EXECUTIVE SUMMARY
i.
Types of Heart Valve Disorders
a. Valvular Stenosis
b. Valvular Regurgitation
c. Valve Prolapse
ii.
Heart Valve Disorder Treatment Strategies
iii. Heart Valve Repairs and Replacements, Combined Procedure Volumes
Forecast
a. Annuloplasty Device Implantations
b. Mechanical Heart Valve Implantations
c. Tissue Valve Implantations
iv.
Heart Valve Repair and Replacement Products, Combined
Market Forecast
a. Annuloplasty Device Sales
b. Mechanical Heart Valve Sales
c. Tissue Heart Valve Sales
v.
Methodology
Exhibit ES-1: Euro Heart Survey on Valvular Heart Disease
Patient Population, Native Heart Valve Disorders, by Type
Exhibit ES-2: Europe, Heart
Valve Repair and Replacement, Combined Procedure Volumes Forecast,
2003-2013
Exhibit ES-3: Europe, Annuloplasty
Device Implantation, Procedure Volumes Forecast, by Country,
2007-2013
Exhibit ES-4: Europe, Mechanical
Heart Valve Implantation, Procedure Volumes Forecast, by Country,
2003-2013
Exhibit ES-5: Europe, Tissue
Heart Valve Implantations, Procedure Volumes Forecast, by Country,
2003-2013
Exhibit ES-6: Europe, Heart
Valve Repair and Replacement Products, Combined Market Forecast,
2003-2013
Exhibit ES-7: Europe, Annuloplasty
Devices, Market Forecast, by Country, 2003-2013
Exhibit ES-8: Europe, Mechanical
Heart Valves, Market Forecast, by Country, 2003-2013
Exhibit ES-9: Europe, Tissue
Heart Valves, Market Forecast, by Country, 2003-2013
1. EUROPEAN HEALTHCARE
MARKETS
1.1
The European Union
1.1.1 A Common Currency
1.1.2 Regulatory Policies
1.1.3 Reimbursement
1.1.4 Healthcare Spending
1.2
Selected European National Healthcare Profiles
1.2.1 France
1.2.1.1 Healthcare Organization and Reform
1.2.1.2 Hospital Services
1.2.1.3 Medical Device Reimbursement
1.2.2 Germany
1.2.2.1 Healthcare Organization and Reform
1.2.2.2 Hospital Services
1.2.2.3 Medical Device Reimbursement
1.2.3 Italy
1.2.3.1 Healthcare Organization and Reform
1.2.3.2 Hospital Services
1.2.3.3 Medical Device Reimbursement
1.2.4 Spain
1.2.4.1 Healthcare Organization and Reform
1.2.4.2 Hospital Services
1.2.4.3 Medical Device Reimbursement
1.2.5 United
Kingdom
1.2.5.1 Healthcare Organization and Reform
1.2.5.2 Hospital Services
1.2.5.3 Medical Device Reimbursement
1.2.6 Benelux
1.2.6.1 Healthcare Organization and Reform
1.2.6.1.1 Belgium
1.2.6.1.2 Luxembourg
1.2.6.1.3 The Netherlands
1.2.6.2 Hospital Services
1.2.6.3 Medical Device Reimbursement
1.2.7 Nordic Countries
1.2.7.1 Healthcare Organization and Reform
1.2.7.1.1 Denmark
1.2.7.1.2 Finland
1.2.7.1.3 Norway
1.2.7.1.4 Sweden
1.2.7.2 Hospital Services
1.2.7.3 Medical Device Reimbursement
Exhibit 1-1: European Union, Medical Devices Risk Classification System
Exhibit 1-2: European Union Population Statistics Comparison for the Years
1996, 2006, and 2016
Exhibit 1-3: France,
Selected National Healthcare Statistics
Exhibit 1-4: Germany,
