cardiac rhythm management – current and future … · reference code gdme1018fpr | publication...

REFERENCE CODE GDME1018FPR | PUBLICATION DATE NOVEMBER 2013

CARDIAC RHYTHM MANAGEMENT – CURRENT AND FUTURE PLAYERS

Cardiac Rhythm Management – Current and Future Players 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.


Table of Contents

1 Table of Contents

1 Table of Contents ...................................................................................................................... 2

1.1 List of Tables ........................................................................................................................ 7

1.2 List of Figures ..................................................................................................................... 11

2 Introduction ............................................................................................................................. 12

2.1 Catalyst ............................................................................................................................... 12

2.2 Related Reports .................................................................................................................. 13

2.3 Upcoming Related Reports ................................................................................................. 13

3 Competitive Assessment ......................................................................................................... 14

3.1 Overview ............................................................................................................................. 14

3.2 Global Market Share ........................................................................................................... 14

3.2.1 Pacemaker and CRT-P Market Company Share Globally ............................................... 14

3.2.2 ICD and CRT-D Market Company Share Globally .......................................................... 16

3.3 Regional Market Share ....................................................................................................... 17

3.3.1 Pacemaker and CRT-P Market Company Share in the US ............................................. 17

3.3.2 ICD and CRT-D Market Company Share in the US ......................................................... 18

3.3.3 Pacemaker and CRT-P Company Share in Europe ........................................................ 19

3.3.4 ICD and CRT-D Market Company Share in Europe ........................................................ 20

3.3.5 Pacemaker and CRT-P Market Company Share in Emerging Markets ........................... 21

3.3.6 ICD and CRT-D Market Company Share in Emerging Markets ....................................... 22

3.3.7 Pacemaker and CRT-P Market Company Share in Japan .............................................. 23

3.3.8 ICD and CRT-D Market Company Share in Japan .......................................................... 24



Table of Contents

4 Pipeline Products .................................................................................................................... 25

4.1 Overview ............................................................................................................................. 25

4.2 Pipeline Products by Phase in Development ....................................................................... 25

4.3 Pacemaker and CRT-P Product Profiles ............................................................................. 26

4.3.1 Aortic Pacemaker (Hadasit Medical Research Services & Development Ltd.) ................ 26

4.3.2 Cardiac Energy Harvesting Pacemaker (University of Michigan) .................................... 27

4.3.3 Endurance Microgenerator (Endurance Rhythm) ............................................................ 27

4.3.4 Implantable Dual-Chamber Pacemaker (MicroPort Scientific) ......................................... 28

4.3.5 Unconditional MRI-Compatible Implantable Pacemaker (Kenergy, Inc.) ......................... 28

4.3.6 Tissue-Engineered Autonomous Pacemaker (Duke University) ...................................... 29

4.3.7 Wireless Cardiac Stimulation Device (EBR Systems, Inc.) .............................................. 29

4.4 ICD and CRT-D Product Profiles ......................................................................................... 30

4.4.1 Atrial Defibrillator (SmartWave Medical Ltd.) ................................................................... 30

4.4.2 CardiaLen (CardiaLen, Inc.) ............................................................................................ 30

4.4.3 Chronicle (Medtronic) ..................................................................................................... 31

4.5 Clinical Trials to Watch ........................................................................................................ 32

4.5.1 Overview ........................................................................................................................ 32

4.5.2 SELECT-LV Trial of WiCS-LV System (EBR Systems, Inc.) ........................................... 32

4.5.3 MultiPoint Pacing Clinical Trial of Quadra Assura CRT-D (Medtronic) ............................ 34

4.5.4 MADIT-ASIA Trial with Invive CRT-P (Boston Scientific) ................................................. 35

4.5.5 MultiPoint Pacing IDE Study of Promote Quadra (St. Jude Medical) ............................... 37

4.5.6 Post Approval Study of S-ICD System (Boston Scientific) ............................................... 38

4.5.7 ProMRI Study of the Evia/Entovis Pacemaker System.................................................... 40



Table of Contents

4.5.8 MIRACLE EF Clinical Study of Consulta CRT-P (Medtronic) .......................................... 42

5 Current and Future Players ..................................................................................................... 45

