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Opportunities in Heart Valve Disease Management: Europe, Japan and Rest of World

548 Pages | 147 Exhibits | Forecasts Through 2010

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Companies Covered

3F Therapeutics, Inc

AorTech International plc

Arbor Surgical Technologies, Inc

ATS Medical, Inc

Axya Medical, Inc


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


OUS Heart Valves Treated by Location and Surgical Approach

OUS Heart Valve Prostheses and Product Markets

Suppliers of Heart Valve Prostheses and Repair Products

Percutaneous Heart Valve Technologies


Summary Exhibit 1: OUS Population, Valve Surgeries and Valves Treated, 2003-2010

Summary Exhibit 2: OUS Valves Treated by Location and Approach, 2003-2010

Summary Exhibit 3: OUS Valve Prostheses by Type, 2003-2010

Summary Exhibit 4: OUS Valve Products Market by Type, 2003-2010

Summary Exhibit 5: OSU Heart Valve Products by Type and Geography, Supplier Shares, 2004

Summary Exhibit 6: Percutaneous Heart Valve Technologies, Market Forecast, 2004-2010



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 Complex Congenital Defects Bicuspid Aortic Valve Disease

1.3.5 Infective 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 Tools

1.5 Treatment of Heart Valve Disease

1.5.1 Medical Management

1.5.2 Surgical Intervention Treatment of Multi-Valve Disease Emerging Techniques Concomitant CABG and Valve Surgery Multi-Valve Surgery Procedure Trends and Geographic Variations

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 Aortic Stenosis Aortic Valve Sclerosis Aortic Valve Regurgitation

1.7.2 Acquired Mitral Valve Disease Mitral Valve Stenosis Mitral Valve Prolapse Mitral Valve Regurgitation


Exhibit 1-1: The Four Heart Valves

Exhibit 1-2: Etiology of Valvular Disease

Exhibit 1-3: Major Congenital Heart Defects

Exhibit 1-4: ESC Indications for Urgent Valve Surgery for Endocarditis

Exhibit 1-5: Selected International Studies of Infective Endocarditis

Exhibit 1-6: Major Techniques Used to Diagnose Heart Valve Disease

Exhibit 1-7: Selected Investigations Used in ESC Heart Survey on Valvular Heart Disease, 2001

Exhibit 1-8: A Typical ECG Trace

Exhibit 1-9: Information Obtained with Other Diagnostic Approaches to Valvular Disease

Exhibit 1-10: Treatment Options for Heart Valve Disease

Exhibit 1-11: Use of Drug Therapy in Treatment of Valvular Disease

Exhibit 1-12: Death Rates from Ischemic Heart Disease in Selected Nations

Exhibit 1-13: Overview of Aortic Valve Diseases

Exhibit 1-14: Hemodynamic Implications of Reduction in Aortic Valve Area

Exhibit 1-15: Classification of Aortic Stenosis by Severity

Exhibit 1-16: Estimated Prevalence of Severe Aortic Stenosis in Major European Nations, 2004-2010

Exhibit 1-17: Estimated Prevalence of Severe Aortic Stenosis in Japan, 2004-2010

Exhibit 1-18: Comparison of Major Mitral Valve Diseases

Exhibit 1-19: Estimated Prevalence of Mitral Regurgitation in Major Nations of Europe, 2004-2010

Exhibit 1-20: Estimated Prevalence of Mitral Regurgitation in Japan, 2004-2010



2.1 Surgical Approaches

2.1.1 Traditional Median Sternotomy

2.1.2 Minimally Invasive Approaches Technique Advantages Limitations Clinical Experience Enabling Technologies Adjunctive Surgical Technologies New Tissue Valve Designs Valve Suturing and Implantation Technologies Conclusions

2.2 Valve Prostheses

2.2.1 Mechanical Valves Designs Materials Advantages Limitations

2.2.2 Xenograft Tissue Valves Tissue Sources Stented versus Stentless Advantages Limitations

2.2.3 Allograft Valves

2.3 Prosthetic Heart Valve Products

2.3.1 Mechanical Heart Valves ATS Medical Medical Carbon Research Institute Medtronic Roscardioinvest St. Jude Medical Sorin Group/CarboMedics TTK Pharma Ltd

2.3.2 Tissue Heart Valves CryoLife Braile Biomedica Edwards Lifesciences Perimount Valves Porcine Stented Valves Kemerovo Cardiac Center Medtronic St. Jude Medical St. Jude Products Biocor Products Shelhigh Sorin Group

