Tissue valves and conduits

Freestyle™ aortic root bioprosthesis

<p>The Freestyle™ aortic root bioprosthesis emulates the native aortic valve,&nbsp;designed for hemodynamics and durability.</p>

Features

Durability 

Published clinical experience demonstrates impressive long-term performance in many age groups.1 Additional factors that may contribute to durability are:

  • Proprietary AOA™ anti-calcification tissue treatment designed to reduce calcification and protect the tissue
  • Physiologic fixation process that reduces the stress applied to the leaflets during fixation
See an illustration of the AOA anti-calcification tissue treatment.
AOA™ anti-calcification tissue treatment

† No clinical data is available which evaluates the long-term impact of the physiologic fixation process or the impact of AOA™ treatment in patients.


Stentless design 

By closely mimicking human physiology, the Freestyle™ valve offers excellent hemodynamics and long-term durability.

Excellent clinical performance

  • Very low rates of SVD, including a rate of freedom from explant due to SVD of 83% at 15 years1
  • Single-digit gradients out to 10 years2

‡ Failure of any component of the bioprosthesis causing stenosis or insufficiency. Excluded is endocarditis and/or thrombosed bioprosthetic valve as cause of dysfunction.


Maximum blood flow

The Freestyle™ valve provides industry leading hemodynamic performance. Studies have shown Freestyle™, with it’s stentless design, has significantly better hemodynamic performance than stented or mechanical aortic surgical valves.3,4  Hemodynamic results with Freestyle™ have shown:

  • Larger post-operative effective orifice areas (EOA) than stented or mechanical valves3
  • Stable, single digit gradients and large EOAs at 10 years1
This is a CT scan showing Freestyle™ hemodynamics.

Advanced tissue fixation 

Our exclusive physiologic fixation process mitigates biomechanical failures and is engineered for long-term valve durability by:

  • Improving preservation of valve structure and leaflet function, allowing it to function like a native valve
  • Allowing leaflets to remain soft and flexible, which protects the tissue from cyclic fatigue

 

This is an illustration of the tissue fixation design with callouts.
  1. Leaflets float at net zero pressure
  2. Roots are pressured at 40 mmHg with glutaraldehyde

Surgical valve replacement risks may include infection, surgical complications, stroke, endocarditis, and death.

Ordering information

Freestyle™ full root aortic bioprosthesis

Item number Valve size (± 0.5 mm) Outside diameter (± 0.5–0.0 mm)
FR995-19 19 19.0
FR995-21 21 21.0
FR995-23 23 23.0
FR995-25 25 25.0
FR995-27 27 27.0
FR995-29 29 29.0
 
Item number Description
7990SET Freestyle™ obturator kit
7639 Freestyle™ holder handle

  1. Freestyle™ aortic root bioprosthesis 15-year clinical compendium, UC201606746EN.
  2. Klautz RJM, Rao, V, Reardon MJ, et al. Examining the typical hemodynamic performance of nearly 3000 modern surgical aortic bioprostheses. Eur J Cardiothorac Surg. 2024 May 3;65(5):ezae 122.

  1. 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. 2005;112(17):2696–2702.
  2. 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(4):1217–1221.