FreestyleAortic 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 — can be used for full root, modified subcoronary, and complete subcoronary configurations.

Full root configuration of the Freestyle aortic root bioprosthesis on white background

Full Root

Complete subcoronary configuration of the Freestyle aortic root bioprosthesis on white background

Complete Subcoronary

Modified subcoronary configuration of the Freestyle aortic root bioprosthesis on white background

Modified Subcoronary

Durability

Published clinical experience demonstrates impressive long-term performance in all age groups. 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 illustration

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
CT scan showing blood flow with Freestyle aortic root bioprosthesis

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

  

  1. Leaflets float at net zero pressure
  2. Roots are pressured at 40 mm Hg with glutaraldehyde
Valve tissue fixation design illustration

Product Specifications and Ordering Information

Freestyle Full Root Bioprosthesis

Freestyle full root configuration with sizing detail illustration

Order Number

Valve Size
(± 0.5 mm)

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

Freestyle Holder Handle: 7639

Prestyled Freestyle Complete Subcoronary Bioprosthesis

Freestyle complete subcoronary configuration with sizing detail illustration
  1. Valve height minimum 9 mm above highest commissure

Order Number

Valve Size
(± 0.5 mm)

Outside Diameter

(± 0.5–0.0 mm)

 

 

(A)

995CS19

19

19.0

995CS21

21

21.0

995CS23

23

23.0

995CS25

25

25.0

995CS27

27

27.0

Freestyle Obturator Kit: 7990SET

Freestyle Holder Handle: 7639

Prestyled Freestyle Modified Subcoronary Bioprosthesis

Freestyle modified subcoronary configuration with sizing detail illustration
  1. Valve height minimum 9 mm above highest commissure

Order Number

Valve Size
(± 0.5 mm)

Outside Diameter
(± 0.5–0.0 mm)

 

 

(A)

995MS19

19

19.0

995MS21

21

21.0

995MS23

23

23.0

995MS25

25

25.0

995MS27

27

27.0

995MS29

29

29.0

Additional Resources

Contact Information

LifeLine Cardiovascular
Technical Support

877-526-7890

Send Us an Email

Medtronic
Mitral Academy

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.