Important Safety Information: Shockwave Reducer

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.sw-reducer.com

Important Safety Information

Indications/Intended Use— 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.

Patient Population— 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)≥30.

• For patients with symptomatic coronary artery disease (CAD), must be not amenable to, not indicated for, or are high risk for revascularization by coronary artery bypass grafting or percutaneous coronary intervention.
• For patients with non-obstructive coronary arteries (INOCA/ANOCA), there must be evidence of coronary microvascular dysfunction.

Contraindications— For a full list, refer to the product Instructions for Use (IFU) at ifu.sw-reducer.com. The Reducer is contraindicated for use in patients with, but not limited to 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.sw-reducer.com. STERILE—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 Shockwave Reducer should only be attempted at a location in the proximal segment of the CS, 2-4 cm distal to the ostium, where the CS diameter is measured to be between 13 mm and 9.5 mm.

Potential adverse effects— Possible adverse effects consistent with cardiac stent implant procedures to include but are not limited to access site complication, acute kidney injury, 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, pain, perforation/rupture of coronary sinus, right atrium or internal jugular vein, pulmonary edema, respiratory failure, spasm of coronary sinus or jugular vein, or vascular event.

Please note, 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.sw-reducer.com for a complete list of indications, contraindications, warnings and precautions.