Contents: 6 Double-ended Aortic Sizers, 1 Valve Holder Handle and 1 Autoclavable Tray with Cover (1 unit per box)
||Trifecta Valve Sizer Set, Complete
||Flexible Holder Handle
||Rigid Holder Handle
||Rigid Extension Handle
Brief Summary: Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions,potential adverse events and directions for use.
Indications: The Trifecta Valve is indicated as a replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic heart valve. Adverse events potentially associated with the use of bioprosthetic heart valves include: angina, cardiac arrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, leak (transvalvular or perivalvular), myocardial infarction, nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other), prosthesis regurgitation, stroke, structural deterioration (calcification, leaflet tear, perforation, or other), thromboembolism and valve thrombosis. It is possible that these complications could lead to reoperation, explantation, permanent disability or death. Long-term low dose aspirin, unless contraindicated, is recommended for all patients with bioprosthetic valves. Long term anticoagulant therapy, unless contraindicated, is recommended for all patients with bioprosthetic valves who have risk factors for thromboembolism. Please see the Instructions for Use (IFU) for a full description of indications, contraindications, side effects, precautions, warnings and Instructions for Use.
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