CARDIOVASCULAR
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Masters HP™ Mechanical Heart Valve FlexCuff™

Masters HP<sup>™</sup> Mechanical Heart Valve FlexCuff<sup>™</sup>

PRODUCT HIGHLIGHTS

  • Sewing cuff redesigned to facilitate supra-annular placement, allowing for an increase in orifice size for a given tissue annulus diameter
  • Increased effective orifice area (EOA), lower pressure gradients, and improved performance1-5
  • 85 degree leaflet opening angle offers improved laminar flow and reduces turbulence1,2,6
  • Controlled torque rotation mechanism allows for easy rotation and intraoperative adjustment
  • The FlexCuff™ is flanged and more pliable than the standard cuff
  • St. Jude Medical heart valves are MR conditional7

ORDERING INFORMATION

Contents: Aortic Valve (1 unit per box)


Reorder Number Tissue Annulus Diameter (mm) Valve Orifice Inner Diameter (mm) Geometric Orifice Area (cm2) Effective Orifice Area (cm2) Cuff Style
17AFHPJ-505 17 14.8 1.63 1.16 FlexCuff
19AFHPJ-505 19 16.7 2.06 1.51 FlexCuff
21AFHPJ-505 21 18.6 2.55 2.03 FlexCuff
23AFHPJ-505 23 20.4 3.09 2.59 FlexCuff
25AFHPJ-505 25 22.5 3.67 3.08 FlexCuff
27AFHPJ-505 27 24.2 4.41 3.73 FlexCuff

1. King, 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.

2. 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):32-9.

3. Shipkowitz T, Ambrus J, Kurk J, et al. Evaluation technique for bileaflet mechanical valves. J Heart Valve Dis. 2002, Mar; 11 (2):275-82.

4. St. Jude Medical MRI Safety Document.

5. Walker DK, Brendzel AM, Scotten LN. The New St. Jude Medical Regent mechanical heart valve: Laboratory measurements of hydrodynamic performance. J Heart Valve Dis. 1999;8(6):687-96.

6. Vitale N, Caldarera I, Muneretto C, et al. Italian multicenter study group for the St. Jude Medical Hemodynamic Plus aortic valve prosthesis. Clinical evaluation of St. Jude Medical Hemodynamic Plus versus standard aortic valve prostheses: The Italian multicenter, prospective, randomized study. J Thorac Cardiovasc Surg. 2001;122(4):691-8.

7. Carrel T, Zingg U, Jenni R, et al. Early in vivo experience with the Hemodynamic Plus St. Jude Medical heart valves in patients with narrowed aortic annulus. Ann Thorac Surg. 1996;61(5):1418-22.


Rx Only

St. Jude Medical prosthetic heart valves are indicated for use as replacement valves in patients with a diseased, damaged, or malfunctioning native or prosthetic valve. Possible side effects for all valvular implants include, but are not limited to: regurgitation, thromboembolic phenomena, resistance to flow, infection, hemolysis, dysrhythmias, and prosthetic dehiscence or failure. Anticoagulation is recommended for patients with mechanical valve implants. Please see the physician’s manual for a full description of indications, contraindications, side effects, precautions, warnings and instructions for use.

100033292 – May 2012

Last Updated: January 02, 2019

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