PROSTHETIC HEART VALVES — GLOBAL … report is a licensed product and is not to be copied, ......

REFERENCE CODE GDME0210MAR | PUBLICATION DATE FEBRUARY 2015

PROSTHETIC HEART VALVES — GLOBAL ANALYSIS AND MARKET FORECASTS

Prosthetic Heart Valves — Global Analysis and Market Forecasts 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.


Executive Summary

Key Metrics in Major Markets

Prosthetic Heart Valves, Key Metrics in Major Markets

(2013) Global Sales Volume 386,464

(2013) Global Market Value ($m) $2,082.4m

(2013) US Market Value ($m) $762.8m

(2013) 5EU Market Value ($m) $882.4m

(2013) Asia-Pacific Market Value ($m) $404.5m

(2013) Brazil Market Value ($m) $32.6m

Key Events

(2013) Edwards Lifesciences receives regulatory approval to market Sapien XT in Japan

(2014) Strong pipeline of transcatheter aortic valve replacement devices that are fully repositionable and retrievable

Forecast

(2020) Global Sales Volume 592,257

(2020) Global Market Value ($m) $4,455.1m

(2020) US Market Value ($m) $1,527m

(2020) 5EU Market Value $2,319m

(2020) Asia-Pacific Market Value ($m) $560.6m

(2020) Brazil Market Value ($m) $48.4m

Source: GlobalData, primary research interviews with leading cardiac surgeons and interventional cardiologists in 10 markets (US, France, Germany, Italy, Spain, UK, Japan, China, India, and Brazil) 5EU = France, Germany, Italy, Spain, and the UK; Asia-Pacific = Japan, China, and India

The global prosthetic heart valve market in 2013 is

estimated to be valued at $2,082m across the 10

major markets covered in this reported, which

includes the United States, France, Germany, Italy,

Spain, the United Kingdom, Japan, India, China,

and Brazil.

By the end of the forecast period in 2020, the

global prosthetic heart valve market will grow to

approximately $4,455m at a Compound Annual

Growth Rate (CAGR) of 11.4%.

The key drivers for the market in the forecast are:

The growing prevalence of valvular heart

disease and an aging population around the

globe

Technological advancements in the field of

interventional cardiology that include

transcatheter aortic valve replacement (TAVR)

and the desire to eliminate the need for open

surgical procedures for valve replacements

The development of TAVR devices that are

fully repositionable and retrievable, providing

better clinical outcomes and reducing

complications associated with valve

replacement procedures



Executive Summary

Global Market Share Comparison By Major Market, 2013 & 2020

36.6%

18.7%11.0%

9.2%

7.1%

6.2%

3.8%3.6% 2.1% 1.6%

United States

Germany

China

France

Italy

Japan

Spain

United Kingdom

India

Brazil

34.3%

25.9%

6.5%

9.9%

8.2%

4.7%

3.5%4.5% 1.4% 1.1%

2013$2.08bn

2023$4.46bn

Source: GlobalData, 2014

The US market accounts for the largest segment of

the prosthetic heart valve market. While China

owns a significant portion of the market in 2013, its

share is expected to decrease in the forecast

period due to the emergence of TAVR, which is

expected to experience rapid growth and is not yet

approved in China. The 5EU countries (France,

Germany, Italy, Spain, and the UK) are

technologically the most advanced market, with the

best availability of TAVR devices. The emerging

markets see the most open surgical procedures

and are restricted due to the high cost of minimally

invasive procedures. As training programs for

surgeons and product prices reduce, the emerging

markets present a strong market opportunity for

additional revenue for manufacturers. The growing

need for multinational companies will be to better

target the fast-growing markets and continue to be

a leader in development to combat the threat of

rising local manufacturers.

Technological Trends

While heart valve replacement has been around for

decades, minimally invasive techniques have only

come into the picture recently. Modern heart valve

replacements show increased durability, improved

conformance to native tissue, and improved

hemodynamics over older models. Advancements

in diagnostic imaging have also streamlined the

valve replacement process by allowing the

physician to visualize the diseased valve and

appropriately size the prosthetic. These imaging

techniques represent an opportunity for prosthetic

heart valve manufacturers to continue training

programs for early detection of asymptomatic valve

disease.

The technological developments in this space will

continue to result in positive market growth. The

primary technological drivers for TAVR devices

include the development of low-profile,

repositionable, and retrievable systems. Low-

profile devices are of particular interest in the Asian



Executive Summary

market, where patient arteries are smaller in

diameter. Generally, there remains room for

improvement in the efficacy of TAVR devices, and

as the products evolve, there will be continued

growth in this market.

Key Players in the Prosthetic Heart Valve Market

Currently, the prosthetic heart valve market is

dominated by two players: Edwards Lifesciences

and Medtronic. Medtronic has a strong presence in

all three segments of this market (mechanical,

tissue, and transcatheter), while Edwards has built

a trusted brand in tissue valves and TAVR. In

terms of transcatheter valves, these companies

have launched products that are considered the

gold standard in the market, and continue to

innovate within this space. Direct Flow Medical and

Boston Scientific are currently developing the next-

generation in TAVR systems, along with the top

two players, and early data from their devices have

been very positive. St. Jude Medical and Sorin

Group are the two big players in the surgical valve

market segments (mechanical and tissue). St.

Jude Medical currently manufactures what is

considered the gold standard in mechanical valves,

and also has a line of tissue valve products as well.

