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St. Jude Medical™ Regent™

The Regent™ aortic valve represents a quantum leap forward in prosthetic valves. The supra-annular Regent valve delivers exceptional hemodynamics and performance while maintaining the same quality design features that set the standard for low complication rates, structural integrity, and durability in a mechanical valve.
Overview

The Regent

The Regent aortic valve represents a quantum leap forward in prosthetic valves. The supra-annular Regent valve delivers exceptional hemodynamics and performance while maintaining the same quality design features that set the standard for low complication rates, structuralintegrity, and durability in a mechanical valve.

Exceptional Hemodynamics
  • Single-digit gradients, even in valve sizes as small as 19 mm2
  • Up to 84% orifice-to-annulus ratio
  • 85° leaflet opening angle offers improved laminar flow and reduces turbulance1c,6,9
  • Significantly larger EOAs2
  • Renders root enlargement practically unnecessary7,10
  • Significant reduction in left ventricular (LV) mass2,7,8
Optimal Implantability
  • Supra-annular placement
  • Low-implant height
  • Controlled torque rotation mechanism that allows for easy rotation and intraoperative adjustment
  • Sewing cuff contains additional suture markers for more accurate placement

 

Cuff Options
  • Flex cuff
  • Standard cuff
Outstanding Durability
  • A gold standard pivot-guard design proven in over 1.8 million implants
Visibility
  • St. Jude Medical heart valves are MR conditional1,1b
  • Radiopaque for improved visualization during X-ray and cinefluoroscopy

References

1 Blais C, Dumesnil JG, Baillot R, Simard S, Doyle D, Pibarot P. Impact of valve prosthesis-patient mismatch on short-term mortality after aortic valve replacement. Circulation. 2003 Aug 26;108(8):983-988.
1b MRI Safety Document – St. Jude Medical Valves and Annuloplasty Rings During MRI [PDF]
1c Shipkowitz T, Ambrus J, Kurk J, Wickramasinghe K. Evaluation Technique for Bileaflet Mechanical Valves. J Heart Valve Dis. 2002, Mar; 11 (2):275-282.
2 St. Jude Medical, Inc. Pre-Market Approval Application Supplement. Regent Heart Valve. Washington, D.C.; U.S. Food and Drug Administration. 2002. P810002/S57.
3 Pibarot P, Dumesnil, JG. Hemodynamic and clinical impact of prosthesis – patient mismatch in the aortic valve position and its prevention. J Am Coll Cardiol 2000;36:1131-1141.
6 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.
7 Bach DS, Sakwa MP, Goldbach M, Petracek MR, Emery RW, Mohr FW. Hemodynamics and early clinical performance of the St. Jude Medical Regent mechanical aortic valve. Ann Thorac Surg. 2002 Dec;74(6):2003-2009; discussion 2009.
8 St. Jude Medical, Inc. Pre-Market Approval Application – Summary of Safety and Effectiveness. SJM Regent heart valve, P810002/S57.
9 Zhonggang F, Takao N, Tetsuo F, Mitsuo U. In Vitro Investigation of Opening Behavior and Hydrodynamics of Bileaflet Valves in the Mitral Position. Artificial Organs 2002;26(1):32-39.
10 Petracek MR. Assessing options for the small aortic root. J Heart Valve Dis. 2002 Jan;11 Suppl 1:S50-S55.

Tech Specs

Regent™ Mechanical Heart Valve FlexCuff™

Ordering Information   View Catalog   

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
19AGFN-756 19 17.8 2.39 1.84 FlexCuff
21AGFN-756 21 19.6 2.90 2.47 FlexCuff
23AGFN-756 23 21.4 3.45 2.91 FlexCuff
25AGFN-756 25 23.0 4.02 3.34 FlexCuff
27AGFN-756 27 24.9 4.69 4.28 FlexCuff

Regent™ Mechanical Heart Valve Standard Cuff

Ordering Information   View Catalog   

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
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

Evidence

Unmatched EOAs Virtually Eliminate Prosthesis-Patient Mismatch

The Effective Orifice Area (EOA) of the Regent valve is larger, size-for-size, than any other valve on the market and virtually eliminates patient-prosthesis mismatch (PPM) in the aortic position. Single-digit in-vivo pressure gradients in valve sizes as small as 19 mm, considerably larger EOAs and excellent patientprosthesis match result in a valve with unmatched hemodynamic performance. St. Jude Medical recognizes that PPM can be a significant problem in the aortic position. The Regent was created and designed to address this issue.

Regent EOAI Chart

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References

1. St. Jude Medical, Inc., Pre-Market Approval Application – Summary of Safety and Effectiveness, SJM Regent heart valve, P810002/S57.
2. Pibarot P, Dumesnil, JG. Hemodynamic and clinical impact of prosthesis - patient mismatch in the aortic valve position and its prevention. JACC. 2000;36:1131-1141.

Indications, Safety & Warnings
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St. Jude Medical prosthetic heart valves are indicated for use as replacement valves in patients with a diseased, damaged, or malfunctioning native or prosthetic valve. Possible side effects for all valvular implants include, but are not limited to: regurgitation, thromboembolic phenomena, resistance to flow, infection, hemolysis, dysrhythmias, and prosthetic dehiscence or failure. Anticoagulation is recommended for patients with mechanical valve implants. Please see the physician’s manual for a full description of indications, contraindications, side effects, precautions, warnings and instructions for use.

Last Updated: November 8, 2013