CARDIOVASCULAR
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The Masters Series Mechanical Heart Valves are rotatable, bileaflet valves designed for implantation in the aortic or mitral position. Abbott minimizes valve bulk with the sleek pivot guard design paired with sewing cuff options that maximize implantability without extraneous material.

The Masters Series was designed with low thrombogenicity at the forefront:

  • Minimized carbon surface area can lessen thrombus formation
  • Large internal diameters up to 26.1 mm promote low pressure gradients,1 which can help minimize shear stress and thrombogenicity2
  • Uniform velocities within hinge recesses help aid washout of blood elements3

Learn about the features of the Masters Series Mechanical Heart Valves.

Masters Series

Learn more about the Masters Series Mechanical Heart Valves by visiting the Abbott Structural Heart website

Ordering Information

Masters Series Product List
  • Masters HP 15 mm Aortic and Mitral Mechanical Heart Valves
  • Masters HP Cuffed Aortic and Mitral Mechanical Heart Valves with Standard and Expanded Cuffs
  • Masters Polyester Cuff Aortic and Mitral Mechanical Heart Valves with Standard and Expanded Cuffs
  • Masters PTFE Cuff Aortic and Mitral Mechanical Heart Valves with Standard Cuff

Masters Series 15 mm Mechanical Heart Valve
Model Tissue Annulus Diameter (mm) Geometric Orifice Area (cm²) Implant Height Open (mm) Overall Height Open (mm) Cuff OD (mm)
Aortic
15 AHPJ-505 15 1.3 4.6 8.5 20
Mitral
15 MHPJ-505 15 1.3 2.2 8.5 20

 

Masters Series Valves: HP Series Cuffed Valves
Model Tissue Annulus Diameter (mm) Geometric Orifice Area (cm²) Implant Height Open (mm) Overall Height Open (mm) Cuff OD (Standard / Expanded) (mm)
Standard Polyester Cuff Expanded Polyester Cuff
Aortic
17 AHPJ-505 17 AEHPJ-505 17 1.6 4.8 9.9 23/24
19 AHPJ-505 19 AEHPJ-505 19 2.1 5.2 10.6 25/26
21 AHPJ-505 21 AEHPJ-505 21 2.6 5.9 12.0 27/28
23 AHPJ-505 23 AEHPJ-505 23 3.1 6.7 13.3 29/31
25 AHPJ-505 25 AEHPJ-505 25 3.8 7.2 13.7 31/33
27 AHPJ-505 27 AEHPJ-505 27 4.4 8.0 14.6 33/35
Mitral
17 MHPJ-505 17 MEHPJ-505 17 1.6 2.9 9.9 23/24
19 MHPJ-505 19 MEHPJ-505 19 2.1 3.0 10.6 25/26
21 MHPJ-505 21 MEHPJ-505 21 2.6 3.3 12.0 27/28
23 MHPJ-505 23 MEHPJ-505 23 3.1 3.3 13.3 29/31
25 MHPJ-505 25 MEHPJ-505 25 3.8 3.8 13.7 31/33
27 MHPJ-505 27 MEHPJ-505 27 4.4 4.6 14.6 33/35

 

Masters Series Valves: Polyester Cuff
Model Tissue Annulus Diameter (mm) Geometric Orifice Area (cm²) Implant Height Open (mm) Overall Height Open (mm) Cuff OD (Standard / Expanded) (mm)
Standard Polyester Cuff Expanded Polyester Cuff
Aortic
19 AJ-501 19 AECJ-502 19 1.6 3.3 9.9 22/23
21 AJ-501 21 AECJ-502 21 2.1 3.7 10.6 24/25
23 AJ-501 23 AECJ-502 23 2.6 4.4 12.0 26/27
25 AJ-501 25 AECJ-502 25 3.1 5.2 13.3 28/29
27 AJ-501 27 AECJ-502 27 3.8 5.7 13.7 31/32
29 AJ-501 29 AECJ-502 29 4.4 6.5 14.6 33/35
31 AJ-501 31 AECJ-502 31 5.1 7.2 15.9 35/37
Mitral
19 MJ-501 19 MECJ-502 19 1.6 4.4 9.9 23/26
21 MJ-501 21 MECJ-502 21 2.1 4.5 10.6 26/29
23 MJ-501 23 MECJ-502 23 2.6 4.8 12.0 28/31
25 MJ-501 25 MECJ-502 25 3.1 4.8 13.3 30/33
27 MJ-501 27 MECJ-502 27 3.8 5.8 13.7 32/36
29 MJ-501 29 MECJ-502 29 4.4 6.6 14.6 35/38
31 MJ-501 31 MECJ-502 31 5.1 7.2 15.9 37/40
33 MJ-501 33 MECJ-502 33 5.1 8.2 15.9 39/42
35 MJ-501 -- 35 5.1 8.2 15.9 40/NA
37 MJ-501 -- 37 5.1 8.2 15.9 40/NA

 

Masters Series Valves: PTFE Cuff
Model Tissue Annulus Diameter (mm) Geometric Orifice Area (cm²) Implant Height Open (mm) Overall Height Open (mm) Cuff OD (Standard / Expanded) (mm)
Standard PTFE Cuff
Aortic
19 ATJ-503 19 1.6 3.3 9.9 22
21 ATJ-503 21 2.1 3.7 10.6 24
23 ATJ-503 23 2.6 4.4 12.0 26
25 ATJ-503 25 3.1 5.2 13.3 28
27 ATJ-503 27 3.8 5.7 13.7 31
29 ATJ-503 29 4.4 6.5 14.6 33
31 ATJ-503 31 5.1 7.2 15.9 35
Mitral
19 MTJ-503 19 1.6 4.4 9.9 23/26
21 MTJ-503 21 2.1 4.5 10.6 26/29
23 MTJ-503 23 2.6 4.8 12.0 28/31
25 MTJ-503 25 3.1 4.8 13.3 30/33
27 MTJ-503 27 3.8 5.8 13.7 32/36
29 MTJ-503 29 4.4 6.6 14.6 35/38
31 MTJ-503 31 5.1 7.2 15.9 37/40
33 MTJ-503 33 5.1 8.2 15.9 39/42

References

  1. Data on file at Abbott.
  2. Alemu Y, Bluestein D. Flow induced platelet activation and damage accumulation in a mechanical heart valve: numerical studies. Artif Organs. 2007;31(9):677-688. doi: 10.1111/j.1525-1594.2007.00446.x.
  3. 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
Important Safety Information

Important Safety Information

rx-only-logo SJM™ MASTERS SERIES MECHANICAL HEART VALVE

INDICATIONS

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.

MAT-2011654 v1.0

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

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