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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/ormitral 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, cardiacarrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolyticanemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructuraldysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis.

CAUTION: Federal law (USA) restricts these devices 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 eIFUs, consultinstructions for use at this website Note: Manuals can beviewed using a current version of any major internet browser.