Selected National Healthcare Statistics
Exhibit 1-5: Italy,
Selected National Healthcare Statistics
Exhibit 1-6: Spain,
Selected National Healthcare Statistics
Exhibit 1-7: United Kingdom,
Selected National Healthcare Statistics
Exhibit 1-8: Belgium,
Selected National Healthcare Statistics
Exhibit 1-9: Luxembourg,
Selected National Healthcare Statistics
Exhibit 1-10: The Netherlands, Selected National Healthcare
Statistics
Exhibit 1-11: Denmark, Selected National Healthcare
Statistics
Exhibit 1-12: Finland, Selected National Healthcare
Statistics
Exhibit 1-13: Norway, Selected National Healthcare
Statistics
Exhibit 1-14: Sweden, Selected National Healthcare
Statistics
2. OVERVIEW OF HEART
VALVE DISORDERS
2.1
Heart Anatomy and Physiology
2.1.1 The Cardiac Conduction System
2.1.2 The Heart Valves
2.1.2.1 Atrioventricular Valves
2.1.2.1.1 Tricuspid Valve
2.1.2.1.2 Mitral Valve
2.1.2.2 Semilunar Valves
2.1.2.2.1 Aortic Valve
2.1.2.2.2 Pulmonary Valve
2.2
Heart Valve Disorders
2.2.1 Types of Heart Valve Disorders
2.2.1.1 Valvular Stenosis
2.2.1.1.1 Aortic Valve Stenosis
2.2.1.1.2 Mitral Valve Stenosis
2.2.1.1.3 Tricuspid/Pulmonary Valve
Stenosis
2.2.1.2 Valvular Regurgitation
2.2.1.2.1 Mitral Valve Regurgitation
2.2.1.2.2 Aortic Valve Regurgitation
2.2.1.2.3 Tricuspid/Pulmonary Valve
Regurgitation
2.2.1.3 Valve Prolapse
2.2.2 Conditions Associated with Heart
Valve Disorders
2.2.2.1 Congenital Defects
2.2.2.1.1 Ebstein’s Anomaly
2.2.2.1.2 Marfan Syndrome
2.2.2.1.3 Pulmonary Atresia
2.2.2.1.4 Tetralogy of Fallot
2.2.2.1.5 Tricuspid Atresia
2.2.2.2 Acquired Disorders
2.2.2.2.1 Calcific Degeneration
2.2.2.2.2 Infective Endocarditis
2.2.2.2.2.1 Acute Infective Endocarditis
2.2.2.2.2.2 Subacute Infective Endocarditis
2.2.2.2.3 Libman-Sacks Endocarditis
2.2.2.2.4 Myxomatous Degeneration
2.2.2.2.5 Rheumatic Fever
2.3
Heart Valve Disorder Treatment Strategies
2.3.1 Pharmaceutical Regimens
2.3.1.1 Anticoagulants and Antiplatelet Drugs
2.3.1.2 Anti-Arrhythmics
2.3.1.3 Diuretics
2.3.1.4 Vasodilators
2.3.1.5 Statins
2.3.2 Surgical Solutions
2.3.2.1 Techniques
2.3.2.1.1 Open-Heart Surgery
2.3.2.1.2 Minimally Invasive Surgery
2.3.2.1.3 Percutaneous Interventions
2.3.2.1.4 Robotic-Assisted Surgery
2.3.2.2 Heart Valve Repair
2.3.2.2.1 Annuloplasty
2.3.2.2.2 Balloon Valvuloplasty
2.3.2.3 Heart Valve Replacement
2.3.2.3.1 Types of Replacement Valves
2.3.2.3.1.1 Mechanical Valves
2.3.2.3.1.2 Tissue Valves
Exhibit 2-1: Cross-Section Diagram of the Normal
Heart
Exhibit 2-2: Euro Heart Survey on Valvular Heart Disease Patient Population,
Native Heart Valve Disorders, by Type
Exhibit 2-3: 2003, Rheumatic Heart Disease, Estimated Number of Reported Cases,
by Selected Country/Region
Exhibit 2-4: Europe, Rheumatic Heart Disease
Mortality, by Selected Country
Exhibit 2-5: Characteristics of the Ideal Prosthetic Heart Valve
3. EUROPEAN MARKETS FOR MECHANICAL HEART VALVES
