2011 CardiacSurgery Catalog US 062811

Cardiac Surgery
U.S. Product Catalog

May 2011
Page TC1
Table of Contents
Tissue Heart Valves
Aortic Supra-Annular Stented Valves
Trifecta
Stented Tissue Valve with Linx
AC Technology ........................................................................TH2
Epic
Supra Stented Tissue Valve with Linx
AC Technology ...................................................................TH3
Biocor
Supra Stented Tissue Valve .......................................................................................................TH4

Aortic Stented Valves
Epic
AC Technology .............................................................................TH5
Biocor
Stented Tissue Valve .................................................................................................................TH6

Mitral Stented Valves
Epic
AC Technology .............................................................................TH7
Biocor

Accessories
Trifecta Valve Sizer Set ........................................................................................................................TH9
Bioprosthetic Heart Valve Sizer Set .......................................................................................................TH10
Mechanical Heart Valves
Aortic Valves
Regent
Mechanical Heart Valve ...........................................................................................................MH2

Masters HP
Mechanical Heart Valve ....................................................................................................MH4

Masters Series Mechanical Heart Valve .................................................................................................MH7
Mitral Valves
Masters HP
Mechanical Heart Valve ..................................................................................................MH10

Masters Series Mechanical Heart Valve ...............................................................................................MH11
Aortic Valved Grafts
Masters HP
Valved Graft with Gelweave Valsalva
Technology .............................................................MH15
Masters Valved Graft with Hemashield
Technology.............................................................................MH16
Accessories
Regent
Mechanical Heart Valve Sizer Set ..........................................................................................MH17

SJM
Mechanical Heart Valve Sizer Set ...............................................................................................MH18

Page TC2
Table of Contents
Valve Repair
Flexible Rings and Band
Attune
Flexible Adjustable Annuloplasty Ring .......................................................................................VR2

Tailor
Flexible Annuloplasty Ring ..........................................................................................................VR3

Tailor
Flexible Annuloplasty Band .........................................................................................................VR4

Rigid / Semi-Rigid Rings
SJM
Rigid Saddle Ring ........................................................................................................................VR5

SJM
Sguin Semi-Rigid Annuloplasty Ring ...........................................................................................VR6

Pericardial Patch
SJM
Pericardial Patch with EnCap
AC Technology ..............................................................................VR7
Accessories
Tailor
Annuloplasty Ring Sizer Set ........................................................................................................VR8

SJM
Rigid Saddle Ring Sizer Set ..........................................................................................................VR9

SJM
Sguin Semi-Rigid Annuloplasty Ring Sizer Set ...........................................................................VR10

Tailor
and Attune
Ring Robotic Sizer Set ...........................................................................................VR11

Cardiac Ablation
Epicor
Cardiac Ablation System

Epicor
Ablation Control System (ACS)...................................................................................................CA2

Epicor
LP Cardiac Ablation System

UltraCinch
LP Ablation Device .............................................................................................................CA3

UltraWand
LP Handheld Ablation Device ..............................................................................................CA4

LP Connecting Cable ..............................................................................................................................CA5
LP Positioning and Sizing (LP PAS) System ............................................................................................CA6
LP Oblique Introducer ............................................................................................................................CA7
Universal IV Set .....................................................................................................................................CA8
Cardiac Surgery Catalog Reorder Number Index
Terms of Sale
Tissue Heart Valves
Page TH1
Tissue Heart Valves Table of Contents
Tissue Heart Valves
Trifecta
AC Technology ........................................................................TH2
Epic
Supra Stented Tissue Valve with Linx
AC Technology ...................................................................TH3
Biocor
Supra Stented Tissue Valve .......................................................................................................TH4

Epic
AC Technology .............................................................................TH5
Biocor

Epic
AC Technology .............................................................................TH7
Biocor

Accessories
Trifecta Valve Sizer Set ........................................................................................................................TH9
Bioprosthetic Heart Valve Sizer Set .......................................................................................................TH10
Total Height
Aortic
Protrusion
Tissue Annulus Diameter
Cuff Outer Diameter
Page TH2
1. St. Jude Medical. Trifecta Valve, Pre-Market Approval Application Summary of Safety and Effectiveness Data, P100029, 2011.
2. Data on File, St. Jude Medical.
* There is no clinical data currently available that evaluates the long-term impact of anticalcication tissue treatment in humans.
Rx Only
Brief Summary: Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions,
potential adverse events and directions for use.
Indications: The Trifecta Valve is indicated as a replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic heart valve. Adverse events
potentially associated with the use of bioprosthetic heart valves include: angina, cardiac arrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia,
hemorrhage, leak (transvalvular or perivalvular), myocardial infarction, nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or
positioning, or other), prosthesis regurgitation, stroke, structural deterioration (calcication, leaet tear, perforation, or other), thromboembolism and valve
thrombosis. It is possible that these complications could lead to reoperation, explantation, permanent disability or death. Long-term low dose aspirin, unless
contraindicated, is recommended for all patients with bioprosthetic valves. Long-term anticoagulant therapy, unless contraindicated, is recommended for all
patients with bioprosthetic valves who have risk factors for thromboembolism. Please see the Instructions for Use (IFU) for a full description of indications,
contraindications, side effects, precautions, warnings and Instructions for Use.
Trifecta, Linx, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are registered
and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies.
2011 St. Jude Medical, Inc. All rights reserved.
Customer Service Number: 1.800.544.1664
Cardiac Surgery U.S. Catalog 100033292 May 2011
Trifecta
Stented Tissue Valve

with Linx
AC Technology
Product Highlights

Exceptional hemodynamic performance
1

Exterior-mounted pericardial leaflets with unique suture attachment allows for
maximum leaflet excursion and large EOAs
2

Designed to provide excellent durability with the pericardial-covered stent for
tissue-to-tissue contact to reduce the risk of abrasion

Includes Linx
AC Technology, which is designed to improve long-term performance

and valve durability*

Designed to maintain structural integrity with a high-strength, fatigue-resistant,
titanium alloy stent
2

Short 2 x 10-second rinse time
Ordering Information
Contents: Aortic Supra-Annular Stented Tissue Valve (1 unit per box)
Model/Reorder
Number
Valve Size
(mm)
Tissue Annulus
Diameter
(mm)
Cuff
Outer
Diameter (mm)
Aortic
Protrusion
(mm)
Total
Height
(mm)
TF-19A 19 19 24 12 15
TF-21A 21 21 26 13 16
TF-23A 23 23 28 13 17
TF-25A 25 25 31 14 18
TF-27A 27 27 33 15 19
TF-29A 29 29 35 16 20
Tissue Heart Valves
Internal
Diameter
Aortic
Protrusion
Total
Height
Tissue
Annulus
Diameter
Page TH3
Tissue Heart Valves
Epic
Supra Stented Tissue Valve

with Linx
AC Technology
Product Highlights

Provides a larger stent-to-annulus ratio than Epic aortic valve

Identical in design to the Biocor
Supra stented tissue valve which delivers proven

20 year durability results
1,2

Includes Linx AC Technology which is designed to improve long-term performance

Three separate porcine leaflets are matched to optimize leaflet coaptation and
reduce stress

The outflow edge is covered with a pericardial shield, providing a tissue-to-tissue
interface to reduce the risk of abrasion

FlexFit
stent reduces leaflet stress, adapts easily to annulus to enhance knot

positioning, and returns stent posts to original shape after deflection

Low profile design provides optimal coronary ostia clearance

Short 2 x 10 second rinse time
Model/Reorder
Number
Valve
Size
(mm)
Tissue
Annulus
Diameter (mm)
Internal
Diameter
(mm)
Aortic
Protrusion
(mm)
Total
Height
(mm)
ESP100-19-00 19 19 19 11 14
ESP100-21-00 21 21 21 11 15
ESP100-23-00 23 23 23 13 16
ESP100-25-00 25 25 25 13 17
ESP100-27-00 27 27 27 14 19
1. Mykn PS, Bech-Hansen O. A 20-year experience of 1712 patients with the Biocor porcine bioprosthesis. J Thorac and Cardiovasc Surg. 2009;137(1):76-81.
2. Eichinger WB, Hettich IM, Ruzicka DJ, et al. Twenty-year experience with St. Jude medical Biocor bioprosthesis in the aortic position. Ann Thorac Surg.
2008;86(4):1204-1210.
Rx Only
St. Jude Medical Stented Tissue Valves are indicated for use as a replacement for malfunctioning native or prosthetic aortic and/or mitral valves. Adverse
events potentially associated with the use of bioprosthetic heart valves include: angina, cardiac arrhythmia, endocarditis, heart failure, hemolysis, hemolytic
anemia, hemorrhage (anticoagulant/antiplatelet-related), leak (transvalvular or paravalvular), myocardial infarction, nonstructural dysfunction (e.g., pannus,
suture, inappropriate sizing, or other), prosthesis regurgitation, stroke, structural deterioration (e.g., calcication, leaet tear, or other), thromboembolism and
valve thrombosis. It is possible that these complications could lead to reoperation, explantation, permanent disability or death. Long-term anticoagulation and/
or anti-platelet therapy should be considered in patients with dilated left atrium, a history of thrombotic events or a cardiac rhythm of atrial brillation or utter.
Please see the Instructions for Use (IFU) for a full description of indications, contraindications, side effects, precautions, warnings and Instructions for Use.
Epic, Linx, Biocor, FlexFit, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK.
are registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies.
Internal
Diameter
Aortic
Protrusion
Total
Height
Tissue
Annulus
Diameter
Page TH4
Tissue Heart Valves
Biocor
Supra Stented Tissue Valve

