Transcatheter Aortic Valve Replacementmarket is forecast to have significant growth during the...

Transcatheter Aortic Valve Replacement Analysis and Market Forecast - US Market GDME1001CFR / Published November 2012

Executive Summary

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Transcatheter Aortic Valve Replacement: Key Metrics in US Device Markets

Diseased population 1.45 million

Severe, Symptomatic Population 0.20 million

High Risk or Inoperable Population 0.13 million

2011 Market Sales

US $28.0m

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

US FDA approval of Sapien valve for inoperable

patients via transfemoral access in 2011 ↑↑↑

US FDA expanded approval for high-risk patients

via transapical access in 2012 ↑↑

US FDA approval of CoreValve in 2014 ↑↑

US FDA approval of Acurate TA valve in 2014 ↑

US FDA of Sapien XT in 2014 ↑

2018 Market Sales

US $1,086m

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 US market in

2011 was $28.0 million, and it is expected to grow to

reach $1,086.1 million by 2018.

The key drivers for the market in the forecast period are:

Increase in the TAVR patient population, primarily

due to an increase in the elderly population and

expanded approval of TAVR

US FDA approval of TAVR using Sapien valve in

inoperable candidates via transfemoral access in

2011

FDA expanded approval of TAVR for high-risk

patients and transapical access in 2012

FDA approval of CoreValve in 2014

FDA approval of Acurate TA valve in 2014

FDA approval of Sapien XT 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


Companies Working to Get Their Devices Approved in the TAVR Market

The TAVR market has been developing quickly as a

result of US rapid adoption of the procedure. Ever since

the Sapien valve was approved by the FDA in the US in

2011, 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 due to launch in the US in

the near future. In parallel development with device

designs, companies are looking to further improve their

delivery systems as well.

Expanded approval of TAVR in the US has generated

considerable interest within the healthcare community.

GlobalData expects that most major heart centers will

offer the procedure in coming years.

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.

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

Edwards is the only company with a device currently

approved in the US. As the US market opens up to other

competitors, 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 Repositionability

High durability and long device lifetime

Most Desirable Features of

TAVR Devices

Proven safety of device

Non-thrombogenic

Dynamic responsivenessFeatures Most Satisfied With

(Met Needs) Valve-tissue interaction

Cost of device

Retrievability of deviceFeatures Least Satisfied With

(Unmet Needs) 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 ...............................................................................................................5

1.1 List of Tables ..............................................................................................................11

1.2 List of Figures .............................................................................................................14

2 Introduction.......................................................................................................................15

2.1 Catalyst.......................................................................................................................15

3 Disease Overview.............................................................................................................16

3.1 Anatomy & Physiology ................................................................................................16

3.1.1 Heart Valves .......................................................................................................16

3.2 Pathophysiology..........................................................................................................18

3.2.1 Heart Valve Disorders .........................................................................................18

3.2.2 Etiology of AVD...................................................................................................19

3.2.3 Acquired Disorders..............................................................................................19

3.2.4 Congenital Defects..............................................................................................21

3.2.5 Other Disorders...................................................................................................22

3.3 Clinical Presentation ...................................................................................................22

3.3.1 Symptoms...........................................................................................................22

3.3.2 Diagnosis............................................................................................................22

3.4 Clinical Outcomes.......................................................................................................26

3.4.1 Treatment Modalities...........................................................................................27

3.4.2 Medication ..........................................................................................................30

3.4.3 Heart Valve Repair..............................................................................................31

3.4.4 Surgical/Intervention Strategies...........................................................................32

3.4.5 Surgical Heart Valve Replacement......................................................................32

3.4.6 Transcatheter Heart Valve Replacement .............................................................34

3.4.7 Associated Mortality............................................................................................37

3.5 Epidemiology ..............................................................................................................37

Table of Contents


3.5.1 Prevalence..........................................................................................................37

3.5.2 Treatment and Mortality ......................................................................................39

3.6 Economic Impact ........................................................................................................41

3.6.1 Individual Costs...................................................................................................42

