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This report analyzes the worldwide markets for Prosthetic Heart Valves in US$ Million by the following Product Segments- Mechanical valves, and Biological/Tissue valves. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, and Rest of World. Annual estimates and forecasts are provided for the period 2009 through 2017. Also, a six-year historic analysis is provided for these markets. The report profiles 18 companies including many key and niche players such as Abbott Vascular, CryoLife, Inc., Edwards Lifesciences Corporation, Medtronic, Inc., Medtronic ATS Medical, Inc., On-X Life Technologies, Inc., SORIN GROUP, and St. Jude Medical, Inc. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.
TABLE OF CONTENTS
PROSTHETIC HEART VALVES MCP-6753
A GLOBAL STRATEGIC BUSINESS REPORT
CONTENTS
1. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS 1
Study Reliability and Reporting Limitations 1
Disclaimers 2
Data Interpretation & Reporting Level 3
Quantitative Techniques & Analytics 3
Product Definitions and Scope of Study 3
Mechanical Valves 3
Biological/Tissue Valves 3
2. OUTLOOK 4
3. INDUSTRY OVERVIEW 5
Metals Giving Way to Carbon Compounds and Polymers in
Mechanical Heart Valves 5
Tissue Valves Prevail Over Mechanical Valves 5
BSE: A Potential Problem for Tissue Segment 5
Major Growth Drivers 5
Aging Demographics 5
Table 1: Ageing (65+) Demographics as % of Total Population
by Country (2000, 2010, 2025) (includes corresponding
Graph/Chart) 6
Under-Treated Population 6
Rheumatic Heart Disease 7
Developing Countries 7
Table 2: Global Heart Valve Procedures (2009): Number of
Heart Valve Procedures Per Million Population (for 55+
Population) and Total Heart Valve Procedures (includes
corresponding Graph/Chart) 7
Technological Developments 8
4. PERCUTANEOUS HEART VALVES 9
An Introduction 9
The Technology 9
Cost of Replacement 10
Introduction and Adoption in Europe 10
Table 3: European Recent Past, Current & Future Analysis for
Transcatheter Heart Valve Independently Analyzed with Annual
Revenues in US$ Million for Years 2009 Through 2017 (includes
corresponding Graph/Chart) 10
Competition Heats Up in US Market 11
Table 4: US Future Analysis for Transcatheter Heart Valve
Independently Analyzed with Annual Revenues in US$ Million
for Years 2011 Through 2017 (includes corresponding
Graph/Chart) 11
A Word of Caution 12
5. COMPETITIVE ANALYSIS 13
Table 5: Global Heart Valve Market (2009): Percentage
Breakdown of Heart Valve Market by Value for Edwards
Lifesciences, St. Jude Medical, Medtronic, and Others
(includes corresponding Graph/Chart) 13
Competition in Percutaneous Heart Valve Segment 13
Mergers and Acquisitions 14
Edwards Lifesciences Leads the Way 14
Medtronic Remains Bullish on Percutaneous Heart Valve Segment 15
Heart Valves in the Pipeline 15
Next-Generation Heart Valves 15
St. Jude’s Trifecta Tissue Valve 15
Edwards Lifesciences’ SAPIEN Transcatheter Heart Valve 15
Medtronic’s CoreValve 16
Sorin Group’s Perceval S Aortic Valve 16
6. PRODUCT OVERVIEW 17
Human Heart - Morphology 17
An Introduction to Heart Valves 17
Heart Valve Disorders 18
Probable Causes of Heart Valve Diseases 19
Diagnosis 19
Replacement or Repair? 19
Heart Valve Replacement 20
Prosthetic Heart Valves - An Introduction 20
Chronology of Important Developments in Prosthetic Heart
Valve Market 21
Designing Considerations for Prosthetic Heart Valves 21
Mechanical Valves 21
Caged Ball Design 22
Tilting Disc Heart Valve 22