Product Highlights

Provides a larger stent-to-annulus ratio than Biocor Aortic Valve

Delivers proven 20-year durability results
1,2

Three separate porcine leaflets are matched to optimize leaflet coaptation
and reduce stress


FlexFit



Model/Reorder
Number
Valve
Size
(mm)
Tissue
Annulus
Diameter (mm)
Internal
Diameter
(mm)
Aortic
Protrusion
(mm)
Total
Height
(mm)
BSP100-19 19 19 19 11 14
BSP100-21 21 21 21 11 15
BSP100-23 23 23 23 13 16
BSP100-25 25 25 25 13 17
BSP100-27 27 27 27 14 19
2008;86(4):1204-1210.
Rx Only
Biocor, FlexFit, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are
registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies.
Internal
Diameter
Aortic
Protrusion Total
Height
Tissue
Annulus
Diameter
Page TH5
Contents: Aortic Stented Tissue Valve (1 unit per box)
Epic

with Linx
AC Technology
Product Highlights

stented tissue valve which delivers proven

1

Includes Linx AC Technology which is designed to improve long-term performance

reduce stress


FlexFit



Tissue Heart Valves
Model/Reorder
Number
Valve
Size
(mm)
Tissue
Annulus
Diameter (mm)
Internal
Diameter
(mm)
Aortic
Protrusion
(mm)
Total
Height
(mm)
E100-21A-00 21 21 19 9 14
E100-23A-00 23 23 21 9 15
E100-25A-00 25 25 23 10 16
E100-27A-00 27 27 25 11 17
E100-29A-00 29 29 27 12 19
Rx Only
Internal
Diameter
Aortic
Protrusion Total
Height
Tissue
Annulus
Diameter
Page TH6
Tissue Heart Valves
Contents: Aortic Stented Tissue Valve (1 unit per box)
Biocor

Product Highlights

Delivers proven 20 year durability results
1,2

Three separate porcine leaflets are matched to optimize leaflet coaptation
and reduce stress


FlexFit



Model/Reorder
Number
Valve
Size
(mm)
Tissue
Annulus
Diameter (mm)
Internal
Diameter
(mm)
Aortic
Protrusion
(mm)
Total
Height
(mm)
B100-21A-00 21 21 19 9 14
B100-23A-00 23 23 21 9 15
B100-25A-00 25 25 23 10 16
B100-27A-00 27 27 25 11 17
B100-29A-00 29 29 27 12 19
2008;86(4):1204-1210.
Rx Only
Internal
Diameter
Ventricular
Protrusion
Total
Height
Tissue
Annulus
Diameter
Page TH7
Tissue Heart Valves
Contents: Mitral Stented Tissue Valve (1 unit per box)
Epic

with Linx
AC Technology
Product Highlights

stented tissue valve which delivers proven

1,2

Includes Linx AC Technology which is designed to improve long-term performance and
valve durability*

Three separate porcine leaflets are matched to optimize leaflet coaptation and reduce stress

The outflow edge is covered with a pericardial shield, providing a tissue-to-tissue interface
to reduce the risk of abrasion

FlexFit
mitral valve holder provides stent deflection (ratcheting), which reduces the potential
for suture looping and maximizes visibility and access to the valve cuff

Low combined valve and holder height facilitates minimally invasive
surgical procedures

Low profile design reduces the risk of LV outflow tract obstruction

FlexFit stent reduces leaflet stress, adapts easily to annulus to enhance knot positioning,
and returns stent posts to original shape after deflection

Model/Reorder
Number
Valve
Size (mm)
Tissue Annulus
Diameter (mm)
Internal
Diameter (mm)
Ventricle
Protrusion (mm)
Total
Height (mm)
E100-25M-00 25 25 23 9 16
E100-27M-00 27 27 25 9 17
E100-29M-00 29 29 27 10 19
E100-31M-00 31 31 29 10 20
E100-33M-00 33 33 31 11 20
2008;86(4):1204-1210.
Rx Only
Internal
Diameter
Ventricular
Protrusion
Total
Height
Tissue
Annulus
Diameter
Page TH8
Tissue Heart Valves
Contents: Mitral Stented Tissue Valve (1 unit per box)
Biocor

Product Highlights

Delivers proven 20-year durability results
1,2

reduce stress


FlexFit
mitral valve holder provides stent deflection (ratcheting), which reduces

the potential for suture looping and maximizes visibility and access to the valve cuff

Low combined valve and holder height facilitates minimally invasive
surgical procedures

Low profile design reduces the risk of LV outflow tract obstruction

FlexFit stent reduces leaflet stress, adapts easily to annulus to enhance knot

Model/Reorder
Number
Valve
Size
(mm)
Tissue
Annulus
Diameter (mm)
Internal
Diameter
(mm)
Ventricle
Protrusion
(mm)
Total
Height
(mm)
B100-25M-00 25 25 23 9 16
B100-27M-00 27 27 25 9 17
B100-29M-00 29 29 27 10 19
B100-31M-00 31 31 29 10 20
B100-33M-00 33 33 31 11 20
2008;86(4):1204-1210.
Rx Only
Page TH9
Tissue Heart Valves
Trifecta
Valve Sizer Set

Accessories
Product Highlights

Designed to facilitate proper size selection of the Trifecta Tissue Valve

Sizes 19 mm 29 mm

The cylindrical end determines the appropriate size of the annulus

The corresponding valve replica end is used to visualize supra-annular placement

Features click-in handle for quick attachment to valve holder

Malleable Nitinol sizer and handle can be bent in any direction (up to 90 degrees)
without degradation

Sizer and holder handle return to original, straight shape during sterilization
Model/Reorder
Number Description
TF2000 Trifecta Valve Sizer Set, Complete
UT2000 Flexible Holder Handle
UT2000-R Rigid Holder Handle
EX2000-R Rigid Extension Handle
Contents: 6 Double-ended Aortic Sizers, 1 Valve Holder Handle and 1 Autoclavable Tray with Cover (1 unit per box)
Rx Only
Brief Summary: Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions,
Indications: The Trifecta Valve is indicated as a replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic heart valve. Adverse events
potentially associated with the use of bioprosthetic heart valves include: angina, cardiac arrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia,
hemorrhage, leak (transvalvular or perivalvular), myocardial infarction, nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or
positioning, or other), prosthesis regurgitation, stroke, structural deterioration (calcication, leaet tear, perforation, or other), thromboembolism and valve
thrombosis. It is possible that these complications could lead to reoperation, explantation, permanent disability or death. Long-term low dose aspirin, unless
contraindicated, is recommended for all patients with bioprosthetic valves. Long-term anticoagulant therapy, unless contraindicated, is recommended for all
patients with bioprosthetic valves who have risk factors for thromboembolism. Please see the Instructions for Use (IFU) for a full description of indications,
contraindications, side effects, precautions, warnings and Instructions for Use.
Trifecta,, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are registered
Cardiac Surgery Customer Service Number: 1.800.544.1664
Page TH10
Tissue Heart Valves
Model/Reorder
Number Description
B1000 Tissue Valve Sizer Set, Complete
B1000-H Replacement Handle
EX-05 Extension Handle
Contents: 6 Double-ended Aortic Sizers, 5 Mitral Sizers, 1 Valve Holder and 1 Autoclavable Tray with Cover (1 unit per box)
Bioprosthetic Heart Valve Sizer Set
Accessories
Product Highlights

Sizers include annular sizing end for measuring patients annulus and Supra sizers
include replica end that provides visual and tactile fit in the supra-annular space

For use with Epic
, Biocor
, Epic Supra and Biocor Supra valves

Tray provides one convenient location for all valve accessories

Malleable nitinol sizer and holder handle can be bent in any direction up to
90 degrees without degradation

Sizer and holder handle return to original straight shape during sterilization
Rx Only
Epic, Biocor, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are registered
Page MH1
Mechanical Heart Valves Table of Contents
Aortic Valves
Regent
Mechanical Heart Valve ...........................................................................................................MH2