3.1
Advantages of Mechanical Heart Valves
3.2
Disadvantages of Mechanical Heart Valves
3.3
Mechanical Heart Valve Designs
3.4 Mechanical Heart Valve Implantation,
Procedure Volumes
3.5
Mechanical Heart Valves, Market Analysis
3.5.1 Products
3.5.2 Market Drivers
3.5.2.1 Reliability and Durability
of Mechanical Heart Valves
3.5.2.2 Increasing Heart Valve Disorder
Prevalence
3.5.2.3 Improvements in Heart Valve
Disorder Diagnosis
3.5.2.4 Earlier Referrals for Heart
Valve Replacement
3.5.3 Market Limiters
3.5.3.1 Mechanical Heart Valves as
Commodity Items
3.5.3.2 Design Issues Associated with
Mechanical Heart Valves
3.5.3.3 Advancements in Tissue Heart
Valve Designs and Delivery Techniques
3.5.4 Combined Market Forecast
3.5.5 Country/Regional Market Forecasts
3.5.6 Competitive Analysis
Exhibit 3-1: Europe, Mechanical Heart Valve
Implantation, Combined Procedure Volumes Forecast, 2003-2013
Exhibit 3-2: Europe, Mechanical Heart Valve
Implantation, Procedure Volumes Forecast, by Country, 2003-2013
Exhibit
3-3: 2008, Selected
Mechanical Heart Valves
Exhibit 3-4: Europe, Mechanical Heart Valves,
Combined Market Forecast, 2003-2013
Exhibit 3-5: Europe, Mechanical Heart Valves,
Market Forecast, by Country, 2003-2013
Exhibit 3-6: 2007, Country/Regional Percentages of the European Mechanical
Heart Valves Market
Exhibit 3-7: France,
Mechanical Heart Valves, Market Forecast, 2003-2013
Exhibit 3-8: Germany,
Mechanical Heart Valves, Market Forecast, 2003-2013
Exhibit 3-9: Italy,
Mechanical Heart Valves, Market Forecast, 2003-2013
Exhibit 3-10: Spain, Mechanical Heart Valves, Market
Forecast, 2003-2013
Exhibit 3-11: United Kingdom, Mechanical Heart Valves,
Market Forecast, 2003-2013
Exhibit 3-12: Benelux Countries,
Mechanical Heart Valves, Market Forecast, 2003-2013
Exhibit 3-13: Nordic Countries, Mechanical Heart Valves,
Market Forecast, 2003-2013
Exhibit 3-14: Rest of Europe,
Mechanical Heart Valves, Market Forecast, 2003-2013
Exhibit 3-15: 2007, Europe,
Mechanical Heart Valves Market, Share by Supplier
Exhibit 3-16: 2007, France, Mechanical Heart Valves Market,
Share by Supplier
Exhibit 3-17: 2007, Germany, Mechanical Heart Valves Market,
Share by Supplier
Exhibit 3-18: 2007, Italy, Mechanical Heart Valves Market,
Share by Supplier
Exhibit 3-19: 2007, Spain, Mechanical Heart Valves Market,
Share by Supplier
Exhibit 3-20: 2007, United Kingdom, Mechanical Heart Valves
Market, Share by Supplier
Exhibit 3-21: 2007, Benelux
Countries, Mechanical Heart Valves Market, Share by Supplier
Exhibit 3-22: 2007, Nordic Countries, Mechanical Heart Valves
Market, Share by Supplier
Exhibit 3-23: 2007, Rest of Europe,
Mechanical Heart Valves Market, Share by Supplier
4. EUROPEAN MARKETS FOR TISSUE HEART VALVES
4.1
Advantages of Tissue Heart Valves
4.2
Disadvantages of Tissue Heart Valves
4.3
Tissue Heart Valve Development
