Transcatheter Aortic Valve Replacement Analysis and Market Forecast - European Markets GDME1002CFR / Published November 2012
Executive Summary
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Transcatheter Aortic Valve Replacement: Key Metrics in EU5 Device Markets
Diseased population 2.02 million
Severe, Symptomatic Population 0.28 million
High Risk or Inoperable Population 0.18 million
2011 Market Sales
EU5 $459.8m
Pipeline Assessment
Number of preclinical devices 7
Number of early clinical devices 4
Number of late clinical devices 3
Pericardium Tissue Valves 87%
Synthetic Polymer Valves 13%
Key events (2011-2018) Level of Impact
CE Mark approval of Portico valve in 2012 ↑↑
CE Mark approval of Direct Flow valve in 2013 ↑↑
CE Mark approval of Sadra Lotus valve in 2013 ↑↑
CE Mark approval of Engager valve in 2014 ↑↑
CE Mark approval of Acurate TF valve in 2013 ↑
CE Mark approval of AorTech valve in 2015 ↑↑
CE Mark approval of Centera valve in 2014 ↑↑
CE Mark approval of Colibri valve in 2014 ↑↑
CE Mark approval of Vanguard valve in 2014 ↑↑↑
CE Mark approval of Trinity valve in 2015 ↑↑
CE Mark approval of Innovare valve in 2014 ↑↑
2018 Market Sales
EU5 $1,510.0m
Source: GlobalData
Transcatheter Aortic Valve Market is forecast to Witness Significant Growth Through 2018
The Transcatheter Aortic Valve Replacement (TAVR)
market is forecast to have significant growth during the
forecast period. GlobalData estimates the EU5 market in
2011 was $459.8m, and it is expected to grow at a CAGR
of 18.5% to reach $1,510.0m by 2018.
The key drivers for the market in the forecast period are:
CE Mark approval of the Portico valve in 2012
CE Mark approval of the Direct Flow valve in 2013
CE Mark approval of the Sadra Lotus valve in 2013
CE Mark approval of the Engager valve in 2014
CE Mark approval of the Acurate TF valve in 2013
CE Mark approval of the AorTech valve in 2015
CE Mark approval of the Centera valve in 2014
CE Mark approval of the Colibri valve in 2014
CE Mark approval of the Vanguard valve in 2014
CE Mark approval of the Trinity valve in 2015
CE Mark approval of Innovare valve in 2014
The major barriers for the TAVR market are:
Lacking and incomplete reimbursement for TAVR
procedures
Slow adoption of TAVR as heart centers are trained
in the procedure
High cost of current devices compared to surgically
implanted valve prosthetics
Executive Summary
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TAVR European Revenue
18%
54%
15%
6%8% France
Germany
Italy
Spain
UK
21%
38%
22%
8%12% France
Germany
Italy
Spain
UK
2011Total: $460m
2018Total: $1,510m
Source: GlobalData
Companies Working to Get Their Devices Approved in the TAVR Market
The TAVR market has been developing quickly as a
result of the Europe’s rapid adoption of the procedure.
Ever since the first TAVR devices received CE Mark in
Europe in 2007, additional companies have been working
to enter the market as well. TAVR device technology has
already entered the next stage of development, with
many second-generation prosthetics approved in Europe
and others due to launch in Europe in the near future. In
parallel development with device designs, companies are
looking to further improve their delivery systems as well.
Germany is leading the way with TAVR procedures,
having completed over 8,000 of them during 2011. Other
European countries are not far behind their German
neighbors in the use of TAVR. Many countries in Europe
have established reimbursement codes for the
procedure, which has increased rates of adoption.
GlobalData expects that most major heart centers will
offer the procedure in coming years.
As TAVR devices enter clinical trials in Japan,
GlobalData expects rapid Japanese adoption of the
technology upon its expected approval in 2014. Heart
centers in Singapore have already started using TAVR
devices, and Southeast Asia is expected to approve
TAVR in the coming few years as well, which will trigger
enormous sales growth in the region. In South America,
one TAVR company has already received approval to
launch their product, and adoption in the region is
expected to increase as well, although at a slower rate
than the US, EU or Japan.