Masters HP
Mechanical Heart Valve ....................................................................................................MH4

Masters Series Mechanical Heart Valve .................................................................................................MH7
Mitral Valves
Masters HP
Mechanical Heart Valve ..................................................................................................MH10

Masters Series Mechanical Heart Valve ...............................................................................................MH11
Masters HP
Valved Graft with Gelweave Valsalva
Technology .............................................................MH15
Masters Valved Graft with Hemashield
Technology.............................................................................MH16
Accessories
Regent
Mechanical Heart Valve Sizer Set ..........................................................................................MH17

SJM
Mechanical Heart Valve Sizer Set ...............................................................................................MH18

Page MH2
Model/Reorder
Number
Tissue Annulus
Diameter
(mm)
Valve Orifice
Inner Diameter
(mm)
Geometric
Orifice Area
(cm
2
)
Effective
Orifice Area
6

(cm
2
) Cuff Style
19AGN-751 19 17.8 2.39 1.84 Standard
21AGN-751 21 19.6 2.90 2.47 Standard
23AGN-751 23 21.4 3.45 2.91 Standard
25AGN-751 25 23.0 4.02 3.34 Standard
27AGN-751 27 24.9 4.69 4.28 Standard
Contents: Aortic Valve (1 unit per box)
Regent
Mechanical Heart Valve

Standard Cuff
Aortic Valves
Product Highlights

Designed to deliver exceptional hemodynamics and performance while
maintaining low complication rates, structural integrity and durability

Single digit gradients, even in sizes as small as 19 mm
1

Up to 84% orifice to annulus ratio

85 degree leaflet opening angle offers improved laminar flow and
reduces turbulence
2-4

Supra-annular placement and low implant height

The FlexCuff
is flanged and more pliable than the standard cuff

St. Jude Medical heart valves are MR Conditional
5
1. St. Jude Medical, Inc. Pre-Market Approval Application Supplement. Regent Heart Valve. Washington, D.C.; U.S. Food and Drug Administration. 2002.
P810002S57.
2. King, M, David T, Fisher J. An Initial Parametric Study on Fluid Flow Through Bileaet Mechanical Heart Valves Using Computational Fluid Dynamics.
J Eng Med 1994: 208:63-72.
3. Feng Z, Nakamura T, Fujimoto T et al. In Vitro Investigation of Opening Behavior and Hydrodynamics of Bileaet Valves in the Mitral Position. Articial Organs
2002;26(1):32-9.
4. Shipkowitz T, Ambrus J, Kurk J, Wickramasinghe K. Evaluation Technique for Bileaet Mechanical Valves. J Heart Valve Dis. 2002, Mar; 11 (2):275-82.
5. St. Jude Medical MRI Safety Document.
6. 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 Nov;8(6):687-96.
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 ow, infection,
hemolysis, dysrhythmias, and prosthetic dehiscence or failure. Anticoagulation is recommended for patients with mechanical valve implants. Please see the
physicians manual for a full description of indications, contraindications, side effects, precautions, warnings and instructions for use.
Regent, FlexCuff, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are
Page MH3
Regent

Flex Cuff
Aortic Valves
Product Highlights

Designed to deliver exceptional hemodynamics and performance while
maintaining low complication rates, structural integrity and durability

Single digit gradients, even in sizes as small as 19 mm
1

Up to 84% orifice to annulus ratio

85 degree leaflet opening angle offers improved laminar flow and
reduces turbulence
2-4

Supra-annular placement and low implant height

The FlexCuff

St. Jude Medical heart valves are MR Conditional
5
Model/Reorder
Number
Tissue Annulus
Diameter
(mm)
Valve Orifice
Inner Diameter
(mm)
Geometric
Orifice Area
(cm
2
)
Effective
Orifice Area
6

(cm
2
) Cuff Style
19AGFN-756 19 17.8 2.39 1.84 FlexCuff
21AGFN-756 21 19.6 2.90 2.47 FlexCuff
23AGFN-756 23 21.4 3.45 2.91 FlexCuff
25AGFN-756 25 23.0 4.02 3.34 FlexCuff
27AGFN-756 27 24.9 4.69 4.28 FlexCuff
1. St. Jude Medical, Inc. Pre-Market Approval Application Supplement. Regent Heart Valve. Washington, D.C.; U.S. Food and Drug Administration. 2002.
P810002S57.
J Eng Med 1994: 208:63-72.
2002;26(1):32-9.
Rx Only
Regent, FlexCuff, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are
Page MH4
Model/Reorder
Number
Tissue Annulus
Diameter
(mm)
Valve Orifice
Inner Diameter
(mm)
Geometric
Orifice Area
(cm
2
)
Effective
Orifice Area
8

(cm
2
) Cuff Style
17AHPJ-505 17 14.8 1.63 1.16 Standard
19AHPJ-505 19 16.7 2.06 1.51 Standard
21AHPJ-505 21 18.6 2.55 2.03 Standard
23AHPJ-505 23 20.4 3.09 2.59 Standard
25AHPJ-505 25 22.5 3.67 3.08 Standard
27AHPJ-505 27 24.2 4.41 3.73 Standard
Masters HP

Standard Cuff
Aortic Valves
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 performance
1-5

85 degree leaflet opening angle offers improved laminar flow
and reduces turbulence
1,2,6

Controlled torque rotation mechanism allows for easy rotation
and intraoperative adjustment

The FlexCuff

St. Jude Medical heart valves are MR conditional
7
J Eng Med 1994: 208:63-72.
2002;26(1):32-9.
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 Oct;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 May;61(5):1418-22.
8. Ismeno G, Renzulli A, De Feo M, et al. Standard versus Hemodynamic Plus 19-mm St. Jude Medical aortic valves. J Thorac Cardiovasc Surg. 2001
Apr;121(4):723-8.
Rx Only
HP, FlexCuff, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are registered
Page MH5
Model/Reorder
Number
Tissue Annulus
Diameter
(mm)
Valve Orifice
Inner Diameter
(mm)
Geometric
Orifice Area
(cm
2
)
Effective
Orifice Area
8

(cm
2
) 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
Masters HP

Flex Cuff
Aortic Valves
Product Highlights


1-5

1,2,6


The FlexCuff

7
J Eng Med 1994: 208:63-72.
2002;26(1):32-9.
Apr;121(4):723-8.
Rx Only
Page MH6
Model/Reorder
Number
Tissue Annulus
Diameter
(mm)
Valve Orifice
Inner Diameter
(mm)
Geometric
Orifice Area
(cm
2
)
Effective
Orifice Area
8

(cm
2
) Cuff Style
17AEHPJ-505 17 14.8 1.63 1.16 Expanded
19AEHPJ-505 19 16.7 2.06 1.51 Expanded
21AEHPJ-505 21 18.6 2.55 2.03 Expanded
23AEHPJ-505 23 20.4 3.09 2.59 Expanded
25AEHPJ-505 25 22.5 3.67 3.08 Expanded
27AEHPJ-505 27 24.2 4.41 3.73 Expanded
Masters HP

Expanded Cuff
Aortic Valves
Product Highlights


1-5

1,2,6


The expanded HP cuff has approximately 15% more cuff than the
standard HP cuff

7
J Eng Med 1994: 208:63-72.
2002;26(1):32-9.
Apr;121(4):723-8.
Rx Only
Page MH7
Model/Reorder
Number
Tissue Annulus
Diameter
(mm)
Valve Orifice
Inner Diameter
(mm)
Geometric
Orifice Area
(cm
2
)
Effective
Orifice Area
6

(cm
2
) Cuff Style
19AJ-501 19 14.8 1.63 1.16 Standard
21AJ-501 21 16.7 2.06 1.51 Standard
23AJ-501 23 18.6 2.55 2.03 Standard
25AJ-501 25 20.4 3.09 2.59 Standard
27AJ-501 27 22.5 3.67 3.08 Standard
29AJ-501 29 24.2 4.41 Not reported Standard
31AJ-501 31 26.1 5.18 Not reported Standard
Masters Series Mechanical Heart Valve
Standard Cuff
Aortic Valves
Product Highlights

Pyrolytic carbon leaflets and orifice ring offer exceptional durability
and increased thromboresistance
1

2-4


The expanded Masters aortic cuff has approximately 25% more cuff
than the standard cuff

5
1. 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; 79:776-83.
J Eng Med 1994: 208:63-72.
2002;26(1):32-9.
6. 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 Nov;8(6):687-96.
Rx Only
ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are registered and
unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies.
Page MH8
Model/Reorder
Number
Tissue Annulus
Diameter
(mm)
Valve Orifice
Inner Diameter
(mm)
Geometric
Orifice Area
(cm
2
)
Effective
Orifice Area
6