2.3.3 Allograft Valves Cryopreservation Sterilization Suppliers

2.3.4 Emerging Prostheses Technologies Autologous Tissue Valves CardioMend International Heart Institute and Nayang Technological University Other Programs New Tissue Valve Designs Arbor Surgical Technologies 3F Therapeutics ValveXchange Tri-Leaflet Mechanical Heart Valves AorTech International Innovia LLC Triflo Medical Tissue-Engineered Valves Advanced Tissue Sciences CryoLife Philogenesis Tepha. Georgia Institute of Technology/Emory Center Other Institution-Based Programs Challenges Prospects for Tissue Engineered Heart Valves

2.3.5 Valve Suturing and Implantation Technologies ANPA Medical Arbor Surgical Technologies Axya Medical Medtronic Teleflex Medical


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 International Studies of Minimally Invasive Valve Surgery

Exhibit 2-5: Selected Enabling Technologies for Minimally Invasive Valve Surgery

Exhibit 2-6: Selected Adjunctive Surgical Technologies Designed to Facilitate Valve Surgery, 2005

Exhibit 2-7: Design Criteria for Ideal Prosthetic Heart Valve

Exhibit 2-8: Comparison of Mechanical, Tissue and Allograft Heart Valves

Exhibit 2-9: Mechanical Valve Designs

Exhibit 2-10: Prosthetic Tissue Valve Materials and Configurations

Exhibit 2-11: Selected Mechanical Heart Valves, 2005

Exhibit 2-12: Selected Xenograft Tissue Valves, 2005

Exhibit 2-13: Selected Stented Tissue Valves

Exhibit 2-14: Selected Stentless Tissue Valves

Exhibit 2-15: Selected Emerging Surgical Valve Technologies, 2005

Exhibit 2-16: Selected Autologous Tissue Valve Technologies, 2005

Exhibit 2-17: Selected Autologous Pericardial Valves

Exhibit 2-18: Selected Valve Technologies Facilitating Minimally Invasive Implantation, 2005

Exhibit 2-19: 3F Therapeutic Heart Valves

Exhibit 2-20: Selected Tri-Leaflet Mechanical Valve Technologies, 2005

Exhibit 2-21: Comparison of Cell Sources for Tissue-Engineered Heart Valves

Exhibit 2-22: Selected Heart Valve Tissue Engineering Programs, 2005

Exhibit 2-23: Challenges to Commercialization of Tissue Engineering Products

Exhibit 2-24: Selected Valve Suturing and Advanced Implantation Technologies, 2005

Exhibit 2-25: AxyaLoop versus Traditional Knotted Suture

Exhibit 2-26: Cinch Advanced Implantation System versus Standard Holder

Exhibit 2-27: Teleflex Medical's Valve Suturing Technologies



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 Edwards Lifesciences Medtronic

3.2.6 Aortic Valve Sparing Surgery

3.3 Annuloplasty Rings

3.3.1 Designs

3.3.2 Traditional Products CarboMedics/Sorin Group Edwards Lifesciences Getinge AB Koehler Chemie Medtronic St. Jude Medical Shelhigh Inc

3.3.3 Emerging Technologies Corazón Technologies CoroNeo Medtentia AB MitralSolutions Myocor QuantumCor


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



4.1 European Heart Valve Market

4.1.1 Major Europe Germany France Italy Spain United Kingdom Benelux

4.1.2 Other Europe

4.2 Japan

4.3 Rest of World (ROW)


Exhibit 4-1: OUS Heart Valve Procedures, Products and Markets, 2003-2010

Exhibit 4-2: European Valve Procedures, Products & Markets, 2003-2010

Exhibit 4-3: European Heart Valve Prostheses and Product Markets by Region, 2003-2010

Exhibit 4-4: European Heart Valve Products, Supplier Shares, 2004

Exhibit 4-5: Major Europe, Heart Valve Procedures, Products and Markets, 2003-2010

Exhibit 4-6: Germany, Trend in Cardiac Surgery Resources and Procedures, 1997-2004

Exhibit 4-7: Germany, Heart Valve Procedures and Market, 2003-2010

Exhibit 4-8: France, Heart Valve Procedures and Market, 2003-2010

Exhibit 4-9: Italy, Heart Valve Procedures and Market, 2003-2010

Exhibit 4-10: Spain, Valve Surgery Data, 2001-2003

Exhibit 4-11: Spain, Heart Valve Procedures and Market, 2003-2010

Exhibit 4-12: National Health Service, Main Operations, 2000-2004

Exhibit 4-13: National Health Service, Total Operations, 2000-2004

Exhibit 4-14: United Kingdom, Heart Valve Procedures and Markets, 2003-2010

Exhibit 4-15: Benelux, Heart Valve Procedures and Markets, 2003-2010

Exhibit 4-16: Other Europe, Heart Valve Procedures and Markets, 2003-2010

Exhibit 4-17: Japan, Heart Valve Procedures by Location, 1996-2004

Exhibit 4-18: Japan, Heart Valve Procedures by Location, Approach & Prosthesis Type, 1996-2004