Bileaflet Valves 22
Biological/Tissue Valves 22
Stentless Tissue Valves 23
Stented Tissue Valves 23
Mechanical Vs. Biological 23
Some Important Facts 24
Valve Failure 24
Symptoms of Malfunctioning Prosthetic Heart Valve 25
Clinical Symptoms 25
Physical Symptoms 26
Sound 26
PHV Murmurs 26
Prosthetic Valve Endocarditis (PVE) 27
Prosthetic Valve Thrombosis (PVT) 28
Embolization 28
Structural Breakdown of Bioprosthetic Valves 28
7. CLINICAL STUDIES/TRIALS 29
Edwards Lifesciences Secures Conditional FDA Approval for
PARTNER II Clinical Trials of Next-Generation Transcatheter
Valve 29
Medtronic Receives Conditional FDA Approval for Clinical
Trials of New CoreValve® System for TAVI 29
Edwards Lifesciences Announces Results for PARTNER I Trial 29
Sorin Group Announces Clinical Study Results for Perceval S™
Self Anchoring Sutureless Aortic Valve 30
On-X Announces Positive Results for Clinical Trials of
Prosthetic Heart Valve 30
On-X Life Technologies Completes Enrollment for PROACT Trial 30
St. Jude Medical Completes European Enrollment for Trifecta™
Stented Tissue Valve Trial 31
8. PRODUCT LAUNCHES/INNOVATIONS/ REGULATORY APPROVALS 32
St. Jude Medical Obtains CE Mark Clearance for TrifectaTM Valve 32
Medtronic Obtains CE Mark for Subclavian Artery Approach for
CoreValve® System 32
CryoLife Obtains FDA 510(k) Clearance for 5-Year Shelf Life
Period for CryoValve® SG Pulmonary Human Heart Valve 32
Medtronic Receives FDA Approval for Medtronic Melody®
Transcatheter Pulmonary Valve 33
RUSNANO Clears Project to Develop Nanostructured Prosthetic
Heart Valves 33
CryoLife’s Synergraft® Processed Human Aortic Heart Valves
Receive HUD Designation from FDA 33
Edwards Lifesciences Secures FDA Approval for Carpentier-
Edwards PERIMOUNT Magna Ease Aortic Heart Valve 34
Edwards Lifesciences Performs First Implant of Transapical
Heart Valve through Ascendra 2 System 34
Edwards Lifesciences Receives FDA Approval for Carpentier-
Edwards PERIMOUNT Magna Mitral Heart Valve 34
CryoLife Implants First Combination Aortic-Mitral Allograft
Human Heart Valve 35
CryoLife Secures 510(k) FDA Clearance for CryoValve® SG
Pulmonary Human Heart Valve 35
9. RECENT INDUSTRY ACTIVITY 36
Boston Scientific Inks Definitive Merger Agreement with Sadra
Medical 36
Medtronic Acquires ATS Medical 36
CARMAT and Edwards Lifesciences Ink Agreement 36
On-X Life Technologies and Senko Medical Trading Ink Agreement
for Prosthetic Heart Valve 37
St. Jude Medical Establishes New Production Facility for Heart
Valves 37
Medtronic Acquires CoreValve 37
Medtronic Takes over Ventor Technologies 37
On-X Life Technologies Signs Global License and Development
Agreement with Cleveland Clinic 38
SynCardia and Aortech Sign PHV Technology Licensing Agreement 38
Sorin Group Inks Long Term Distribution Agreement with Japan
Lifeline 38
Medtronic and Arbor Sign Exclusive Licensing Agreement for
Pericardial Heart Valve Technology 39
10. FOCUS ON SELECT GLOBAL PLAYERS 40
Abbott Vascular (US) 40
CryoLife, Inc. (US) 40
Edwards Lifesciences Corporation (US) 40
Medtronic, Inc. (US) 40
Medtronic ATS Medical, Inc. (US) 41
On-X Life Technologies, Inc. (US) 41
SORIN GROUP (Italy) 41
St. Jude Medical, Inc. (US) 42
11. GLOBAL MARKET PERSPECTIVE 43
Table 6: World Recent Past, Current & Future Analysis for
Prosthetic Heart Valves by Geographic Region - US, Canada,
Japan, Europe, Asia-Pacific and Rest of World Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2009 Through 2017 (includes corresponding
Graph/Chart) 43