5.1 Overview ............................................................................................................................. 45

5.2 Trends in Corporate Strategy .............................................................................................. 45

5.3 Biotronik .............................................................................................................................. 46

5.3.1 Overview ........................................................................................................................ 46

5.3.2 Portfolio Evaluation ......................................................................................................... 48

5.3.3 Commercial Positioning .................................................................................................. 58

5.3.4 Company SWOT Analysis .............................................................................................. 59

5.4 Boston Scientific ................................................................................................................. 59

5.4.1 Overview ........................................................................................................................ 59




5.5 Impulse Dynamics ............................................................................................................... 71

5.5.1 Overview ........................................................................................................................ 71




5.6 Medtronic ............................................................................................................................ 73

5.6.1 Overview ........................................................................................................................ 73


5.6.3 Marketed Products.......................................................................................................... 77



Table of Contents

5.6.4 Additional Products ......................................................................................................... 85



5.7 Sorin Group ........................................................................................................................ 89

5.7.1 Overview ........................................................................................................................ 89





5.8 St. Jude Medical ................................................................................................................. 94

5.8.1 Overview ........................................................................................................................ 94



5.8.4 Commercial Positioning ................................................................................................ 110

5.8.5 Company SWOT Analysis ............................................................................................ 111

6 Appendix ............................................................................................................................... 112

6.1 Bibliography ...................................................................................................................... 112

6.2 Abbreviations .................................................................................................................... 125

6.3 Report Methodology .......................................................................................................... 130

6.3.1 Overview ...................................................................................................................... 130

6.3.2 Coverage ...................................................................................................................... 130

6.3.3 Secondary Research .................................................................................................... 130

6.3.4 Forecasting Methodology.............................................................................................. 131



Table of Contents

6.3.5 Primary Research – Key Opinion Leader Interviews ..................................................... 132

6.3.6 Expert Panel Validation................................................................................................. 133

6.4 Physicians and Specialists Included in this Study ............................................................. 134

6.5 About the Authors ............................................................................................................. 136

6.5.1 Analysts ........................................................................................................................ 136

6.5.2 Global Head of Healthcare ............................................................................................ 137

6.6 About MediPoint ................................................................................................................ 138

6.7 About GlobalData .............................................................................................................. 138

6.8 Disclaimer ......................................................................................................................... 138



Table of Contents

1.1 List of Tables

Table 1: Pacemaker and CRT-P Market, Global, Company Share (%), 2012 .................................................. 15

Table 2: ICD and CRT-D Market, Global, Company Share (%), 2012 ............................................................. 16

Table 3: Pacemaker and CRT-P Market, US, Revenue ($) and Company Share (%), 2012 ............................ 17

Table 4: ICD and CRT-D Market, US, Revenue ($) and Company Share (%), 2012 ....................................... 18

Table 5: Pacemaker and CRT-P Market, Europe, Revenue ($) and Company Share (%), 2012...................... 19

Table 6: ICD and CRT-D Market, Europe, Revenue ($) and Company Share (%), 2012 ................................. 20

Table 7: Pacemaker and CRT-P Market, Emerging Markets, Revenue ($) and Company Share (%), 2012 ..... 21

Table 8: ICD and CRT-D Market, Emerging Markets, Revenue ($) and Company Share (%), 2012 ................ 22

Table 9: Pacemaker and CRT-P Market, Japan, Revenue ($) and Company Share (%), 2012 ....................... 23

Table 10: ICD and CRT-D Market, Japan, Revenue ($) and Company Share (%), 2012 ................................. 24

Table 11: Product Profile – Aortic Pacemaker ................................................................................................ 26

Table 12: Product Profile – Cardiac Energy Harvesting Pacemaker ............................................................... 27

Table 13: Product Profile – Endurance Microgenerator .................................................................................. 27

Table 14: Product Profile – MicroPort Pacemaker .......................................................................................... 28

Table 15: Product Profile – Kenergy Pacemaker ............................................................................................ 28

Table 16: Product Profile – Tissue-Engineered Autonomous Pacemaker ....................................................... 29

Table 17: Product Profile – Wireless Cardiac Stimulation Device.................................................................... 29

Table 18: Product Profile – Atrial Defibrillator ................................................................................................. 30