Significant Unmet Needs in TAVR Market
Use of TAVR in high-risk and inoperable patients has
proven effective in treating aortic valve disease; however,
there is still much room for improvement. Paravalvular
regurgitation and a high incidence of stroke have plagued
first-generation devices, and emerging products aim to
reduce these side effects while also reducing the cost of
the device. Additionally, physicians have called for other
device improvements, most notably repositionability and
reduced delivery sheath sizes. Improvements to the
device design will help TAVR be approved for moderate
and low surgical risk patients by improving patient
outcomes, reducing device cost, and making TAVR
superior to surgical valve replacement.
Executive Summary
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TAVR Market by Company, 2011
61%
35%
2%2%
2011 Total: $488m
Edwards Lifesciences
Medtronic
JenaValve
Symetis
Source: GlobalData
Remaining Opportunities for New Entrants
Significant market opportunities still exist for novel TAVR
devices in terms of superior efficacy, improved ease of
use, lower adverse effects, and cost. There have been
numerous design adaptations across the TAVR industry
as companies look to differentiate their product from the
competition. Compared to the first TAVR products
approved, many second-generation devices are smaller
in profile size as well as repositionable. Looking ahead,
others including Direct Flow Medical and AorTech
International are working to develop devices with
prosthetic valve leaflets made of synthetic polymers in an
attempt to improve durability and reduce the device cost.
Also working towards improved durability, ValveXchange
has developed a TAVR system with exchangeable
leaflets that can be replaced as they wear out. In an
attempt to reduce regurgitation, Boston Scientific and
Symetis are both developing valves that utilize sealing
membrane skirts to increase prosthetic conformance to
the native valve annulus and reduce paravalvular
regurgitation.
Most device improvements have been related to accurate
positioning of the prosthetic, secure anchoring, improved
durability, ease of deployment and cost. As more
companies enter the market, these points of difference
between various TAVR products are likely to drive sales.
Leading TAVR Companies and Future Landscape
Currently, the TAVR market is dominated by two key
players, both of which have had multiple device iterations
and both of which are developing additional TAVR
products for the market. In 2011, Edwards Lifesciences
controlled roughly 61% of the global TAVR market,
followed by Medtronic who had 35%. As other
competitors’ devices enter the market, it is expected that
Edwards and Medtronic will continue to see sales growth
but will see a decrease in their market share.
As of now, both JenaValve and Symetis have approved
devices in Europe, and Braile Biomedica in Brazil, with
other companies due for approval in the near term;
however, Edwards is the only company with a device
currently approved in the US. As new opportunities
develop in Asia and South America, GlobalData believes
the TAVR market will continue to grow rapidly in the near
term. Additionally, several medical device giants have still
not developed their own TAVR technologies, and so
GlobalData expects significant merger and acquisition
activity within the TAVR market.
New players entering the market will combat initial
challenges with physician adoption as a result of the
retraining necessary for new TAVR devices; each
prosthetic behaves differently. The market is still very
young, though, and there is great potential for new
entrants with superior efficacy, lower costs, or both.
Executive Summary
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Assessment of TAVR Device Features
Most Desirable Features of
TAVR Devices
Repositionability
High durability and long device lifetime
Proven safety of device
Features Most Satisfied With
(Met Needs)
Non-thrombogenic
Dynamic responsiveness
Valve-tissue interaction
Features Least Satisfied With
(Unmet Needs)
Cost of device
Retrievability of device
Self-repairing ability of device
Source: GlobalData
What do Physicians Think?
Physicians feel strongly that TAVR adoption will be
strong in coming years.
“I think that most patients are probably going to go for transcatheter valves once the newer technology is available…TAVR is going to explode. It’s going to be THE valve platform in ten years, I mean, nobody’s going to be doing open valve anymore.”
Key Opinion Leader, October 2012
While adoption of TAVR in the US has been slower
than in Europe, many believe the approval of second
generation devices will boost sales.