(cm
2
) Cuff Style
19AECJ-502 19 14.8 1.63 1.16 Expanded
21AECJ-502 21 16.7 2.06 1.51 Expanded
23AECJ-502 23 18.6 2.55 2.03 Expanded
25AECJ-502 25 20.4 3.09 2.59 Expanded
27AECJ-502 27 22.5 3.67 3.08 Expanded
29AECJ-502 29 24.2 4.41 Not reported Expanded
31AECJ-502 31 26.1 5.18 Not reported Expanded
Expanded Cuff
Aortic Valves
Product Highlights

1

2-4


The expanded Masters aortic cuff has approximately 25% more cuff
than the standard cuff

5
Ann Thorac Surg. 2005; 79:776-83.
J Eng Med 1994: 208:63-72.
2002;26(1):32-9.
Rx Only
Page MH9
Model/Reorder
Number
Tissue Annulus
Diameter
(mm)
Valve Orifice
Inner Diameter
(mm)
Geometric
Orifice Area
(cm
2
)
Effective
Orifice Area
6

(cm
2
) Cuff Style
19ATJ-503 19 14.8 1.63 1.16 PTFE
21ATJ-503 21 16.7 2.06 1.51 PTFE
23ATJ-503 23 18.6 2.55 2.03 PTFE
25ATJ-503 25 20.4 3.09 2.59 PTFE
27ATJ-503 27 22.5 3.67 3.08 PTFE
29ATJ-503 29 24.2 4.41 Not reported PTFE
31ATJ-503 31 26.1 5.18 Not reported PTFE
PTFE Cuff
Aortic Valves
Product Highlights

1

2-4


5
Ann Thorac Surg. 2005; 79:776-83.
J Eng Med 1994: 208:63-72.
2002;26(1):32-9.
Rx Only
Page MH10
Model/Reorder
Number
Tissue Annulus
Diameter (mm)
Valve Orifice Inner
Diameter (mm)
Geometric Orifice
Area (cm
2
) Cuff Style
17MHPJ-505 17 14.8 1.63 Standard
19MHPJ-505 19 16.7 2.06 Standard
21MHPJ-505 21 18.6 2.55 Standard
23MHPJ-505 23 20.4 3.09 Standard
25MHPJ-505 25 22.5 3.67 Standard
27MHPJ-505 27 24.2 4.41 Standard
Contents: Mitral Valve (1 unit per box)
Masters HP

Standard Cuff
Mitral Valves
Product Highlights


Increased geometric orifice area (GOA), lower pressure gradients,
1,2

1-3


Minimizes interference with sub-valvular structures

4
2002;26(1):32-9.
J Eng Med 1994: 208:63-72.
Rx Only
HP, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are registered
Page MH11
Model/Reorder
Number
Tissue Annulus
Diameter (mm)
Valve Orifice Inner
Diameter (mm)
Geometric Orifice
Area (cm
2
) Cuff Style
19MJ-501 19 14.8 1.63 Standard
21MJ-501 21 16.7 2.06 Standard
23MJ-501 23 18.6 2.55 Standard
25MJ-501 25 20.4 3.09 Standard
27MJ-501 27 22.5 3.67 Standard
29MJ-501 29 24.2 4.41 Standard
31MJ-501 31 26.1 5.18 Standard
33MJ-501 33 26.1 5.18 Standard
35MJ-501 35 26.1 5.18 Standard
37MJ-501 37 26.1 5.18 Standard
Standard Cuff
Mitral Valves
Product Highlights

1

2-4


5
Ann Thorac Surg. 2005; 79:776-83.
J Eng Med 1994: 208:63-72.
2002;26(1):32-9.
Rx Only
Page MH12
Model/Reorder
Number
Tissue Annulus
Diameter (mm)
Valve Orifice Inner
Diameter (mm)
Geometric Orifice
Area (cm
2
) Cuff Style
19MECJ-502 19 14.8 1.63 Expanded
21MECJ-502 21 16.7 2.06 Expanded
23MECJ-502 23 18.6 2.55 Expanded
25MECJ-502 25 20.4 3.09 Expanded
27MECJ-502 27 22.5 3.67 Expanded
29MECJ-502 29 24.2 4.41 Expanded
31MECJ-502 31 26.1 5.18 Expanded
33MECJ-502 33 26.1 5.18 Expanded
Expanded Cuff
Mitral Valves
Product Highlights

1

2-4


The expanded mitral cuff has approximately 25% more cuff than
the standard mitral cuff

5
Ann Thorac Surg. 2005; 79:776-83.
J Eng Med 1994: 208:63-72.
2002;26(1):32-9.
Rx Only
Page MH13
Model/Reorder
Number
Tissue Annulus
Diameter (mm)
Valve Orifice Inner
Diameter (mm)
Geometric Orifice
Area (cm
2
) Cuff Style
19MTJ-503 19 14.8 1.63 PTFE
21MTJ-503 21 16.7 2.06 PTFE
23MTJ-503 23 18.6 2.55 PTFE
25MTJ-503 25 20.4 3.09 PTFE
27MTJ-503 27 22.5 3.67 PTFE
29MTJ-503 29 24.2 4.41 PTFE
31MTJ-503 31 26.1 5.18 PTFE
33MTJ-503 33 26.1 5.18 PTFE
PTFE Cuff
Mitral Valves
Product Highlights

1

2-4


The expanded PTFE cuf has approximately 16% more cuff than the
standard PTFE cuff

5
Ann Thorac Surg. 2005; 79:776-83.
J Eng Med 1994: 208:63-72.
2002;26(1):32-9.
Rx Only
Page MH14
Model/Reorder
Number
Tissue Annulus
Diameter (mm)
Valve Orifice Inner
Diameter (mm)
Geometric Orifice
Area (cm
2
) Cuff Style
19METJ-504 19 14.8 1.63 Expanded PTFE
Expanded PTFE Cuff
Mitral Valves
Product Highlights

1

2-4


The expanded PTFE cuf has approximately 16% more cuff than the
standard PTFE cuff

5
Ann Thorac Surg. 2005; 79:776-83.
J Eng Med 1994: 208:63-72.
2002;26(1):32-9.
Rx Only
Page MH15
Model/Reorder
Number
Tissue Annulus
Diameter
(mm)
Graft Inner
Diameter
(mm)
Skirt Diameter
(mm) +/- 10%
(inflated)
Valve Orifice
Inner Diameter
(mm)
Geometric
Orifice Area
(cm
2
)
19VAVGJ-515 19 20 26 16.7 2.06
21VAVGJ-515 21 22 28 18.6 2.55
23VAVGJ-515 23 24 32 20.4 3.09
25VAVGJ-515 25 26 34 22.5 3.67
27VAVGJ-515 27 28 36 24.2 4.41
29VAVGJ-515 29 30 38 26.1 5.18
Contents: Aortic Valved Graft (1 unit per box)
Masters HP
Valved Graft
with Gelweave Valsalva
Technology
Product Highlights

Patented Valsalva design mimics natural anatomy and eases
anastomotic suturing
1-3

Gelweave technology gelatin coating aids in tissue ingrowth
4

Low porosity graft enables zero pre-clotting
4

Expanded cuff designed to minimize potential for paravalvular leak

Graft length is 10 cm minimum

5
1. De Paulis R, De Matteis GM, Nardi P, et al. A New Aortic Dacron Conduit for Surgical Treatment of Aortic Root Pathology. Ital Heart J. 2000 Jul;1(7):457-63.
2. De Paulis R, Bassano C, Scaffa R, et al. Bentall Producures with a Novel Valved Conduit Incorporating Sinuses of Valsalva. Surg Technol Int.
2004;12:195-200.
3. De Paulis R, De Matteis GM, Nardi P, et al. One-year Appraisal of a New Aortic Root Conduit with Sinuses of Valsalva. J Thorac Cardiovasc Surg.
2002 Jan;123(1):33-9.
4. From Manufacturers Literature: Vascutek, Ltd.
Gelweave Valsalva is a trademark of Vascutek, Ltd.
Rx Only
Page MH16
Model/Reorder
Number
Tissue Annulus
Diameter
(mm)
Graft Inner
Diameter
(mm)
Valve Orifice
Inner Diameter
(mm)
Geometric
Orifice Area
(cm
2
)
19CAVGJ-514-00 19 20 14.7 1.63
21CAVGJ-514-00 21 22 16.7 2.06
23CAVGJ-514-00 23 24 18.5 2.55
25CAVGJ-514-00 25 28 20.4 3.09
27CAVGJ-514-00 27 30 22.3 3.67
29CAVGJ-514-00 29 32 24.1 4.41
31CAVGJ-514-00 31 34 26.0 5.18
33CAVGJ-514-00 33 34 26.0 5.18
Contents: Aortic Valved Graft (1 unit per box)
Masters Valved Graft
with Hemashield
Technology
Product Highlights