Prosthetic Heart Valve Market Future Outlook

The growth of the prosthetic heart valve market will

be driven primarily by the adoption of TAVR

around the globe. While surgical valves will

continue to have a presence in the market, they

are not expected to see rapid growth in any of the

regions. Despite the high product price of TAVR,

physicians recognize the clinical benefits of a

minimally invasive procedure as opposed to open

surgery. As physician education improves and they

have access to more robust clinical data, the

outlook for the TAVR market looks strong, with

much room for further product improvement in

next-generation devices.

The global market is expected to grow at a CAGR

of 11.4%. The fastest growing markets will be

Germany, Italy, and France, at CAGRs of 16.6%,

13.5%, and 12.5%, respectively. This is because a

much greater number of TAVR devices are

approved in the major European markets as

opposed to others. The slowest growth will be seen

in Brazil, India, and China, with CAGRs of 5.7%,

5.2%, and 3.3%, respectively. This is because high

device cost restricts patient access to TAVR in

Brazil and India, while China has not yet approved

the procedure at all.

The market outlook for prosthetic heart valves

looks strong in Western markets, as there is still

much room for product adoption and growth.

Regionally, one can expect slightly different drivers

for growth. In the Western markets, availability of

TAVR devices is expected to drive growth. In the

Asia-Pacific (APAC) countries, lower costing

devices will allow for more widespread adoption. In

Japan in particular, low-profile devices will allow

manufacturers to access a larger subset of

patients.



Executive Summary

What Do Physicians Think?

Physicians assert that the future of TAVR is bright

due to positive clinical outcomes:

“I have a conflict of interest because I do the

procedure, of course, but the outlook is very

positive, clearly. The results are very positive. The

discussion now is: where do the indications stop?”

Key Opinion Leader

“The market opportunity is going to be to let most

referring physicians and general internists and

cardiologists know that there’s a whole world out

there that they can offer their patients that will both

improve their symptoms and lengthen their lives.”

Key Opinion Leader

High procedure and device cost is the primary

barrier to adoption of TAVR in emerging markets:

“The costing is important in the US… and the

costing will be important here also. There has to be

a practical and pragmatic approach to that. It

should not be too expensive.”

Key Opinion Leader

There is an increasing patient preference for

bioprosthetic valves over mechanical valves:

“We don’t see many patients under the age of 15

needing valve surgery, but when we do, we have

to emphasize to them that it probably is in their

best overall long-term interest to have the

mechanical valve, but sometimes that takes some

persuading.”

Key Opinion Leader

Physicians mention unmet needs in the

transcatheter valve space:

“…we thought the issue of severe aortic stenosis is

solved if the patient has a new valve. And if he is

still suffering from moderate paravalvular aortic

regurgitation that will not be an issue for the

patient. But actually, we were not right, and many

of these patients did not really come out very well

out of the procedure.”

Key Opinion Leader

“I think the only uncertainties are… the durability

question, because we simply don’t have the data. I

think we need to solve the Pacemaker issue,

particularly in some of the device[s]… and we need

to work out how we’re going to deliver… to match

the demand.”

Key Opinion Leader



Executive Summary

“…we need to learn from the TAVR story and get

busy in the mitral valve as well. That’s the next

major area for development, in my opinion…

there’s an opportunity waiting to be filled by

somebody who can work out the easiest and safest

way to put devices into the mitral position.”

Key Opinion Leader


Table of Contents


1 Table of Contents

1 Table of Contents ....................................................................................................................... 7

1.1 List of Tables .................................................................................................................... 15

1.2 List of Figures ................................................................................................................... 21

2 Introduction ............................................................................................................................... 24

2.1 Anatomy............................................................................................................................ 24

2.2 Epidemiology .................................................................................................................... 24

2.3 Related Reports ................................................................................................................ 25

3 Industry Overview ..................................................................................................................... 26

3.1 Overview ........................................................................................................................... 26

3.1.1 Mechanical Heart Valves ............................................................................................... 26

3.1.2 Tissue Heart Valves ...................................................................................................... 28

3.1.3 Transcatheter Heart Valves ........................................................................................... 29

3.2 Indications ......................................................................................................................... 30

3.2.1 Valvular Stenosis .......................................................................................................... 30

3.2.2 Valvular Regurgitation ................................................................................................... 31

3.3 Clinical Presentation ......................................................................................................... 31

3.3.1 Diagnosis ...................................................................................................................... 31

3.3.2 Risk Assessment Tools ................................................................................................. 31

3.4 Clinical Outcomes ............................................................................................................. 33

3.4.1 Treatment Options......................................................................................................... 33

3.4.2 Life Style Changes ........................................................................................................ 34


Table of Contents


3.4.3 Complications................................................................................................................ 34

3.5 Applications of Technology ............................................................................................... 35

3.6 Market Access .................................................................................................................. 35

3.6.1 Purchasing Decisions .................................................................................................... 35

3.7 Influence of Clinical Trials ................................................................................................. 35

3.8 Brand Loyalty .................................................................................................................... 35

3.9 Adoption............................................................................................................................ 36

3.10 Regulation ......................................................................................................................... 37

3.10.1 US ................................................................................................................................. 37

3.10.2 5EU ............................................................................................................................... 38

3.10.3 APAC ............................................................................................................................ 39

3.10.4 South America............................................................................................................... 42

3.11 Reimbursement ................................................................................................................. 43

3.11.1 US ................................................................................................................................. 43

3.11.2 5EU ............................................................................................................................... 45

3.11.3 APAC ............................................................................................................................ 49

3.11.4 South America............................................................................................................... 52

3.12 Procedure Trends ............................................................................................................. 53

3.12.1 Global Overview ............................................................................................................ 53

3.12.2 By Country .................................................................................................................... 54

3.13 Regulatory Issues/Recalls ................................................................................................. 75

3.13.1 Portico TAVR Implants Halted Due to Safety Concerns ................................................ 75

3.14 M&A, Key Partnerships ..................................................................................................... 75