“Once the FDA approves the smaller devices, you will see a big increase in the number of implants in the US and also the number of approaches.”
Key Opinion Leader, October 2012
From a patient standpoint, the procedure and
recovery time for TAVR is much less compared with
conventional surgical valve replacement.
“Transcatheter procedures take two hours instead of the usual four or five hours [with surgical implantation]…we’re shifting, and more patients that were otherwise operated on will in the future be treated with transcatheter heart valves.”
Key Opinion Leader, October 2012
While TAVR is currently only approved for high-risk
and inoperable patients, it is likely that moderate and
low-risk patients will be candidates for TAVR in the
future.
“We already, more or less, are convinced that lower risk patients may benefit from a transcatheter heart valve. So, we’re already shifting to these lower risk patients.”
Key Opinion Leader, October 2012
But before TAVR is approved for lower risk patients,
many are calling for further improvement.
“Limitations have to be addressed before offering TAVR to lower risk patients...so maybe in a short time, maybe five years, the surgical-risk requirement for TAVR will go down.”
Key Opinion Leader, November 2012
While physicians are calling for numerous device
improvements, two attributes are of particular
importance.
“The two most important things will be the development of more predictable devices with fewer complications, and the price of the valves going down. If these two things happen, the numbers will further increase.”
Key Opinion Leader, November 2012
Table of Contents
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1 Table of Contents 1 Table of Contents ............................................................................................................... 6
1.1 List of Tables .............................................................................................................. 13
1.2 List of Figures ............................................................................................................. 17
2 Introduction ....................................................................................................................... 18
2.1 Catalyst....................................................................................................................... 18
3 Disease Overview ............................................................................................................. 19
3.1 Anatomy & Physiology ................................................................................................ 19
3.1.1 Heart Valves ....................................................................................................... 19
3.2 Pathophysiology.......................................................................................................... 21
3.2.1 Heart Valve Disorders ......................................................................................... 21
3.2.2 Etiology of AVD ................................................................................................... 22
3.2.3 Acquired Disorders.............................................................................................. 22
3.2.4 Congenital Defects .............................................................................................. 24
3.2.5 Other Disorders................................................................................................... 25
3.3 Clinical Presentation ................................................................................................... 25
3.3.1 Symptoms ........................................................................................................... 25
3.3.2 Diagnosis ............................................................................................................ 26
3.4 Clinical Outcomes ....................................................................................................... 30
3.4.1 Treatment Modalities ........................................................................................... 31
3.4.2 Medication .......................................................................................................... 32
3.4.3 Heart Valve Repair .............................................................................................. 33
3.4.4 Surgical/Intervention Strategies ........................................................................... 34
3.4.5 Surgical Heart Valve Replacement ...................................................................... 35
3.4.6 Transcatheter Heart Valve Replacement ............................................................. 36
3.4.7 Associated Mortality ............................................................................................ 39
3.5 Epidemiology .............................................................................................................. 40
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3.5.1 Prevalence .......................................................................................................... 40
3.5.2 Treatment and Mortality ...................................................................................... 43
3.6 Economic Impact ........................................................................................................ 44
3.6.1 Individual Costs................................................................................................... 44
3.6.2 Industry Costs ..................................................................................................... 46
4 Competitive Assessment ................................................................................................... 47
4.1 Overview..................................................................................................................... 47
4.1.1 Initial Devices ...................................................................................................... 48
4.1.2 Current Devices .................................................................................................. 48
4.1.3 Competitive Assessment ..................................................................................... 49
4.2 EU5 Marketed Products Profiles .................................................................................. 50
4.2.1 Sapien valve (Edwards Lifesciences) .................................................................. 50
4.2.2 Sapien XT valve (Edwards Lifesciences) ............................................................. 52
4.2.3 CoreValve (Medtronic, Inc.) ................................................................................. 55