3.6.2 Industry Costs.....................................................................................................43

4 Competitive Assessment...................................................................................................44

4.1 Overview.....................................................................................................................44

4.1.1 Initial Devices......................................................................................................45

4.1.2 Current Devices ..................................................................................................45

4.1.3 Competitive Assessment.....................................................................................46

4.2 US Marketed Product Profile .......................................................................................47

4.2.1 Sapien valve (Edwards Lifesciences) ..................................................................47

5 Unmet Needs....................................................................................................................50

5.1 Delivery & Implantation ...............................................................................................51

5.1.1 Repositionable ....................................................................................................51

5.1.2 Low Profile..........................................................................................................51

5.1.3 Accurate Anatomic Positioning............................................................................52

5.1.4 Expansion Mechanism ........................................................................................53

5.1.5 Rapid Pacing ......................................................................................................53

5.1.6 Motorized Delivery Systems................................................................................53

5.1.7 Coronary Ostia Impairment .................................................................................54

5.2 Conformance ..............................................................................................................54

5.2.1 Regurgitation ......................................................................................................54

5.2.2 Sizing..................................................................................................................55

5.2.3 Effective Orifice Area ..........................................................................................55

5.2.4 Removal of Native Valve Leaflets........................................................................55

5.3 Lifetime.......................................................................................................................56

5.3.1 Durability.............................................................................................................56

5.3.2 Retrievability .......................................................................................................57

Table of Contents


5.3.3 Pacemaker Placement (heart block)....................................................................57

5.3.4 Replaceable Leaflets...........................................................................................57

5.4 Materials.....................................................................................................................58

5.4.1 Alternative Surfaces............................................................................................58

5.4.2 Endothelialization................................................................................................58

5.4.3 Regenerative Medicine........................................................................................59

5.4.4 Tailored Treatment..............................................................................................59

5.5 Pre-Crimped Packaging ..............................................................................................59

5.6 Embolic Protection ......................................................................................................59

5.7 Robotic Assistance......................................................................................................60

5.8 Hemodynamic Performance........................................................................................60

6 Pipeline Products..............................................................................................................61

6.1 Overview.....................................................................................................................61

6.2 Pipeline by Phases in Development ............................................................................62

6.3 Pipeline Products Profiles ...........................................................................................64

6.3.1 Acurate TA Valve (Symetis) ................................................................................64

6.3.2 Acurate TF valve (Symetis) .................................................................................65

6.3.3 AorTech valve (AorTech International) ................................................................67

6.3.4 AorTx valve (Hansen Medical).............................................................................68

6.3.5 Centera valve (Edwards Lifesciences).................................................................70

6.3.6 Colibri valve (Colibri Heart Valve)........................................................................71

6.3.7 Cormove (Perouse Medical)................................................................................72

6.3.8 CoreValve (Medtronic, Inc.).................................................................................73

6.3.9 Direct Flow valve (Direct Flow Medical) ...............................................................76

6.3.10 Engager valve (Medtronic, Inc.)...........................................................................79

6.3.11 Heart Leaflet Technology (Bracco SpA)...............................................................80

6.3.12 Innovare valve (Braile Biomedica) .......................................................................81

6.3.13 JenaValve (JenaValve) .......................................................................................83

6.3.14 Portico valve (St. Jude Medical, Inc.)...................................................................84

Table of Contents


6.3.15 Sadra Lotus valve (Boston Scientific) ..................................................................85

6.3.16 Sapien XT valve (Edwards Lifesciences) .............................................................87

6.3.17 Sapien 3 (Edwards Lifesciences) ........................................................................89

6.3.18 Trinity valve (Transcatheter Technologies GmbH) ...............................................90

6.3.19 Vanguard Exchangeable Heart Valve System (ValveXchange)............................91

6.4 Clinical Trial Analysis ..................................................................................................94

6.4.1 Overview.............................................................................................................94

6.4.2 Trials to Watch....................................................................................................94

6.4.3 Summary ............................................................................................................96

7 Industry Overview.............................................................................................................97