Table 7: World Historic Review for Prosthetic Heart Valves by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific
and Rest of World Markets Independently Analyzed with Annual
Revenue Figures in US$ Million for Years 2003 Through 2008
(includes corresponding Graph/Chart) 44
Table 8: World 15-Year Perspective for Prosthetic Heart Valves
by Geographic Region - Percentage Breakdown of Dollar Revenues
for US, Canada, Japan, Europe, Asia-Pacific and Rest of World
Markets for Years 2003, 2010 & 2017 (includes corresponding
Graph/Chart) 45
Table 9: World Recent Past, Current & Future Analysis for
Tissue Heart Valves by Geographic Region - US, Canada, Japan,
Europe, Asia-Pacific and Rest of World Markets Independently
Analyzed with Annual Revenue Figures in US$ Million for Years
2009 Through 2017 (includes corresponding Graph/Chart) 46
Table 10: World Historic Review for Tissue Heart Valves by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific
and Rest of World Markets Independently Analyzed with Annual
Revenue Figures in US$ Million for Years 2003 Through 2008
(includes corresponding Graph/Chart) 47
Table 11: World 15-Year Perspective for Tissue Heart Valves by
Geographic Region - Percentage Breakdown of Dollar Revenues
for US, Canada, Japan, Europe, Asia-Pacific and Rest of World
Markets for Years 2003, 2010 & 2017 (includes corresponding
Graph/Chart) 48
Table 12: World Recent Past, Current & Future Analysis for
Mechanical Heart Valves by Geographic Region - US, Canada,
Japan, Europe, Asia-Pacific and Rest of World Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2009 Through 2017 (includes corresponding
Graph/Chart) 49
Table 13: World Historic Review for Mechanical Heart Valves by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific
and Rest of World Markets Independently Analyzed with Annual
Revenue Figures in US$ Million for Years 2003 Through 2008
(includes corresponding Graph/Chart) 50
Table 14: World 15-Year Perspective for Mechanical Heart
Valves by Geographic Region - Percentage Breakdown of Dollar
Revenues for US, Canada, Japan, Europe, Asia- Pacific and Rest
of World Markets for Years 2003, 2010 & 2017 (includes
corresponding Graph/Chart) 51
12. THE UNITED STATES 52
A.Market Analysis 52
Current and Future Analysis 52
Valvular Disease Statistics 52
Table 15: Number of People Suffering from Severe and
Moderate to Severe AS (in Thousands) (includes
corresponding Graph/Chart) 52
Table 16: Number of People Suffering from Severe and
Moderate to Severe Mitral Regurgitation (MR) (in Thousands)
(includes corresponding Graph/Chart) 53
Table 17: Prevalence of Mildly Severe to Extremely Severe
Valvular Regurgitation in Men & Women (includes
corresponding Graph/Chart) 53
Table 18: US Heart Valve Replacement Procedures (2009):
Percentage Breakdown of Heart Replacement Procedures by
Aortic, Mitral, and Tricuspid & Pulmonary Valve Replacement
(includes corresponding Graph/Chart) 54
Demographics Spur Growth 54
Table 19: Population of the Elderly in the US (in
Millions): Population of 50-54, 55-59, 60-64, 65-69 and
70-74 Age Groups for 2001, 2006 and 2011 (includes
corresponding Graph/Chart) 54
Minimally Invasive Surgeries for Aortic Stenosis Treatment
Gaining in Popularity 55
Complications in Prosthetic Heart Valve 55
Competitive Scenario 55
FDA Regulations for Medical Devices 56
Prosthetic Heart Valves Approved by the FDA Since 2000 57
Clinical Studies/Trials 57
Product Launches/Innovations/ Regulatory Approvals 59
Strategic Corporate Developments 61