Hemashield technology graft with collagen impregnation provides
uniform tissue ingrowth and biocompatibility
1

Low porosity graft requires no pre-clotting
1

No pleats at valve cuff allow for easy positioning and attachment
of coronary anastomosis
1

Graft length is 12 cm

2
1. From Manufacturers Literature: MAQUET Cardiovascular.
Hemashield is a registered trademark of Maquet Cardiovascular LLC.
Rx Only
Page MH17
Contents: 7 Double-ended Aortic Sizers, 1 Valve Holder Handle and 1 Autoclave-able Tray with Cover (1 unit per box)
Regent
Mechanical Heart Valve Sizer Set

Accessories
Product Highlights

Designed to facilitate proper size selection of the Regent mechanical heart valve
in a supra-annular position

Sizes 17 mm 29 mm


The corresponding Regent valve replica end is used to visualize placement


Model/Reorder
Number Description
907 Sizer Set, Complete
905-HH Valve Holder Handle
AG-RHR Replacement Regent Valve Holder/Rotators, Sizes 17 mm29mm
LT100 Mechanical Valve Leaet Tester
Rx Only
Regent, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are registered
Page MH18
SJM
Mechanical Heart Valve Sizer Set

Accessories
Product Highlights

Designed to facilitate proper size selection of the Masters and Masters HP


Aortic valve sizes 17 mm 31 mm

Mitral valve sizes 17 mm 33 mm


Malleable nitinol sizer and holder handle can be bent in any direction
up to 90 degrees without degradation

Model/Reorder
Number Description
905 Sizer Set, Complete
905-HH Valve Holder Handle
905-MHH Mitral Valve Holder Handle
905-RHH Rigid Valve Holder Handle
A-RHR
Replacement Aortic Masters Series Valve Holder/Rotators
Sizes 19 mm 31 mm
M-RHR
Replacement Mitral Masters Series Valve Holder/Rotators
Sizes 19 mm 37 mm
AHP-RHR
Replacement Aortic Masters HP Valve Holder/Rotators
Sizes 17 mm 27 mm
LT100 Mechanical Valve Leaet Tester
Contents: 6 Double-ended Sizers, 3 Single-ended Sizers, 1 Valve Holder Handle and 1 Autoclavable Tray with Cover
(1 unit per box)
Rx Only
Valve Repair
Page VR1
Valve Repair Table of Contents
Valve Repair
Flexible Rings and Band
Attune
Flexible Adjustable Annuloplasty Ring .......................................................................................VR2

Tailor
Flexible Annuloplasty Ring ..........................................................................................................VR3

Tailor
Flexible Annuloplasty Band .........................................................................................................VR4

SJM
Rigid Saddle Ring ........................................................................................................................VR5

SJM
Sguin Semi-Rigid Annuloplasty Ring ...........................................................................................VR6

Pericardial Patch
SJM
Pericardial Patch with EnCap
AC Technology ..............................................................................VR7
Accessories
Tailor
Annuloplasty Ring Sizer Set ........................................................................................................VR8

SJM
Rigid Saddle Ring Sizer Set ..........................................................................................................VR9

SJM
Sguin Semi-Rigid Annuloplasty Ring Sizer Set ...........................................................................VR10

Tailor
and Attune
Ring Robotic Sizer Set ...........................................................................................VR11

Page VR2
Valve Repair
Model/Reorder
Number Ring Size
Fixed Dimension
(mm) (A)
Ring Inner
Dimension (mm) (B)
Ring Outer
Dimension (mm) (C)
AFR-25 25 25 28.4 33.4
AFR-27 27 27 31.2 36.2
AFR-29 29 29 34.0 39.0
AFR-31 31 31 36.6 41.6
AFR-33 33 33 39.4 44.4
AFR-35 35 35 40.9 45.9
AFR-37 37 37 43.7 48.7
AFR-39 39 39 46.2 51.2
AFR-41 41 41 49.0 54.0
AFR-43 43 43 51.6 56.6
Contents: Flexible Adjustable Annuloplasty Ring (1 unit per box)
Attune
Flexible Adjustable Annuloplasty Ring

Flexible Ring
Product Highlights

Fully flexible design allows dynamic movement of the annulus

Symmetrical and asymmetrical adjustability is designed to achieve ideal
leaflet coaptation and match each patients annulus

Adjustability after placement is designed to help eliminate residual
mitral regurgitation

Independent adjustability allows the annuloplasty to be localized to one side

Suitable for implant using open sternotomy, minimally invasive
and robotic approaches
Rx Only
Please review the Instructions for Use prior to using these devices for a complete listing of indications,
contraindications, warnings, precautions, potential adverse events, and directions for use.
Attune, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are registered
Page VR3
Valve Repair
Contents: Flexible Ring (1 unit per box)
Tailor
Flexible Annuloplasty Ring

Flexible Ring
Product Highlights

Designed to maintain the size of a repaired mitral or tricuspid annulus while
sustaining physiologic movement

Anterior and posterior support allows dynamic annular motion during the
cardiac cycle

Flexible design aids cardiac output and left ventricular function, supporting
optimal hemodynamics
1-3

Large target area eases suturing

Model/Reorder
Number Ring Size
Inside
Dimension (mm) (B)
Outside
Dimension (mm) (C)
Intertrigonal
Dimension (mm) (A)
TARP-25 25 28.4 34.4 25
TARP-27 27 31.2 37.2 27
TARP-29 29 34.0 40.0 29
TARP-31 31 36.6 42.6 31
TARP-33 33 39.4 45.4 33
TARP-35 35 40.9 47.9 35
1. Yamaura Y, Yoshikawa J, Yoshida K, et al. Three-dimensional analysis of configuration and dynamics in patients with an annuloplasty ring by multiplane
transesophageal echocardiography: Comparison between flexible and rigid annuloplasty rings. J Heart Valve Dis. 1995;4(6)61822.
2. Kunzelman K, Reimink S, Cochran P. Flexible versus rigid ring annuloplasty for mitral valve annular dilatation: A finite element model. J Heart Valve Dis.
1998;7(1)108.
3. David T, Armstrong S, Sun Z. Left ventricular function after mitral valve surgery. J Heart Valve Dis. 1995;4(Supl) S17580.
Rx Only
Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential
adverse events, and directions for use.
Tailor, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are registered
Page VR4
Valve Repair
Contents: Flexible Band (1 unit per box)
Tailor
Flexible Annuloplasty Band

Flexible Band
Product Highlights

Band offers simple alternative and time-saving simplicity to flexible rings

Posterior support allows dynamic annular motion

Flexible design aids cardiac output and left ventricular function, supporting
optimal hemodynamics
1-3

Large target area eases suturing

Model/Reorder
Number Ring Size
Inside
Dimension (mm) (B)
Outside
Dimension (mm) (C)
Intertrigonal
Dimension (mm) (A)
TAB-25 25 28.4 34.4 25
TAB-27 27 31.2 37.2 27
TAB-29 29 34.0 40.0 29
TAB-31 31 36.6 42.6 31
TAB-33 33 39.4 45.4 33
TAB-35 35 40.9 47.9 35
1. Yamaura Y, Yoshikawa J, Yoshida K, et al. Three-dimensional analysis of configuration and dynamics in patients with an annuloplasty ring by multiplane
transesophageal echocardiography: Comparison between flexible and rigid annuloplasty rings. J Heart Valve Dis. 1995;4(6)61822.
2. Kunzelman K, Reimink S, Cochran P. Flexible versus rigid ring annuloplasty for mitral valve annular dilatation: A finite element model. J Heart Valve Dis.
1998;7(1)108.
3. David T, Armstrong S, Sun Z. Left ventricular function after mitral valve surgery. J Heart Valve Dis. 1995;4(Supl) S17580.
Rx Only
Tailor, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are registered
A
A
B
C
Internal 2-D
Orifice Area
Page VR5
Valve Repair
Contents: Rigid Saddle Ring (1 unit per box)
SJM
Rigid Saddle Ring

Product Highlights

Designed to restore the shape of a healthy mitral annulus
1

Titanium core maintains the anatomical shape and provides annular remodeling

Saddle shape contributes to efficient distribution of leaflet stress and chordal tension
which may increase repair durability
1-4