Table of Contents


3.14.1 Licensing Agreement Between Symetis and Endoluminal Sciences .............................. 75

3.14.2 Manufacturing Agreement Between Sorin Group and Boston Scientific ......................... 75

3.15 Economic Impact .............................................................................................................. 75

3.15.1 Indirect Costs ................................................................................................................ 75

3.15.2 Direct Costs .................................................................................................................. 77

4 Unmet Needs ............................................................................................................................ 78

4.1 Delivery & Implantation ..................................................................................................... 78

4.1.1 Mechanism of Deployment ............................................................................................ 78

4.1.2 Anchoring ...................................................................................................................... 78

4.1.3 Retrievability.................................................................................................................. 79

4.1.4 Repositionability ............................................................................................................ 79

4.1.5 Artery Accessibility ........................................................................................................ 79

4.1.6 Rapid Pacing ................................................................................................................. 80

4.1.7 Coronary Ostia Occlusion.............................................................................................. 81

4.1.8 Motorized Delivery Systems .......................................................................................... 81

4.2 Performance ..................................................................................................................... 82

4.2.1 Durability ....................................................................................................................... 82

4.2.2 Thrombogenicity ............................................................................................................ 83

4.2.3 Effective Orifice Area ..................................................................................................... 83

4.2.4 Coefficient of Friction ..................................................................................................... 83

4.3 Crimping ........................................................................................................................... 84

4.4 Stenting............................................................................................................................. 84

4.5 Replaceable Leaflets......................................................................................................... 84


Table of Contents


4.6 Embolic Protection ............................................................................................................ 85

4.7 Pacemaker Placement ...................................................................................................... 85

5 Market Opportunity Analysis ..................................................................................................... 87

5.1 Overview ........................................................................................................................... 87

5.2 Emerging Markets for TAVR ............................................................................................. 87

5.3 Increasing Tissue Valve Lifespan ...................................................................................... 88

5.4 Valve-in-Valve Procedures (Re-replacement) ................................................................... 89

5.5 Transcatheter Mitral Valve Replacement........................................................................... 90

5.6 Balloon Valvuloplasty ........................................................................................................ 91

6 Market Drivers and Barriers ...................................................................................................... 92

6.1 Driver: Rising Disease Prevalence .................................................................................... 92

6.2 Driver: Multimodality Imaging ............................................................................................ 93

6.3 Driver: Alternative Access Routes ..................................................................................... 94

6.4 Driver: Lower Risk Patient Access .................................................................................... 94

6.5 Driver: Patient Demand and Awareness............................................................................ 95

6.6 Driver: Advanced Computational Tools ............................................................................. 96

6.7 Driver: Rising Competition and Innovation ........................................................................ 96

6.8 Barrier: High Device and Procedure Cost .......................................................................... 97

6.9 Barrier: Burden of Rising Regulation ................................................................................. 97

6.10 Barrier: Medical Device Excise Tax ................................................................................... 98

6.11 Barrier: Proving Long-Term Efficacy ................................................................................. 98

6.12 Substitute: Valve Repair .................................................................................................... 99

6.13 Substitute: Balloon Valvuloplasty ...................................................................................... 99


Table of Contents


7 Competitive Assessment ........................................................................................................ 100

7.1 Overview ......................................................................................................................... 100

7.2 Classification Based on Features .................................................................................... 100

7.2.1 Mechanical Heart Valves ............................................................................................. 100

7.2.2 Tissue Heart Valves .................................................................................................... 103

7.2.3 Transcatheter Heart Valves ......................................................................................... 106

7.3 Market Dynamics Analysis .............................................................................................. 107

7.4 Product Profiles ............................................................................................................... 109

7.4.1 Mechanical Heart Valves ............................................................................................. 109

7.4.2 Tissue Heart Valves .................................................................................................... 115

7.4.3 Transcatheter Heart Valves ......................................................................................... 121

8 Pipeline Assessment............................................................................................................... 135

8.1 Overview ......................................................................................................................... 135

8.2 Product Profiles ............................................................................................................... 135

8.2.1 Cytograft Tissue Valve (Cytograft Tissue Engineering) ............................................... 135

8.2.2 Centera Valve (Edwards Lifesciences) ........................................................................ 136

8.2.3 Colibri Heart Valve (Colibri Heart Valve) ...................................................................... 137

8.2.4 Cormove (Perouse Medical) ........................................................................................ 138

8.2.5 Endovalve (Micro Interventional Devices) .................................................................... 139

8.2.6 HLT Transcatheter Valve System (Heart Leaflet Technology) ..................................... 140

8.2.7 Kalangos Valve (Leman Cardiovascular) ..................................................................... 141

8.2.8 Tiara Valve (Neovasc) ................................................................................................. 142

8.2.9 Trinity Valve (Transcatheter Technologies GmbH) ...................................................... 143


Table of Contents


8.2.10 Vanguard Exchangeable Heart Valve System (ValveXchange) ................................... 144

9 Clinical Trials to Watch ........................................................................................................... 146

9.1 Overview ......................................................................................................................... 146

9.2 CoreValve Evolut R (Medtronic) ...................................................................................... 146

9.3 TRANSFORM Trial — Intuity Valve System (Edwards Lifesciences) .............................. 146

9.4 PROACT Trial — On-X Plus 1.5 Mechanical Heart Valve (On-X Life Technologies) ....... 147

9.5 PARTNER II Trial — Sapien XT (Edwards Lifesciences) ................................................ 147

9.6 PARTNER III Trial — Sapien 3 (Edwards Lifesciences) .................................................. 147

9.7 REPRISE III IDE/PMA Trial — Lotus Valve System (Boston Scientific) ........................... 148

9.8 SENTINEL-H Trial — Sentinel Cerebral Protection System (Claret Medical) .................. 148

10 Current and Future Players ..................................................................................................... 149

