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Hancock II and Hancock II Ultra

Bioprostheses

Hancock II and Hancock II Ultra Bioprostheses

Since the first implant in 1982, the Hancock® II valve has provided more than 25 years of excellent hemodynamic performance and durability.1

Summary

Excellence in Durability and Implantability

The Hancock® II porcine bioprosthesis is a second-generation valve that can be used in either aortic or mitral positions. The Hancock II Ultra® valve, featuring a reduced sewing cuff, is specifically designed for implant in a small aortic root.

Durability

  • More than 25 years of clinical experience.
  • Long-term clinical results show the Hancock II valve is an excellent choice for valve replacement surgery, with low rates of long-term structural valve dysfunction (SVD) and very low rates of other valve-related complications.1,2 Published clinical experience demonstrates that the Hancock II aortic and mitral valve long-term performance is impressive in all age groups.3
  • T6 (sodium dodecyl sulfate) removes phospholipids from the xenograft tissue.
  • Shown to decrease the severity of calcification in a large animal model study.4,5
  • Modified fixation process minimizes septal muscle shelf allowing for improved hemodynamics.

Implantability

The Cinch® Advanced Implant System, provided with Medtronic aortic and mitral stented bioprostheses, serves as an automated deflection system attached to the valve with sutures.

  • Assists with valve insertion, especially in the tight sinotubular junction.
  • Improves visualization.
  • Capitalizes on stent flexibility.
  • Can be deflected to allow tying behind the stent posts for aortic replacement.
  • Helps prevent suture looping.
  • May help facilitate minimally invasive surgery.
  • Protects the tissue from inadvertent damage.
  • Laser-engraved size denotes the largest native valve leaflet.

Maximum Flow

  • The sewing ring is mounted flush with the inflow edge of the scalloped stent
  • Aligns the internal diameter of the valve with the patient’s annulus
  • Increases the flow area over other supra-annular component
  • Allows blood flow through the annulus to encounter only tissue, not obstructive components such as the stent and sewing ring

Important Safety Information

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.


References

1

Valfre C, lus P, G, et al. The fate of Hancock II porcine valve recipients 25 years after implant. Eur J Cardiothorac Surg. (2010) doi:10.1016/j.ejcts.2010.01.046.

2

Borger MA. Twenty year results of the Hancock II bioprosthesis. J Heart Valve Dis 2006;15:49-56.

3

Reis RL, Hancock WD, Yarbrough JW, et al. The flexible stent: A new concept in the fabrication of tissue heart valve prostheses. J Thorac Cardiovasc Surg. 1971; 62:683-689.

4

Jones M, Eidbo E, Hilbert S, Ferrans V, Clark R. Anticalcification treatments of bioprosthetic heart valves: In vivo studies in sheep. J Card Surg 1989; 4:69-73.

5

Thiene G, Valente M. Bioprosthetic valves – How to improve long-term durability. Bus. Briefing/Global Surg Extract 2004; 5.