EZ Suture Cuff is supported by a unique triangular core for a larger suture target
Model/Reorder
Number Ring Size
Commisure
Dimension
(mm) (A)
Inside
Dimension
(mm) (B)
Outside
Dimension
(mm) (C)
A-P
Dimension
(mm) (D)
Internal 2-D
Orifice Area
(mm
2
)
RSAR-24 24 24 22 30 13.6 227
RSAR-26 26 26 24 32 15.1 276
RSAR-28 28 28 26 34 16.2 331
RSAR-30 30 30 28 26 17.9 387
RSAR-32 32 32 30 38 19.2 450
RSAR-34 34 34 32 40 20.6 511
1. Jimenez JH, Soerensen DD, He Z, et al. Effects of a saddle shaped annulus on mitral valve function and chordal force distribution: an in vitro study.
Ann Biomed Eng. 2003;31(10):1171-81.
2. Salgo IS, Gorman JH 3rd, Gorman RC, et al. Effect of annular shape on leaet curvature in reducing mitral leaet stress. Circulation. 2002;106(6):711-7.
3. Jimenez JH, Liou SW, Padala M, et al. A saddle-shaped annulus reduces systolic strain on the central region of the mitral valve anterior leaet.
J Thorac Cardiovasc Surg. 2007;134(6):1562-8.
4. Gorman JH 3rd, Jackson BM, Enomoto Y, et al. The effect of regional ischemia on mitral valve annular saddle shape. Ann Thorac Surg. 2004;77(2):544-8.
Rx Only
ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are registered
Internal 2-D
Orifice Area
B
C
A
Page VR6
Valve Repair
Contents: Semi-Rigid Ring (1 unit per box)
SJM
Sguin Semi-Rigid Annuloplasty Ring

Product Highlights

Designed to aid cardiac output and left ventricular function
1

Semi-rigid, three-dimensional posterior section is designed to preserve the
physiologic movement of the valve annulus
1

Increased rigidity of the anterior section of the ring promotes annular remodeling
1

The solid, one piece inner core resists needle penetration, reducing the potential
for suturing through the core
Model/Reorder
Number Ring Size
Commisure
Dimension
(mm) (A)
Inside
Dimension
(mm) (B)
Outside
Dimension
(mm) (C)
Internal 2-D
Orifice Area
(mm
2
)
SARP-24 24 24 22 29 284
SARP-26 26 26 24 31 334
SARP-28 28 28 27 34 404
SARP-30 30 30 28 35 463
SARP-32 32 32 30 37 541
SARP-34 34 34 34 41 602
SARP-36 36 36 36 43 630
SARP-38 38 38 37 45 735
SARP-40 40 40 39 46 815
1. Sguin J, Demaria R, Chaptal PA. Preservation of three-dimensional annular movement with the SJM-Seguin mitral annuloplasty ring. J Heart Valve Dis.
1996;5(6):641-46.
Rx Only
Page VR7
Valve Repair
Contents: Pericardial Patch (1 unit per box)
SJM
Pericardial Patch
with EnCap
AC Technology
Pericardial Patch
Product Highlights

Flexible and durable to provide enhanced biocompatibility and lasting performance
1-3

Bovine pericardium provides improved handling and suturability compared
with synthetic patches
4

Anti-calcification treatment enhances tissue healing, biocompatibility and long-term
tissue stability
1*

Thinner patch available to accommodate pediatric applications
5

Soft, pliable tissue conforms to the anatomy and easily sutures into place

Ready-to use, rinseless preparation saves time during procedures
*There is no clinical data currently available which evaluates the long-term impact of anticalcication treatment in humans.
1. Frater RWM, Seifter E, Liao K, et al. Anticalcication, proendothelial, and anti-inammatory effect of post-aldehyde polyol treatment of bioprosthetic material.
In: Gabbay S, Wheatley DJ (eds.). Advances in Anticalcic and Antidegenerative Treatment of Heart Valve Bioprostheses. Austin, TX: Silent Partners Inc;
1997:105-14.
2. Frater RWM, Liao K, Seifter E. Stentless chordally supported mitral bioprosthetic valve. In: Gabbay S, Frater RWM (eds.) New Horizons and the Future of Heart
Valve Bioprostheses. Austin, TX: Silent Partners Inc; 1994:103-19.
3. Hoffman D, Gong G, Liao K, et al. Spontaneous host endothelial growth on bioprostheses. Circulation. 1992;86[suppl II]:II-75-II-79.
4. Crawford FA Jr, Sade RM, Spinale F. Bovine pericardium for correction of congenital heart defects. Ann Thorac Surg. 1986;41(6):602-5.
5. Hopkins, et. al. Surgical Patch Closure of Atrial Septal Defects. Ann Thorac Surg. 2001;77-2144-50.
EnCap is a trademark of Glycar, Inc.
Rx Only
Cardiac Surgery U.S. Catalog 100033292 June 2011
Model/Reorder
Number
Patch Size
(cm)
Nominal Thickness
(mm)
C0205 2 x 5 0.20 0.40
C0405 4 x 5 0.150.25
C0510 5 x 10 0.20 0.40
C0914 9 x 14 0.20 0.40
Page VR8
Valve Repair
Tailor
Annuloplasty Ring Sizer Set

Accessories
Product Highlights

Designed to facilitate proper size selection of the Tailor ring and band
and Attune
ring

Sizes 25 mm 35 mm

Contents: 6 Sizers, 1 Malleable Holder Handle, 1 Extension Handle and 1 Autoclavable Tray and Cover
Model/Reorder
Number Description
TAR-505 Tailor Flexible Ring Set, Complete
HH-05 Replacement Holder Handle
EX-05 Replacement Extension Handle
Rx Only
Tailor, Attune, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are registered
Page VR9
Valve Repair
Contents: 6 Sizers, 1 Malleable Holder Handle, 1 Extension Handle and 1 Autoclavable Tray and Cover
SJM
Rigid Saddle Ring Sizer Set

Accessories
Product Highlights

Designed to facilitate proper size selection of the SJM Rigid Saddle annuloplasty ring

Sizes 24 mm 34 mm

Model/Reorder
Number Description
RSAR-507A SJM Rigid Saddle Ring Sizer Set, Compete
Rx Only
Page VR10
Valve Repair
SJM
Sguin Semi-Rigid Annuloplasty Ring

Sizer Set
Accessories
Product Highlights

Designed to facilitate proper size selection for the SJM Seguin annuloplasty ring

Sizes 24 mm 40 mm

Contents: 9 Mitral Sizers, 1 Malleable Holder Handle, 1 Extension Handle and 1 Autoclavable Tray and Cover
Model/Reorder
Number Description
SAR-501 SJM Sguin Semi-Rigid Ring Sizer Set, Complete
Rx Only
Page VR11
Contents: 10 Low-profile Robotic Sizers and 1 Autoclavable Tray and Cover
Tailor
and Attune
Ring Robotic Sizer Set

Accessories
Product Highlights

Designed to facilitate proper size selection of the Tailor ring and band
and Attune ring

Sizes 25 mm 43 mm

Radiopaque titanium construction

Laser-etched anatomical indicators for easy identification
Model/Reorder
Number Description
TAR-510R Tailor and Attune Ring Robotic Sizer Set, Complete
Valve Repair
Rx Only
Tailor, Attune, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are registered
Cardiac Ablation
Page CA1
Cardiac Ablation
Epicor
Cardiac Ablation System

Epicor
Ablation Control System (ACS)...................................................................................................CA2

Epicor

UltraCinch
LP Ablation Device .............................................................................................................CA3

UltraWand
LP Handheld Ablation Device ..............................................................................................CA4

LP Connecting Cable ..............................................................................................................................CA5
LP Positioning and Sizing (LP PAS) System ............................................................................................CA6
LP Oblique Introducer ............................................................................................................................CA7
Universal IV Set .....................................................................................................................................CA8
Cardiac Ablation Table of Contents
Page CA2
Cardiac Ablation
Contents: Ablation Control System (1 unit per box)
Epicor
Ablation Control System (ACS)

Epicor Cardiac Ablation System
Product Highlights

Utilizes high intensity focused ultrasound (HIFU) to surgically ablate cardiac tissue
concomitant with cardiac surgery

Designed to create lesions entirely epicardially while the patient is off-pump

Simple one-button control

Intuitive user display provides real-time information on ablation cycle progress
and system performance

Power, frequency, and temperature display and monitoring

Integrated safety features and real-time help screens

Scalable architecture for ongoing system and software upgrades
Model/Reorder
Number
Power
Configuration
ACS-US-2 100-120 V, 60 Hz, 1000 VA
Rx Only
Please review the Instructions for Use prior to using these devices for Use for a complete listing of indications,
Epicor, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are registered
Page CA3
Cardiac Ablation
Contents: UltraCinch LP Ablation Device (1 unit per box)
UltraCinch
LP Ablation Device
Epicor

Product Highlights

An array of high intensity focused ultrasound (HIFU) emitting transducers creates a
contiguous, circular lesion in a single step, entirely epicardially and off-pump

A flexible transducer cell array, low transducer cell profile and a tapered distal end
make it equally suited for use in open- or closed-chest procedures

