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Indications, Safety, and WarningsIndications for use The Avalus™ bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Contraindications None known.Warning, precautions, and adverse events Only physicians who have received proper training in valve replacement should use this device. Accelerated structural deterioration due to calcific degeneration of bioprosthesis may occur in: children, adolescents, young adults, and patients with altered calcium metabolism (e.g., chronic renal failure, or hyperparathyroidism). Adverse events can include: angina, cardiac dysrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, infection other than endocarditis, transvalvular or paravalvular leak, myocardial infarction, nonstructural valve dysfunction (leaflet entrapment/impingement, obstructive pannus ingrowth, suture dehiscence, inappropriate sizing or positioning, or other), pericardial effusion or tamponade, prosthesis regurgitation, prosthesis stenosis, prosthesis thrombosis, stroke, structural valve deterioration (calcification, leaflet tear or perforation, or other), thromboembolism, tissue dehiscence, and transient ischemic attack. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death.CautionFederal law (United States) restricts this device to sale by or on the order of a physician.For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the instructions for use. For countries that use electronic instructions for use (EIFUs), consult instructions for use at medtronic.com/manuals.UC202408469EN

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