Exhibit 4-19: Japan, Heart Valve Procedures and Markets, 2003-2010

Exhibit 4-20: Japan Heart Valve Products, Supplier Shares, 2004

Exhibit 4-21: Rest of World, Heart Valve Procedures, Products and Markets, 2003-2010

Exhibit 4-22: Rest of World Heart Valve Products, Supplier Shares, 2004



5.1 Percutaneous Balloon Valvuloplasty

5.1.1 Clinical Applications

5.1.2 Procedure

5.1.3 Comparison of Available Techniques Single vs. Double Balloon Techniques for Mitral Stenosis Metallic Valvulotome

5.1.4 Clinical Outcomes

5.1.5 Products Balt Extrusion NuMED Tyshak Z-Med COEfficient Nucleus Multi-Track Toray

5.1.6 Procedures

5.1.7 Market Analysis

5.2 Percutaneous Valve Repair and Replacement

5.2.1 Rationale

5.2.2 Approaches Percutaneous Valve Repair Edge-To-Edge Annuloplasty Other Approaches Percutaneous Valve Replacement Valve Design Criteria Implantation Approaches Obstacles to Percutaneous Valve Replacement

5.2.3 Specialists Performing

5.2.4 Products and Suppliers Advanced Bio Prosthetic Surfaces Ample Medical Cardiac Dimensions Cook Biotech Corazón Technologies CoreValve Direct Flow Medical Edwards Lifesciences LifeStitch Edge-To-Edge Coronary Sinus Annuloplasty Aortic Valve Replacement Endoluminal Technology Research Evalve 3F Therapeutics Heart Leaflet Technologies University of Kiel Medtronic/NuMED Mitralign QuantumCor Sadra Medical ValveXchange Viacor

5.2.5 Procedure Trends

5.2.6 Market Forecast


Exhibit 5-1: Suggested Indications for Balloon Aortic Valvuloplasty in Adults

Exhibit 5-2: Selected Studies of PBV for Mitral Stenosis

Exhibit 5-3: Reported Complications in Aortic Valvuloplasty Registries

Exhibit 5-4: Selected Studies of PBV for Aortic Stenosis

Exhibit 5-5: A Thirty-Year Experience with Aortic Valve Stenosis

Exhibit 5-6: Selected Percutaneous Balloon Valvuloplasty Catheters, 2005

Exhibit 5-7: Percutaneous Balloon Valvuloplasty, Procedure and Market Forecast, 2004-2010

Exhibit 5-8: Percutaneous Valvuloplasty Catheters, Supplier Shares, 2004

Exhibit 5-9: Percutaneous Approaches to Heart Valve Disease Management

Exhibit 5-10: Design Criteria for Percutaneous Heart Valve

Exhibit 5-11: Major Approaches to Percutaneous Aortic Valve Replacement

Exhibit 5-12: Potential Challenges for Percutaneous Valve Replacement

Exhibit 5-13: Selected Percutaneous Valve Repair and Replacement Programs, 2005

Exhibit 5-14: Advanced Bio Prosthetic Surfaces’ PercValve System

Exhibit 5-15: Ample Medical’s Percutaneous Septal Sinus Shortening (PS³) System

Exhibit 5-16: The Cook-SIS Valve

Exhibit 5-17: Corazón Technologies' BHAVR System (Prototype)

Exhibit 5-18: CoreValve's ReValving System

Exhibit 5-19: Edwards Lifesciences' Percutaneous Valve Technologies

Exhibit 5-20: Clinical Outcomes of the Cribier-Edwards Valve (I-REVIVE Registry)

Exhibit 5-21: Endoluminal Technology Research Valve

Exhibit 5-22: Evalve's MitraClip System

Exhibit 5-23: 3F Therapeutics' Transcatheter Valve Technologies

Exhibit 5-24: Medtronic/NuMED Percutaneous Valve

Exhibit 5-25: Mitralign Mitral Valve Annuloplasty System

Exhibit 5-26: Viacor Percutaneous Transvenous Mitral Annuloplasty Technology

Exhibit 5-27: Projected Rollout of Selected Percutaneous Valve Programs

Exhibit 5-28: Transcatheter Valve Repair and Replacement, Procedure Forecast, 2004-2010

Exhibit 5-29: Transcatheter Valve Repair and Replacement Products, Market Forecast, 2006-2010



