St. Jude Medical® Regent™

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 turbulance^1c,6,9
• Significantly larger EOAs²
• Renders root enlargement practically unnecessary^7,10
• Significant reduction in left ventricular (LV) mass^2,7,8

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 cuf

Outstanding Durability

• A gold standard pivot-guard design proven in over 1.8 million implants

Visibility

• St. Jude Medical heart valves are MR conditional^1,1b 
• Radiopaque for improved visualization during X-ray and cinefluoroscopy

References

¹Blais 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]

^1cShipkowitz T, Ambrus J, Kurk J, Wickramasinghe K. Evaluation Technique for Bileaflet Mechanical Valves. J Heart Valve Dis. 2002, Mar; 11 (2):275-282.

²St. Jude Medical, Inc. Pre-Market Approval Application Supplement. Regent Heart Valve. Washington, D.C.; U.S. Food and Drug Administration. 2002. P810002/S57.

³Pibarot 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.

⁶King, 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.

⁷Bach 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.

⁸St. Jude Medical, Inc. Pre-Market Approval Application – Summary of Safety and Effectiveness. SJM Regent heart valve, P810002/S57.

⁹Zhonggang 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.

¹⁰Petracek MR. Assessing options for the small aortic root. J Heart Valve Dis. 2002 Jan;11 Suppl 1:S50-S55.

Unmatched EOAs Virtually Eliminate Patient-Prosthesis 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.