3f Aortic Bioprosthesis
 
3f Aortic Bioprosthesis 

3f Aortic Bioprosthesis

Based on the engineering concept that "form follows function,"1 the 3f® Aortic Bioprosthesis is the only pericardial tissue valve designed to function like a native human aortic valve.

Summary

The 3f Aortic Bioprosthesis’ tubular structure includes sides that collapse in response to pressure, reproducing the functional characteristics of a native aortic valve. This design compensates for naturally occurring changes within the aortic root, which may explain a low incidence of central prosthetic regurgitation.2

Through the innovative use of three equine pericardial leaflets shaped in the form of a tube, the 3f ® Aortic Bioprosthesis preserves aortic sinuses,3 restores native stress distribution,1 and offers excellent hemodynamics.2,4,5

Preservation of Aortic Sinuses

  • Maintains continuity between the annulus and the sinotubular junction
  • Preserves sinus form and function without the need for a second suture line3

Native Stress Distribution

  • Designed to restore native valve stress distribution to the entire aortic root1
  • Unlike other commercially available tissue valves where the greatest stress is on the commissures, the 3f Aortic Bioprosthesis valve’s greatest stress is toward the semilunar “belly” of the cusps – as observed in healthy aortic valves1
  • Even distribution of stresses may lead to increased durability2,6
The 3f Bioprosthesis restores healthy aortic valve stress.

The 3f Bioprosthesis restores healthy aortic valve stress.

Excellent Hemodynamics

  • Recent studies have shown excellent hemodynamic performance with single-digit mean gradients ranging from 5 mmHg to 9 mmHg2,4,5
  • Tubular design helps restore physiologic, non-turbulent transvalvular flow1
  • Maintains aortic root geometry and enhances coronary perfusion7

Important Safety Information

Only physicians who have received proper training in valve repair should use this device.

Adverse events potentially associated with the use of bioprosthetic heart valves include: angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage (anticoagulant/antiplatelet-related), leak (transvalvular or paravalvular), myocardial infarction, nonstructural dysfunction (obstructive pannus ingrowth, suture dehiscence, inappropriate sizing, other), stroke, structural deterioration (calcification, leaflet tear, stenosis, other), thromboembolism, valve thrombosis. It is possible that these complications could lead to: reoperation, explantation, permanent disability, or death.

For additional information please refer to the Instructions for Use provided with the product or contact your local Medtronic representative.

References

  1. Cox J, Ad N, Myers K, Gharib M, Quijano RC. Tubular heart valves: A new tissue prosthesis design—Preclinical evaluation of the 3f aortic bioprosthesis. J Thoracic Surg. 2005;130:520-7.
  2. Pillai R, Ratnatunga C, Soon JL, et al. 3f prosthesis aortic cusp replacement: implantation technique and early results. Asian Cardiovasc Thorac Ann. 2010;18:13-16.
  3. Jin XY. Implications of stentless valve design and implantation techniques for aortic root geometry [abstract]. Paper presented at: Advanced Cardiac Techniques in Surgery, May 2-3, 2007; New York, NY.
  4. Medtronic data on file: 3f Implant Surveys
  5. Wendt D, Thielmann M, Buck T, et al. First clinical experience and 1-year follow-up with the sutureless 3f-Enable aortic valve prosthesis. Eur J Cardiothorac Surg. 2008;33:542-547.
  6. Vesely I. The influence of design on bioprosthetic valve durability. J Long Term Eff Med Implants. 2001;11(3-4):137-149.
  7. Bargenda S, Sirat S, Moritz A, Doss M. Five years’ clinical experience with the 3f stentless aortic bioprosthesis. South African Medical Journal. 2007;97(11):1091-1091.
Last updated: 19 Apr 2011
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