4cm distal to the ostium, where the CS diameter is measured to be between 13mm and 9.5mm.
Potential adverse effects— Possible adverse effects consistent with cardiac stent implant procedures to include but are not limited to access site complication, allergic reaction, arrhythmia, bleeding event, cardiac valve injury, conduction disturbance, device or vessel occlusion, device fracture, malposition, migration or embolization, dissection, embolism, hypotension/hypertension, infection, ischemic event, myocardial damage, neurological event, perforation/rupture of coronary sinus, right atrium or internal jugular vein, pulmonary edema, pyrogenic, immunological or toxicological reaction, respiratory failure, spasm of coronary sinus or jugular vein, or vascular event.
Judicious selection of patients is necessary. Administration of appropriate anticoagulant, antiplatelet and coronary vasodilator therapy is critical to successful Reducer implantation and follow-up. Only physicians who have received appropriate training should perform implantation of the Reducer.
Go to ifu.neovasc.com for a complete list of indications, contraindications, warnings and precautions.