Freestyle

Indications, Safety, and Warnings

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.