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3F Therapeutics
Advanced Tissue Sciences
AorTech International plc
ATS Medical
Autogenics
Axya Medical
Boston Scientific Corporation/Scimed
CardioMend
Corazon Technologies
Cryolife
Edwards Lifesciences
Evalve
Genzyme Biosurgery
JOMED NV
Jostra
Medical Carbon Research Institute
Medtronic
MitraLife
Percutaneous Valve Technologies
Sorin Biomedica
St. Jude Medical
Sulzer Medica (Sulzer Carbomedics)
Tepha
Toray Group
Triflo Medical
EXECUTIVE SUMMARY
Overview of Heart Valve Disease
Procedure Trends
Product Markets
Surgical Valve Products
Transcatheter Valve Products
Companies
Summary Exhibit 1: Major Categories of Valvular Disease
Summary Exhibit 2: Valve Interventions, Procedure Forecast, 2000-2006
Summary Exhibit 3: Valve Products, Market Forecast, 2000-2006
Summary Exhibit 4: Prosthetic Valves, Market Forecast, 2000-2006
Summary Exhibit 5: Leading Suppliers of Surgical Heart Valve Products, 2001
1.0 OVERVIEW OF HEART VALVE DISEASE
1.1 Valve Types and Function
1.2 Role of Valves in Cardiac Cycle
1.3 Epidemiology of Heart Valve Disease
1.3.1 Rheumatic Heart Disease
1.3.2 Acquired Valve Disorders
1.3.3 Congenital Heart Defects
1.3.4 Bacterial Endocarditis
1.4 Diagnosis of Heart Valve Disease
1.4.1 Ausculation
1.4.2 Electrocardiography
1.4.3 Chest X-Rays
1.4.4 Echocardiography
1.4.5 Coronary Angiography
1.5 Treatment of Heart Valve Disease
1.5.1 Medical Management
1.5.2 Surgical Intervention
1.5.3 Transcatheter Valve Repair and Replacement
Exhibit 1-1: The Four Heart Valves
Exhibit 1-2: Overview of Heart Valve Disorders
Exhibit 1-3: Major Categories of Valvular Disease
Exhibit 1-4: Major Congenital Heart Defects
Exhibit 1-5: Major Techniques Used to Diagnose Heart Valve Disease
Exhibit 1-6: Treatment Options for Heart Valve Disease
2.0 SURGICAL VALVE REPLACEMENT
2.1 Replacement Procedure
2.1.1 Traditional Median Sternotomy Approach
2.1.2 Minimally Invasive Approaches
2.1.2.1 Procedure
2.1.2.2 Advantages
2.1.2.3 Limitations
2.1.2.4 Preliminary Outcomes
2.1.2.5 Enabling Technologies
2.1.2.6 Conclusions
2.2 Valve Prostheses
2.2.1 Major Heart Valve Types
2.2.1.1 Mechanical Valves
2.2.1.2 Xenograft Tissue Valves
2.2.1.3 Allograft Valves
2.2.2 Configurations
2.2.2.1 Mechanical Valve Designs
2.2.2.2 Tissue Valve Sources and Designs
2.2.2.2.1 Porcine versus Bovine
2.2.2.2.2 Stented versus Stentless
2.3 Prosthetic Heart Valve Products
2.3.1 Mechanical Heart Valves
2.3.1.1 ATS Medical
2.3.1.2 Medical CV Inc
2.3.1.3 Medical Carbon Research Institute
2.3.1.4 Medtronic
2.3.1.5 St. Jude Medical
2.3.1.6 Sorin Biomedica
2.3.1.7 Sulzer Carbomedics
2.3.2 Tissue Heart Valves
2.3.2.1 Cryolife
2.3.2.2 Edwards Lifesciences
2.3.2.3 Medtronic
2.3.2.4 St. Jude Medical
2.3.2.4.1 St. Jude Products
2.3.2.4.2 Biocor Products
2.3.2.5 Sorin Biomedica
2.3.2.6 Sulzer Carbomedics
2.3.3 Allograft Valves
2.3.3.1 Cryopreservation
2.3.3.2 Fresh Allograft Transplantation
2.3.3.3 Suppliers
2.3.4 Emerging Prosthesis Technologies
2.3.4.1 Autograft Valves
2.3.4.1.1 Autogenics
2.3.4.1.2 CardioMend
2.3.4.2 Tissue-Engineered Valves
2.3.4.2.1 Advanced Tissue Sciences
