Aortic Root Bioprosthesis
You just clicked a link to go to another website. If you continue, you will leave this site and go to a site run by someone else.
It is possible that some of the products on the other site not be licensed for sale in Canada.
Your browser is out of date
With an updated browser, you will have a better Medtronic website experience. Update my browser now.
By choosing to accept, you acknowledge that you are a Certified Healthcare Professional.
Aortic Root Bioprosthesis
Every aspect of the Freestyle® bioprosthesis is meant to closely emulate the native aortic valve and offer comparable benefits.
The Freestyle® valve is a stentless bioprosthesis with 12 years of long-term data1 that mimics human physiology to create physiologic flow resulting in superior patient outcomes.2 From the stentless full-root design to the Physiologic Fixation™ Process and AOA® Treatment, the Freestyle valve offers superior hemodynamics and excellent durability.2,3
The unique full root design of the Freestyle bioprosthesis offers multiple implant options to address valve and root pathologies. Similar to a natural valve, the Freestyle valve stentless design offers the following benefits.
Stentless valves are proven to perform similarly to native aortic valves and are hemodynamically superior to stented4 and mechanical valves5 in the aortic position. The absence of a stent and sewing ring leaves more room for blood to flow through the Freestyle bioprosthesis.
The Freestyle bioprosthesis, offered in a full-root configuration, is designed to offer the surgeon unmatched surgical versatility in implant options and the flexibility to meet diverse patient clinical indications.
The Freestyle aortic root bioprosthesis is the evolutionary result of more than 30 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:
|Adverse Events Potentially Associated With the Use of Bioprosthetic Heart Valves||Adverse Events Observed in the Freestyle Bioprosthesis Clinical Trial|
For complete information, refer to the Instructions for Use provided with the product.
The stentless Prestyled Freestyle™ bioprosthesis is available in widely used configurations.
The Prestyled Freestyle bioprosthesis offers the following advantages:
IMPORTANT INFORMATION ON INDICATIONS, SAFETY AND WARNINGS
For listing of Indications, Contraindications, Warnings, Precautions, and Potential Adverse Events, please refer to the Instructions For Use .
AOA is a registered trademark of Biomedical Design, Inc., Atlanta, Georgia. No clinical data are available which evaluate the long-term impact of the AOA treatment in patients.
No clinical data are available which evaluate the long-term impact of the Physiologic Fixation process in patients.
Freestyle Aortic Root Bioprosthesis 12-year Clinical Compendium. UC200704939a EN. © 2007 Medtronic, Inc.
Bach DS, et al. Ten year outcome after aortic valve replacement with the Freestyle stentless bioprosthesis. Ann Thorac Surg 2005;80:480-7.
Kon N, et al. Eight year results of aortic root replacement with the Freestyle stentless porcine aortic root bioprosthesis. Ann Thorac Surg 2002;73:1817-21.
Westaby S, Jin X, Katsumata T, Arifi A, Braidley P. Valve replacement with a stentless bioprosthesis: Versatility of the porcine aortic root. J Thorac Cardiovasc Surg 1998;116:477-84.
Bach D, Metras J, Doty J, et al. Freedom from structural valve deterioration among patients aged =60 years undergoing Freestyle stentless aortic valve replacement. J Heart Valve Disease 2007;16:649-56.
El-Hamamsy I, Zaki M, Clark L, et al. Rate of progression and functional significance of aortic valve and root calcification up to 8 years following total aortic root replacement using a homograft versus Freestyle prosthesis: Results from a randomized trial. Presented by Dr. M. Yacoub at AHA, 2008.