10.1 Overview ......................................................................................................................... 149

10.2 Trends in Corporate Strategy .......................................................................................... 149

10.3 Company Profiles ............................................................................................................ 150

10.3.1 AorTech International .................................................................................................. 150

10.3.2 Boston Scientific .......................................................................................................... 152

10.3.3 Braile Biomédica ......................................................................................................... 153

10.3.4 CardiAQ Valve Technologies ...................................................................................... 154

10.3.5 Claret Medical ............................................................................................................. 155

10.3.6 Colibri Heart Valve ...................................................................................................... 156

10.3.7 Cytograft Tissue Engineering ...................................................................................... 157

10.3.8 Direct Flow Medical ..................................................................................................... 158

10.3.9 Edwards Lifesciences .................................................................................................. 159


Table of Contents


10.3.10 Heart Leaflet Technologies.......................................................................................... 161

10.3.11 JenaValve Technology ................................................................................................ 162

10.3.12 Leman Cardiovascular ................................................................................................ 163

10.3.13 Micro Interventional Devices ....................................................................................... 164

10.3.14 Neovasc ...................................................................................................................... 165

10.3.15 On-X Life Technologies, Inc. ....................................................................................... 166

10.3.16 Perouse Medical ......................................................................................................... 167

10.3.17 Sorin Group ................................................................................................................. 168

10.3.18 St. Jude Medical .......................................................................................................... 169

10.3.19 Symetis ....................................................................................................................... 171

10.3.20 Transcatheter Technologies GmbH ............................................................................. 172

10.3.21 TTK Healthcare ........................................................................................................... 173

10.3.22 ValveXchange ............................................................................................................. 174

11 Strategic Competitive Assessment.......................................................................................... 176

11.1 Company Market Share .................................................................................................. 176

11.1.1 Global Overview .......................................................................................................... 176

11.1.2 By Region ................................................................................................................... 177

11.1.3 By Country .................................................................................................................. 179

12 Market Outlooks by Market Segment ...................................................................................... 187

12.1 Market Segment Share ................................................................................................... 187

12.1.1 Global.......................................................................................................................... 187

12.1.2 By Region ................................................................................................................... 188

13 Market Outlooks by Geography .............................................................................................. 192


Table of Contents


13.1 Global Overview .............................................................................................................. 192

13.2 US................................................................................................................................... 196

13.3 France ............................................................................................................................ 199

13.4 Germany ......................................................................................................................... 203

13.5 Italy ................................................................................................................................. 207

13.6 Spain .............................................................................................................................. 211

13.7 UK................................................................................................................................... 214

13.8 Japan .............................................................................................................................. 218

13.9 China .............................................................................................................................. 222

13.10 India ................................................................................................................................ 226

13.11 Brazil ............................................................................................................................... 230

14 Appendix................................................................................................................................. 234

14.1 Bibliography .................................................................................................................... 234

14.2 Abbreviations .................................................................................................................. 245

14.3 Report Methodology ........................................................................................................ 248

14.3.1 Overview ..................................................................................................................... 248

14.3.2 Coverage .................................................................................................................... 248

14.3.3 Secondary Research ................................................................................................... 248

14.4 Forecasting Methodology ................................................................................................ 250

14.5 Physicians and Specialists Included in This Study .......................................................... 251

14.6 About the Authors ........................................................................................................... 252

14.6.1 Analysts ...................................................................................................................... 252

14.6.2 Global Head of Healthcare .......................................................................................... 253


Table of Contents


14.7 About GlobalData ............................................................................................................ 254

14.8 Disclaimer ....................................................................................................................... 254

1.1 List of Tables

Table 1: Overview of Symptoms, Risk Factors, and Treatments ................................................................ 26

Table 2: Evolution of the Mechanical Heart Valve ...................................................................................... 27

Table 3: Evolution of the Tissue Heart Valve ............................................................................................. 29

Table 4: Comparison of Surgical and Transcatheter Procedures ............................................................... 30

Table 5: NYHA Functional Classification of Cardiac Disease Patients ....................................................... 32

Table 6: Drug Treatment Paradigm for Aortic Valve Disease ..................................................................... 33

Table 7: Regulatory Differences Between the US and EU ......................................................................... 38

Table 8: Medicare National Average of Inpatient Hospital Reimbursement for Valve Replacement, 2014–

2015............................................................................................................................................ 44

Table 9: ICD-9 Coding Guide for Valvular Heart Disease, 2014 ................................................................. 45

Table 10: Forecast Indirect National Costs For Aortic Valve Disease in the US ($bn), 2011–2020 ............... 76

Table 11: Forecast Indirect National Costs For Aortic Valve Disease in the EU ($bn), 2011–2020 ............... 76

Table 12: Minimum Arterial Diameter Required for TAVR Systems .............................................................. 80

Table 13: Global Projected Prevalence of Aortic Stenosis, 2013–2020 ........................................................ 92

Table 14: Current Access Routes for Transcatheter Aortic Valve Replacement ........................................... 94

Table 15: Mechanical Heart Valves, SWOT Analysis, 2014 ....................................................................... 101

Table 16: Marketed Mechanical Heart Valve Products, 2014 ..................................................................... 102

Table 17: Tissue Heart Valves, SWOT Analysis, 2014 .............................................................................. 104

Table 18: Marketed Tissue Heart Valve Products, 2014 ............................................................................ 105

