The physician featured is a paid consultant for Shockwave Medical.

Important Safety Information

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. Megha Prasad is a paid consultant of Shockwave Medical.

Important Safety Information

Shockwave Reducer System

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.

Dr. Allen Jeremias is a paid consultant of Shockwave Medical.

Important Safety Information

Shockwave Reducer System

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.

Dr. Stefan Verheye is a paid consultant of Shockwave Medical.

Important Safety Information

Shockwave Reducer System

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.

Jean, an active 80-year-old Londoner, had started becoming depressed as severe and increasingly untreatable angina negatively affected her quality of life. Her doctor recommended Reducer therapy, which helped Jean get her life back.

Trevor, a 59-year-old individual, began experiencing cardiovascular symptoms during his 30s, leading to his hospitalization on 24 separate occasions due to these issues. In February 2022, Trevor suffered from persistent angina, prompting his doctor to suggest Reducer therapy. This treatment not only alleviated his symptoms but also enhanced his overall activity level and quality of life.

In his 80s, Dipak, facing refractory angina, found relief with Reducer after conventional treatments failed. Climbing stairs once triggered heart attack-like symptoms, but now, post-implantation, he can ascend without pain. Previously at the end of the road with traditional approaches, Dipak’s transformative experience brings a sense of freedom and joy:

The physicians featured are paid consultants for Shockwave Medical.

*Shockwave Reducer is CE-marked in Europe and has been implanted in over 3,500 patients. It is currently under clinical investigation in the US.

CAUTION: In the United States, the 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 warnings, precautions and adverse events: ifu.neovasc.com

The physicians featured are paid consultants for Shockwave Medical.

*Shockwave Reducer is CE-marked in Europe and has been implanted in over 3,500 patients. It is currently under clinical investigation in the US.

CAUTION: In the United States, the 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 warnings, precautions and adverse events: ifu.neovasc.com

The physicians featured are paid consultants for Shockwave Medical.

*Shockwave Reducer is CE-marked in Europe and has been implanted in over 3,500 patients. It is currently under clinical investigation in the US.

CAUTION: In the United States, the 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 warnings, precautions and adverse events: ifu.neovasc.com