The views expressed are those of medical professionals and not necessarily the views of Medtronic. These individuals are consultants for Medtronic.
Product Brief Statement
Freestyle® Aortic
Root Bioprosthesis: Indications: For the replacement of malfunctioning native
or prosthetic aortic valves with the option of aortic root replacement. 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: cardiac dysrhythmias,
death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak,
nonstructural dysfunction, structural deterioration, thromboembolism, valve
thrombosis, or intracuspal hematoma. 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.
Freestyle is a registered trademark of Medtronic.
UC200904603EN1W