Table 19: Transcatheter Heart Valves, SWOT Analysis, 2014 ................................................................... 106


Table of Contents


Table 20: Marketed Transcatheter Heart Valve Products, 2014 ................................................................. 107

Table 21: Product Profile — Carbomedics Standard Aortic Mechanical Valve (Sorin Group) ...................... 109

Table 22: Carbomedics Standard Aortic Mechanical Valve, SWOT Analysis, 2014 .................................... 110

Table 23: Product Profile — Open Pivot Mechanical Valve (Medtronic) ..................................................... 111

Table 24: Open Pivot Mechanical Valve, SWOT Analysis, 2014 ................................................................ 111

Table 25: Product Profile — On-X Mechanical Heart Valve (On-X Life Technologies) ................................ 112

Table 26: On-X Mechanical Heart Valve, SWOT Analysis, 2014 ................................................................ 113

Table 27: Product Profile — On-X Plus 1.5 Mechanical Heart Valve (On-X Life Technologies) .................. 113

Table 28: On-X Plus 1.5 Mechanical Heart Valve, SWOT Analysis, 2014 .................................................. 114

Table 29: Product Profile — Regent Valve (St. Jude Medical) ................................................................... 114

Table 30: Regent Valve, SWOT Analysis, 2014......................................................................................... 115

Table 31: Product Profile — Carpentier-Edwards Perimount Pericardial Valve (Edwards Lifesciences) ...... 116

Table 32: Carpentier-Edwards Perimount Pericardial Valve, SWOT Analysis, 2014 ................................... 116

Table 33: Product Profile — 3f Enable Sutureless Aortic Bioprosthesis (Medtronic) ................................... 117

Table 34: 3f Enable Sutureless Aortic Bioprosthesis, SWOT Analysis, 2014 .............................................. 117

Table 35: Product Profile — Hancock II (Medtronic) .................................................................................. 118

Table 36: Medtronic Hancock II, SWOT Analysis, 2014 ............................................................................. 118

Table 37: Product Profile — Mitroflow Aortic Pericardial Heart Valve (Sorin Group) ................................... 119

Table 38: Sorin Group Mitroflow Aortic Pericardial Heart Valve, SWOT Analysis, 2014.............................. 119

Table 39: Product Profile — Trifecta Heart Valve (St. Jude Medical).......................................................... 120

Table 40: St. Jude Medical Trifecta Heart Valve, SWOT Analysis, 2014 .................................................... 121

Table 41: Product Profile — Acurate TA/Acurate neo (Symetis) ................................................................ 121

Table 42: Acurate TA/Acurate neo, SWOT Analysis, 2014 ........................................................................ 122

Table 43: Product Profile — Lotus Valve System (Boston Scientific) ......................................................... 123


Table of Contents


Table 44: Boston Scientific Lotus Valve System, SWOT Analysis, 2014 .................................................... 124

Table 45: Product Profile — Direct Flow Medical Transcatheter Valve (Direct Flow Medical) ..................... 125

Table 46: Direct Flow Medical Valve, SWOT Analysis, 2014 ..................................................................... 125

Table 47: Product Profile — Sapien XT Valve (Edwards Lifesciences) ...................................................... 126

Table 48: Sapien XT Valve, SWOT Analysis, 2014.................................................................................... 127

Table 49: Product Profile — JenaValve (JenaValve Technology)............................................................... 128

Table 50: JenaValve, SWOT Analysis, 2014 ............................................................................................. 128

Table 51: Product Profile — CoreValve (Medtronic) .................................................................................. 129

Table 52: CoreValve, SWOT Analysis, 2014 ............................................................................................. 130

Table 53: Product Profile — CoreValve Evolut R (Medtronic) .................................................................... 131

Table 54: CoreValve Evolut R, SWOT Analysis, 2014 ............................................................................... 131

Table 55: Product Profile — Portico Valve (St. Jude Medical) .................................................................... 132

Table 56: Portico Valve, SWOT Analysis, 2014 ......................................................................................... 132

Table 57: Product Profile — Inovare Valve (Braile Biomédica)................................................................... 133

Table 58: Inovare Valve, SWOT Analysis, 2014 ........................................................................................ 134

Table 59: Product Profile — Cytograft Tissue Valve (Cytograft Tissue Engineering) .................................. 135

Table 60: Cytograft Tissue Valve, SWOT Analysis, 2014 .......................................................................... 136

Table 61: Product Profile — Centera Valve (Edwards Lifesciences Corporation) ....................................... 136

Table 62: Centera Valve, SWOT Analysis, 2014 ....................................................................................... 137

Table 63: Product Profile — Colibri Heart Valve (Colibri Heart Valve) ........................................................ 138

Table 64: Colibri Heart Valve, SWOT Analysis, 2014 ................................................................................ 138

Table 65: Product Profile — Cormove (Perouse Medical) .......................................................................... 139

Table 66: Cormove, SWOT Analysis, 2014 ............................................................................................... 139

Table 67: Product Profile — Endovalve (Micro Interventional Devices) ...................................................... 140


Table of Contents


Table 68: Endovalve, SWOT Analysis, 2014 ............................................................................................. 140

Table 69: Product Profile — HLT Transcatheter Valve System (Heart Leaflet Technology) ........................ 141

Table 70: HLT Transcatheter Valve System, SWOT Analysis, 2014 .......................................................... 141

Table 71: Product Profile — Kalangos Valve (Leman Cardiovascular) ....................................................... 142

Table 72: Kalangos Valve, SWOT Analysis, 2014 ..................................................................................... 142

Table 73: Product Profile — Tiara Valve (Neovasc.) .................................................................................. 142

Table 74: Tiara Valve, SWOT Analysis, 2014 ............................................................................................ 143