B.Market Analytics 64
Table 20: US Recent Past, Current & Future Analysis for
Prosthetic Heart Valve by Product Segment - Tissue and
Mechanical Markets Independently Analyzed with Annual
Revenues in US$ Million for Years 2009 Through 2017
(includes corresponding Graph/Chart) 64
Table 21: US Historic Review for Prosthetic Heart Valve by
Product Segment - Tissue and Mechanical Markets
Independently Analyzed with Annual Revenues in US$ Million
for Years 2003 Through 2008 (includes corresponding
Graph/Chart) 65
Table 22: US 15-Year Perspective for Prosthetic Heart Valve
by Product Segment - Percentage Breakdown of Dollar Revenues
for Tissue and Mechanical Markets for Years 2003, 2010 &
2017 (includes corresponding Graph/Chart) 65
13. CANADA 66
Market Analysis 66
Table 23: Canadian Recent Past, Current & Future Analysis
for Prosthetic Heart Valve by Product Segment - Tissue and
Mechanical Markets Independently Analyzed with Annual
Revenues in US$ Million for Years 2009 Through 2017
(includes corresponding Graph/Chart) 66
Table 24: Canadian Historic Review for Prosthetic Heart
Valve by Product Segment - Tissue and Mechanical Markets
Independently Analyzed with Annual Revenues in US$ Million
for Years 2003 Through 2008 (includes corresponding
Graph/Chart) 67
Table 25: Canadian 15-Year Perspective for Prosthetic Heart
Valve by Product Segment - Percentage Breakdown of Dollar
Revenues for Tissue and Mechanical Markets for Years 2003,
2010 & 2017 (includes corresponding Graph/Chart) 67
14. JAPAN 68
A.Market Analysis 68
Current and Future Analysis 68
Strategic Corporate Developments 68
B.Market Analytics 69
Table 26: Japanese Recent Past, Current & Future Analysis
for Prosthetic Heart Valve by Product Segment - Tissue and
Mechanical Markets Independently Analyzed with Annual
Revenues in US$ Million for Years 2009 Through 2017
(includes corresponding Graph/Chart) 69
Table 27: Japanese Historic Review for Prosthetic Heart
Valve by Product Segment - Tissue and Mechanical Markets
Independently Analyzed with Annual Revenues in US$ Million
for Years 2003 Through 2008 (includes corresponding
Graph/Chart) 70
Table 28: Japanese 15-Year Perspective for Prosthetic Heart
Valve by Product Segment - Percentage Breakdown of Dollar
Revenues for Tissue and Mechanical Markets for Years 2003,
2010 & 2017 (includes corresponding Graph/Chart) 70
15. EUROPE 71
A.Market Analysis 71
Current and Future Analysis 71
Central and Eastern Europe Markets Offer Growth Opportunities 71
TAVI Devices Provide a Boost 71
Reimbursements Prove a Stumbling Block 72
CE Mark for Medical Devices 72
Clinical Studies/Trials 72
Product Launches/Innovations/ Regulatory Approvals 73
Strategic Corporate Development 74
B.Market Analytics 75
Table 29: European Recent Past, Current & Future Analysis
for Prosthetic Heart Valve by Geographic Region - France,
Germany, Italy, UK, and Rest of Europe Markets Independently
Analyzed with Annual Revenues in US$ Million for Years 2009
Through 2017 (includes corresponding Graph/Chart) 75
Table 30: European Historic Review for Prosthetic Heart
Valve by Geographic Region - France, Germany, Italy, UK, and
Rest of Europe Markets Independently Analyzed with Annual
Revenues in US$ Million for Years 2003 Through 2008
(includes corresponding Graph/Chart) 76
Table 31: European 15-Year Perspective for Prosthetic Heart
Valve by Geographic Region - Percentage Breakdown of Dollar
Revenues for France, Germany, Italy, UK, and Rest of Europe
