Prosthetic Heart Valves - Global Strategic Business Report

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 17 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 primarily based upon search engine sources in the public domain.

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I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-3
Quantitative Techniques & Analytics I-3
Product Definitions and Scope of Study I-3
Mechanical Valves I-3
Biological/Tissue Valves I-3


II. Executive Summary

1. OUTLOOK II-1
Transcatheter Heart Valves Market Poised For Growth II-2

2. INDUSTRY OVERVIEW II-3
Metals Giving Way to Carbon Compounds and Polymers in
Mechanical Heart Valves II-3
Tissue Valves Prevail Over Mechanical Valves II-3
BSE: A Potential Problem for Tissue Segment II-3
Major Growth Drivers II-3
Aging Demographics II-3
Table 1: Ageing (65+) Demographics as % of Total Population
by Country (2000, 2010, 2025) (includes corresponding
Graph/Chart) II-4
Under-Treated Population II-4
Rheumatic Heart Disease II-4
Developing Countries II-5
Table 2: Global Heart Valve Procedures (2010): Number of
Heart Valve Procedures Per Million Population (for 55+
Population) and Total Heart Valve Procedures (includes
corresponding Graph/Chart) II-5
Technological Developments II-6

3. PERCUTANEOUS HEART VALVES II-7
An Introduction II-7
The Technology II-7
Cost of Replacement II-8
Introduction and Adoption in Europe II-8
Table 3: European Recent Past, Current & Future Analysis for
Transcatheter Heart Valve Market with Annual Revenues in US$
Million for Years 2009 through 2017 (includes corresponding
Graph/Chart) II-8
Competition Heats Up in US Market II-9
Table 4: US Recent Past, Current & Future Analysis for
Transcatheter Heart Valve Market with Annual Revenues in US$
Million for Years 2009 through 2017 (includes corresponding
Graph/Chart) II-9
A Word of Caution II-10

4. COMPETITIVE ANALYSIS II-11
Table 5: Global Heart Valve Market (2010): Percentage
Breakdown of Heart Valve Market by Value for Edwards
Lifesciences, St. Jude Medical, Medtronic, and Others
(includes corresponding Graph/Chart) II-11
Competition in Percutaneous Heart Valve Segment II-11
Mergers and Acquisitions II-12
Edwards Lifesciences Leads the Way II-12
Medtronic Remains Bullish on Percutaneous Heart Valve Segment II-12
Heart Valves in the Pipeline II-13
Next-Generation Heart Valves II-13
St. Jude's Trifecta Tissue Valve II-13
Edwards Lifesciences' SAPIEN Transcatheter Heart Valve II-13
Medtronic's CoreValve II-13
Sorin Group's Perceval S Aortic Valve II-13

5. PRODUCT OVERVIEW II-14
Human Heart - Morphology II-14
An Introduction to Heart Valves II-14
Heart Valve Disorders II-15
Probable Causes of Heart Valve Diseases II-16
Diagnosis II-16
Replacement or Repair? II-16
Heart Valve Replacement II-17
Prosthetic Heart Valves - An Introduction II-17
Chronology of Important Developments in Prosthetic Heart
Valve Market II-18
Designing Considerations for Prosthetic Heart Valves II-18
Mechanical Valves II-18
Caged Ball Design II-19
Tilting Disc Heart Valve II-19
Bileaflet Valves II-19
Biological/Tissue Valves II-19
Stentless Tissue Valves II-20
Stented Tissue Valves II-20
Mechanical Vs. Biological II-20
Some Important Facts II-21
Valve Failure II-21
Symptoms of Malfunctioning Prosthetic Heart Valve II-22
Clinical Symptoms II-22
Physical Symptoms II-23
Sound II-23
PHV Murmurs II-23
Prosthetic Valve Endocarditis (PVE) II-24
Prosthetic Valve Thrombosis (PVT) II-25
Embolization II-25
Structural Breakdown of Bioprosthetic Valves II-25

6. CLINICAL STUDIES/TRIALS II-26
Edwards Lifesciences Secures Conditional FDA Approval for
PARTNER II Clinical Trials of Next-Generation Transcatheter
Valve II-26
Medtronic Receives Conditional FDA Approval for Clinical
Trials of New CoreValve® System for TAVI II-26
Edwards Lifesciences Announces Results for PARTNER I Trial II-26
Sorin Group Announces Clinical Study Results for Perceval S™
Self Anchoring Sutureless Aortic Valve II-27
On-X Announces Positive Results for Clinical Trials of
Prosthetic Heart Valve II-27
On-X Life Technologies Completes Enrollment for PROACT Trial II-27
St. Jude Medical Completes European Enrollment for Trifecta™
Stented Tissue Valve Trial II-28

