Indications for Use
For patients who require replacement of their native or prosthetic aortic and/or mitral valves.
Contraindications
None known.
Warnings / Precautions / Adverse Events
Accelerated 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, hyperparathyroidism). Adverse events can include: angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis.
For additional information, please refer to the Instructions for Use provided with the product.
Caution
Federal law (USA) restricts this device to sale by or on the order of a physician.