CARDIOVASCULAR
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Implant Confidently

The Regent™ aortic mechanical valve offers surgeon-friendly implantability, featuring a low valve implant height that helps ensure coronary ostia clearance. Two distinct cuff types—FlexCuff™ or Standard Cuff—provide you with different options. The Regent™ valve features exceptional hemodynamics in small aortic root patients.1*

Because prosthesis-patient mismatch (PPM) can be problematic in the aortic position, Abbott designed the Regent™ valve specifically to avoid this issue. The orifice-to-annulus ratio of the Regent™ valve ensures large effective orifice areas (EOAs) and reduces PPM.2

The Regent™ valve shows low thromboembolism, thrombosis, and bleeding over a wide international normalized ratio (INR) range, making this valve an excellent choice.3-6

*Measured one year post-surgery.

Learn about the features of the Regent™ Aortic Mechanical Heart Valve.

Regent Aortic

Confidently Implant the Most Trusted Mechanical Valves in the World.

Learn more about the Regent™ Aortic Mechanical Heart Valve by visiting the Abbott Structural Heart website

Ordering Information

Regent™ Aortic Mechanical Heart Valve
Catalog Number Tissue Annulus Diameter (mm) Geometric Orifice Area (cm²) Implant Height Open (mm) Overall Height Open (mm) Cuff Outer Diameter (mm)
Standard Cuff
19 AGN-751 19 2.4 6.1 11.6 24.7
21 AGN-751 21 2.9 7.3 13.0 26.7
23 AGN-751 23 3.5 8.0 14.3 28.7
25 AGN-751 25 4.0 8.2 14.6 30.7
27 AGN-751 27 4.7 9.1 15.4 32.7
FlexCuff™
19 AGFN-756 19 2.4 6.1 11.6 27.0
21 AGFN-756 21 2.9 7.3 13.0 29.0
23 AGFN-756 23 3.5 8.0 14.3 31.0
25 AGFN-756 25 4.0 8.2 14.6 33.0
27 AGFN-756 27 4.7 9.1 15.4 35.0

References

  1. Regent PMA Supplement.
  2. 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(4):1131-1141. doi.org/10.1016/s0735-1097(00)00859-7.
  3. Bach DS, Sakwa MP, Goldbach M, et al. Hemodynamics and early clinical performance of the St. Jude Medical Regent mechanical aortic valve. Ann Thorac Surg. 2002;74(6):2003-2009.
  4. Torella M, Torella D, Chiodini P, et al. LOWERing the INtensity of oral anticoaGulant Therapy in patients with bileaflet mechanical aortic valve replacement: results from the "LOWERING-IT" Trial. Am Heart J. 2010;160(1); 171-178. doi: 10.1016/j.ahj.2010.05.005
  5. Koertke H, Zittermann A, Wagner O, et al. Efficacy and safety of very low-dose self-management of oral anticoagulation in patients with mechanical heart valve replacement. Ann Thorac Surg. 2010;90(5):1487-1493.
  6. Emery RW, Krogh CC, Arom KV, et al. The St. Jude Medical cardiac valve prosthesis: a 25-year experience with single valve replacement. Ann Thorac Surg. 2005;79(3):776-82. doi: 10.1016/j.athoracsur.2004.08.047
Important Safety Information

Important Safety Information

rx-only-logo SJM REGENT™ MECHANICAL HEART VALVE

INDICATION FOR USE

The SJM Regent™ Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic valve. This device may also be used to replace a previously implanted aortic prosthetic heart valve.

CONTRAINDICATIONS

The SJM Regent™ Mechanical Heart Valve is contraindicated for individuals unable to tolerate anticoagulation therapy.

WARNINGS

  • For single use only. Attempts to reuse the valve may result in valve malfunction, inadequate sterilization, or patient harm.
  • Do not use if:
    • The valve has been dropped, damaged, or mishandled in any way.
    • The expiration date has elapsed.
    • The tamper-evident container seal or inner/outer tray seals are damaged, broken or missing.
  • Remove any residual tissue that may impair valve size selection, correct seating of the valve, rotation of the valve, or leaflet motion.
  • Proper valve size selection is crucial. Do not oversize the valve. If the native annulus measurement falls between two SJM Regent™ Mechanical Heart Valve sizes, use the smaller size SJM Regent™ Mechanical Heart Valve.
  • Use only St. Jude Medical ™ mechanical heart valve sizers.
  • The outer tray is not sterile, and should not be placed in the sterile field.
  • To minimize direct handling of the valve during implantation, do not remove the holder/rotator until the valve has been seated in the annulus.
  • Do not use hard or rigid instruments to test leaflet mobility, as this may result in structural damage to the valve or thromboembolic complications. Use a St. Jude Medical™ leaflet tester to gently test valve leaflet mobility.
  • Do not use cutting edge needles in the sewing cuff. If use of these needles is necessary, placement of sutures in the outer half of the sewing cuff is imperative.
  • Never apply force to the valve leaflets. Force may cause structural damage to the valve.
  • Use only the valve holder/rotator packaged with the SJM Regent™ Mechanical Heart Valve to perform valve rotation. Use of other instruments could result in structural damage. The valve holder/ rotator is intended for single use only and should be discarded after surgery.
  • The two retention sutures on the valve holder/ rotator must be cut and removed before the SJM Regent™ Mechanical Heart Valve can be rotated.
  • Do not pass catheters or other instruments through St. Jude Medical™ mechanical heart valves. This could result in scratched or damaged valve components, or leaflet fracture or dislodgment.
  • Cut suture ends short, especially in the vicinity of the pivot guards, to prevent leaflet impingement.

PRECAUTIONS

  • Do not touch the prosthetic valve unnecessarily, even with gloved hands. This may cause scratches or surface imperfections that may lead to thrombus formation.
  • Be careful not to cut or tear the valve sewing cuff when removing the identification tag and the holder/rotator from the SJM Regent™ Mechanical Heart Valve.
  • Before placing sutures in the valve cuff, verify that the valve is mounted correctly on the valve holder/rotator.
  • To avoid structural damage, the valve must be rotated in the fully closed position.
  • To minimize rotational torque, verify that the valve holder/rotator is properly seated in the valve, and that the valve holder handle is perpendicular to the valve (Figures 15a and 15b).
  • Remove any loose suture or thread, which may be a source of thrombus or thromboembolism.

POTENTIAL ADVERSE EVENTS

Complications associated with replacement mechanical heart valves include, but are not limited to:

hemolysis; infections; thrombus; or thromboembolism; valve dehiscence; unacceptable hemodynamic performance; hemorrhagic complications secondary to anticoagulation therapy; prosthetic failure; and heart failure or death.

Any of these complications may require reoperation or explantation of the device.

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.