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3F Therapeutics, Inc
AorTech International plc
Arbor Surgical Technologies, Inc.
ATS Medical, Inc
Axya Medical, Inc
CardioMend
Corazón Technologies, Inc.
CoreValve S.A.
CryoLife, Inc
Edwards Lifesciences Corporation
Evalve, Inc.
Medical Carbon Research Institute, LLC
Medtronic, Inc
NuMED, Inc
Sorin Group
St. Jude Medical, Inc
EXECUTIVE SUMMARY
Overview of Heart Valve Disease
Procedure Trends
Product Markets
Surgical Valve Replacement and Repair Products
Percutaneous Valve Therapy
Suppliers
Summary Exhibit 1: Prevalence of Major Heart Valve Diseases, 2003-2010
Summary Exhibit 2: Interventions for Heart Valve Disease by Type, 2003-2010
Summary Exhibit 3: Valve Procedures by Anatomic Location, 2003-2010
Summary Exhibit 4: Valve Replacement and Repair Products, Market Forecast by Segment, 2003-2010
Summary Exhibit 5: Surgical Valve Products, Market Forecast by Type, 2003-2010
Summary Exhibit 6: Percutaneous Valve Therapies, Market Forecast, 2003-2010
Summary Exhibit 7: Leading Suppliers of Surgical Heart Valve Products, 2004
1.0 OVERVIEW OF HEART VALVE DISEASE
1.1 Valve Types and Function
1.2 Role of Valves in Cardiac Cycle
1.3 Etiology of Heart Valve Disease
1.3.1 Rheumatic Heart Disease
1.3.2 Degenerative Valve Disorders
1.3.3 Functional Valve Disorders
1.3.4 Congenital Valve Disorders
1.3.4.1 Complex Congenital Defects
1.3.4.2 Bicuspid Aortic Valve Disease
1.3.5 Bacterial Endocarditis
1.4 Diagnosis of Heart Valve Disease
1.4.1 Auscultation
1.4.2 Electrocardiography
1.4.3 Chest X-rays
1.4.4 Echocardiography
1.4.5 Coronary Angiography
1.4.6 Other Diagnostic Methods
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
1.6 Mortality
1.7 Epidemiology and Characteristics by Valve Type
1.7.1 Aortic Valve Disease
1.7.1.1 Aortic Stenosis
1.7.1.2 Aortic Valve Sclerosis
1.7.1.3 Aortic Valve Regurgitation
1.7.2 Acquired Mitral Valve Disease
1.7.2.1 Mitral Valve Stenosis
1.7.2.2 Mitral Valve Prolapse
1.7.2.3 Mitral Valve Regurgitation
1.7.3 Tricuspid Valve Disease
1.7.4 Pulmonary Valve Disease
1.8 Guidelines for Management of Valvular Disease
1.8.1 Major Developments
1.8.2 Projected Changes by Valve Condition
1.8.2.1 Aortic Stenosis
1.8.2.2 Aortic Regurgitation
1.8.2.3 Mitral Stenosis
1.8.2.4 Mitral Regurgitation
1.8.2.5 Endocarditis
1.8.2.6 Valve Selection
Exhibit 1-1: The Four Heart Valves
Exhibit 1-2: Etiology of Valvular Disease
Exhibit 1-3: Major Congenital Heart Defects
Exhibit 1-4: Major Techniques Used to Diagnose Heart Valve Disease
Exhibit 1-5: A Typical ECG Trace
Exhibit 1-6: Information from Other Diagnostic Approaches to Valvular Disease
Exhibit 1-7: Treatment Options for Heart Valve Disease
Exhibit 1-8: Use of Drug Therapy in Treatment of Valvular Disease
Exhibit 1-9: Trends in Valvular Surgery, 1985-2002
Exhibit 1-10: Mitral and Aortic Surgery Survival Rates
Exhibit 1-11: Trends in Mitral and Aortic Disease Discharges, 1985–2002
Exhibit 1-12: Overview of Aortic Valve Diseases
Exhibit 1-13: Hemodynamic Implications of Reduction in Aortic Valve Area
Exhibit 1-14: Classification of Aortic Stenosis by Severity
Exhibit 1-15: Severe Aortic Stenosis (AS), Patient Forecast, 2003-2010
Exhibit 1-16: Comparison of Major Mitral Valve Diseases
Exhibit 1-17: Mitral Valve Regurgitation, Patient Forecast by Type, 2003-2010
Exhibit 1-18: Overview of Tricuspid and Pulmonary Valve Diseases
Exhibit 1-19: Existing ACC/AHA Guidelines for Management of Aortic Valve Disease
