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IMPLANT CONFIDENTLY
WITH ABBOTT MHV.
CONSIDERED THE GOLD
STANDARD.

IMPLANT CONFIDENTLY
WITH ABBOTT MHV.
CONSIDERED THE GOLD
STANDARD.

At Abbott, we take a great deal of pride in our life-changing technologies and our ability to help you treat patients with structural heart disease.

Our family of Mechanical Heart Valves has been implanted in over 3 million patients1; the only mechanical valves to reach this milestone and have been studied in more than 1,000 peer reviewed publications.2

Over the past 40+ years, the Abbott family of Mechanical Heart Valves has been implanted in over 3 million patients; the only mechanical valve to reach this milestone. This impacts not only the lives of 3 million patients, but also their loved ones and friends. Our Abbott mechanical heart valves are an important part of our legacy, helping surgeons to rebuild healthier hearts for their patients over several decades.

Addressing an unmet need for high-risk pediatric patients

Only Abbott provides the world's smallest pediatric mechanical heart valve, the 15 mm Masters HP, for aortic and mitral heart valves. Developed to address an unmet need for high-risk pediatric patients who formerly had limited options. The patients who need the valve are usually younger than 1 year old with complex heart defects, have had multiple prior heart surgeries and require a valve replacement.

Meet Sadie: A recipient of the world’s smallest 15 mm Pediatric Mechanical Heart Valve

Diagnosed with a heart condition before birth, Sadie received an Abbott mechanical heart valve that saved her life.

A long-term solution for heart valve replacement

The Masters Mechanical Heart Valve is made of carbon material that offers unmatched strength and durability. Long-term studies have shown the Masters valve has notable longevity and may last for at least 30 years.4,5 The newest generation, Regent™ aortic mechanical heart valve is designed to provide exception hemodynamics and low thrombogenicity.

Meet Allen: A 37-Year mechanical heart valve replacement

Diagnosed with endocarditis at 19 years old, Allen had his aortic valve replaced in his mid-30s with an Abbott Mechanical Heart Valve. After 37 years, Allen is still living a full life without any restrictions.

MASTERS SERIES MECHANICAL HEART VALVE

REGENT™ MECHANICAL HEART VALVE

Design-driven hemodynamic confidence & low thrombogenicity

Abbott mechanical heart valves lead the way with a proven bileaflet design that results in low thrombogenicity and excellent patient outcomes.

  • Leaflets open to an 85-degree angle in systole due to their upstream positioning, enabled by unique pivot guards (shown at right)
  • Strong, uniform velocities within hinge recesses aid washout of blood elements6
  • Low carbon surface area means less thrombus formation
  • Orifice-to-annulus ratio (as high as 84%) ensures large effective orifice areas (EOAs) and reduces prosthesis-patient mismatch7
Abbott mechanical heart valves have a bileaflet design

The pivot guard design an Abbott hallmark

Featured in all Abbott Mechanical Heart Valves, the Pivot Guard offers benefits both during implant and post-implant

  • Recessed design minimizes interaction with sub-annular native mitral valve apparatus
  • Minimized carbon surface area can lessen thrombus formation
  • Pivot guards help shield pivot mechanism from pannus ingrowth
  • Enables a consistent 85-degree opening angle, promoting minimized leaflet flutter and more laminar flow through the orifice
Abbott mechanical heart valves feature the pivot guard design

To learn more about Abbott Mechanical Heart Valves visit structural­heart.­abbott


STRUCTURAL­HEART.­ABBOTT


MAT-2106693 v2.0 | Item approved for U.S. use only.

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References
  1. Internal Sales Tracking Spreadsheet. Data on file at Abbott.
  2. MHV Paper List. Data on file at Abbott.
  3. Data on file at Abbott.
  4. Saito S, Tsukui H, Iwasa S, et al. Bileaflet mechanical valve replacement: an assessment of outcomes with 30 years of follow-up. Interact Cardiovasc Thorac Surg. 2016;23(4):599-607.
  5. 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):776-783.
  6. Jun BH, Saikrishnan N, Yoganathan AP. Micro particle image velocimetry measurements of steady diastolic leakage flow in the hinge of a St. Jude Medical Regent™ mechanical heart valve. Ann Biomed Eng. 2014;42(3):526–540. Published online 2013 Oct 2.doi: 10.1007/s10439-013- 0919-y
  7. 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
Important Safety Information
  • Regent
  • MASTERS SERIES

  • 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.

  • SJM™ MASTERS SERIES
    MECHANICAL HEART VALVE


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

    CONTRAINDICATIONS

    The SJM™ Masters Series 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™ Masters Series Mechanical Heart Valve sizes, use the smaller size SJM™ Masters Series 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.
    • Place sutures in the outer half of the valve sewing cuff.
    • Never apply force to the valve leaflets. Force may cause structural damage to the valve.
    • Use only SJM™ Valve Holder/Rotators 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™ Masters Series 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.
    • Three cases of impeded leaflet motion not satisfactorily explained were reported in a survey of 149 centers reporting on 4,934 patients implanted over a period of three (3) years. A number of other cases occurred early in the investigation of this prosthesis; however, the rates of occurrence are not statistically determinable.

    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™ Masters Series Mechanical Heart Valve.
    • Before placing sutures in the valve sewing 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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