2011 cardiacsurgery catalog us 062811

8/13/2019 2011 CardiacSurgery Catalog US 062811

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Cardiac Surgery

U.S. Product Catalog

May 2011


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Table of Contents

Tissue Heart Valves

Aortic Supra-Annular Stented Valves

TrifectaStented Tissue Valve with Linx AC Technology ........................................................................TH2

EpicSupra Stented Tissue Valve with LinxAC Technology ...................................................................TH3

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

Aortic Stented Valves

EpicStented Tissue Valve with LinxAC Technology .............................................................................TH5

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

Mitral Stented ValvesEpicStented Tissue Valve with LinxAC Technology .............................................................................TH7


Accessories

Trifecta Valve Sizer Set ........................................................................................................................TH9

Bioprosthetic Heart Valve Sizer Set .......................................................................................................TH10

Mechanical Heart Valves

Aortic Valves

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

Masters HPMechanical Heart Valve ....................................................................................................MH4

Masters Series Mechanical Heart Valve .................................................................................................MH7

Mitral Valves

Masters HPMechanical Heart Valve ..................................................................................................MH10 Masters Series Mechanical Heart Valve ...............................................................................................MH11

Aortic Valved Grafts

Masters HPValved Graft with Gelweave ValsalvaTechnology .............................................................MH15

Masters Valved Graft with Hemashield Technology.............................................................................MH16

Accessories

RegentMechanical Heart Valve Sizer Set ..........................................................................................MH17

SJMMechanical Heart Valve Sizer Set ...............................................................................................MH18


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Table of Contents

Valve Repair

Flexible Rings and Band

AttuneFlexible Adjustable Annuloplasty Ring .......................................................................................VR2

TailorFlexible Annuloplasty Ring ..........................................................................................................VR3

TailorFlexible Annuloplasty Band .........................................................................................................VR4

Rigid / Semi-Rigid Rings

SJMRigid Saddle Ring ........................................................................................................................VR5

SJMSguin Semi-Rigid Annuloplasty Ring ...........................................................................................VR6

Pericardial Patch SJMPericardial Patch with EnCapAC Technology ..............................................................................VR7

Accessories

TailorAnnuloplasty Ring Sizer Set ........................................................................................................VR8

SJMRigid Saddle Ring Sizer Set ..........................................................................................................VR9

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

Tailorand AttuneRing Robotic Sizer Set...........................................................................................VR11

Cardiac Ablation

EpicorCardiac Ablation System

EpicorAblation Control System (ACS)...................................................................................................CA2

EpicorLP Cardiac Ablation System

UltraCinchLP Ablation Device .............................................................................................................CA3

UltraWandLP 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


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Tissue Heart Valves


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Tissue Heart Valves Table of Contents

Tissue Heart Valves

Aortic Supra-Annular Stented Valves

TrifectaStented Tissue Valve with Linx AC Technology ........................................................................TH2

EpicSupra Stented Tissue Valve with LinxAC Technology ...................................................................TH3

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

Aortic Stented Valves

EpicStented Tissue Valve with LinxAC Technology .............................................................................TH5


Mitral Stented ValvesEpicStented Tissue Valve with LinxAC Technology .............................................................................TH7


Accessories

Trifecta Valve Sizer Set ........................................................................................................................TH9

Bioprosthetic Heart Valve Sizer Set .......................................................................................................TH10


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Total Height AorticProtrusion

Tissue Annulus Diameter

Cuff Outer Diameter

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 anticalcification 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 aor tic heart valve. Adverse events

potentially associated with the use of bioprosthetic hear t 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 (calcification, leaflet 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

TrifectaStented Tissue Valve

with LinxAC TechnologyAortic Supra-Annular Stented Valves

Product Highlights Exceptional hemodynamic performance1

Exterior-mounted pericardial leaflets with unique suture attachment allows for

maximum leaflet excursion and large EOAs2

Designed to provide excellent durability with the pericardial-covered stent for

tissue-to-tissue contact to reduce the risk of abrasion

Includes LinxAC 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 stent2

Short 2 x 10-second rinse time

Ordering InformationContents: 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


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InternalDiameter

AorticProtrusion

TotalHeight

TissueAnnulusDiameter

Tissue Heart Valves

Ordering InformationContents: Aortic Supra-Annular Stented Tissue Valve (1 unit per box)

BiocorSupra Stented Tissue ValveAortic Supra-Annular Stented Valves

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

Delivers proven 20-year durability results1,2

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 FlexFitstent 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)

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


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. Adverseevents 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., calcification, leaflet 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 fibrillation or flutter.

