U.S. Opportunities in Heart Valve Disease Management

Companies Covered

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

Table of Contents

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