7.1 Procedure Trends .......................................................................................................97

7.1.1 Reimbursement Hinders Adoption.......................................................................97

7.2 Market Access ............................................................................................................98

7.2.1 Adoption of TAVR ...............................................................................................98

7.2.2 Heart Teams for Specialized Care.....................................................................100

7.2.3 Facilities Enabling TAVR...................................................................................102

7.2.4 Training and Protocols for Care.........................................................................102

7.3 Reimbursement Trends............................................................................................. 103

7.4 Regulatory Issues/Recalls......................................................................................... 104

7.5 Mergers & Acquisitions/Key Partnerships ..................................................................105

8 Current and Future Players............................................................................................. 107

8.1 Overview...................................................................................................................107

8.2 Trends in Corporate Strategy ....................................................................................107

8.3 Company Profiles......................................................................................................108

8.3.1 AorTech International plc ..................................................................................108

8.3.2 Boston Scientific ............................................................................................... 109

8.3.3 Bracco SpA.......................................................................................................110

8.3.4 Braile Biomedica............................................................................................... 112

8.3.5 Colibri Heart Valve, LLC....................................................................................113

Table of Contents


8.3.6 Direct Flow Medical........................................................................................... 114

8.3.7 Edwards Lifesciences, Inc. ................................................................................115

8.3.8 Hansen Medical ................................................................................................ 117

8.3.9 JenaValve Technology...................................................................................... 118

8.3.10 Medtronic, Inc. ..................................................................................................119

8.3.11 Perouse Medical ............................................................................................... 120

8.3.12 St. Jude Medical ............................................................................................... 121

8.3.13 Symetis.............................................................................................................123

8.3.14 Transcatheter Technologies GmbH...................................................................124

8.3.15 ValveXchange...................................................................................................125

9 Market Drivers, Opportunities and Barriers......................................................................127

9.1 Market Drivers ..........................................................................................................127

9.1.1 Superior to Conventional Treatment ..................................................................127

9.1.2 New Alternative for Patients with No Options.....................................................128

9.1.3 Expected Launch of CoreValve, Acurate TA, and Sapien XT in US....................128

9.1.4 Expanded Approval in US .................................................................................128

9.1.5 Supportive Imaging ........................................................................................... 128

9.2 Opportunities ............................................................................................................129

9.2.1 Repositionability................................................................................................ 130

9.2.2 Miniaturization of Valve Systems.......................................................................130

9.2.3 Single Operator Devices ...................................................................................131

9.2.4 Lower Cost .......................................................................................................131

9.2.5 Dilation Scoring Balloon ....................................................................................131

9.2.6 Removal of Native Valve Leaflets......................................................................132

9.2.7 Temporary Aortic Valves ...................................................................................132

9.3 Market Barriers .........................................................................................................133

9.3.1 Reimbursement.................................................................................................133

9.3.2 Slow Adoption...................................................................................................133

9.3.3 Cost ..................................................................................................................133

Table of Contents


9.3.4 Substitutes........................................................................................................133

10 Country Outlooks & Forecasts ........................................................................................ 135

10.1 US Markets Overview ............................................................................................... 135

10.2 United States ............................................................................................................137

10.2.1 United States Market Analysis...........................................................................137

11 Appendix ........................................................................................................................ 140

11.1 Abbreviations ..........................................................................................................140

11.2 Bibliography............................................................................................................142

11.3 Methodology ...........................................................................................................146

11.4 Coverage ................................................................................................................146

11.5 Secondary Research............................................................................................... 147

11.6 Forecasting Methodology ........................................................................................ 147

11.6.1 Diagnosed Aortic Valve Disease (AVD) Patients................................................148

11.6.2 Percent Transcatheter Aortic Valve Replacement Patients ................................ 148

11.6.3 Pricing Assumptions.......................................................................................... 148

11.6.4 Prevalence in Surgical Risk Segments .............................................................. 148

11.6.5 Cost of Aortic Valve Disease .............................................................................148

11.7 Physicians and Specialists Included in this Study ....................................................149

11.8 Primary Research ...................................................................................................149