Table 19: Product Profile – CardiaLen ........................................................................................................... 30

Table 20: Product Profile – Chronicle ............................................................................................................. 31

Table 21: Clinical Trial for WiCS-LV System .................................................................................................. 32

Table 22: Clinical Trial for Quadra Assura CRT-D .......................................................................................... 34

Table 23: Clinical Trial for Invive CRT-P......................................................................................................... 35



Table of Contents

Table 24: MultiPoint Pacing IDE Study for Promote Quadra ........................................................................... 37

Table 25: Post Approval Study of S-ICD System ............................................................................................ 38

Table 26: ProMRI Study of the Evia/Entovis Pacemaker System .................................................................... 40

Table 27: MIRACLE EF Clinical Study of Consulta CRT-P ............................................................................. 42

Table 28: Company Profile – Biotronik ........................................................................................................... 48

Table 29: Product Profile – Cylos 990 ............................................................................................................ 51

Table 30: Product Profile – Effecta ................................................................................................................. 52

Table 31: Product Profile – Evia/Entovis ........................................................................................................ 53

Table 32: Product Profile – Estella ................................................................................................................. 54

Table 33: Product Profile – Stratos ................................................................................................................ 55

Table 34: Product Profile – Ilesto 7 ................................................................................................................ 55

Table 35: Product Profile – Lumax ................................................................................................................. 58

Table 36: Biotronik SWOT Analysis, 2012 ...................................................................................................... 59

Table 37: Company Profile – Boston Scientific ............................................................................................... 60

Table 38: Product Profile – Advantio .............................................................................................................. 63

Table 39: Product Profile – Altrua .................................................................................................................. 64

Table 40: Product Profile – Cognis ................................................................................................................. 65

Table 41: Product Profile – Energen .............................................................................................................. 66

Table 42: Product Profile – Incepta ................................................................................................................ 66

Table 43: Product Profile – Ingenio ................................................................................................................ 67

Table 44: Product Profile – Invive .................................................................................................................. 68

Table 45: Product Profile – Punctua ............................................................................................................... 69

Table 46: Product Profile – S-ICD System 2.0 ................................................................................................ 69

Table 47: Product Profile – Teligen ................................................................................................................ 70



Table of Contents

Table 48: Boston Scientific SWOT Analysis, 2012.......................................................................................... 71

Table 49: Company Profile – Impulse Dynamics ............................................................................................ 71

Table 50: Product Profile – Optimizer IVs ....................................................................................................... 72

Table 51: Impulse Dynamics SWOT Analysis, 2012 ....................................................................................... 72

Table 52: Company Profile – Medtronic ......................................................................................................... 74

Table 53: Product Profile – Advisa ................................................................................................................. 77

Table 54: Product Profile – Adapta ................................................................................................................ 78

Table 55: Product Profile – Brava/Viva ........................................................................................................... 79

Table 56: Product Profile – Consulta .............................................................................................................. 80

Table 57: Product Profile – EnPulse............................................................................................................... 80

Table 58: Product Profile – EnRhythm ........................................................................................................... 81

Table 59: Product Profile – Ensura MRI ......................................................................................................... 81

Table 60: Product Profile – Evera .................................................................................................................. 82

Table 61: Product Profile – Protecta............................................................................................................... 82

Table 62: Product Profile – Secura ................................................................................................................ 83

Table 63: Product Profile – Syncra ................................................................................................................. 84

Table 64: Product Profile – Revo ................................................................................................................... 84

Table 65: Product Profile – Concerto ............................................................................................................. 85

Table 66: Product Profile – EnTrust ............................................................................................................... 86

Table 67: Product Profile – Maximo II ............................................................................................................ 86

Table 68: Medtronic SWOT Analysis, 2012 .................................................................................................... 89

Table 69: Company Profile – Sorin Group ...................................................................................................... 91

Table 70: Product Profile – Esprit ................................................................................................................... 92

Table 71: Product Profile – Paradym.............................................................................................................. 92



Table of Contents

Table 72: Product Profile – Reply 2000 .......................................................................................................... 93

Table 73: Sorin Group SWOT Analysis, 2012 ................................................................................................ 94