4.3.1 Autograft, Homograft, and Heterograft Valves
4.3.2 Stented versus Stentless Valves
4.3.3 Tissue Engineered Valves
4.4 Tissue Heart Valve Implantation,
Procedure Volumes
4.5
Tissue Heart Valves, Market Analysis
4.5.1 Products
4.5.2 Market Drivers
4.5.2.1 Reduced Anticoagulant Requirements
for Tissue Heart Valve Patients
4.5.2.2 Increased Longevity of Tissue
Heart Valves
4.5.2.3 Increasing Heart Valve Disorder
Prevalence
4.5.2.4 Introduction of Transcatheter
and Minimally Invasive Heart Valve Replacement Procedures
4.5.3 Market Limiters
4.5.3.1 The Issue of Structural Valve
Deterioration
4.5.3.2 Emerging Percutaneous Valve
Repair Procedures
4.5.3.3 Potential Increase in the
Utilization of Homograft Valves
4.5.3.4 Development of Tissue Engineered
Heart Valves
4.5.4 Combined Market Forecast
4.5.5 Country/Regional Market Forecasts
4.5.6 Competitive Analysis
Exhibit 4-1: Europe, Tissue Heart Valve Implantation,
Combined Procedure Volumes Forecast, 2003-2013
Exhibit 4-2: Europe, Tissue Heart Valve Implantations,
Procedure Volumes Forecast, by Country, 2003-2013
Exhibit
4-3: 2008, Selected
Tissue Heart Valves
Exhibit 4-4: Europe, Tissue Heart Valves,
Combined Market Forecast, 2003-2013
Exhibit 4-5: Europe, Tissue Heart Valves,
Market Forecast, by Country, 2003-2013
Exhibit 4-6: 2007, Country/Regional Percentages of the European Tissue Heart
Valves Market
Exhibit 4-7: France,
Tissue Heart Valves, Market Forecast, 2003-2013
Exhibit 4-8: Germany,
Tissue Heart Valves, Market Forecast, 2003-2013
Exhibit 4-9: Italy,
Tissue Heart Valves, Market Forecast, 2003-2013
Exhibit 4-10: Spain, Tissue Heart Valves, Market
Forecast, 2003-2013
Exhibit 4-11: United Kingdom, Tissue Heart Valves,
Market Forecast, 2003-2013
Exhibit 4-12: Benelux Countries,
Tissue Heart Valves, Market Forecast, 2003-2013
Exhibit 4-13: Nordic Countries, Tissue Heart Valves, Market
Forecast, 2003-2013
Exhibit 4-14: Rest of Europe,
Tissue Heart Valves, Market Forecast, 2003-2013
Exhibit 4-15: 2007, Europe,
Tissue Heart Valves Market, Share by Supplier
Exhibit 4-16: 2007, France, Tissue Heart Valves Market,
Share by Supplier
Exhibit 4-17: 2007, Germany, Tissue Heart Valves Market,
Share by Supplier
Exhibit 4-18: 2007, Italy, Tissue Heart Valves Market,
Share by Supplier
Exhibit 4-19: 2007, Spain, Tissue Heart Valves Market,
Share by Supplier
Exhibit 4-20: 2007, United Kingdom, Tissue Heart Valves
Market, Share by Supplier
Exhibit 4-21: 2007, Benelux
Countries, Tissue Heart Valves Market, Share by Supplier
Exhibit 4-22: 2007, Nordic Countries, Tissue Heart Valves
Market, Share by Supplier
Exhibit 4-23: 2007, Rest of Europe,
Tissue Heart Valves Market, Share by Supplier
5. EUROPEAN MARKETS FOR ANNULOPLASTY DEVICES
5.1
Heart Valve Repair Surgery
5.1.1 Annuloplasty
5.1.1.1 Annuloplasty Device Designs
5.2 Annuloplasty Device Implantation,
Procedure Volumes
5.3
Annuloplasty Devices, Market Analysis