Exhibit 1-20: Existing ACC/AHA Guidelines for Management of Mitral Stenosis
Exhibit 1-21: Existing ACC/AHA Guidelines for Management of Nonischemic Severe Mitral Regurgitation
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 Clinical Experience
2.1.2.5 Enabling Technologies
2.1.2.5.1 Adjunctive Surgical Technologies
2.1.2.5.2 New Tissue Valve Designs
2.1.2.5.3 Valve Suturing and Implantation Technologies
2.1.2.6 Conclusions
2.2 Valve Prostheses
2.2.1 Mechanical Valves
2.2.1.1 Designs
2.2.1.2 Materials
2.2.1.3 Advantages
2.2.1.4 Limitations
2.2.2 Xenograft Tissue Valves
2.2.2.1 Tissue Sources
2.2.2.2 Stented versus Stentless
2.2.2.3 Advantages
2.2.2.4 Limitations
2.2.3 Allograft Valves
2.3 Prosthetic Heart Valve Products
2.3.1 Mechanical Heart Valves
2.3.1.1 ATS Medical
2.3.1.2 CarboMedics (Sorin Group)
2.3.1.3 Medical CV Inc
2.3.1.4 Medical Carbon Research Institute
2.3.1.5 Medtronic
2.3.1.6 St. Jude Medical
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 Shelhigh
2.3.2.6 Sorin Group
2.3.3 Allograft Valves
2.3.3.1 Cryopreservation
2.3.3.2 Sterilization
2.3.3.3 Suppliers
2.3.4 Emerging Prostheses Technologies
2.3.4.1 Autologous Tissue Valves
2.3.4.1.1 CardioMend
2.3.4.1.2 International Heart Institute and Nayang Technological University
2.3.4.1.3 Other Programs
2.3.4.2 New Tissue Valve Designs
2.3.4.2.1 Arbor Surgical Technologies
2.3.4.2.2 3F Therapeutics
2.3.4.2.3 ValveXchange
2.3.4.3 Tri-Leaflet Mechanical Heart Valves
2.3.4.3.1 AorTech International
2.3.4.3.2 Innovia LLC
2.3.4.3.3 Triflo Medical
2.3.4.4 Tissue-Engineered Valves
2.3.4.4.1 Advanced Tissue Sciences
2.3.4.4.2 CryoLife
2.3.4.4.3 Philogenesis
2.3.4.4.4 Tepha
2.3.4.4.5 Georgia Institute of Technology/Emory Center
2.3.4.4.6 Other Institution-Based Programs
2.3.4.4.7 Challenges
2.3.4.4.8 Prospects for Tissue Engineered Heart Valves
2.3.5 Valve Suturing and Implantation Technologies
2.3.5.1 ANPA Medical
2.3.5.2 Arbor Surgical Technologies
2.3.5.3 Axya Medical
2.3.5.4 Medtronic
2.3.5.5 Teleflex Medical
2.4 Surgical Valve Replacements
2.5 Market Analysis
2.5.1 Mechanical Valves
2.5.2 Xenograft Tissue Valves
Exhibit 2-1: Comparison of Surgical Approaches for Valve Replacement
Exhibit 2-2: Potential Advantages of Minimally Invasive Valve Replacement
Exhibit 2-3: Potential Drawbacks of Minimally Invasive Valve Replacement
Exhibit 2-4: Selected Enabling Technologies for Minimally Invasive Valve Surgery
Exhibit 2-5: Selected Adjunctive Surgical Technologies Designed to Facilitate Valve Surgery, 2005
Exhibit 2-6: Design Criteria for Ideal Prosthetic Heart Valve
Exhibit 2-7: Comparison of Mechanical, Tissue and Allograft Heart Valves
Exhibit 2-8: Mechanical Valve Designs
Exhibit 2-9: Prosthetic Tissue Valve Materials and Configurations
Exhibit 2-10: Selected Mechanical Heart Valves, 2005
Exhibit 2-11: Selected Xenograft Tissue Valves, 2005
Exhibit 2-12: Selected Stented Tissue Valves
Exhibit 2-13: Selected Stentless Tissue Valves
Exhibit 2-14: Selected Emerging Surgical Valve Technologies, 2005
Exhibit 2-15: Selected Autologous Tissue Valve Technologies, 2005
Exhibit 2-16: Selected Autologous Pericardial Valves
Exhibit 2-17: Selected Valve Technologies Facilitating Minimally Invasive Implantation, 2005
Exhibit 2-18: 3F Therapeutic Heart Valves
Exhibit 2-19: Selected Tri-Leaflet Mechanical Valve Technologies, 2005
Exhibit 2-20: Comparison of Cell Sources for Tissue-Engineered Heart Valves
Exhibit 2-21: Selected Heart Valve Tissue Engineering Programs, 2005
