Healthcare Professionals
Freestyle™
Aortic Root Bioprosthesis
The Freestyle™ bioprosthesis is our most physiologic valve. Every aspect 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.
Indications
The Freestyle™ bioprosthesis is for the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement.
Product details
Natural Performance
Maximal blood flow, excellent durability and outcomes, from a valve designed to mimic nature.
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.
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*
Excellent clinical performance
Stentless design
By closely mimicking human physiology, the Freestyle™ valve offers excellent hemodynamics — just like nature, with laminar flow and low gradients.
Maximum blood flow
The Freestyle™ valve is hemodynamically superior to stented3 and mechanical4 valves in the aortic position because it’s 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:
- Improved 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
Product specifications
Freestyle™ Full Root Bioprosthesis
| Order Number |
Valve Size (±0.5 mm) |
Outside Diameter (±0.5 mm-0.0 mm) |
Profile Height (±2 mm) |
Inner Cloth Height (±0.5 mm) |
|---|---|---|---|---|
| (A) | (B) | (C) | ||
| FR99519 | 19 | 19.0 | 30 | 3.0 |
| FR99521 | 21 | 21.0 | 32 | 3.0 |
| FR99523 | 23 | 23.0 | 32 | 3.0 |
| FR99525 | 25 | 25.0 | 34 | 3.0 |
| FR99527 | 27 | 27.0 | 34 | 3.0 |
| FR99529 | 29 | 29.0 | 39 ±3 mm | 3.0 |
| Freestyle™ Obturator Kit: 7990SET | ||||
| Freestyle™ Holder Handle: 7639 | ||||
Prestyled Freestyle™ complete
subcoronary bioprosthesis
| Order Number |
Valve Size (±0.5 mm) |
Outside Diameter (±0.5 mm-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
| Order Number |
Valve Size (±0.5 mm) |
Outside Diameter (±0.5 mm-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 |
*
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. ©2016 Medtronic.
2
Freestyle Aortic Root Bioprosthesis 12-year Clinical Compendium. ©2007 Medtronic.
3
de Arenaza D, Lees B, Flather M, et al. Randomized comparison of stentless versus stented valves for aortic stenosis. Circulation 2005;112:2696-2702.
4
Silberman S, Shaheen J, Merin O, et al. Exercise hemodynamics of aortic prostheses: Comparison between stentless bioprostheses and mechanical valves. Ann Thorac Surg 2001;72:1217-21.