Table 75: Product Profile — Trinity Valve (Transcatheter Technologies GmbH) ......................................... 143

Table 76: Trinity VALVE, SWOT Analysis, 2014 ........................................................................................ 144

Table 77: Product Profile — Vanguard Exchangeable Heart Valve System (ValveXchange) ...................... 145

Table 78: Vanguard Exchangeable Heart Valve System, SWOT Analysis, 2014 ........................................ 145

Table 79: AorTech International plc, Company Profile, 2014 ..................................................................... 151

Table 80: AorTech International, SWOT Analysis, 2014 ............................................................................ 151

Table 81: Boston Scientific Corporation, Company Profile, 2014 ............................................................... 152

Table 82: Boston Scientific Corporation, SWOT Analysis, 2014 ................................................................. 153

Table 83: Braile Biomédica, Company Profile, 2014 .................................................................................. 154

Table 84: Braile Biomédica, SWOT Analysis, 2014 ................................................................................... 154

Table 85: CardiAQ Valve Technologies, Company Profile, 2014 ............................................................... 155

Table 86: CardiAQ Valve Technologies, SWOT Analysis, 2014 ................................................................. 155

Table 87: Claret Medical, Inc., Company Profile, 2014 .............................................................................. 156

Table 88: Claret Medical, SWOT Analysis, 2014 ....................................................................................... 156

Table 89: Colibri Heart Valve, LLC, Company Profile, 2014 ....................................................................... 157

Table 90: Colibri Heart Valve, SWOT Analysis, 2014 ................................................................................ 157

Table 91: Cytograft Tissue Engineering, Inc., Company Profile, 2014 ........................................................ 158


Table of Contents


Table 92: Cytograft Tissue Engineering, SWOT Analysis, 2014 ................................................................. 158

Table 93: Direct Flow Medical, Inc., Company Profile, 2014 ...................................................................... 159

Table 94: Direct Flow Medical, SWOT Analysis, 2014 ............................................................................... 159

Table 95: Edwards Lifesciences Corporation, Company Profile, 2014 ....................................................... 160

Table 96: Edwards Lifesciences, SWOT Analysis, 2014 ............................................................................ 161

Table 97: Heart Leaflet Technologies, Company Profile, 2014................................................................... 161

Table 98: Heart Leaflet Technologies, SWOT Analysis, 2014 .................................................................... 162

Table 99: JenaValve Technology, Company Profile, 2014 ......................................................................... 162

Table 100: JenaValve Technology, SWOT Analysis, 2014 .......................................................................... 163

Table 101: Leman Cardiovascular, Company Profile, 2014 ......................................................................... 163

Table 102: Leman Cardiovascular, SWOT Analysis, 2014 ........................................................................... 164

Table 103: Micro Interventional Devices, Inc., Company Profile, 2014 ......................................................... 164

Table 104: Micro Interventional Devices, SWOT Analysis, 2014 .................................................................. 165

Table 105: Neovasc, Inc., Company Profile, 2014 ....................................................................................... 165

Table 106: Neovasc, SWOT Analysis, 2014 ................................................................................................ 166

Table 107: On-X Life Technologies, Inc., Company Profile, 2014 ................................................................ 166

Table 108: On-X Life Technologies, SWOT Analysis, 2014 ......................................................................... 167

Table 109: Perouse Medical, Company Profile, 2014 .................................................................................. 167

Table 110: Perouse Medical, SWOT Analysis, 2014.................................................................................... 168

Table 111: Sorin Group, Company Profile, 2014 ......................................................................................... 168

Table 112: Sorin Group, SWOT Analysis, 2014 ........................................................................................... 169

Table 113: St. Jude Medical, Inc., Company Profile, 2014 ........................................................................... 170

Table 114: St. Jude Medical, Inc., SWOT Analysis, 2014 ............................................................................ 170

Table 115: Symetis, Company Profile, 2014 ................................................................................................ 171


Table of Contents


Table 116: Symetis, SWOT Analysis, 2014 ................................................................................................. 171

Table 117: Transcatheter Technologies GmbH, Company Profile, 2014 ...................................................... 172

Table 118: Transcatheter Technologies, SWOT Analysis, 2014 .................................................................. 172

Table 119: TTK Healthcare, Company Profile, 2014 .................................................................................... 173

Table 120: TTK Healthcare, SWOT Analysis, 2014 ..................................................................................... 173

Table 121: ValveXchange, Inc., Company Profile, 2014 .............................................................................. 174

Table 122: ValveXchange, SWOT Analysis, 2014 ....................................................................................... 175

Table 123: Global Market Value Forecast by Market Segment for Prosthetic Heart Valves, $m, 2011–2020 188

Table 124: 5EU Market Value Forecast by Market Segment for Prosthetic Heart Valves, $m, 2011–2020 ... 189

Table 125: APAC Market Value Forecast by Market Segment for Prosthetic Heart Valves, $m, 2011–2020 . 191

Table 126: US Market Value Forecast by Market Segment for Prosthetic Heart Valves, $m, 2011–2020 ..... 197

Table 127: France Market Value Forecast by Market Segment for Prosthetic Heart Valves, $m, 2011–2020200

Table 128: Germany Market Value Forecast by Market Segment for Prosthetic Heart Valves, $m, 2011–2020

................................................................................................................................................. 204

Table 129: Italy Market Value Forecast by Market Segment for Prosthetic Heart Valves, $m, 2011–2020 .... 208

Table 130: Spain Market Value Forecast by Market Segment for Prosthetic Heart Valves, $m, 2011–2020 . 212

Table 131: UK Market Value Forecast by Market Segment for Prosthetic Heart Valves, $m, 2011–2020 ..... 215