Please see the Instructions for Use (IFU) for a full description of indications, contraindications, side effects, precautions, warnings and Instructions for Use.

Biocor FlexFit ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are


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InternalDiameter

AorticProtrusionTotal

Height


Ordering InformationContents: Aortic Stented Tissue Valve (1 unit per box)

EpicStented Tissue Valve

with LinxAC TechnologyAortic Stented Valves

Product Highlights Identical in design to the Biocorstented tissue valve which delivers proven

20 year durability results1

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 andreduce stress


interface to reduce the risk of abrasion

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




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







Epic Linx Biocor FlexFit ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK


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InternalDiameter

AorticProtrusionTotal

Height


Tissue Heart Valves

Ordering InformationContents: Aortic Stented Tissue Valve (1 unit per box)

BiocorStented Tissue ValveAortic Stented Valves

Product Highlights Delivers proven 20 year durability results1,2

Three separate porcine leaflets are matched to optimize leaflet coaptation

and reduce stress



FlexFit

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



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









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InternalDiameter

VentricularProtrusion

TotalHeight


Tissue Heart Valves

Ordering InformationContents: Mitral Stented Tissue Valve (1 unit per box)

EpicStented Tissue Valve

with LinxAC Technology

Mitral Stented Valves

Product Highlights Identical in design to the Biocorstented tissue valve which delivers proven

20 year durability results1,2

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

FlexFitmitral 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







Epic Linx Biocor FlexFit ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK


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InternalDiameter

VentricularProtrusion

TotalHeight


Tissue Heart Valves

Ordering InformationContents: Mitral Stented Tissue Valve (1 unit per box)

BiocorStented Tissue ValveMitral Stented Valves

Product Highlights Delivers proven 20-year durability results1,2

Three separate porcine leaflets are matched to optimize leaflet coaptation and

reduce stress



FlexFit

mitral valve holder provides stent deflection (ratcheting), which reducesthe 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.

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Tissue Heart Valves

TrifectaValve Sizer SetAccessories

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

Ordering InformationContents: 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,

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 aor tic heart valve. Adverse events

potentially associated with the use of bioprosthetic hear t 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 (calcification, leaflet 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


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Mechanical Heart Valves Table of Contents


Aortic Valves

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

Masters HPMechanical Heart Valve ....................................................................................................MH4

Masters Series Mechanical Heart Valve .................................................................................................MH7

Mitral Valves

Masters HPMechanical Heart Valve ..................................................................................................MH10

Masters Series Mechanical Heart Valve ...............................................................................................MH11


Masters HPValved Graft with Gelweave ValsalvaTechnology .............................................................MH15

Masters Valved Graft with Hemashield Technology.............................................................................MH16

Accessories

RegentMechanical Heart Valve Sizer Set ..........................................................................................MH17

SJMMechanical Heart Valve Sizer Set ...............................................................................................MH18


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Model/Reorder

Number

Tissue Annulus

Diameter

(mm)

Valve Orifice

Inner Diameter

(mm)

Geometric

Orifice Area

(cm2)

Effective

Orifice Area6

(cm2) 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

Ordering InformationContents: Aortic Valve (1 unit per box)

RegentMechanical 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 mm1

Up to 84% orifice to annulus ratio

85 degree leaflet opening angle offers improved laminar flow and

reduces turbulence2-4

Supra-annular placement and low implant height

The FlexCuffis flanged and more pliable than the standard cuff

St. Jude Medical heart valves are MR Conditional5

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 Bileaflet Mechanical Heart Valves Using Computational Fluid Dynamics.