4.2.4 Sapien vs. CoreValve .......................................................................................... 58
4.2.5 Acurate TA Valve (Symetis) ................................................................................ 59
4.2.6 JenaValve (JenaValve) ....................................................................................... 61
4.2.7 Portico valve (St. Jude Medical, Inc.) ................................................................... 62
5 Unmet Needs.................................................................................................................... 64
5.1 Delivery & Implantation ............................................................................................... 65
5.1.1 Repositionable .................................................................................................... 65
5.1.2 Low Profile .......................................................................................................... 65
5.1.3 Accurate Anatomic Positioning ............................................................................ 66
5.1.4 Expansion Mechanism ........................................................................................ 67
5.1.5 Rapid Pacing ...................................................................................................... 67
5.1.6 Motorized Delivery Systems ................................................................................ 67
5.1.7 Coronary Ostia Impairment ................................................................................. 68
5.2 Conformance .............................................................................................................. 68
5.2.1 Regurgitation ...................................................................................................... 68
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5.2.2 Sizing .................................................................................................................. 69
5.2.3 Effective Orifice Area .......................................................................................... 69
5.2.4 Removal of Native Valve Leaflets ........................................................................ 70
5.3 Lifetime ....................................................................................................................... 70
5.3.1 Durability............................................................................................................. 70
5.3.2 Retrievability ....................................................................................................... 71
5.3.3 Pacemaker Placement (heart block) .................................................................... 71
5.3.4 Replaceable Leaflets ........................................................................................... 71
5.4 Materials ..................................................................................................................... 73
5.4.1 Alternative Surfaces ............................................................................................ 73
5.4.2 Endothelialization ................................................................................................ 73
5.4.3 Regenerative Medicine........................................................................................ 74
5.4.4 Tailored Treatment .............................................................................................. 74
5.5 Pre-Crimped Packaging .............................................................................................. 74
5.6 Embolic Protection ...................................................................................................... 74
5.7 Robotic Assistance...................................................................................................... 75
5.8 Hemodynamic Performance ........................................................................................ 75
6 Pipeline Products .............................................................................................................. 77
6.1 Overview..................................................................................................................... 77
6.2 Pipeline by Phases in Development ............................................................................ 78
6.3 Pipeline Products Profiles ........................................................................................... 80
6.3.1 Acurate TF valve (Symetis) ................................................................................. 80
6.3.2 AorTech valve (AorTech International) ................................................................ 81
6.3.3 AorTx valve (Hansen Medical)............................................................................. 83
6.3.4 Centera valve (Edwards Lifesciences) ................................................................. 84
6.3.5 Colibri valve (Colibri Heart Valve) ........................................................................ 85
6.3.6 Cormove (Perouse Medical) ................................................................................ 86
6.3.7 Direct Flow valve (Direct Flow Medical) ............................................................... 87
6.3.8 Engager valve (Medtronic, Inc.) ........................................................................... 90
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6.3.9 Heart Leaflet Technology (Bracco SpA) ............................................................... 91
6.3.10 Innovare valve (Braile Biomedica) ....................................................................... 92
6.3.11 Sadra Lotus valve (Boston Scientific) .................................................................. 94
6.3.12 Sapien 3 (Edwards Lifesciences) ........................................................................ 95
6.3.13 Trinity valve (Transcatheter Technologies GmbH) ............................................... 96
6.3.14 Vanguard Exchangeable Heart Valve System (ValveXchange) ............................ 98
6.4 Clinical Trial Analysis .................................................................................................. 99
6.4.1 Overview............................................................................................................. 99
6.4.2 Trials to Watch .................................................................................................. 100
6.4.3 Summary .......................................................................................................... 102
7 Industry Overview ........................................................................................................... 103
