Hancock II Bioprosthesis

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COMMITMENT

How we have improved supply chain and processes for Hancock™ II bioprosthesis.

$20 Million - manufacturing site investments
30% - increase in manufacturing footprint
100 - manufacturing employees
40% - increase in operations staffing
30% - increase in tissue supply

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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. 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, consult instructions for use at this website www.medtronic.com/manuals. NOTE: Manuals can be viewed using a current version of any major internet browser.

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