J Eng Med1994: 208:63-72.

3. 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.

4. Shipkowitz T, Ambrus J, Kurk J, Wickramasinghe K. Evaluation Technique for Bileaflet 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 flow, 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


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RegentMechanical Heart Valve

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 mm1

Up to 84% orifice to annulus ratio

85 degree leaflet opening angle offers improved laminar flow and

reduces turbulence2-4

Supra-annular placement and low implant height

The FlexCuffis flanged and more pliable than the standard cuff

St. Jude Medical heart valves are MR Conditional5

Model/Reorder

Number

Tissue Annulus

Diameter

(mm)

Valve Orifice

Inner Diameter

(mm)

Geometric

Orifice Area

(cm2)

Effective

Orifice Area6

(cm2) 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 Med1994: 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


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Model/Reorder

Number

Tissue Annulus

Diameter

(mm)

Valve Orifice

Inner Diameter

(mm)

Geometric

Orifice Area

(cm2)

Effective

Orifice Area8

(cm2) 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 HPMechanical Heart Valve

Expanded 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 performance1-5

85 degree leaflet opening angle offers improved laminar flowand reduces turbulence1,2,6

Controlled torque rotation mechanism allows for easy rotation

and intraoperative adjustment

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

standard HP cuff

St. Jude Medical heart valves are MR conditional7


J Eng Med1994: 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 Organs2002;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


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Model/Reorder

Number

Tissue Annulus

Diameter

(mm)

Valve Orifice

Inner Diameter

(mm)

Geometric

Orifice Area

(cm2)

Effective

Orifice Area6

(cm2) 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

Ordering Information

Contents: Aortic Valve (1 unit per box)

Masters Series Mechanical Heart Valve

Standard Cuff

Aortic Valves

Product Highlights Pyrolytic carbon leaflets and orifice ring offer exceptional durability

and increased thromboresistance1

85 degree leaflet opening angle offers improved laminar flow

and reduces turbulence2-4

Controlled torque rotation mechanism allows for easy rotationand intraoperative adjustment

The expanded Masters aortic cuff has approximately 25% more cuff

than the standard cuff


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 Med1994: 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

M h i l H t V l


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Model/Reorder

Number

Tissue Annulus

Diameter

(mm)

Valve Orifice

Inner Diameter

(mm)

Geometric

Orifice Area

(cm2)

Effective

Orifice Area6

(cm2) 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


Contents: Aortic Valve (1 unit per box)


Expanded Cuff

Aortic Valves






The expanded Masters aortic cuff has approximately 25% more cuff

than the standard cuff





J Eng Med1994: 208:63-72.


2002;26(1):32-9.





Rx Only








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Model/Reorder

Number

Tissue AnnulusDiameter

(mm)

Valve OrificeInner Diameter

(mm)

GeometricOrifice Area

(cm2)

EffectiveOrifice Area6

(cm2) 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










J Eng Med1994: 208:63-72.


2002;26(1):32-9.





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Model/Reorder

Number

Tissue Annulus

Diameter (mm)

Valve Orifice Inner

Diameter (mm)

Geometric Orifice

Area (cm2) 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

Ordering InformationContents: Mitral Valve (1 unit per box)

Masters HPMechanical Heart Valve

Standard Cuff

Mitral 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 geometric orifice area (GOA), lower pressure gradients,

and improved performance1,2

85 degree leaflet opening angle offers improved laminar flowand reduces turbulence1-3

Controlled torque rotation mechanism allows for easy rotation

and intraoperative adjustment

Minimizes interference with sub-valvular structures



2002;26(1):32-9.



J Eng Med1994: 208:63-72.


Rx Only





HP ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are registered



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Model/ReorderNumber

Tissue AnnulusDiameter (mm)

Valve Orifice InnerDiameter (mm)

Geometric OrificeArea (cm2) 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 Standard31MJ-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

Ordering InformationContents: Mitral Valve (1 unit per box)


Standard Cuff

Mitral Valves










J Eng Med1994: 208:63-72.


