Professionisti del settore sanitario


Aortic Root Bioprosthesis

Indications, Safety, and Warnings

Freestyle Bioprosthesis

Indications: For the replacement of malfunctioning native or prosthetic aortic valves with theoption of aortic root replacement.

Contraindications: None known.

Warnings/Precautions/Adverse Events: Accelerated deterioration due to calcificdegeneration of bioprosthesis may occur in: children, adolescents, young adults, and patientswith altered calcium metabolism (e.g., chronic renal failure, hyperparathyroidism). Adverseevents can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage,transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration,thromboembolism, valve thrombosis, or intracuspal hematoma.

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 adverseevents, 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.