7. PRODUCT LAUNCHES/INNOVATIONS/ REGULATORY APPROVALS II-29
FDA Approves Edwards Lifesciences' Sapien Valve II-29
St. Jude Medical Obtains CE Mark Clearance for TrifectaTM Valve II-29
Medtronic Obtains CE Mark for Subclavian Artery Approach for
CoreValve® System II-29
CryoLife Obtains FDA 510(k) Clearance for 5-Year Shelf Life
Period for CryoValve® SG Pulmonary Human Heart Valve II-29
Medtronic Receives FDA Approval for Medtronic Melody®
Transcatheter Pulmonary Valve II-30
RUSNANO Clears Project to Develop Nanostructured Prosthetic
Heart Valves II-30
CryoLife's Synergraft® Processed Human Aortic Heart Valves
Receive HUD Designation from FDA II-31
Edwards Lifesciences Secures FDA Approval for Carpentier-
Edwards PERIMOUNT Magna Ease Aortic Heart Valve II-31
Edwards Lifesciences Performs First Implant of Transapical
Heart Valve through Ascendra 2 System II-31
Edwards Lifesciences Receives FDA Approval for Carpentier-
Edwards PERIMOUNT Magna Mitral Heart Valve II-32
CryoLife Implants First Combination Aortic-Mitral Allograft
Human Heart Valve II-32
CryoLife Secures 510(k) FDA Clearance for CryoValve® SG
Pulmonary Human Heart Valve II-32

8. RECENT INDUSTRY ACTIVITY II-33
Boston Scientific Inks Definitive Merger Agreement with Sadra
Medical II-33
Medtronic Acquires ATS Medical II-33
CARMAT and Edwards Lifesciences Ink Agreement II-33
On-X Life Technologies and Senko Medical Trading Ink Agreement
for Prosthetic Heart Valve II-34
St. Jude Medical Establishes New Production Facility for Heart
Valves II-34
Medtronic Acquires CoreValve II-34
Medtronic Takes over Ventor Technologies II-34
On-X Life Technologies Signs Global License and Development
Agreement with Cleveland Clinic II-35
SynCardia and Aortech Sign PHV Technology Licensing Agreement II-35
Sorin Group Inks Long Term Distribution Agreement with Japan
Lifeline II-35
Medtronic and Arbor Sign Exclusive Licensing Agreement for
Pericardial Heart Valve Technology II-36

9. FOCUS ON SELECT GLOBAL PLAYERS II-37
Abbott Vascular (US) II-37
CryoLife, Inc. (US) II-37
Edwards Lifesciences Corporation (US) II-37
Medtronic, Inc. (US) II-37
Medtronic ATS Medical, Inc. (US) II-38
On-X Life Technologies, Inc. (US) II-38
SORIN GROUP (Italy) II-38
St. Jude Medical, Inc. (US) II-39

10. GLOBAL MARKET PERSPECTIVE II-40
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) II-40

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) II-41

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, 2011 & 2017 (includes corresponding
Graph/Chart) II-42

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) II-43

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) II-44

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, 2011 & 2017 (includes corresponding
Graph/Chart) II-45

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) II-46

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) II-47

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, 2011 & 2017 (includes
corresponding Graph/Chart) II-48


III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Valvular Disease Statistics III-1
Table 15: Number of People Suffering from Severe and
Moderate to Severe AS (in Thousands) (includes
corresponding Graph/Chart) III-1

Table 16: Number of People Suffering from Severe and
Moderate to Severe Mitral Regurgitation (MR) (in Thousands)
(includes corresponding Graph/Chart) III-2

Table 17: Prevalence of Mildly Severe to Extremely Severe
Valvular Regurgitation in Men & Women (includes
corresponding Graph/Chart) III-2

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) III-3
Demographics Spur Growth III-3
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) III-3
Minimally Invasive Surgeries for Aortic Stenosis Treatment
Gaining in Popularity III-3
Complications in Prosthetic Heart Valve III-4
Competitive Scenario III-4
FDA Regulations for Medical Devices III-5
Prosthetic Heart Valves Approved by the FDA Since 2000 III-6
Clinical Studies/Trials III-6
Product Launches/Innovations/ Regulatory Approvals III-8
Strategic Corporate Developments III-11
B.Market Analytics III-13
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) III-13

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) III-14

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, 2011 &
2017 (includes corresponding Graph/Chart) III-15

2. CANADA III-16
Market Analtics III-16
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) III-16

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) III-17

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,
2011 & 2017 (includes corresponding Graph/Chart) III-18

3. JAPAN III-19
A.Market Analysis III-19
Strategic Corporate Developments III-19
B.Market Analytics III-20
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) III-20

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) III-21

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,
2011 & 2017 (includes corresponding Graph/Chart) III-22

4. EUROPE III-23
A.Market Analysis III-23
Central and Eastern Europe Markets Offer Growth Opportunities III-23
TAVI Devices Provide a Boost III-23
Reimbursements Prove a Stumbling Block III-23
CE Mark for Medical Devices III-23
Clinical Studies/Trials III-24
Product Launches/Innovations/ Regulatory Approvals III-24
Strategic Corporate Development III-26
B.Market Analytics III-27
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) III-27

