{"id":3939,"date":"2024-10-30T14:17:42","date_gmt":"2024-10-30T19:17:42","guid":{"rendered":"https:\/\/shockwavemedical.com\/important-safety-information\/"},"modified":"2025-10-28T09:51:26","modified_gmt":"2025-10-28T14:51:26","slug":"isi","status":"publish","type":"page","link":"https:\/\/shockwavemedical.com\/de\/isi\/","title":{"rendered":"Important Safety Information"},"content":{"rendered":"\n
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Important Safety Information<\/h1>\n\t\t\t\t\t

Please contact your local Shockwave representative for specific country availability.<\/h3>\n\t\t\t<\/div>\n<\/section>\n\n\n\t
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Please refer to the Shockwave C2, Shockwave C2+, Shockwave C2 Aero, Shockwave S4, Shockwave M5, Shockwave M5+, Shockwave L6, Shockwave E8, Shockwave Javelin and Shockwave Reducer instructions for use containing important safety information.<\/p>\n

Coronary IVL<\/h2>\n

Shockwave C2, Shockwave C2+, and Shockwave C2 Aero Safety Information<\/h3>\n

Indications for Use\u2014<\/strong>\u00a0The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2, Shockwave C2+, and Shockwave C2 Aero Coronary IVL Catheters is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic\u00a0de novo<\/em>\u00a0coronary arteries prior to stenting.<\/p>\n

Contraindications\u2014<\/strong> The Shockwave C2, Shockwave C2+, and Shockwave C2 Aero Coronary IVL Systems are contraindicated for the following: These devices are not intended for stent delivery. These devices are not intended for use in carotid or cerebrovascular arteries.<\/p>\n

Warnings\u2014<\/strong>\u00a0Use the IVL Generator in accordance with recommended settings as stated in the Operator\u2019s 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.<\/p>\n

Precautions\u2014<\/strong>\u00a0Only 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 5 mm of target lesion IVL pulses may potentially interfere with certain implanted electrical devices (e.g., ventricular support systems).<\/p>\n

Cautions\u2014<\/strong>\u00a0Shockwave C2 and Shockwave C2+ should not be re-inserted once they are pulled out of the patient\u2019s body. Shockwave C2 Aero may be re-inserted up to 3 times in the same patient when used in accordance with the IFU.<\/p>\n

Potential adverse effects consistent with standard based cardiac interventions include<\/strong>\u2013 Abrupt vessel closure \u2013 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.<\/p>\n

Risks identified as related to the device(s) and its use:<\/strong>\u00a0Allergic\/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.<\/p>\n

Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions and adverse events.\u00a0www.shockwavemedical.com\/IFU<\/a><\/p>\n

Peripheral IVL<\/h2>\n

Shockwave M5, Shockwave M5+, Shockwave S4, Shockwave L6 and Shockwave E8 Safety Information<\/h3>\n

Indications for Use\u2014<\/strong>\u00a0The 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, and infra-popliteal arteries. Not for use in the coronary, carotid or cerebral vasculature. Peripheral IVL is also indicated for use in renal arteries in certain jurisdictions, including the United States. Please reference Instructions For Use for country specific information.<\/p>\n

Contraindications\u2014<\/strong>\u00a0Do not use if unable to pass 0.014\u2033 (M5, M5+, S4, E8) or 0.018\u2033 (L6) guidewire across the lesion-Not intended for treatment of in-stent restenosis or in coronary, carotid, or cerebrovascular arteries.<\/p>\n

Warnings\u2014<\/strong>\u00a0Only to be used by physicians who are familiar with interventional vascular procedures\u2014Physicians must be trained prior to use of the device\u2014 Use the generator in accordance with recommended settings as stated in the Operator\u2019s Manual.<\/p>\n

Precautions\u2014<\/strong>\u00a0use only the recommended balloon inflation medium\u2014Appropriate anticoagulant therapy should be administered by the physician\u2014 Decision regarding use of distal protection should be made based on physician assessment of treatment lesion morphology.<\/p>\n

Adverse effects\u2014<\/strong>\u00a0Possible adverse effects consistent with standard angioplasty include-Access site complications -Allergy to contrast or blood thinner- Arterial bypass surgery\u2014Bleeding complications\u2014Death\u2014 Fracture of guidewire or device\u2014Hypertension\/Hypotension\u2014 Infection\/sepsis\u2014Placement of a stent\u2014renal failure\u2014 Shock\/pulmonary edema\u2014target vessel stenosis or occlusion\u2014 Vascular complications. Risks unique to the device and its use\u2014 Allergy to catheter material(s)\u2014 Device malfunction or failure\u2014 Excess heat at target site.<\/p>\n

Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions and adverse events.\u00a0www.shockwavemedical.com\/IFU<\/a><\/p>\n

Shockwave Javelin Peripheral IVL Catheter Safety Information<\/h3>\n

Indications for Use\u2014<\/strong>\u00a0The 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.<\/p>\n

Not for use in coronary, carotid, or cerebral vasculature. Additionally, not for use in pulmonary vasculature in the U.S. and New Zealand.<\/p>\n

Contraindications\u2014<\/strong>\u00a0Do not use if unable to pass 0.014\u2033 (0.36 mm) guidewire across the treatment site-Not intended for treatment of in-stent restenosis or in coronary, carotid, cerebral or pulmonary arteries.<\/p>\n

Warnings\u2014<\/strong>\u00a0Only to be used by physicians who are familiar with interventional vascular procedures\u2014Physicians must be trained prior to use of the device\u2014 Use the generator in accordance with recommended settings as stated in the Operator\u2019s Manual.<\/p>\n

Precautions\u2014<\/strong>\u00a0Avoid applying acoustic pressure pulses while IVL window is not filled with sterile saline\u2014Appropriate anticoagulant therapy should be administered by the physician\u2014 Decision regarding use of distal protection should be made based on physician assessment of treatment lesion morphology.<\/p>\n

Adverse effects\u2014\u00a0<\/strong>Possible adverse effects consistent with standard angioplasty include-Access site complications -Allergy to contrast or blood thinner- Arterial bypass surgery\u2014Bleeding complications\u2014Death\u2014 Fracture of guidewire or device\u2014Hypertension\/Hypotension\u2014 Infection\/sepsis\u2014Placement of a stent\u2014renal failure\u2014 Shock\/pulmonary edema\u2014target vessel stenosis or occlusion\u2014 Vascular complications. Risks unique to the device and its use\u2014 Allergy to catheter material(s)\u2014 Device malfunction or failure.<\/p>\n

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

Shockwave Reducer<\/h2>\n

Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions and adverse events: ifu.sw-reducer.com<\/a>.<\/p>\n

Indications\/Intended Use\u2014<\/strong> The Shockwave Reducer is indicated for use in patients with angina pectoris who are refractory to medical and interventional therapies and have objective evidence of reversible myocardial ischemia. These patients are not amenable to, not indicated for, or at high risk for revascularization by coronary artery bypass grafting or percutaneous coronary intervention.<\/p>\n

Patient Population\u2014<\/strong> For patients over 18 years, with refractory angina despite attempted optimal medical therapy, evidence of reversible myocardial ischemia by current diagnostic standards and left ventricular ejection fraction (LVEF)\u226530.<\/p>\n