Important Safety Information

Reducer System

 

Caution: In the United States, 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.

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