Medtronic Freestyle Aortic Root Bioprosthesis

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Indications, contraindications, warnings, precautions, and adverse events

Freestyle® Aortic Root Bioprosthesis

Advanced Technologies

The Freestyle® aortic root bioprosthesis is the evolutionary result of 25 years of experience in tissue technology. Much has been learned about how design and processing techniques can impact valve performance. The Freestyle valve is the first stentless tissue valve to offer the following advancements in technology: The AOA®* treatment and the Physiologic Fixation™** process.

AOA treatment has been shown in multiple animal studies to be effective in mitigating leaflet calcification, but not significantly affecting calcification of the wall. Its long-term impact in patients has not been shown.

Physiologic Fixation Process is a unique process that retains the valve's natural anatomical shape as well as the underlying structure of the leaflets, providing improved blood flow characteristics.

* AOA is a registered trademark of Biomedical Design, Inc., Atlanta, Georgia. No clinical data are available that evaluate the long-term impact of the AOA treatment in patients.

** No clinical data are available that evaluate the long-term impact of the Physiologic Fixation process in patients.