Hancock II and Hancock II Ultra

Indications, Safety, and Warnings

Hancock^® II Bioprosthesis

Indications: 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: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only.