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) III-28

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, 2011 & 2017 (includes corresponding
Graph/Chart) III-29

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) III-30

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) III-31

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,
2011 & 2017 (includes corresponding Graph/Chart) III-32

4a. FRANCE III-33
Market Analtics III-33
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) III-33

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) III-34

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,
2011 & 2017 (includes corresponding Graph/Chart) III-35

4b. GERMANY III-36
A.Market Analysis III-36
Reimbursements III-36
B.Market Analytics III-37
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) III-37

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) III-38

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,
2011 & 2017 (includes corresponding Graph/Chart) III-39

4c. ITALY III-40
Market Analtics III-40
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) III-40

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) III-41

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,
2011 & 2017 (includes corresponding Graph/Chart) III-42

4d. THE UNITED KINGDOM III-43
Market Analtics III-43
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) III-43

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) III-44

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, 2011 &
2017 (includes corresponding Graph/Chart) III-45

4e. REST OF EUROPE III-46
Market Analtics III-46
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) III-46

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) III-47

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, 2011 & 2017 (includes corresponding Graph/Chart) III-48

5. ASIA-PACIFIC III-49
A.Market Analysis III-49
Potential for Growth in Asia III-49
India - An Emerging Hotspot for Medical Tourism III-49
Table 50: Comparison of Heart Valve Replacement Surgery
Costs in Different Countries (includes corresponding
Graph/Chart) III-49
B.Market Analytics III-50
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) III-50

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) III-51

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, 2011 & 2017 (includes corresponding Graph/Chart) III-52

6. REST OF WORLD III-53
A.Market Analysis III-53
Strategic Corporate Developments III-53
B.Market Analytics III-54
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) III-54

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) III-55

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, 2011 & 2017 (includes corresponding Graph/Chart) III-56


IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 17 (including Divisions/Subsidiaries - 18)

------------------------------------------
Region/Country Players
------------------------------------------
The United States 11
Europe 5
Germany 2
The United Kingdom 1
Italy 1
Rest of Europe 1
Asia-Pacific (Excluding Japan) 2
------------------------------------------

Prosthetic heart valve market is on the cusp of an important paradigm shift, with the US market set to witness the introduction of percutaneous heart valves also known as transcatheter heart valves. Introduction of the transcatheter aortic valve implantation (TAVI) device has already led to a significant increase in the number of aortic valve procedures in the European market. Currently, the procedure is recommended for high-risk surgical patients with a frail heart or patients who are not advised open-heart surgery. Apart from gaining market share from traditional procedures, the percutaneous heart valve procedure is expected to expand the entire prosthetic heart valve market. Moreover, the average selling price of the new TAVI device is five times that of standard aortic valve, which is likely to further boost value sales of the market.

Apart from transcatheter valves, other technological advancements such as durable tissue heart valves, suture-less valves, and anti-calcification technology, which enhances valve durability through treatment of the prosthetic valve with surface-active compounds, are all expected to propel market penetration of prosthetic heart valves. In addition, favorable demographics, in the form of a rapidly rising aging populace, higher risk of heart valve diseases due to obesity and diabetes, are also likely to propel the prosthetic heart valve market.

Metals, which are being used from the beginning in mechanical heart valves, are gradually being replaced by carbon compounds and sophisticated plastics including polymers. The tissue valve segment is slowly and steadily weaning away market share from the mechanical segment, a trend that is likely to accelerate with the adoption of the transcatheter valves in the US and the rest of world markets.

Tissue valves represent both the larger and faster growing segment, as stated by Global Industry Analysts new market research report on Prosthetic Heart Valves. The US represents the largest market for prosthetic heart valves. Valvular diseases affect more than 2.5% of the American populace, with the incidence rate particularly high in the 75 years and above category. The tissue valve market represents the larger market. Europe represents the other significant market for prosthetic heart valves. European prosthetic heart valve market is being driven primarily by the introduction of the TAVI procedure in 2007. However, mechanical valves remains the preferred choice for implantation in young people due to their durability factor.

Prosthetic Heart Valve market is a highly consolidated one with the three leading players, Edwards Lifesciences, St. Jude Medical and Medtronic accounting for more than four-fifth of the global market share. Edwards Lifesciences leads the market for tissue valves, while St. Jude Medical leads the market for mechanical valves. Medtronic has moved aggressively in the prosthetic heart valve market, particularly the transcatheter segment, by acquiring three companies during the last two years.

Global Industry Analysts ©

- Abbott Vascular
- CryoLife, Inc.
- Edwards Lifesciences Corporation
- Medtronic, Inc.
- Medtronic ATS Medical, Inc.
- On-X Life Technologies, Inc.
- SORIN GROUP
- St. Jude Medical, Inc

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