Markets for Years 2003, 2010 & 2017 (includes corresponding
Graph/Chart) 77
Table 32: European Recent Past, Current & Future Analysis
for Prosthetic Heart Valve by Product Segment - Tissue and
Mechanical Markets Independently Analyzed with Annual
Revenues in US$ Million for Years 2009 Through 2017
(includes corresponding Graph/Chart) 78
Table 33: European Historic Review for Prosthetic Heart
Valve by Product Segment - Tissue and Mechanical Markets
Independently Analyzed with Annual Revenues in US$ Million
for Years 2003 Through 2008 (includes corresponding
Graph/Chart) 79
Table 34: European 15-Year Perspective for Prosthetic Heart
Valve by Product Segment - Percentage Breakdown of Dollar
Revenues for Tissue and Mechanical Markets for Years 2003,
2010 & 2017 (includes corresponding Graph/Chart) 80
15a. FRANCE 81
Market Analysis 81
Table 35: French Recent Past, Current & Future Analysis for
Prosthetic Heart Valve by Product Segment - Tissue and
Mechanical Markets Independently Analyzed with Annual
Revenues in US$ Million for Years 2009 Through 2017
(includes corresponding Graph/Chart) 81
Table 36: French Historic Review for Prosthetic Heart Valve
by Product Segment - Tissue and Mechanical Markets
Independently Analyzed with Annual Revenues in US$ Million
for Years 2003 Through 2008 (includes corresponding
Graph/Chart) 82
Table 37: French 15-Year Perspective for Prosthetic Heart
Valve by Product Segment - Percentage Breakdown of Dollar
Revenues for Tissue and Mechanical Markets for Years 2003,
2010 & 2017 (includes corresponding Graph/Chart) 82
15b. GERMANY 83
A.Market Analysis 83
Current and Future Analysis 83
Reimbursements 83
B.Market Analytics 84
Table 38: German Recent Past, Current & Future Analysis for
Prosthetic Heart Valve by Product Segment - Tissue and
Mechanical Markets Independently Analyzed with Annual
Revenues in US$ Million for Years 2009 Through 2017
(includes corresponding Graph/Chart) 84
Table 39: German Historic Review for Prosthetic Heart Valve
by Product Segment - Tissue and Mechanical Markets
Independently Analyzed with Annual Revenues in US$ Million
for Years 2003 Through 2008 (includes corresponding
Graph/Chart) 85
Table 40: German 15-Year Perspective for Prosthetic Heart
Valve by Product Segment - Percentage Breakdown of Dollar
Revenues for Tissue and Mechanical Markets for Years 2003,
2010 & 2017 (includes corresponding Graph/Chart) 85
15c. ITALY 86
Market Analysis 86
Table 41: Italian Recent Past, Current & Future Analysis for
Prosthetic Heart Valve by Product Segment - Tissue and
Mechanical Markets Independently Analyzed with Annual
Revenues in US$ Million for Years 2009 Through 2017
(includes corresponding Graph/Chart) 86
Table 42: Italian Historic Review for Prosthetic Heart Valve
by Product Segment - Tissue and Mechanical Markets
Independently Analyzed with Annual Revenues in US$ Million
for Years 2003 Through 2008 (includes corresponding
Graph/Chart) 87
Table 43: Italian 15-Year Perspective for Prosthetic Heart
Valve by Product Segment - Percentage Breakdown of Dollar
Revenues for Tissue and Mechanical Markets for Years 2003,
2010 & 2017 (includes corresponding Graph/Chart) 87
15d. THE UNITED KINGDOM 88
Market Analysis 88
Table 44: UK Recent Past, Current & Future Analysis for
Prosthetic Heart Valve by Product Segment - Tissue and
Mechanical Markets Independently Analyzed with Annual
Revenues in US$ Million for Years 2009 Through 2017
(includes corresponding Graph/Chart) 88
Table 45: UK Historic Review for Prosthetic Heart Valve by
