Freestyle™ Aortic Root Bioprosthesis for Heart Valve Replacement
Freestyle is our most physiologic valve. It is meant to closely emulate the native aortic valve, offering excellent hemodynamics, durability, and patient outcomes.
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Overview
Our Most Physiologic Valve
Every aspect of the Freestyle bioprosthesis is meant to closely emulate the native aortic valve and offer comparable benefits. It is a great choice for younger, more active patients — and those with challenging anatomies — because of its excellent hemodynamics, durability, and patient outcomes.
Product Details
Product Design
The full root, stentless design of the Freestyle porcine bioprosthesis — based on more than 30 years of Medtronic tissue valve design improvements.
Full Root
Durability
Published clinical experience demonstrates impressive long-term performance in all age groups5. Additional factors that may contribute to durability are:
- Proprietary AOA™ anti-calcification tissue treatment that mitigates calcification and protects the tissue*
- Physiologic Fixation process that minimizes the stress applied to the leaflets during fixation*
AOA anti-calcification tissue treatment
Stentless Design
By closely mimicking human physiology, the Freestyle valve offers excellent hemodynamics, just like nature with laminar flow and low gradients.
Excellent Clinical Performance
- Freedom from explant due to SVD is 83% at 15 years1
- Single-digit gradients out to 10 years2
Maximum Blood Flow
The Freestyle valve is hemodynamically superior to stented3 and mechanical4 valves in the aortic position because it is stentless and has no sewing ring. This means you get:
- Larger postoperative effective orifice areas (EOA)3
- Stable, single-digit gradients and EOAs at 10 years2
Advanced Tissue Fixation
Our exclusive Physiologic Fixation* process mitigates biomechanical failures and promotes long-term valve durability by:
- Improving preservation of valve structure and leaflet function, allowing it to function similar to a native valve
- Allowing leaflets to remain soft and flexible, which protects the tissue from cyclic fatigue
- Leaflets float at net zero pressure
- Roots are pressured at 40 mm Hg with glutaraldehyde
Product Specifications and Ordering Information
Freestyle Full Root Bioprosthesis
| Order Number |
Valve Size |
Outside Diameter (± 0.5–0.0 mm) |
Profile Height (± 2 mm) |
Inner Cloth Height (± 0.5 mm) |
|---|---|---|---|---|
|
|
|
(A) |
(B) |
(C) |
| FR995-19 |
19 |
19.0 |
30 |
3.0 |
| FR995-21 |
21 |
21.0 |
32 |
3.0 |
| FR995-23 |
23 |
23.0 |
32 |
3.0 |
| FR995-25 |
25 |
25.0 |
34 |
3.0 |
| FR995-27 |
27 |
27.0 |
34 |
3.0 |
| FR995-29 |
29 |
29.0 |
39 ± 3 mm |
3.0 |
| Freestyle Obturator Kit: 7990SET |
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| Freestyle Holder Handle: 7639 |
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Additional Resources
Medical Education
Training, education, and collaboration on the treatment of mitral and tricuspid valve disease.
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*
No clinical data is available which evaluates the long-term impact of the Physiologic Fixation process or the impact of AOA treatment in patients.
References
1
Freestyle Aortic Root Bioprosthesis 15-year Clinical Compendium.
2
Freestyle Aortic Root Bioprosthesis 12-year Clinical Compendium.
3
Perez de Arenaza D, Lees B, Flather M, et al. Randomized comparison of stentless versus stented valves for aortic stenosis: effects on left ventricular mass. Circulation. October 25, 2005;112(17):2696-2702.
4
Silberman S, Shaheen J, Merin O, et al. Exercise hemodynamics of aortic prostheses: comparison between stentless bioprostheses and mechanical valves. Ann Thorac Surg. October 2001;72(4):1217-1221.
5
David S. Bach, MD, and Neal D. Kon, MD. Long-Term Clinical Outcomes 15 Years After Aortic Valve Replacement With the Freestyle Stentless Aortic Bioprosthesis. Ann Thorac Surg 2014;97:544–51