2002;26(1):32-9.



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c c

Model/Reorder

Number

Tissue Annulus

Diameter (mm)

Valve Orifice Inner

Diameter (mm)

Geometric Orifice


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


Contents: Mitral Valve (1 unit per box)


Expanded Cuff

Mitral Valves






The expanded mitral cuff has approximately 25% more cuff than

the standard mitral cuff





J Eng Med1994: 208:63-72.


2002;26(1):32-9.



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Model/Reorder

Number

Tissue Annulus

Diameter (mm)

Valve Orifice Inner

Diameter (mm)

Geometric Orifice


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






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

standard PTFE cuff





J Eng Med1994: 208:63-72.


2002;26(1):32-9.



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Model/Reorder

Number

Tissue Annulus

Diameter (mm)

Valve Orifice Inner

Diameter (mm)

Geometric Orifice


19METJ-504 19 14.8 1.63 Expanded PTFE











Expanded PTFE Cuff

Mitral Valves






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

standard PTFE cuff





J Eng Med1994: 208:63-72.


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Model/Reorder

Number

Tissue Annulus

Diameter

(mm)

Graft Inner

Diameter

(mm)

Skirt Diameter

(mm) +/- 10%

(inflated)

Valve Orifice

Inner Diameter

(mm)

Geometric

Orifice Area

(cm2)

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

Ordering InformationContents: Aortic Valved Graft (1 unit per box)

Masters HPValved Graft

with Gelweave ValsalvaTechnology


Product Highlights Patented Valsalva design mimics natural anatomy and eases

anastomotic suturing1-3

Gelweave technology gelatin coating aids in tissue ingrowth4

Low porosity graft enables zero pre-clotting4

Expanded cuff designed to minimize potential for paravalvular leak Graft length is 10 cm minimum


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








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Model/Reorder

Number

Tissue Annulus

Diameter

(mm)

Graft Inner

Diameter

(mm)

Valve Orifice

Inner Diameter

(mm)

Geometric

Orifice Area

(cm2)

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 3.6729CAVGJ-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

Ordering InformationContents: Aortic Valved Graft (1 unit per box)

Masters Valved Graft

with HemashieldTechnology


Product Highlights Hemashield technology graft with collagen impregnation provides

uniform tissue ingrowth and biocompatibility1

Low porosity graft requires no pre-clotting1

No pleats at valve cuff allow for easy positioning and attachment

of coronary anastomosis

1

Graft length is 12 cm


1. From Manufacturers Literature: MAQUET Cardiovascular.


Hemashield is a registered trademark of Maquet Cardiovascular LLC.

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Ordering InformationContents: 7 Double-ended Aortic Sizers, 1 Valve Holder Handle and 1 Autoclave-able Tray with Cover (1 unit per box)

RegentMechanical Heart Valve Sizer SetAccessories

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 cylindrical end determines the appropriate size of the annulus

The corresponding Regent valve replica end is used to visualize placement

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

Model/ReorderNumber Description

907 Sizer Set, Complete

905-HH Valve Holder Handle

AG-RHR Replacement Regent Valve Holder/Rotators, Sizes 17 mm29mm

LT100 Mechanical Valve Leaflet Tester

Rx Only





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Valve Repair


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Valve Repair


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Model/ReorderNumber Ring Size

Fixed Dimension(mm) (A)

Ring InnerDimension (mm) (B)

Ring OuterDimension (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

Ordering InformationContents: Flexible Adjustable Annuloplasty Ring (1 unit per box)

AttuneFlexible Adjustable Annuloplasty RingFlexible 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.

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Ordering InformationContents: Flexible Ring (1 unit per box)

TailorFlexible Annuloplasty RingFlexible 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 hemodynamics1-3

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.