5.3.1 Products
5.3.2 Market Drivers
5.3.2.1 Increasing Heart Valve Disorder
Prevalence
5.3.2.2 Recognized Undertreatment
of Elderly Heart Valve Disorder Patients
5.3.2.3 Development/Emergence of Percutaneous
Heart Valve Repair Technologies
5.3.3 Market Limiters
5.3.3.1 Delays in Payments to Heart
Valve Repair Product Suppliers
5.3.3.2 Small Number of Heart Valve
Repair Product Suppliers
5.3.3.3 Development of Tissue Engineering
and Stem Cell Technologies
5.3.4 Combined Market Forecast
5.3.5 Country/Regional Market Forecasts
5.3.6 Competitive Analysis
Exhibit 5-1: 2008, Selected Design Characteristics of Annuloplasty Devices
Exhibit 5-2: Europe, Annuloplasty Device Implantation,
Combined Procedure Volumes Forecast, 2003-2013
Exhibit 5-3: Europe, Annuloplasty Device Implantation,
Procedure Volumes Forecast, by Country, 2007-2013
Exhibit
5-4: 2008, Selected
Annuloplasty Products
Exhibit 5-5: Europe, Annuloplasty Devices,
Combined Market Forecast, 2003-2013
Exhibit 5-6: Europe, Annuloplasty Devices,
Market Forecast, by Country, 2003-2013
Exhibit 5-7: 2007, Country/Regional Percentages of the European Annuloplasty
Devices Market
Exhibit 5-8: France,
Annuloplasty Devices, Market Forecast, 2003-2013
Exhibit 5-9: Germany,
Annuloplasty Devices, Market Forecast, 2003-2013
Exhibit 5-10: Italy, Annuloplasty Devices, Market
Forecast, 2003-2013
Exhibit 5-11: Spain, Annuloplasty Devices, Market
Forecast, 2003-2013
Exhibit 5-12: United Kingdom, Annuloplasty Devices,
Market Forecast, 2003-2013
Exhibit 5-13: Benelux Countries,
Annuloplasty Devices, Market Forecast, 2003-2013
Exhibit 5-14: Nordic Countries, Annuloplasty Devices, Market
Forecast, 2003-2013
Exhibit 5-15: Rest of Europe,
Annuloplasty Devices, Market Forecast, 2003-2013
Exhibit 5-16: 2007, Europe,
Annuloplasty Devices Market, Share by Supplier
Exhibit 5-17: 2007, France, Annuloplasty Devices Market,
Share by Supplier
Exhibit 5-18: 2007, Germany, Annuloplasty Devices Market,
Share by Supplier
Exhibit 5-19: 2007, Italy, Annuloplasty Devices Market,
Share by Supplier
Exhibit 5-20: 2007, Spain, Annuloplasty Devices Market,
Share by Supplier
Exhibit 5-21: 2007, United Kingdom, Annuloplasty Devices
Market, Share by Supplier
Exhibit 5-22: 2007, Benelux
Countries, Annuloplasty Devices Market, Share by Supplier
Exhibit 5-23: 2007, Nordic Countries, Annuloplasty Devices
Market, Share by Supplier
Exhibit 5-24: 2007, Rest of Europe,
Annuloplasty Devices Market, Share by Supplier
6. COMPANY PROFILES
6.1 ATS Medical, Inc.
6.2 CoreValve, Inc.
6.3 CryoLife, Inc.
6.4 Edwards Lifesciences Corporation
6.5 Evalve, Inc.
6.6 Leman Cardiovascular SA
6.7 Maquet GmbH & Company KG/Getinge AB
6.8 Medical Carbon Research Institute LLC
6.9 Medtronic, Inc.
6.10 Mitralign, Inc.
6.11 Sorin Group SPA
6.12 St. Jude Medical, Inc.
6.13 Vascutek LTD/Terumo Corporation
6.14 Viacor, Inc.
APPENDIX: COMPANY LISTING