Regent™ Mechanical Heart Valve Standard Cuff
CARDIOVASCULAR
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Regent™ Mechanical Heart Valve Standard Cuff

PRODUCT HIGHLIGHTS

  • Designed to deliver exceptional hemodynamics and performance while maintaining low complication rates, structural integrity and durability
  • Single-digit gradients, even in sizes as small as 19 mm1
  • Up to 84% orifice to annulus ratio
  • 85 degree leaflet opening angle offers improved laminar flow and reduces turbulence2-4
  • Supra-annular placement and low implant height
  • The FlexCuff™ is flanged and more pliable than the standard cuff
  • St. Jude Medical heart valves are MR Conditional5

ORDERING INFORMATION

Contents: Aortic Valve (1 unit per box)


Reorder Number Tissue Annulus Diameter (mm) Valve Orifice Inner Diameter (mm) Geometric Orifice Area (cm2) Effective Orifice Area (cm2) Cuff Style
17AGN-751 17 15.9 1.87 1.42 Standard
19AGN-751 19 17.8 2.39 1.84 Standard
21AGN-751 21 19.6 2.90 2.47 Standard
23AGN-751 23 21.4 3.45 2.91 Standard
25AGN-751 25 23.0 4.02 3.34 Standard
27AGN-751 27 24.9 4.69 4.28 Standard
29AGN-751 29 26.8 5.44 Not reported Standard
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*All sizes currently not available in all markets.

1. St. Jude Medical, Inc. Pre-Market Approval Application Supplement. Regent Heart Valve. Washington, D.C.; U.S. Food and Drug Administration. 2002. P810002/S57.

2. King, M, David T, Fisher J. An initial parametric study on fluid flow through bileaflet mechanical heart valves using computational fluid dynamics. J Eng Med. 1994;208:63-72.

3. Feng Z, Nakamura T, Fujimoto T, et al. In vitro investigation of opening behavior and hydrodynamics of bileaflet valves in the mitral position. Artificial Organs. 2002;26(1):32-9.

4. Shipkowitz T, Ambrus J, Kurk J, et al. Evaluation technique for bileaflet mechanical valves. J Heart Valve Dis. 2002;11(2):275-82.

5. St. Jude Medical MRI Safety Document.


Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Product referenced is approved for CE Mark.

GMCSD176EN (May 2012)

Last Updated: January 02, 2019

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