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Ordering InformationContents: Flexible Band (1 unit per box)

TailorFlexible Annuloplasty BandFlexible 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 hemodynamics1-3

Large target area eases suturing



Model/ReorderNumber Ring Size

InsideDimension (mm) (B)

OutsideDimension (mm) (C)

IntertrigonalDimension (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



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Valve Repair


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A

A

B

C

Internal 2-DOrifice Area

Ordering InformationContents: Rigid Saddle Ring (1 unit per box)

SJMRigid Saddle RingRigid / Semi-Rigid Rings

Product Highlights Designed to restore the shape of a healthy mitral annulus1

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 durability1-4

EZ Suture Cuff is supported by a unique triangular core for a larger suture target

Model/Reorder

Number Ring Size

CommisureDimension

(mm) (A)

InsideDimension

(mm) (B)

OutsideDimension

(mm) (C)

A-PDimension

(mm) (D)


(mm2)

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 leaflet curvature in reducing mitral leaflet 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 leaflet.

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



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Valve Repair

SJM S i S i Ri id A l l t Ri


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Internal 2-D

Orifice Area

B

C

A

Ordering InformationContents: Semi-Rigid Ring (1 unit per box)

SJMSguin Semi-Rigid Annuloplasty RingRigid / Semi-Rigid Rings

Product Highlights Designed to aid cardiac output and left ventricular function1

Semi-rigid, three-dimensional posterior section is designed to preserve the

physiologic movement of the valve annulus1

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

CommisureDimension

(mm) (A)

InsideDimension

(mm) (B)

OutsideDimension

(mm) (C)


(mm2)

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




Valve Repair

SJM P i a dial Pat h


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Ordering InformationContents: Pericardial Patch (1 unit per box)

SJMPericardial Patch

with EnCapAC TechnologyPericardial Patch

Product Highlights Flexible and durable to provide enhanced biocompatibility and lasting performance1-3

Bovine pericardium provides improved handling and suturability compared

with synthetic patches4

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

tissue stability1*

Thinner patch available to accommodate pediatric applications5

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 anticalcification treatment in humans.

1. Frater RWM, Seifter E, Liao K, et al. Anticalcification, proendothelial, and anti-inflammatory effect of post-aldehyde polyol treatment of bioprosthetic material.

In: Gabbay S, Wheatley DJ (eds.). Advances in Anticalcific 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




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

Valve Repair

Tailor Annuloplasty Ring Sizer Set


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Tailor Annuloplasty Ring Sizer SetAccessories

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

and Attunering

Sizes 25 mm 35 mm



Ordering InformationContents: 6 Sizers, 1 Malleable Holder Handle, 1 Extension Handle and 1 Autoclavable Tray and Cover


TAR-505 Tailor Flexible Ring Set, Complete

HH-05 Replacement Holder Handle

EX-05 Replacement Extension Handle

Rx Only



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SJM Rigid Saddle Ring Sizer Set


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Ordering InformationContents: 6 Sizers, 1 Malleable Holder Handle, 1 Extension Handle and 1 Autoclavable Tray and Cover

SJM Rigid Saddle Ring Sizer SetAccessories

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

Sizes 24 mm 34 mm




RSAR-507A SJM Rigid Saddle Ring Sizer Set, Compete



Rx Only




Valve Repair

SJM Sguin Semi-Rigid Annuloplasty Ring


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SJM Sguin Semi Rigid Annuloplasty Ring

Sizer SetAccessories

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

Sizes 24 mm 40 mm



Ordering InformationContents: 9 Mitral Sizers, 1 Malleable Holder Handle, 1 Extension Handle and 1 Autoclavable Tray and Cover


SAR-501 SJM Sguin Semi-Rigid Ring Sizer Set, Complete



Rx Only





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Cardiac Ablation

Cardiac Ablation

Cardiac Ablation Table of Contents


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EpicorCardiac Ablation System

Epicor

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


UltraCinchLP Ablation Device .............................................................................................................CA3

UltraWandLP 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

EpicorAblation Control System (ACS)


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Ordering InformationContents: Ablation Control System (1 unit per box)

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,


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Cardiac Ablation

UltraCinchLP Ablation Device


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Ordering InformationContents: UltraCinch LP Ablation Device (1 unit per box)


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



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2011 cardiacsurgery catalog us 062811

Documents