Table 132: Japan Market Value Forecast by Market Segment for Prosthetic Heart Valves, $m, 2011–2020. 219

Table 133: China Market Value Forecast by Market Segment for Prosthetic Heart Valves, $m, 2011–2020 . 223

Table 134: India Market Value Forecast by Market Segment for Prosthetic Heart Valves, $m, 2011–2020... 227

Table 135: Brazil Market Value Forecast by Market Segment for Prosthetic Heart Valves, $m, 2011–2020 . 231


Table of Contents


1.2 List of Figures

Figure 1: Hierarchy of Valvular Heart Disease ............................................................................................ 30

Figure 2: Operative Risk for Severe, Symptomatic Aortic Valve Disease Patients, 2009 ............................. 37

Figure 3: US Procedure Volume Forecast by Market Segment, 2011–2020 ................................................ 55

Figure 4: US Procedure Volume Comparison by Market Segment, 2013 & 2020 ........................................ 56

Figure 5: France Procedure Volume Forecast by Market Segment, 2011–2020 .......................................... 57

Figure 6: France Procedure Volume Comparison by Market Segment, 2013 & 2020 .................................. 58

Figure 7: Germany Procedure Volume Forecast by Market Segment, 2011–2020 ...................................... 59

Figure 8: Germany Procedure Volume Comparison by Market Segment, 2013 & 2020 ............................... 60

Figure 9: Italy Procedure Volume Forecast by Market Segment, 2011–2020 .............................................. 61

Figure 10: Italy Procedure Volume Comparison by Market Segment, 2013 & 2020 ....................................... 62

Figure 11: Spain Procedure Volume Forecast by Market Segment, 2011–2020 ............................................ 63

Figure 12: Spain Procedure Volume Comparison by Market Segment, 2013 & 2020 .................................... 64

Figure 13: UK Procedure Volume Forecast by Market Segment, 2011–2020 ................................................ 65

Figure 14: UK Procedure Volume Comparison by Market Segment, 2013 & 2020 ........................................ 66

Figure 15: Japan Procedure Volume Forecast by Market Segment, 2011–2020 ........................................... 67

Figure 16: Japan Procedure Volume Comparison by Market Segment, 2013 & 2020 .................................... 68

Figure 17: China Procedure Volume Forecast by Market Segment, 2011–2020 ............................................ 69

Figure 18: China Procedure Volume Comparison by Market Segment, 2013 & 2020 .................................... 70

Figure 19: India Procedure Volume Forecast by Market Segment, 2011–2020 ............................................. 71

Figure 20: India Procedure Volume Comparison by Market Segment, 2013 & 2020 ...................................... 72

Figure 21: Brazil Procedure Volume Forecast by Market Segment, 2011–2020 ............................................ 73

Figure 22: Brazil Procedure Volume Comparison by Market Segment, 2013 & 2020..................................... 74

Figure 23: Global Company Market Shares for Prosthetic Heart Valves, 2012 ............................................ 176


Table of Contents


Figure 24: EU Company Market Share for Prosthetic Heart Valves, 2012 ................................................... 178

Figure 25: APAC Company Market Shares for Prosthetic Heart Valves, 2012............................................. 179

Figure 26: US Company Market Shares for Prosthetic Heart Valves, 2012 ................................................. 180

Figure 27: France Company Market Shares for Prosthetic Heart Valves, 2012 ........................................... 180

Figure 28: Germany Company Market Shares for Prosthetic Heart Valves, 2012 ........................................ 181

Figure 29: Italy Company Market Shares for Prosthetic Heart Valves, 2012 ................................................ 182

Figure 30: Spain Company Market Shares for Prosthetic Heart Valves, 2012 ............................................. 182

Figure 31: UK Company Market Shares for Prosthetic Heart Valves, 2012 ................................................. 183

Figure 32: Japan Company Market Shares for Prosthetic Heart Valves, 2012............................................. 184

Figure 33: China Company Market Shares for Prosthetic Heart Valves, 2012 ............................................. 184

Figure 34: India Company Market Shares for Prosthetic Heart Valves, 2012 .............................................. 185

Figure 35: Brazil Company Market Shares for Prosthetic Heart Valves, 2012 ............................................. 186

Figure 36: Global Market Value Forecast by Market Segment for Prosthetic Heart Valves, $m, 2011–2020 187

Figure 37: 5EU Market Value Forecast by Market Segment for Prosthetic Heart Valves, 2011–2020 .......... 189

Figure 38: APAC Market Value Forecast by Market Segment for Prosthetic Heart Valves, 2011–2020 ....... 190

Figure 39: Global Sales Volume for Prosthetic Heart Valves, Number of Units, 2011–2020 ........................ 192

Figure 40: Global Market Value Forecast by Country, $m, 2011–2020........................................................ 193

Figure 41: Global Market Share Comparison by Country, 2013 & 2020 ...................................................... 195

Figure 42: US Market Value Forecast by Market Segment, $m, 2011–2020 ............................................... 196

Figure 43: US Market Value Comparison by Market Segment, 2013 & 2020 ............................................... 198

Figure 44: US Average Selling Price by Market Segment, 2011–2020 ........................................................ 199

Figure 45: France Market Value Forecast by Market Segment, $m, 2011–2020 ......................................... 200

Figure 46: France Market Value Comparison by Market Segment, 2013 & 2020 ......................................... 202

Figure 47: France Average Selling Price by Market Segment, 2011–2020 .................................................. 203


Table of Contents


Figure 48: Germany Market Value Forecast by Market Segment, $m, 2011–2020 ...................................... 204