Integrated tensioning sutures prevent device migration and keep energy focused
on targeted tissue

Single-plane energy delivery designed to reduce the risk of collateral damage

Multiple sizes accommodate varying anatomy

Ablates through fat, eliminating the need for dissection
Model/Reorder
Number
Size
(cells)
UC-LP-7 7
UC-LP-8 8
UC-LP-9 9
UC-LP-10 10
UC-LP-11 11
UC-LP-12 12
UC-LP-13 13
Rx Only
UltraCinch, Epicor, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are
Page CA4
Cardiac Ablation
Contents: UltraWand LP Handheld Ablation Device (1 unit per box)
UltraWand
LP Handheld Ablation Device

Epicor

Product Highlights

Two high intensity focused ultrasound (HIFU) emitting transducers create lesions
up to 3.2 cm in length, entirely epicardially and off-pump

Provides the precision and flexibility needed to create additional linear lesions
specific to each patients needs

Low transducer cell profile makes it equally suited for use in open-or closed-chest
procedures

Flexible neck enhances positioning and access

Specially designed shaft provides reach and stability

Ablates through fat eliminating the need for dissection
Model/Reorder
Number
UW-LP-2
Rx Only
UltraCinch, Epicor, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are
Page CA5
Cardiac Ablation
Contents: LP Connecting Cable (1 unit per box)
LP Connecting Cable
Epicor

Product Highlights

Reusable and non-sterilizable interface between the UltraCinch
LP
and UltraWand
LP ablation devices and the Epicor Ablation Control

System (ACS) unit
Model/Reorder
Number
Length
(cm)
CC-6-LP-CE 183
Rx Only
UltraWand, Epicor, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are
Page CA6
Cardiac Ablation
Contents: 1 Introducer / Sizer, 2 Suture Snares and 2 Tourniquets (1 set per box)
LP Positioning and Sizing (LP PAS) System
Epicor

Product Highlights

Sizing marks on the introducer/sizer allow appropriate UltraCinch
LP ablation
device selection

Locking mechanism attaches the introducer / sizer to the UltraCinch LP device,
facilitating smooth introduction and proper placement of the ablation array around
the heart

Soft atraumatic tip of the introducer / sizer promotes smooth device placement

Suture snares and tourniquets help hold the UltraCinch LP device securely in place
during ablation to ensure creation of a contiguous, circular lesion
Model/Reorder
Number
LP-PAS-1
Rx Only
Epicor, UltraCinch, UltraWand, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK.
Page CA7
Cardiac Ablation
Contents: LP Oblique Introducer (1 unit per box)
LP Oblique Introducer
Epicor

Product Highlights

Designed to work together with the LP PAS system to facilitate access, sizing
and proper placement of the UltraCinch
LP device in a closed-chest procedure

Soft atraumatic tip promotes smooth device placement

Handle provides reach and stability
Model/Reorder
Number
LP-OBL-1
Rx Only
Epicor, UltraCinch, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are
Page CA8
Cardiac Ablation
Contents: Universal IV Set Device (1 unit per box)
Universal IV Set
Epicor

Product Highlights

Provides a standard IV line for use with the UltraCinch
LP ablation device

Lack of injection ports reduces the potential for air entrapment

Supplied by Alaris
Products*
Model/Reorder
Number
Length
(cm)
IVS-UC 264
Rx Only
*Alaris is a registered or unregistered trademark of Cardinal Health
Epicor, UltraCinch, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are
Page NI1
Tissue Heart Valves
Reorder Number Page Number
B1000 TH8
B1000-H TH8
B100-21A-00 TH5
B100-23A-00 TH5
B100-25A-00 TH5
B100-25M-00 TH7
B100-27A-00 TH5
B100-27M-00 TH7
B100-29A-00 TH5
B100-29M-00 TH7
B100-31M-00 TH7
B100-33M-00 TH7
BSP100-19 TH3
BSP100-21 TH3
BSP100-23 TH3
BSP100-25 TH3
BSP100-27 TH3
E100-21A-00 TH4
E100-23A-00 TH4
E100-25A-00 TH4
E100-25M-00 TH6
E100-27A-00 TH4
E100-27M-00 TH6
E100-29A-00 TH4
E100-29M-00 TH6
E100-31M-00 TH6
E100-33M-00 TH6
ESP100-19-00 TH2
ESP100-21-00 TH2
ESP100-23-00 TH2
ESP100-25-00 TH2
ESP100-27-00 TH2
EX-05 TH8
905 MH18
907 MH17
17AEHPJ-505 MH6
17AFHPJ-505 MH5
17AHPJ-505 MH4
17MHPJ-505 MH10
19AECJ-502 MH8
19AEHPJ-505 MH6
19AFHPJ-505 MH5
19AGFN-756 MH3
19AGN-751 MH2
19AHPJ-505 MH4
19AJ-501 MH7
19ATJ-503 MH9
19CAVGJ-514-00 MH16
19MECJ-502 MH12
19METJ-504 MH14
19MHPJ-505 MH10
19MJ-501 MH11
19MTJ-503 MH13
19VAVGJ-515 MH15
21AECJ-502 MH8
21AEHPJ-505 MH6
21AFHPJ-505 MH5
21AGFN-756 MH3
21AGN-751 MH2
21AHPJ-505 MH4
21AJ-501 MH7
21ATJ-503 MH9
21CAVGJ-514-00 MH16
21MECJ-502 MH12
21METJ-504 MH14
21MHPJ-505 MH10
21MJ-501 MH11
21MTJ-503 MH13
21VAVGJ-515 MH15
23AECJ-502 MH8
23AEHPJ-505 MH6
23AFHPJ-505 MH5
23AGFN-756 MH3
23AGN-751 MH2
23AHJP-505 MH4
23AJ-501 MH7
23ATJ-503 MH9
23CAVGJ-514-00 MH16
23MECJ-502 MH12
23METJ-504 MH14
23MHPJ-505 MH10
23MJ-501 MH11
23MTJ-503 MH13
23VAVGJ-515 MH15
25AECJ-502 MH8
25AEHPJ-505 MH6
25AFHPJ-505 MH5
25AGFN-756 MH3
25AGN-751 MH2
25AHJP-505 MH4
25AJ-501 MH7
25ATJ-503 MH9
25CAVGJ-514-00 MH16
Page NI2
25MECJ-502 MH12
25METJ-504 MH14
25MHPJ-505 MH10
25MJ-501 MH11
25MTJ-503 MH13
25VAVGJ-515 MH15
27AECJ-502 MH8
27AEHPJ-505 MH6
27AFHPJ-505 MH5
27AGFN-756 MH3
27AGN-751 MH2
27AHJP-505 MH4
27AJ-501 MH7
27ATJ-503 MH9
27CAVGJ-514-00 MH16
27MECJ-502 MH12
27METJ-504 MH14
27MJ-501 MH11
27MHPJ-505 MH10
27MTJ-503 MH13
27VAVGJ-515 MH15
29AECJ-502 MH8
29AJ-501 MH7
29ATJ-503 MH9
29CAVGJ-514-00 MH16
29MECJ-502 MH12
29METJ-504 MH14
29MJ-501 MH11
29MTJ-503 MH13
29VAVGJ-515 MH15
31AECJ-502 MH8
31AJ-501 MH7
31ATJ-503 MH9
31CAVGJ-514-00 MH16
31MECJ-502 MH12
31METJ-504 MH14
31MJ-501 MH11
31MTJ-503 MH13
33CAVGJ-514-00 MH16
33MECJ-502 MH12
33METJ-504 MH14
33MJ-501 MH11
33MTJ-503 MH13
35MJ-501 MH11
37MJ-501 MH11
905-HH MH17
905-HH MH18
905-MHH MH18
905-RHH MH18
AG-RHR MH17
AHP-RHR MH18
A-RHR MH18
LT100 MH17, 18
M-RHR MH18
Valve Repair
AFR-25 VR2
AFR-27 VR2
AFR-29 VR2
AFR-31 VR2
AFR-33 VR2
AFR-35 VR2
AFR-37 VR2
AFR-39 VR2
AFR-41 VR2
AFR-43 VR2
C0205 VR7
C0405 VR7
C0510 VR7
C0914 VR7
EX-05 VR8, 9, 10
HH-05 VR8, 9, 10
RSAR-057A VR9
RSAR-24 VR5
RSAR-26 VR5
RSAR-28 VR5
RSAR-30 VR5
RSAR-32 VR5
RSAR-34 VR5
SAR-501 VR10
SARP-24 VR6
SARP-26 VR6
SARP-28 VR6
SARP-30 VR6
SARP-32 VR6
SARP-34 VR6
SARP-36 VR6
SARP-38 VR6
SARP-40 VR6
TAB-25 VR4
TAB-27 VR4
Page NI3
Valve Repair
TAB-29 VR4
TAB-31 VR4
TAB-33 VR4
TAB-35 VR4
TAR-505 VR8
TAR-510R VR11
TARP-25 VR3
TARP-27 VR3
TARP-29 VR3
TARP-31 VR3
TARP-33 VR3
TARP-35 VR3
Cardiac Ablation
ACS-US-2 CA2
CC-6-LP-CE CA5
IVS-UC CA8
LP-OBL-1 CA7
LP-PAS-1 CA6
UC-LP-7 CA3
UC-LP-8 CA3
UC-LP-9 CA3
UC-LP-10 CA3
UC-LP-11 CA3
UC-LP-12 CA3
UC-LP-13 CA3
UW-LP-2 CA4
Page TS1
Placing Orders
Orders received by St. Jude Medical (SJM) are
subject to acceptance at its St. Paul, Minnesota
facility and are deemed accepted only when
conrmed in writing or upon SJMs commencement
of performance.
Orders may be placed:
In Writing
St. Jude Medical
177 East Country Road B
St. Paul MN 55117
When placing an order in writing, the following
information should be provided:
Your account number, if known
Billing and shipping address information
Contact name/ contact phone number
Method of shipment or due date
Reorder number and quantity desired
Purchase Order Number
Pricing, if known
Serial number
By Direct Dial Telephone
(800) 544-1664
When placing an order by telephone, you will
be asked to provide the following information:
Pricing will be veried

