U.S. Opportunities in Heart Valve Disease Management

Companies Covered

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

Table of Contents

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