RegentTM

Setting the Standard
for Mechanical Valve
Performance

The RegentTM mechanical heart valve, a supra-annular valve, delivers exceptional hemodynamics and performance while also maintaining its long-term legacy for structural integrity and durability.
 

Exceptional Hemodynamics

The RegentTM mechanical valve features a low implant height and either flex or standard cuff options. It is also radiopaque for improved visualization during x-ray and fluoroscopy. Yet what particularly distinguishes the RegentTM valve are features such as:

    • Single-digit gradients, even in valve sizes as small as 19 mm1
    • 85° leaflet opening angle offers improved laminar flow and reduces turbulance2-4
    • Typically larger effective orifice areas (EOA) than competitors’5,6
    • Rapid and significant reduction in left ventricular (LV) mass5
    • ROOT ENLARGEMENT VERY RARE (eg, 1%)5,7

    AP2947044-WBU Rev. A

    References
    1. St. Jude Medical. Pre-market approval application supplement, Regent heart valve, P810002/S57. Washington, D.C. 2002.
    2. Shipkowitz T, et al. Evaluation technique for bileaflet mechanical valves. J Heart Valve Dis. 2002;11(2):275-282. http://www.icr-heart.com/?cid=2902
    3. King M, David T, Fisher J. An initial parametric study on fluid flow through bileaflet mechanical heart valves using computational fluid dynamics. J Engineering Med. 1994;208(2):63-72. pih.sagepub.com/content/208/2/63.abstract
    4. 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):32-39. http://dx.doi.org/10.1046/j.1525-1594.2002.06833.x
    5. 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. www.ncbi.nlm.nih.gov/pubmed/12643387
    6. 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.
    7. Petracek MR. Assessing options for the small aortic root. J Heart Valve Dis. 2002;11(Suppl. 1):S50-S55.
       
    Important safety information

    SJM REGENTTM MECHANICAL HEART VALVE
    INDICATION FOR USE


    The SJM RegentTM 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 RegentTM 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 RegentTM Mechanical Heart Valve sizes, use the smaller size SJM RegentTM Mechanical Heart Valve.
    • Use only St. Jude MedicalTM 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 MedicalTM 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 RegentTM 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 RegentTM Mechanical Heart Valve can be rotated.
    • Do not pass catheters or other instruments through St. Jude MedicalTM 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 RegentTM 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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