7.1 Procedure Trends ..................................................................................................... 103
7.1.1 EU Austerity ...................................................................................................... 103
7.1.2 Reimbursement Hinders Adoption ..................................................................... 104
7.2 Market Access .......................................................................................................... 105
7.2.1 Adoption of TAVR ............................................................................................. 105
7.2.2 Heart Teams for Specialized Care ..................................................................... 107
7.2.3 Facilities Enabling TAVR ................................................................................... 108
7.2.4 Training and Protocols for Care ......................................................................... 109
7.3 Reimbursement Trends ............................................................................................. 110
7.4 Regulatory Issues/Recalls ......................................................................................... 111
7.5 Mergers & Acquisitions/Key Partnerships .................................................................. 111
8 Current and Future Players ............................................................................................. 113
8.1 Overview................................................................................................................... 113
8.2 Trends in Corporate Strategy .................................................................................... 113
8.3 Company Profiles ...................................................................................................... 114
8.3.1 AorTech International plc .................................................................................. 114
8.3.2 Boston Scientific ............................................................................................... 116
8.3.3 Bracco SpA ....................................................................................................... 117
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8.3.4 Braile Biomedica ............................................................................................... 118
8.3.5 Colibri Heart Valve, LLC .................................................................................... 120
8.3.6 Direct Flow Medical ........................................................................................... 121
8.3.7 Edwards Lifesciences, Inc. ................................................................................ 123
8.3.8 Hansen Medical ................................................................................................ 124
8.3.9 JenaValve Technology ...................................................................................... 125
8.3.10 Medtronic, Inc. .................................................................................................. 126
8.3.11 Perouse Medical ............................................................................................... 127
8.3.12 St. Jude Medical ............................................................................................... 128
8.3.13 Symetis ............................................................................................................. 131
8.3.14 Transcatheter Technologies GmbH ................................................................... 132
8.3.15 ValveXchange ................................................................................................... 133
9 Market Drivers, Opportunities and Barriers ...................................................................... 135
9.1 Market Drivers .......................................................................................................... 135
9.1.1 Superior to Conventional Treatment .................................................................. 135
9.1.2 New Alternative for Patients with No Options ..................................................... 136
9.1.3 Expected Launch of CE Mark Devices............................................................... 136
9.1.4 Expanded Approval in US and EU ..................................................................... 136
9.1.5 Supportive Imaging ........................................................................................... 137
9.2 Opportunities ............................................................................................................ 138
9.2.1 Repositionability ................................................................................................ 138
9.2.2 Miniaturization of Valve Systems ....................................................................... 138
9.2.3 Single Operator Devices ................................................................................... 139
9.2.4 Lower Cost ....................................................................................................... 139
9.2.5 Dilation Scoring Balloon .................................................................................... 139
9.2.6 Removal of Native Valve Leaflets ...................................................................... 140
9.2.7 Temporary Aortic Valves ................................................................................... 140
9.3 Market Barriers ......................................................................................................... 141
9.3.1 Reimbursement................................................................................................. 141
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9.3.2 Slow Adoption ................................................................................................... 141
9.3.3 Cost .................................................................................................................. 141
9.3.4 Substitutes ........................................................................................................ 142
10 Country Outlooks & Forecasts ........................................................................................ 143
10.1 European Market Overview ...................................................................................... 144
10.2 France ..................................................................................................................... 147
10.2.1 France Market Analysis ..................................................................................... 147
10.3 Germany .................................................................................................................. 148
