transcatheter aortic valve replacement - …the transcatheter aortic valve replacement (tavr) market...

Transcatheter Aortic Valve Replacement Analysis and Market Forecast - European Markets GDME1002CFR / Published November 2012

Executive Summary

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. GDME1002CFR / Published NOV 2012

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


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


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


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.”


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.”


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.”


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


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

Table of Contents


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

Table of Contents


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

Table of Contents


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

Table of Contents


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

Table of Contents


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


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


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

Table of Contents


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

Table of Contents


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

Table of Contents


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

Table of Contents


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


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

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 167 GDME1002CFR / Published NOV 2012

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

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.

transcatheter aortic valve replacement - …the transcatheter aortic valve replacement (tavr) market...

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