For more information on these acquisitions and how they support Medtronic CardioVascular go to: www.medtronic.com/cvinnovation
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.
Mosaic® Porcine Bioprosthesis
Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart 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.
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.
Cardioblate® Surgical Ablation Systems: See Instructions for Use for a complete list of the warnings, precautions and contraindications.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
Cardioblate, DLP, Freestyle, Mosaic, RBC and Resting Heart are registered trademarks of Medtronic, Inc.
The CoreValve ReValving® System and the Ventor Embracer™ System are not currently available in the USA for clinical trials or for commercialization.