10.3.1 Germany Market Analysis ................................................................................. 148
10.4 Italy ......................................................................................................................... 150
10.4.1 Italy Market Analysis ......................................................................................... 150
10.5 Spain ....................................................................................................................... 151
10.5.1 Spain Analysis .................................................................................................. 151
10.6 United Kingdom ....................................................................................................... 152
10.6.1 United Kingdom Market Analysis ....................................................................... 152
11 Appendix ........................................................................................................................ 153
11.1 Abbreviations ........................................................................................................... 153
11.2 Bibliography ............................................................................................................. 155
11.3 Methodology ............................................................................................................ 159
11.4 Coverage ................................................................................................................. 159
11.5 Secondary Research ................................................................................................ 160
11.6 Forecasting Methodology ......................................................................................... 160
11.6.1 Diagnosed Aortic Valve Disease (AVD) Patients................................................ 161
11.6.2 Percent Transcatheter Aortic Valve Replacement Patients ................................ 161
11.6.3 Pricing Assumptions .......................................................................................... 161
11.6.4 Prevalence in Surgical Risk Segments .............................................................. 161
11.6.5 Cost of Aortic Valve Disease ............................................................................. 161
11.7 Physicians and Specialists Included in this Study ..................................................... 162
11.8 Primary Research .................................................................................................... 162
Table of Contents
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11.9 Physician Survey ...................................................................................................... 163
11.10 About the Authors ............................................................................................. 164
11.10.1 Analysts ............................................................................................................ 164
11.10.2 Global Head of Healthcare ................................................................................ 165
11.11 Definitions ......................................................................................................... 166
11.12 About GlobalData .............................................................................................. 167
11.13 Contact Us ........................................................................................................ 167
11.14 Disclaimer ......................................................................................................... 167
Table of Contents
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1.1 List of Tables
Table 1: Etiology of Single Left-Side Valve Disease .............................................................. 22
Table 2: Initial Presenting Symptoms of Aortic Valve Disease ............................................... 25
Table 3: Basic Frequency of Examination ............................................................................. 27
Table 4: Modifiers of Examination Frequency ....................................................................... 28
Table 5: Cardiovascular Risk Factors and Comorbidities ...................................................... 28
Table 6: Investigations Performed to Diagnose AVD ............................................................. 29
Table 7: Basic Principles for Management of AVD Patients................................................... 30
Table 8: Aortic Valve Disease National Indirect and Direct Costs ($bn), 2009-2018............... 46
Table 9: TAVR Product Approvals by Date ........................................................................... 48
Table 10: Assessment of TAVR Device Features.................................................................... 49
Table 11: Product Profile - Sapien .......................................................................................... 50
Table 12: Sapien SWOT Analysis, 2012 ................................................................................. 52
Table 13: Product Profile - Sapien XT ..................................................................................... 53
Table 14: Sapien XT SWOT Analysis, 2012 ............................................................................ 55
Table 15: Product Profile - CoreValve ..................................................................................... 55
Table 16: CoreValve SWOT Analysis, 2012 ............................................................................ 57
Table 17: Product Profile - Acurate TA.................................................................................... 59
Table 18: Acurate TA SWOT Analysis, 2012........................................................................... 60
Table 19: Product Profile - JenaValve ..................................................................................... 61
Table 20: JenaValve SWOT Analysis, 2012 ............................................................................ 62
Table 21: Product Profile - Portico .......................................................................................... 62
Table 22: Portico SWOT Analysis, 2012 ................................................................................. 63
Table 23: TAVR Global Product Pipeline, 2012 ....................................................................... 79
Table 24: Product Profile - Acurate TF .................................................................................... 80
Table 25: Acurate TF SWOT Analysis, 2012 ........................................................................... 81