2.3.4.2.2 Cryolife
2.3.4.2.3 St. Jude Medical
2.3.4.2.4 TEI Biosciences
2.3.4.2.5 Tepha
2.3.4.2.6 Institution-Based Programs
2.3.4.2.7 Conclusions
2.3.4.3 Tri-Leaflet Mechanical Heart Valves
2.3.4.3.1 AorTech International
2.3.4.3.2 Triflo Medical
2.3.4.4 Collapsible Tissue Valves
2.3.4.4.1 Cleveland Clinic Foundation
2.3.4.4.2 Columbia Technologies
2.3.4.4.3 3F Therapeutics
2.3.5 Valve Suturing Technologies
2.3.5.1 Genzyme Biosurgery
2.3.5.2 Axya Medical
2.4 Surgical Valve Replacement Procedures
2.5 Market Analysis
2.5.1 Mechanical Valves
2.5.2 Xenograft Tissue Valves
2.5.3 Allograft Valves
Exhibit 2-1: Comparison of Surgical Approaches for Valve Replacment
Exhibit 2-2: Apparent Advantages of Minimally Invasive Valve Replacement
Exhibit 2-3: Technologies to Enable Minimally Invasive Valve Replacement
Exhibit 2-4: Design Criteria for Ideal Prosthetic Heart Valve
Exhibit 2-5: Comparison of Mechanical, Tissue and Allograft Heart Valves
Exhibit 2-6: Prosthetic Valve Configurations
Exhibit 2-7: Selected Mechanical Heart Valves, 2002
Exhibit 2-8: Selected Mechanical Heart Valves
Exhibit 2-9: Selected Xenograft Tissue Valves, 2002
Exhibit 2-10: Selected Stented Tissue Valves
Exhibit 2-11: Selected Stentless Tissue Valves
Exhibit 2-12: Selected Emerging Surgical Valve Technologies, 2002
Exhibit 2-13: Comparison of Cell Sources for Tissue-Engineered Heart Valves
Exhibit 2-14: Genzyme Biosurgery NextStitch Cardiovascular Valve Suture
Exhibit 2-15: AxyaLoop versus Traditional Knotted Suture
Exhibit 2-16: Surgical Valve Replacement, Procedure Forecast, 2000-2006
Exhibit 2-17: Prosthetic Valves, Market Forecast, 2000-2006
Exhibit 2-18: Mechanical Heart Valves, Market Forecast, 2000-2006
Exhibit 2-19: Mechanical Heart Valves, Supplier Shares, 2001
Exhibit 2-20: Xenograft Heart Valves, Market Forecast by Type, 2000-2006
Exhibit 2-21: Stented Xenograft Tissue Valves, Supplier Shares, 2001
Exhibit 2-22: Stentless Tissue Valves, Supplier Shares, 2001
Exhibit 2-23: Allograft Heart Valves, Market Forecast, 2000-2006
Exhibit 2-24: Allograft Heart Valves, Supplier Shares, 2001
3.0 SURGICAL VALVE REPAIR
3.1 Techniques
3.2 Operative Approaches
3.2.1 Traditional Open Heart Surgery
3.2.2 Direct Vision Minimal Access Heart Valve Repair
3.2.3 Video-Assisted Endoscopic Valve Repair
3.2.4 Beating Heart Valve Repair
3.3 Annuloplasty Rings
3.3.1 Designs
3.3.2 Products
3.3.2.1 AorTech International
3.3.2.2 Edwards Lifesciences
3.3.2.3 Jostra
3.3.2.4 Medtronic
3.3.2.5 St. Jude Medical
3.3.2.6 Sulzer Carbomedics
3.4 Procedure Forecast
3.5 Market Analysis
Exhibit 3-1: Heart Valve Surgical Repair Techniques
Exhibit 3-2: Current and Emerging Surgical Approaches for Valve Repair
Exhibit 3-3: Edwards Lifesciences’ Minimally Invasive Surgical Valve Repair System
Exhibit 3-4: Design Characteristics of Annuloplasty Rings
Exhibit 3-5: Selected Annuloplasty Rings, 2002
Exhibit 3-6: Surgical Valve Repair, Procedure Forecast, 2000-2006
Exhibit 3-7: Annuloplasty Rings and Accessories, Market Forecast, 2000-2006
Exhibit 3-8: Annuloplasty Rings and Accessories, Supplier Shares, 2001