Exhibit 2-22: Challenges to Commercialization of Tissue Engineering Products
Exhibit 2-23: Selected Valve Suturing and Advanced Implantation Technologies, 2005
Exhibit 2-24: AxyaLoop versus Traditional Knotted Suture
Exhibit 2-25: Cinch Advanced Implantation System versus Standard Holder
Exhibit 2-26: Teleflex Medical’s Valve Suturing Technologies
Exhibit 2-27: Surgical Valve Replacement, Procedure and Valve Forecast, 2003-2010
Exhibit 2-28: Prosthetic Heart Valves, Market Forecast, 2003-2010
Exhibit 2-29: Mechanical Heart Valves, Market Forecast, 2003-2010
Exhibit 2-30: Mechanical Heart Valves, Supplier Shares, 2004
Exhibit 2-31: Xenograft Heart Valves, Market Forecast by Type, 2003-2010
Exhibit 2-32: Xenograft Hert Valves, Supplier Shares by Type, 2004
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 Robotically-Assisted Mitral Valve Repair
3.2.5 Beating Heart Valve Repair
3.2.5.1 Edwards Lifesciences
3.2.5.2 Medtronic
3.2.6 Aortic Valve Sparing Surgery
3.3 Annuloplasty Rings
3.3.1 Designs
3.3.2 Traditional Products
3.3.2.1 CarboMedics/Sorin Group
3.3.2.2 Edwards Lifesciences
3.3.2.3 Getinge AB
3.3.2.4 Koehler Chemie
3.3.2.5 Medtronic
3.3.2.6 St. Jude Medical
3.3.2.7 Shelhigh Inc.
3.3.3 Emerging Technologies
3.3.3.1 Corazón Technologies
3.3.3.2 CoroNeo
3.3.3.3 MitralSolutions
3.3.3.4 Myocor
3.3.3.5 QuantumCor
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’ LifeStitch Surgical Valve Repair Technology
Exhibit 3-4: Design Characteristics of Annuloplasty Rings
Exhibit 3-5: Selected Annuloplasty Rings, 2005
Exhibit 3-6: Selected Emerging Valve Repair Technologies, 2005
Exhibit 3-7: Corazón Technologies Stopped Heart Aortic Valve Repair System
Exhibit 3-8: Myocor's Coapsys Annuloplasty System
Exhibit 3-9: Surgical Valve Repair, Procedure Forecast, 2003-2010
Exhibit 3-10: Annuloplasty Rings and Accessories, Market Forecast, 2003-2010
Exhibit 3-11: Annuloplasty Rings and Accessories, Supplier Shares, 2004
4.0 SPECIALTY VALVE PRODUCTS
4.1 Clinical Applications
4.1.1 Rastelli Procedure
4.1.2 Ross Procedure
4.1.2.1 Clinical Modifications
4.1.2.2 Advantages and Limitations
4.1.2.3 International Ross Registry
4.1.2.4 Clinical Experience
4.1.3 Ross II Procedure
4.1.4 Thoracic Aortic Aneurysm with Valve Involvement
4.1.5 Aortic Endocarditis
4.1.6 Bentall Procedure
4.2 Products and Suppliers
4.2.1 ATS Medical
4.2.2 CarboMedics
4.2.3 CryoLife
4.2.4 Edwards Lifesciences
4.2.5 LifeNet/St. Jude Medical
4.2.6 Medtronic
4.2.7 Regeneration Technologies/ATS Medical
4.2.8 Shelhigh
4.2.9 St. Jude Medical
4.3 Procedure Forecast
4.4 Market Analysis
Exhibit 4-1: Major Applications for Specialty Valve Products
Exhibit 4-2: Normal Heart and Rastelli Repaired Heart
Exhibit 4-3: Overview of Ross Procedure
Exhibit 4-4: Overview of Ross Procedure
Exhibit 4-5: International Ross Registry, Procedure Trend, 1992-2004
Exhibit 4-6: Characteristics of Ross Procedure Patients
Exhibit 4-7: Major Aortic Components and Selected Aneurysms
Exhibit 4-8: Button Bentall Procedure
Exhibit 4-9: Selected Specialty Valve Products, 2005
Exhibit 4-10: Comparison of Homograft vs Contegra Pulmonary Valved Conduit
Exhibit 4-11: Selected Studies of Shelhigh BioConduit
Exhibit 4-12: Specialty Valve Procedures, Forecast, 2003-2010
Exhibit 4-13: Specialty Valve Products, Market Forecast, 2003-2010
Exhibit 4-14: Specialty Valve Products, Supplier Shares, 200
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 Emerging Trends