Product Segment - Tissue and Mechanical Markets
Independently Analyzed with Annual Revenues in US$ Million
for Years 2003 Through 2008 (includes corresponding
Graph/Chart) 89
Table 46: UK 15-Year Perspective for Prosthetic Heart Valve
by Product Segment - Percentage Breakdown of Dollar Revenues
for Tissue and Mechanical Markets for Years 2003, 2010 &
2017 (includes corresponding Graph/Chart) 89
15e. REST OF EUROPE 90
Market Analysis 90
Table 47: Rest of Europe Recent Past, Current & Future
Analysis for Prosthetic Heart Valve by Product Segment -
Tissue and Mechanical Markets Independently Analyzed with
Annual Revenues in US$ Million for Years 2009 Through 2017
(includes corresponding Graph/Chart) 90
Table 48: Rest of Europe Historic Review for Prosthetic
Heart Valve by Product Segment - Tissue and Mechanical
Markets Independently Analyzed with Annual Revenues in US$
Million for Years 2003 Through 2008 (includes corresponding
Graph/Chart) 91
Table 49: Rest of Europe 15-Year Perspective for Prosthetic
Heart Valve by Product Segment - Percentage Breakdown of
Dollar Revenues for Tissue and Mechanical Markets for Years
2003, 2010 & 2017 (includes corresponding Graph/Chart) 92
16. ASIA-PACIFIC 93
A.Market Analysis 93
Current and Future Analysis 93
Potential for Growth in Asia 93
India - An Emerging Hotspot for Medical Tourism 93
Table 50: Comparison of Heart Valve Replacement Surgery
Costs in Different Countries (includes corresponding
Graph/Chart) 94
B.Market Analytics 94
Table 51: Asia-Pacific Recent Past, Current & Future
Analysis for Prosthetic Heart Valve by Product Segment -
Tissue and Mechanical Markets Independently Analyzed with
Annual Revenues in US$ Million for Years 2009 Through 2017
(includes corresponding Graph/Chart) 94
Table 52: Asia-Pacific Historic Review for Prosthetic Heart
Valve by Product Segment - Tissue and Mechanical Markets
Independently Analyzed with Annual Revenues in US$ Million
for Years 2003 Through 2008 (includes corresponding
Graph/Chart) 95
Table 53: Asia-Pacific 15-Year Perspective for Prosthetic
Heart Valve by Product Segment - Percentage Breakdown of
Dollar Revenues for Tissue and Mechanical Markets for Years
2003, 2010 & 2017 (includes corresponding Graph/Chart) 96
17. REST OF WORLD 97
A.Market Analysis 97
Current and Future Analysis 97
Strategic Corporate Developments 97
B.Market Analytics 98
Table 54: Rest of World Recent Past, Current & Future
Analysis for Prosthetic Heart Valve by Product Segment -
Tissue and Mechanical Markets Independently Analyzed with
Annual Revenues in US$ Million for Years 2009 Through 2017
(includes corresponding Graph/Chart) 98
Table 55: Rest of World Historic Review for Prosthetic Heart
Valve by Product Segment - Tissue and Mechanical Markets
Independently Analyzed with Annual Revenues in US$ Million
for Years 2003 Through 2008 (includes corresponding
Graph/Chart) 99
Table 56: Rest of World 15-Year Perspective for Prosthetic
Heart Valve by Product Segment - Percentage Breakdown of
Dollar Revenues for Tissue and Mechanical Markets for Years
2003, 2010 & 2017 (includes corresponding Graph/Chart) 99
COMPETITIVE LANDSCAPE
Total Companies Profiled: 18 (including Divisions/Subsidiaries - 19)
------------------------------------------
Region/Country Players
------------------------------------------
The United States 12
Europe 6
Germany 2
The United Kingdom 1
Italy 1
Rest of Europe 2
Asia-Pacific (Excluding Japan) 1
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