Table 26: Product Profile - AorTech ........................................................................................ 81
Table 27: AorTech SWOT Analysis, 2012 ............................................................................... 82
Table 28: Product Profile - AorTx ............................................................................................ 83
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Table 29: AorTx SWOT Analysis, 2012 ................................................................................... 84
Table 30: Product Profile - Centera ......................................................................................... 84
Table 31: Centera SWOT Analysis, 2012................................................................................ 85
Table 32: Product Profile - Colibri ........................................................................................... 85
Table 33: Colibri SWOT Analysis, 2012 .................................................................................. 86
Table 34: Product Profile - Cormove ....................................................................................... 86
Table 35: Cormove SWOT Analysis, 2012 .............................................................................. 87
Table 36: Product Profile - Direct Flow.................................................................................... 88
Table 37: Direct Flow SWOT Analysis, 2012........................................................................... 89
Table 38: Product Profile - Engager ........................................................................................ 90
Table 39: Engager SWOT Analysis, 2012 ............................................................................... 91
Table 40: Product Profile - Heart Leaflet Technology .............................................................. 91
Table 41: Heart Leaflet Technology SWOT Analysis, 2012 ..................................................... 92
Table 42: Product Profile - Innovare ....................................................................................... 92
Table 43: Innovare SWOT Analysis, 2012 .............................................................................. 93
Table 44: Product Profile - Sadra Lotus .................................................................................. 94
Table 45: Sadra Lotus SWOT Analysis, 2012 ......................................................................... 95
Table 46: Product Profile - Sapien 3 ....................................................................................... 95
Table 47: Sapien 3 SWOT Analysis, 2012 .............................................................................. 96
Table 48: Product Profile - Trinity ........................................................................................... 96
Table 49: Trinity SWOT Analysis, 2012 .................................................................................. 97
Table 50: Product Profile - Vanguard ...................................................................................... 98
Table 51: Vanguard SWOT Analysis, 2012 ............................................................................. 99
Table 52: Company Profile - AorTech International plc ......................................................... 115
Table 53: AorTech International SWOT Analysis, 2012 ......................................................... 115
Table 54: Company Profile - Boston Scientific ...................................................................... 116
Table 55: Boston Scientific SWOT Analysis, 2012 ................................................................ 117
Table 56: Company Profile - Bracco SpA .............................................................................. 117
Table 57: Bracco SpA SWOT Analysis, 2012........................................................................ 118
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Table 58: Company Profile - Braile Biomedica ...................................................................... 119
Table 59: Braile Biomedica SWOT Analysis, 2012 ................................................................ 119
Table 60: Company Profile - Colibri Heart Valve ................................................................... 120
Table 61: Colibri Heart Valve SWOT Analysis....................................................................... 121
Table 62: Company Profile - Direct Flow Medical .................................................................. 121
Table 63: Direct Flow Medical SWOT Analysis, 2012............................................................ 122
Table 64: Company Profile - Edwards Lifesciences .............................................................. 123
Table 65: Edwards Lifesciences SWOT Analysis, 2012 ........................................................ 124
Table 66: Company Profile - Hansen Medical ....................................................................... 124
Table 67: Hansen Medical SWOT Analysis, 2012 ................................................................. 125
Table 68: Company Profile - JenaValve Technology ............................................................. 125
Table 69: JenaValve Technology SWOT Analysis, 2012 ....................................................... 126
Table 70: Company Profile - Medtronic ................................................................................. 126
Table 71: Medtronic SWOT Analysis, 2012 ........................................................................... 127
Table 72: Company Profile - Perouse Medical ...................................................................... 128
Table 73: Perouse Medical SWOT Analysis, 2012 ................................................................ 128
Table 74: Company Profile - St. Jude Medical ...................................................................... 129
Table 75: St. Jude Medical SWOT Analysis, 2012 ................................................................ 130
Table 76: Company Profile - Symetis .................................................................................... 131
Table 77: Symetis SWOT Analysis, 2012.............................................................................. 131
Table 78: Company Profile - Transcatheter Technologies ..................................................... 132
Table 79: Transcatheter Technologies SWOT Analysis, 2012 ............................................... 132
Table 80: Company Profile - ValveXchange .......................................................................... 133