11.9 Physician Survey ....................................................................................................150

11.10 About the Authors ...................................................................................................151

11.10.1 Analysts............................................................................................................151

11.10.2 Global Head of Healthcare ................................................................................152

11.11 Definitions.............................................................................................................153

11.12 About GlobalData..................................................................................................154

11.13 Contact Us............................................................................................................154

11.14 Disclaimer.............................................................................................................154

Table of Contents


1.1 List of Tables

Table 1: Etiology of Single Left-Side Valve Disease ..............................................................19

Table 2: Initial Presenting Symptoms of Aortic Valve Disease...............................................22

Table 3: Basic Frequency of Examination.............................................................................24

Table 4: Modifiers of Examination Frequency .......................................................................24

Table 5: Cardiovascular Risk Factors and Comorbidities ......................................................25

Table 6: Investigations Performed to Diagnose AVD.............................................................26

Table 7: Basic Principles for Management of AVD Patients...................................................27

Table 8: Aortic Valve Disease National Indirect and Direct Costs ($bn), 2009-2018...............43

Table 9: TAVR Product Approvals by Date ...........................................................................45

Table 10: Assessment of TAVR Device Features....................................................................46

Table 11: Product Profile - Sapien ..........................................................................................47

Table 12: Sapien SWOT Analysis, 2012 .................................................................................49

Table 13: TAVR Global Product Pipeline, 2012.......................................................................63

Table 14: Product Profile - Acurate TA....................................................................................64

Table 15: Acurate TA SWOT Analysis, 2012...........................................................................65

Table 16: Product Profile - Acurate TF....................................................................................66

Table 17: Acurate TF SWOT Analysis, 2012...........................................................................67

Table 18: Product Profile - AorTech........................................................................................67

Table 19: AorTech SWOT Analysis, 2012...............................................................................68

Table 20: Product Profile - AorTx............................................................................................69

Table 21: AorTx SWOT Analysis, 2012...................................................................................70

Table 22: Product Profile - Centera.........................................................................................70

Table 23: Centera SWOT Analysis, 2012................................................................................71

Table 24: Product Profile - Colibri ...........................................................................................71

Table 25: Colibri SWOT Analysis, 2012 ..................................................................................72

Table 26: Product Profile - Cormove.......................................................................................73

Table 27: Cormove SWOT Analysis, 2012..............................................................................73

Table 28: Product Profile - CoreValve.....................................................................................74

Table of Contents


Table 29: CoreValve SWOT Analysis, 2012............................................................................76

Table 30: Product Profile - Direct Flow....................................................................................77

Table 31: Direct Flow SWOT Analysis, 2012...........................................................................78

Table 32: Product Profile - Engager........................................................................................79

Table 33: Engager SWOT Analysis, 2012...............................................................................80

Table 34: Product Profile - Heart Leaflet Technology ..............................................................80

Table 35: Heart Leaflet Technology SWOT Analysis, 2012 .....................................................81

Table 36: Product Profile - Innovare .......................................................................................81

Table 37: Innovare SWOT Analysis, 2012 ..............................................................................82

Table 38: Product Profile - JenaValve.....................................................................................83

Table 39: JenaValve SWOT Analysis, 2012............................................................................84

Table 40: Product Profile - Portico ..........................................................................................84

Table 41: Portico SWOT Analysis, 2012 .................................................................................85

Table 42: Product Profile - Sadra Lotus ..................................................................................86

Table 43: Sadra Lotus SWOT Analysis, 2012 .........................................................................87

Table 44: Product Profile - Sapien XT.....................................................................................87

Table 45: Sapien XT SWOT Analysis, 2012............................................................................89

Table 46: Product Profile - Sapien 3 .......................................................................................89

Table 47: Sapien 3 SWOT Analysis, 2012 ..............................................................................90

Table 48: Product Profile - Trinity ...........................................................................................91

Table 49: Trinity SWOT Analysis, 2012 ..................................................................................91