4.0 SPECIALTY VALVE PRODUCTS
4.1 Clinical Applications
4.1.1 Rastelli Procedure
4.1.2 Ross Procedure
4.1.3 Thoracic Aortic Aneurysm with Valve Involvement
4.1.4 Aortic Endocarditis
4.2 Products and Suppliers
4.2.1 ATS Medical
4.2.2 Cryolife
4.2.3 Edwards Lifesciences
4.2.4 Medtronic
4.2.5 Shelhigh
4.2.6 St. Jude Medical
4.2.7 Sulzer Carbomedics
4.3 Procedure Forecast
4.4 Market Analysis
Exhibit 4-1: Major Applications for Specialty Valve Products
Exhibit 4-2: Overview of Ross Procedure
Exhibit 4-3: International Ross Registry, Procedure Trend, 1990-2001
Exhibit 4-4: Characteristics of Ross Procedure Patients
Exhibit 4-5: Selected Specialty Valve Products, 2002
Exhibit 4-6: Specialty Valve Procedures, Forecast, 2000-2006
Exhibit 4-7: Specialty Valve Products, Market Forecast, 2000-2006
Exhibit 4-8: Mechanical Graft Valves, Supplier Shares, 2001
5.0 TRANSCATHETER VALVE TECHNOLOGIES
5.1 Percutaneous Balloon Valvuloplasty
5.1.1 Clinical Applications
5.1.2 Procedure
5.1.3 Single versus Double Balloon Techniques
5.1.4 Clinical Outcomes
5.1.5 Products
5.1.5.1 Boston Scientific
5.1.5.2 NuMED
5.1.5.3 Toray
5.1.5.4 University Technologies International
5.1.6 Procedures
5.1.7 Market Analysis
5.2 Percutaneous Valve Repair and Replacement
5.2.1 Rationale
5.2.2 Approaches
5.2.2.1 Percutaneous Annuloplasty
5.2.2.2 Percutaneous Valve Repair
5.2.2.3 Percutaneous Valve Replacement
5.2.3 Products and Suppliers
5.2.3.1 3F Therapeutics
5.2.3.2 Cleveland Clinic Foundation
5.2.3.3 Columbia Technologies
5.2.3.4 Corazon Technologies
5.2.3.5 Edwards Lifesciences
5.2.3.6 Evalve
5.2.3.7 University of Freiburg (Germany)
5.2.3.8 JOMED
5.2.3.9 MitraLife
5.2.3.10 NuMED
5.2.3.11 Percutaneous Valve Technologies
5.2.4 Procedure Trends
5.2.5 Market Forecast
Exhibit 5-1: AHA/ACC Recommendations for Balloon Aortic Valvuloplasty
Exhibit 5-2: Reported Complications in Aortic Valvuloplasty Registries
Exhibit 5-3: A Thirty-Year Experience with Aortic Valve Stenosis
Exhibit 5-4: Selected Percutaneous Balloon Valvuloplasty Catheters, 2002
Exhibit 5-5: Percutaneous Balloon Valvuloplasty, Procedure Forecast, 2000-2006
Exhibit 5-6: Balloon Valvuloplasty Catheters, Market Forecast, 2000-2006
Exhibit 5-7: Balloon Valvuloplasty Catheters, Supplier Shares, 2001
Exhibit 5-8: Percutaneous Approaches to Valve Disease Management
Exhibit 5-9: Selected Percutaneous Valve Repair/Replacement Programs, 2002
Exhibit 5-10: Transcatheter Valve Repair/Replacement, Forecast, 2004-2010
Exhibit 5-11: Transcatheter Valve Products, Market Forecast, 2004-2010
6.0 COMPANY PROFILES
6.1 Advanced Tissue Sciences
6.2 AorTech International plc
6.3 ATS Medical
6.4 Autogenics
6.5 Axya Medical
6.6 Boston Scientific Corporation/Scimed
6.7 CardioMend
6.8 Corazon Technologies
6.9 Cryolife
6.10 Edwards Lifesciences
6.11 Evalve
6.12 3F Therapeutics
6.13 Genzyme Biosurgery
6.14 JOMED NV
6.15 Jostra
6.16 Medical Carbon Research Institute
6.17 Medtronic
6.18 MitraLife
6.19 Percutaneous Valve Technologies
6.20 St. Jude Medical
6.21 Sorin Biomedica
6.22 Sulzer Medica (Sulzer Carbomedics)
6.23 Tepha
6.24 Toray Group
6.25 Triflo Medical
APPENDIX: COMPANY LIST