Table 81: ValveXchange SWOT Analysis, 2012 ................................................................... 134
Table 82: Major Events Affecting the Global TAVR Market ................................................... 145
Table 83: Sales Forecasts for TAVR in the EU5 Markets, 2009-2018 .................................... 146
Table 84: Sales Forecasts for TAVR in France, 2011-2018 ................................................... 147
Table 85: Sales Forecasts for TAVR in Germany, 2011-2018 ............................................... 148
Table 86: Sales Forecasts for TAVR in Italy, 2011-2018 ....................................................... 150
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Table 87: Sales Forecasts for TAVR in Spain, 2011-2018 ..................................................... 151
Table 88: Sales Forecasts for TAVR in the UK, 2011-2018 ................................................... 152
Table 89: Physicians Surveyed, By Country ......................................................................... 163
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1.2 List of Figures
Figure 1: Diagram of Human Heart ........................................................................................ 20
Figure 2: Strategy for Evaluating Heart Murmurs.................................................................... 26
Figure 3: General Treatment Modalities for Aortic Valve Disease ........................................... 31
Figure 4: Transcatheter Access Approaches by Frequency of Use, Europe 2011 ................... 37
Figure 5: Surgical Risk of Symptomatic, Severe AVD Patients, 2011 ..................................... 41
Figure 6: Prevalence of Moderate or Severe Valve Disease in EU Population 2011 ............... 41
Figure 7: Prevalence of AVD in Patients 65+ ......................................................................... 42
Figure 8: Compound Annual Growth Rate of AVD 2011 ......................................................... 42
Figure 9: Breakdown of Severe AVD Patients Receiving Surgical Valve Replacement &
Transcatheter Valve Replacement .......................................................................... 44
Figure 10:Total Costs at One Year for TAVR and SAVR as Calculated in 2011 in Europe ...... 45
Figure 11:Companies in TAVR Market with Approved Devices ............................................... 47
Figure 12:TAVR Device Attributes by Current Satisfaction and Importance, 2011 ................... 78
Figure 13:TAVR Pipeline by Stage in Clinical Development, 2012 .......................................... 78
Figure 14:TAVR Procedures Per Year.................................................................................. 143
Figure 15:TAVR Rate of Adoption versus Reimbursement by Country, 2011 ........................ 144
Figure 16:Global Sales Forecast for TAVR, 2009-2018 ........................................................ 145
Figure 17:EU5 Market Sales for TAVR by Region, 2011-2018 .............................................. 146
Figure 18:Sales for TAVR by Company, 2011 ...................................................................... 147
Figure 19:Sales Forecasts for TAVR in France, 2011-2018 .................................................. 148
Figure 20:Sales Forecasts for TAVR in Germany, 2011-2018............................................... 149
Figure 21:Sales Forecasts for TAVR in Italy, 2011-2018....................................................... 150
Figure 22:Sales Forecasts for TAVR in Spain, 2011-2018 .................................................... 151
Figure 23:Sales Forecasts for TAVR in the UK, 2011-2018 .................................................. 152
Introduction
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2 Introduction For patients suffering from severe aortic valve disease or valve dysfunction, percutaneous
Transcatheter Aortic Valve Replacement (TAVR) enables implantation of a prosthetic heart valve
within the diseased native aortic valve without the need for open heart surgery or cardiopulmonary
bypass; TAVR provides a new therapeutic option for elderly patients who are considered to have
high surgical risk or contraindications to open heart surgery, in addition to an alternative option for
all other aortic valve disease patients. TAVR is becoming an increasingly popular alternative to
open heart surgery as professional and commercial interest intensifies and effectiveness becomes
proven; the percutaneous approach is less invasive and has a shorter recovery time compared with
open-heart access. As approved indications for use of TAVR expand as well as more competitors
enter the market, this industry will grow substantially in coming years.
2.1 Catalyst
Transcatheter Aortic Valve Replacement offers a novel and groundbreaking technology for
accessing the heart valves in patients who are extremely high-risk or inoperable candidates for
conventional surgical valve replacement, with the expectation that this technology may be utilized
in lower risk surgical candidates in the future. An estimated 55,000 patients worldwide have already
undergone TAVR (Holmes et al., 2012). TAVR has been adopted in many centers in Europe, and
has a huge potential for market penetration in Asia, South America, and Australia. As centers
around the world improve their catheterization facilities as well as introduce training to their staff for
TAVR procedures, it is expected that TAVR could be used on upwards of 10%-20% of the Aortic
Valve Disease (AVD) population in coming years, and has an estimated 2018 market value of over
$2 billion. This report examines procedural volumes in the US, France, Germany, Italy, Spain and
the UK, as well as adoption trends in these countries for the quickly spreading TAVR procedure.
With improvements in cardiac imaging and robotics, it’s expected that TAVR procedures will be
easier to perform in the future and have fewer associated side effects as training improves.
Additionally, as TAVR is reliant on so many different types of technology, there is much room for
improvement across the board in how these procedures are carried out. This report examines
current unmet needs, opportunities for development and market penetration, expectations for an
expanding target market, and associated complications with TAVR. This report looks at market
breakdown by company, new entrants to the TAVR industry, and drivers for future growth.
Appendix
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11.12 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 medical device 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, Boston, London, India and Singapore.
11.14 Disclaimer
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