A conrmation number will be given at the
conclusion of the order.
By Fax
(651) 481-7702
When placing an order by fax, the following
information should be provided:
Billing and shipping address information
Contact name/ contact phone number /

contact fax number
Pricing, if known
A conrmation number will be faxed back to
the contact with any corrections noted.

Payment Terms = Net 30 Days

Shipping
FOB: Shipping Point

Transit Damage
Although SJM takes special care in packaging
its products, damage may occur in transit. All
products should, therefore, be inspected upon
receipt. Any damage should be noted on the freight
bill and reported to the carrier within ve (5) days
of shipment arrival. SJM cannot accept responsibility
for damage after shipments have been accepted by
the carriers agent.
Terms of Sale
Page TS2
Product Returns
Advance authorization and an assigned return goods
authorization number (RGA #) are required from
SJM prior to return of any product. An RGA # may
be obtained by contacting your sales representative.
If your sales rep is not known, you may call
Customer Service, who will be able to put you in
contact with the appropriate sales personnel.
The following information will be required to obtain
a return goods authorization number (RGA #):
Your account number
Reorder number, batch, lot or serial number(s)
Quantity to be returned
Reason for return
Original purchase order number or SJMs

invoice number
Serial number

Limited Warranty
St. Jude Medical, Inc. (SJM) warrants that reasonable
care has been used in the manufacturing of this
device. THIS WARRANTY IS IN LIEU OF AND
EXCLUDES ALL OTHER WARRANTIES NOT
EXPRESSLY SET FORTH HEREIN, WHETHER
EXPRESS OR IMPLIED BY OPERATION OF LAW OR
OTHERWISE INCLUDING, BUT NOT LIMITED TO,
ANY IMPLIED WARRANTIES OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE, since
handling, storage, cleaning, and sterilization of this
device as well as factors relating to the patient,
diagnosis, treatment, surgical procedures, and other
matters beyond SJMs control directly affect this
device and the results obtained from its use. SJM
SHALL NOT BE LIABLE FOR ANY INCIDENTAL OR
CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE
directly or indirectly arising from the use of this device
other than the replacement of all or part of it. SJM
neither assumes, nor authorizes any other person
to assume for it, any other or additional liability or
responsibility in connection with this device.
Some states in the United States do not allow
limitations on how long an implied warranty lasts,
so the above limitations may not apply to you. This
limited warranty gives you specic legal rights, and
you may have other rights which vary from jurisdiction
to jurisdiction.
Descriptions of the specications appearing in SJM
literature are meant solely to generally describe
the device at the time of manufacture and do not
constitute any express warranties.
Terms of Sale
Rx only
Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions,
Unless otherwise noted
indicates a registered or unregistered trademark or service mark owned by, or licensed to, St. Jude Medical, Inc. or one
of its subsidiaries. Attune, Biocor, Epic, FlexFit, Regent, HP, SJM Rigid Saddle Ring, SJM Sguin Semi-Rigid Ring, Tailor, Linx, FlexCuff, Trifecta,
Epicor, UltraWand, UltraCinchSJM Pericardial Patch, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are trademarks
and service marks of St. Jude Medical, Inc. and its related companies. Hemashield
is a registered trademark of Maquet Cardiovascular LLC.

Gelweave Valsalva Technology
is a trademark of Vascutek, Ltd. EnCap is a trademark of Glycar, Inc.

2011 St. Jude Medical. All rights reserved.
Item 100033292 May 2011
SJMprofessional.com
Global Headquarters
One St. Jude Medical Drive
St. Paul, Minnesota 55117
USA
+1 651 756 2000
+1 651 756 3301 Fax
St. Jude Medical US Division
6300 Bee Cave Road
Building Two, Suite 100
Austin, Texas 78746
USA
+1 512 732 7400
+1 512 732 2418 Fax
ATRIAL FIBRILLATION CARDIAC RHYTHM MANAGEMENT CARDIOVASCULAR NEUROMODULATION
St. Jude Medical Cardiovascular
6300 Bee Cave Road
Building Two, Suite 100
Austin, Texas 78746
USA
+1 512 732 7400
+1 512 732 2418 Fax

2011 CardiacSurgery Catalog US 062811

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Cardiac Surgery

U.S. Product Catalog

Stented Tissue Valve with Linx

Supra Stented Tissue Valve with Linx

Supra Stented Tissue Valve .......................................................................................................TH4

Stented Tissue Valve with Linx

Stented Tissue Valve .................................................................................................................TH6

Stented Tissue Valve with Linx

Stented Tissue Valve .................................................................................................................TH8

Mechanical Heart Valve ...........................................................................................................MH2

Mechanical Heart Valve ....................................................................................................MH4

Mechanical Heart Valve ..................................................................................................MH10

Valved Graft with Gelweave Valsalva

Mechanical Heart Valve Sizer Set ..........................................................................................MH17

Mechanical Heart Valve Sizer Set ...............................................................................................MH18

Flexible Adjustable Annuloplasty Ring .......................................................................................VR2

Flexible Annuloplasty Ring ..........................................................................................................VR3

Flexible Annuloplasty Band .........................................................................................................VR4

Rigid Saddle Ring ........................................................................................................................VR5

Sguin Semi-Rigid Annuloplasty Ring ...........................................................................................VR6

Pericardial Patch with EnCap

Annuloplasty Ring Sizer Set ........................................................................................................VR8

Rigid Saddle Ring Sizer Set ..........................................................................................................VR9

Sguin Semi-Rigid Annuloplasty Ring Sizer Set ...........................................................................VR10

Ring Robotic Sizer Set ...........................................................................................VR11

Cardiac Ablation System

Ablation Control System (ACS)...................................................................................................CA2

LP Cardiac Ablation System

LP Ablation Device .............................................................................................................CA3

LP Handheld Ablation Device ..............................................................................................CA4

Stented Tissue Valve with Linx

Supra Stented Tissue Valve with Linx

Supra Stented Tissue Valve .......................................................................................................TH4

Stented Tissue Valve with Linx

Stented Tissue Valve .................................................................................................................TH6

Stented Tissue Valve with Linx

Stented Tissue Valve .................................................................................................................TH8

Stented Tissue Valve

AC Technology, which is designed to improve long-term performance

Supra Stented Tissue Valve

Supra stented tissue valve which delivers proven

stent reduces leaflet stress, adapts easily to annulus to enhance knot

Supra Stented Tissue Valve

stent reduces leaflet stress, adapts easily to annulus to enhance knot

Stented Tissue Valve

stented tissue valve which delivers proven

stent reduces leaflet stress, adapts easily to annulus to enhance knot

Stented Tissue Valve

stent reduces leaflet stress, adapts easily to annulus to enhance knot

Stented Tissue Valve

stented tissue valve which delivers proven

Stented Tissue Valve

mitral valve holder provides stent deflection (ratcheting), which reduces

Valve Sizer Set

, Epic Supra and Biocor Supra valves

Mechanical Heart Valve ...........................................................................................................MH2

Mechanical Heart Valve ....................................................................................................MH4

Mechanical Heart Valve ..................................................................................................MH10

Valved Graft with Gelweave Valsalva

Mechanical Heart Valve Sizer Set ..........................................................................................MH17

Mechanical Heart Valve Sizer Set ...............................................................................................MH18

Mechanical Heart Valve

is flanged and more pliable than the standard cuff

Mechanical Heart Valve