6.1 Overview of European Health Care

6.1.1 Health Care Spending and Reform

6.1.2 Health Care Facilities and Manpower

6.1.3 Reimbursement

6.1.4 Impact of the European Community EC Directives Pricing

6.1.5 National Profiles Germany Healthcare Systemand Resources DRG System Proposed Legislation Cardiac Procedures and Resources France Health Care System and Resources Health Care Spending Health Care Administration Product Regulation Product Reimbursement French Medical Device Market Cardiac Procedures and Resources United Kingdom Health Care Statistics Overview National Health Service Medical Products Regulation Health Care Reforms U.K. Medical Device Market Cardiac Procedures and Resources Italy Emerging Private Sector Product Issues Cardiac Procedures Spain Health Care Funding and Delivery Health Care Resources Ambulatory Care Reforms Product Issues Cardiac Resources and Procedures Belgium Health Care Spending and Administration Product Regulation and Reimbursement Health Care Resources Cardiac Procedures The Netherlands Health Care Overview Health Care Resources Health Care Spending and Programs Health Care Administration Product Issues Cardiac Resources and Procedures

6.2 Other Europe

6.3 Japan

6.3.1 Structure of Health Insurance System

6.3.2 Health Care Spending and Legislation

6.3.3 Health Care Facilities

6.3.4 Health Manpower

6.3.5 Medical Device Market

6.3.6 Product Regulation and Reimbursement

6.3.7 Cardiovascular Resources and Procedures

6.4 Overview of Asia-Pacific Health Care (ex Japan)

6.4.1 Health Care Spending

6.4.2 Health Care Resources

6.4.3 Selected Country Overviews China India Malaysia Philippines Singapore South Korea Thailand

6.5 Overview of Latin American Health Care

6.5.1 Brazil

6.5.2 Mexico

6.5.3 Argentina


Exhibit 6-1: Health Care Expenditures by Country, 2003

Exhibit 6-2: Physicians by Country, 2003

Exhibit 6-3: Acute Care Hospital Beds and Utilization, 2003

Exhibit 6-4: Germany, Health Care Profile

Exhibit 6-5: Germany, Health Expenditures as Share of GDP, 1998-2003

Exhibit 6-6: Distribution of Statutory Health Insurance Expenditures, 2003

Exhibit 6-7: Germany, Cardiac Resources and Procedures

Exhibit 6-8: France, Health Care Profile

Exhibit 6-9: France, Health Expenditures as Share of GDP, 1998-2003

Exhibit 6-10: France, Reimbursement for Heart Valve Procedures and Products

Exhibit 6-11: United Kingdom, Health Care Profile

Exhibit 6-12: United Kingdom, Health Expenditures as Share of GDP, 1998-2003

Exhibit 6-13 : Cardiac Surgeries, Total Operations, England, 2000-2004

Exhibit 6-14: Italy, Health Care Profile

Exhibit 6-15: Italy, Health Expenditures as Share of GDP, 1998-2003

Exhibit 6-16: Italy, Distribution of Cardiac Surgeries, 2003

Exhibit 6-17: Health Care Profile, Spain

Exhibit 6-18: Spain, Health Expenditures as Share of GDP, 1998-2003

Exhibit 6-19: Spain, Trend in Cardiac Surgeries, 2001-2003

Exhibit 6-20: Belgium, Health Care Profile

Exhibit 6-21: Belgium, Health Expenditures as Share of GDP, 1998-2003

Exhibit 6-22: Belgium, Cardiac Surgical Procedures, 2001-2002

Exhibit 6-23: The Netherlands, Health Care Profile

Exhibit 6-24: Annual Trend in Dutch Health Expenditures as Share of GDP

Exhibit 6-25: Selected Other European Nations, Health Care Indicators

Exhibit 6-26: Overview of Japanese Health Insurance Programs

Exhibit 6-27: Comparison of Three Major Japanese Health Insurance Programs

Exhibit 6-28: Japan, Health Expenditures as Share of GDP, 1998-2003

Exhibit 6-29: Overview of Japan’s Health Facilities and Personnel

Exhibit 6-30: Japan, Cardiac Operations by Major Type, 1997-2003

Exhibit 6-31: Health Care Indicators for Selected Asia Pacific Nations

Exhibit 6-32: Health Care Resources in Selected Asia-Pacific Nations

Exhibit 6-33: Per Capita Mortality Rates by Type Among Selected Latin American Regions

Exhibit 6-34: Per Capita Health Care Resources in Selected Latin American Regions

Exhibit 6-35: National Health Care Spending in Latin America, 2004



7.1 AorTech International plc

7.2 ATS Medical, Inc

7.3 Arbor Surgical Technologies, Inc

7.4 Axya Medical, Inc

7.5 CardioMend

7.6 Corazón Technologies, Inc

7.7 CoreValve S.A.

7.8 CryoLife, Inc

7.9 Edwards Lifesciences Corporation

7.10 Evalve, Inc

7.11 Medical Carbon Research Institute, LLC

7.12 Medtronic, Inc

7.13 NuMED, Inc

7.14 St. Jude Medical, Inc

7.15 Sorin Group

7.16 3F Therapeutics, Inc

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