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Freestyle

Aortic Root Bioprosthesis

Freestyle Aortic Root Bioprosthesis

Every aspect of the Freestyle® bioprosthesis is meant to closely emulate the native aortic valve and offer comparable benefits.

Why Choose the Freestyle Aortic Root Bioprosthesis?

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.

Better Blood Flow

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.

Implant Versatility

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.

Advances in Tissue Technology

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:

  • The AOA®* treatment is an anticalcification treatment that slows the diffusion of calcium on tissue. The treatment has consistently demonstrated its effectiveness in multiple animal and human studies.6 After eight years, the Freestyle valve had a lower propensity to calcify than the homograft6 – historically considered the gold standard.
  • 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.

Important Safety Information

Adverse Events Potentially Associated With the Use of Bioprosthetic Heart Valves Adverse Events Observed in the Freestyle Bioprosthesis Clinical Trial

As with any open chest surgical procedure, certain complications may occur. The adverse events potentially associated with the use of bioprosthetic heart valves include:

A prospective non-randomized multicenter clinical study was performed to evaluate the Freestyle bioprosthesis. The observed adverse events include the following:

  • Cardiac dysrhythmias
  • Death
  • Death
  • Thromboembolism (with permanent or transient neurological event)
  • Endocarditis
  • Thrombosis
  • Hemolysis
  • Structural deterioration
  • Hemorrhage (anticoagulant/antiplatelet-related)
  • Nonstructural dysfunction
  • Leak (transvalvular or paravalvular)
  • Major anti-thromboembolic-related
  • Nonstructural dysfunction (pannus, suture, in appropriate sizing, or other)
  • Primary paravalvular leak
  • Structural deterioration (calcification, leaflet tear, or other)
  • Endocarditis
  • Thromboembolism
  • Primary hemolysis
  • Valve thrombosis
  • Reoperation
  • Intracuspal hematoma
  • Explant

Prestyled Freestyle Bioprosthesis – Tailored for Your Convenience

The stentless Prestyled Freestyle bioprosthesis is available in widely used configurations.

The Prestyled Freestyle bioprosthesis offers the following advantages:

  • Convenience: A pre-trimmed version of the Freestyle® aortic root bioprosthesis to match your preferred implant technique – the complete or modified sub-coronary.
  • Advanced technology: Uses the same AOA® tissue treatment and Physiologic Fixation process that has made the Freestyle valve the world's most implanted stentless bioprosthesis.
  • Simplified handling: Freehand implantation is simplified through the use of an integrated holder system.

 


Important Safety Information

Adverse Events Potentially Associated With the Use of Bioprosthetic Heart Valves Adverse Events Observed in the Freestyle Bioprosthesis Clinical Trial

As with any open chest surgical procedure, certain complications may occur. The adverse events potentially associated with the use of bioprosthetic heart valves include:

A prospective non-randomized multicenter clinical study was performed to evaluate the Freestyle bioprosthesis. The observed adverse events include the following:

  • Cardiac dysrhythmias
  • Death
  • Death
  • Thromboembolism (with permanent or transient neurological event)
  • Endocarditis
  • Thrombosis
  • Hemolysis
  • Structural deterioration
  • Hemorrhage (anticoagulant/antiplatelet-related)
  • Nonstructural dysfunction
  • Leak (transvalvular or paravalvular)
  • Major anti-thromboembolic-related
  • Nonstructural dysfunction (pannus, suture, in appropriate sizing, or other)
  • Primary paravalvular leak
  • Structural deterioration (calcification, leaflet tear, or other)
  • Endocarditis
  • Thromboembolism
  • Primary hemolysis
  • Valve thrombosis
  • Reoperation
  • Intracuspal hematoma
  • Explant

*

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.


References

1

Freestyle Aortic Root Bioprosthesis 12-year Clinical Compendium. UC200704939a EN. © 2007 Medtronic, Inc.

2

Bach DS, et al. Ten year outcome after aortic valve replacement with the Freestyle stentless bioprosthesis. Ann Thorac Surg 2005;80:480-7.

3

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.

4

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.

5

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.

6

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.