Hancock® II Bioprostheses

Product technical manual must be reviewed prior to use for detailed disclosure.

Indications:

Replacement of impaired native or prosthetic aortic and mitral heart 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, 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.