Figure 49: Germany Market Value Comparison by Market Segment, 2013 & 2020 ..................................... 206

Figure 50: Germany Average Selling Price by Market Segment, 2011–2020............................................... 207

Figure 51: Italy Market Value Forecast by Market Segment, $m, 2011–2020 .............................................. 208

Figure 52: Italy Market Value Comparison by Market Segment, 2013 & 2020 ............................................. 209

Figure 53: Italy Average Selling Price by Market Segment, 2011–2020 ...................................................... 210

Figure 54: Spain Market Value Forecast by Market Segment, $m, 2011–2020 ........................................... 211

Figure 55: Spain Market Value Comparison by Market Segment, 2013 & 2020 ........................................... 213

Figure 56: Spain Average Selling Price by Market Segment, 2011–2020 .................................................... 214

Figure 57: UK Market Value Forecast by Market Segment, $m, 2011–2020 ............................................... 215

Figure 58: UK Market Value Comparison By Market Segment, 2013 & 2020 .............................................. 217

Figure 59: UK Average Selling Price by Market Segment, 2011–2020 ........................................................ 218

Figure 60: Japan Market Value Forecast by Market Segment, $m, 2011–2020 ........................................... 219

Figure 61: Japan Market Value Comparison by Market Segment, 2013 & 2020 .......................................... 221

Figure 62: Japan Average Selling Price by Market Segment, 2011–2020 ................................................... 222

Figure 63: China Market Value Forecast by Market Segment, $m, 2011–2020 ........................................... 223

Figure 64: China Market Value Comparison by Market Segment, 2013 & 2020 .......................................... 225

Figure 65: China Average Selling Price by Market Segment, 2011–2020 .................................................... 226

Figure 66: India Market Value Forecast by Market Segment, $m, 2011–2020 ............................................. 227

Figure 67: India Market Value Comparison by Market Segment, 2013 & 2020 ............................................ 229

Figure 68: India Average Selling Price by Market Segment, 2011–2020 ..................................................... 230

Figure 69: Brazil Market Value Forecast by Market Segment, $m, 2011–2020............................................ 231

Figure 70: Brazil Market Value Comparison by Market Segment, 2013 & 2020 ........................................... 232

Figure 71: Brazil Average Selling Price by Market Segment, 2011–2020 .................................................... 233



Introduction

2 Introduction

2.1 Anatomy

Healthy heart valves ensure that blood flows in the proper direction at the appropriate time and with

the appropriate pressure. The contraction and relaxation of the heart generates pressure

differences that cause the valves to open and shut, allowing blood to fill the atria and ventricles at

alternating times. The four valves in the heart are the aortic, mitral, pulmonic, and tricuspid valves.

Note that the aortic, pulmonic and tricuspid valves consist of three leaflets each, while the mitral, or

bicuspid, valve consists of two leaflets, anterior and posterior.

2.2 Epidemiology

Valvular heart disease (VHD) is characterized by damage to one of the four valves. The most

commonly affected valves are the aortic valve, which controls blood flow between the aorta and the

rest of the body, and the mitral valve, which controls blood flow between the atria and ventricles.

Depending on the severity of damage, VHD can result in congestive heart failure (CHF) or other

serious complications.

VHD can be treated via implantation of a prosthetic heart valve that mimics the function of a human

heart valve, thus improving hemodynamics. These prostheses have a passive mode of functioning

in that they open and close in response to pressure and flow changes within the heart. For the

purposes of this report, the aortic and mitral valves are of primary concern because they are most

commonly affected by this disorder.

Valve replacement, whether surgical or via transcatheter methods, has been shown to improve

both patient morbidity and mortality outcomes. These days, surgeons utilize both open-heart as

well as percutaneous valve replacement devices. However, while both the aortic and mitral valves

are commonly replaced using open-heart techniques, transcatheter technology has thus far

focused on the aortic valve; there are no transcatheter mitral valve replacement products on the

market to date.

While the transcatheter mitral market segment is slowly growing, the majority of heart valve

prosthesis global revenue is generated by three categories of devices: mechanical heart valves

and tissue heart valves, which are both designed for open-heart replacement of the mitral or aortic

valve, and transcatheter aortic valve replacement (TAVR). Mechanical valves are typically made

Valve replacement, whether surgical or via transcatheter methods, has been shown to improve both patient morbidity and mortality outcomes.



Introduction

from non-biological materials such as metals, while tissue valves originate from animals such as

pigs. The implantation of both mechanical valves and bioprosthetic valves requires surgery, while

TAVR is breaking new ground as a minimally invasive technique that improves patient comfort and

recovery time.

2.3 Related Reports

GlobalData (2014). Coronary Stents – Global Market Analysis and Forecasts, December 2014,

GDME1119CFR

GlobalData (2013). Drug Eluting Balloons – Global Market Analysis and Forecasts, September

2013, GDME0179MAR

GlobalData (2013). Cardiac Assist Devices – Global Market Analysis and Forecasts, March

2013, GDME0175MAR

GlobalData (2012). Bioabsorbable Stents – Global Market Analysis and Forecasts, December

2012, GDME0164MAR


Appendix


14.7 About GlobalData

GlobalData is a leading global provider of business intelligence in the Healthcare industry.

GlobalData provides its clients with up-to-date information and analysis on the latest developments

in drug research, disease analysis, and clinical research and development. Our integrated business

intelligence solutions include a range of interactive online databases, analytical tools, reports and

forecasts. Our analysis is supported by a 24/7 client support and analyst team.

GlobalData has offices in New York, San Francisco, Boston, London, India, Korea, Japan,

Singapore, and Australia.

14.8 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any

form by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior

permission of the publisher, GlobalData.

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