Table 50: Product Profile - Vanguard......................................................................................92

Table 51: Vanguard SWOT Analysis, 2012.............................................................................93

Table 52: Company Profile - AorTech International plc ......................................................... 108

Table 53: AorTech International SWOT Analysis, 2012......................................................... 109

Table 54: Company Profile - Boston Scientific ......................................................................109

Table 55: Boston Scientific SWOT Analysis, 2012 ................................................................ 110

Table 56: Company Profile - Bracco SpA..............................................................................111

Table 57: Bracco SpA SWOT Analysis, 2012........................................................................112

Table of Contents


Table 58: Company Profile - Braile Biomedica......................................................................112

Table 59: Braile Biomedica SWOT Analysis, 2012................................................................ 113

Table 60: Company Profile - Colibri Heart Valve ...................................................................113

Table 61: Colibri Heart Valve SWOT Analysis.......................................................................114

Table 62: Company Profile - Direct Flow Medical..................................................................115

Table 63: Direct Flow Medical SWOT Analysis, 2012............................................................ 115

Table 64: Company Profile - Edwards Lifesciences .............................................................. 116

Table 65: Edwards Lifesciences SWOT Analysis, 2012 ........................................................ 117

Table 66: Company Profile - Hansen Medical .......................................................................117

Table 67: Hansen Medical SWOT Analysis, 2012.................................................................118

Table 68: Company Profile - JenaValve Technology............................................................. 118

Table 69: JenaValve Technology SWOT Analysis, 2012....................................................... 119

Table 70: Company Profile - Medtronic.................................................................................119

Table 71: Medtronic SWOT Analysis, 2012...........................................................................120

Table 72: Company Profile - Perouse Medical ......................................................................120

Table 73: Perouse Medical SWOT Analysis, 2012................................................................ 121

Table 74: Company Profile - St. Jude Medical ......................................................................121

Table 75: St. Jude Medical SWOT Analysis, 2012 ................................................................ 122

Table 76: Company Profile - Symetis....................................................................................123

Table 77: Symetis SWOT Analysis, 2012..............................................................................123

Table 78: Company Profile - Transcatheter Technologies .....................................................124

Table 79: Transcatheter Technologies SWOT Analysis, 2012...............................................124

Table 80: Company Profile - ValveXchange..........................................................................125

Table 81: ValveXchange SWOT Analysis, 2012 ...................................................................126

Table 82: Major Events Affecting the Global TAVR Market ...................................................136

Table 83: Sales Forecasts for TAVR in the US, 2011-2018...................................................137

Table 84: Physicians Surveyed, By Country .........................................................................150

Table of Contents


1.2 List of Figures

Figure 1: Diagram of Human Heart ........................................................................................17

Figure 2: Strategy for Evaluating Heart Murmurs....................................................................23

Figure 3: General Treatment Modalities for Aortic Valve Disease ...........................................28

Figure 4: Aortic Valve Replacement Treatment Modalities in the US ......................................29

Figure 5: Surgical Risk of Symptomatic, Severe AVD Patients, 2011 .....................................38

Figure 6: Prevalence of Moderate or Severe Valve Disease in US Population 2011 ...............39

Figure 7: Prevalence of AVD in Patients 65+ .........................................................................39

Figure 8: Breakdown of Severe AVD Patients Receiving Surgical Valve Replacement &

Transcatheter Valve Replacement ..........................................................................41

Figure 9: Total Costs at One Year for TAVR and SAVR as Calculated in 2011 in Europe.......42

Figure 10:Companies in TAVR Market with Approved Devices...............................................44

Figure 11:TAVR Device Attributes by Current Satisfaction and Importance, 2011...................62

Figure 12:TAVR Pipeline by Stage in Clinical Development, 2012 ..........................................63

Figure 13:TAVR Procedures Per Year..................................................................................135

Figure 14:Sales Forecasts for TAVR in the US, 2011-2018 ..................................................138

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 the US. 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, as well as adoption trends

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 154 GDME1001CFR / 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.

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