5.1.6 Products
5.1.6.1 NuMED
5.1.6.1.1 Tyshak
5.1.6.1.2 Z-Med
5.1.6.1.3 COEfficient
5.1.6.1.4 Nucleus
5.1.6.1.5 Multi-Track
5.1.6.2 Toray
5.1.7 Procedures
5.1.8 Market Analysis
5.2 Percutaneous Valve Repair and Replacement
5.2.1 Rationale
5.2.2 Approaches
5.2.2.1 Percutaneous Valve Repair
5.2.2.1.1 Edge-To-Edge
5.2.2.1.2 Annuloplasty
5.2.2.1.3 Other Approaches
5.2.2.2 Percutaneous Valve Replacement
5.2.2.2.1 Valve Design Criteria
5.2.2.2.2 Implantation Approaches
5.2.2.2.3 Obstacles to Percutaneous Valve Replacement
5.2.3 Specialists Performing
5.2.4 Products and Suppliers
5.2.4.1 Advanced Bio Prosthetic Surfaces
5.2.4.2 Cardiac Dimensions
5.2.4.3 Cook Biotech
5.2.4.4 Corazón Technologies
5.2.4.5 CoreValve
5.2.4.6 Direct Flow Medical
5.2.4.7 Edwards Lifesciences
5.2.4.7.1 LifeStitch Edge-To-Edge
5.2.4.7.2 Coronary Sinus Annuloplasty
5.2.4.7.3 Aortic Valve Replacement
5.2.4.8 Endoluminal Technology Research
5.2.4.9 Evalve
5.2.4.10 3F Therapeutics
5.2.4.11 Heart Leaflet Technologies
5.2.4.12 University of Kiel
5.2.4.13 Medtronic/NuMED
5.2.4.14 Mitralign
5.2.4.15 QuantumCor
5.2.4.16 Sadra Medical
5.2.4.17 ValveXchange
5.2.4.18 Viacor
5.2.5 Procedure Trends
5.2.6 Market Forecast
Exhibit 5-1: AHA/ACC Recommendations for Balloon Aortic Valvuloplasty in Adults with Aortic Stenosis
Exhibit 5-2: Selected Studies of PBV for Mitral Stenosis
Exhibit 5-3: Reported Complications in Aortic Valvuloplasty Registries
Exhibit 5-4: A Thirty-Year Experience with Aortic Valve Stenosis
Exhibit 5-5: Selected Percutaneous Balloon Valvuloplasty Catheters, 2005
Exhibit 5-6: Percutaneous Balloon Valvuloplasty, Procedure and Market Forecast, 2004-2010
Exhibit 5-7: Balloon Valvuloplasty Catheters, Supplier Shares, 2004
Exhibit 5-8: Percutaneous Approaches to Heart Valve Disease Management
Exhibit 5-9: Design Criteria for Percutaneous Heart Valve
Exhibit 5-10: Major Approaches to Percutaneous Aortic Valve Replacement
Exhibit 5-11: Potential Challenges for Percutaneous Valve Replacement
Exhibit 5-12: Selected Percutaneous Valve Repair and Replacement Programs, 2005
Exhibit 5-13: Advanced Bio Prosthetic Surfaces' PercValve System
Exhibit 5-14: The Cook-SIS Valve
Exhibit 5-15: Corazón Technologies' BHAVR System (Prototype)
Exhibit 5-16: CoreValve's ReValving System
Exhibit 5-17: Edwards Lifesciences' Percutaneous Valve Technologies
Exhibit 5-18: Clinical Outcomes of the Cribier-Edwards Valve (I-REVIVE Registry)
Exhibit 5-19: Endoluminal Technology Research Valve
Exhibit 5-20: Evalve's Mitral Repair System
Exhibit 5-21: 3F Therapeutics' Transcatheter Valve Technologies
Exhibit 5-22: Medtronic/NuMED Percutaneous Valve
Exhibit 5-23: Mitralign Mitral Valve Annuloplasty System
Exhibit 5-24: Viacor Percutaneous Transvenous Mitral Annuloplasty (PTMA) Technology
Exhibit 5-25: Projected Rollout of Selected Percutaneous Valve Programs
Exhibit 5-26: Transcatheter Valve Repair and Replacement, Procedure Forecast, 2004-2010
Exhibit 5-27: Transcatheter Valve Repair and Replacement Products, Market Forecast, 2007-2010
6.0 COMPANY PROFILES
6.1 AorTech International plc
6.2 ATS Medical, Inc
6.3 Arbor Surgical Technologies, Inc.
6.4 Axya Medical, Inc
6.5 CardioMend
6.6 Corazón Technologies, Inc.
6.7 CoreValve S.A.
6.8 CryoLife, Inc
6.9 Edwards Lifesciences Corporation
6.10 Evalve, Inc.
6.11 Medical Carbon Research Institute, LLC
6.12 Medtronic, Inc
6.13 NuMED, Inc
6.14 St. Jude Medical, Inc
6.15 Sorin Group
6.16 3F Therapeutics, Inc