Table 74: Company Profile – St. Jude Medical ............................................................................................... 95

Table 75: Product Profile – Accent ................................................................................................................. 98

Table 76: Product Profile – Accent MRI.......................................................................................................... 99

Table 77: Product Profile – Anthem.............................................................................................................. 100

Table 78: Product Profile – Allure Quadra .................................................................................................... 101

Table 79: Product Profile – AnalyST Accel ................................................................................................... 101

Table 80: Product Profile – Assurity ............................................................................................................. 102

Table 81: Product Profile – Current Accel .................................................................................................... 102

Table 82: Product Profile – Current Plus ...................................................................................................... 103

Table 83: Product Profile – Ellipse ............................................................................................................... 103

Table 84: Product Profile – Endurity ............................................................................................................. 104

Table 85: Product Profile – Fortify Assura .................................................................................................... 104

Table 86: Product Profile – Fortify ................................................................................................................ 105

Table 87: Product Profile – Microny ............................................................................................................. 105

Table 88: Product Profile – Leadless Pacemaker ......................................................................................... 106

Table 89: Product Profile – Promote Plus ..................................................................................................... 107

Table 90: Product Profile – Quadra Assura .................................................................................................. 108

Table 91: Product Profile – Unify Assura ...................................................................................................... 108

Table 92: Product Profile – Unify Quadra ..................................................................................................... 109

Table 93: Product Profile – Unify.................................................................................................................. 109

Table 94: Product Profile – Zephyr ............................................................................................................... 110

Table 95: St. Jude Medical SWOT Analysis, 2012........................................................................................ 111



Table of Contents

1.2 List of Figures

Figure 1: Pacemaker and CRT-P Market, Global, Company Share (%), 2012 ................................................ 14

Figure 2: ICD and CRT-D Market, Global, Company Share (%), 2012 ............................................................ 16

Figure 3: Pacemaker and CRT-P Market, US, Company Share (%), 2012 ...................................................... 17

Figure 4: ICD and CRT-D Market, US, Company Share (%), 2012 ................................................................. 18

Figure 5: Pacemaker and CRT-P Market, Europe, Company Share (%), 2012 ............................................... 19

Figure 6: ICD and CRT-D Market, Europe, Company Share (%), 2012 ........................................................... 20

Figure 7: Pacemaker and CRT-P Market, Emerging Markets, Company Share (%), 2012 .............................. 21

Figure 8: ICD and CRT-D Market, Emerging Markets, Company Share (%), 2012 .......................................... 22

Figure 9: Pacemaker and CRT-P Market, Japan, Company Share (%), 2012 ................................................. 23

Figure 10: ICD and CRT-D Market, Japan, Company Share (%), 2012 .......................................................... 24

Figure 11: CRM Pipeline Products by Phase in Development......................................................................... 25



Introduction

2 Introduction

Cardiac rhythm management (CRM) comprises any method of treatment aimed at regulating the

heart’s rhythm, including medication, medical devices, and occasionally surgery. There can be a

number of reasons why CRM is needed, all of which generally involve malfunctions of the heart’s

electrical system, and are related to cardiac dyssynchrony. While medication can be effective in

mild to moderate cases, patients with more severe conditions must turn to device use or surgical

intervention in order to receive the therapy they require. Over the years, CRM device treatment has

become less invasive, and significant advances in pacing and pulse generator technology have

enabled effective long-term device therapy with limited complications.

There are a number of devices that are utilized for CRM, and depending on the patient’s

arrhythmia, they may receive a pacemaker (PM), implantable cardioverter-defibrillator (ICD),

cardiac resynchronization therapy pacemaker (CRT-P) or cardiac resynchronization therapy

defibrillator (CRT-D). CRM device implementation depends on the patient’s current status and how

the physician expects their dysrhythmia to progress, although other concerns in regards to pricing,

reimbursement, and complication rates all have an effect on the decision to implant as well,

especially in emerging markets where patient awareness is lacking and healthcare budgets are

limited.

2.1 Catalyst

The CRM industry continues to experience meaningful growth through improved device therapy,

adoption in emerging markets, increased patient awareness, and updates in national and

international guidelines. Companies are increasingly looking to provide tiered product offerings to

target larger patient populations with differing reimbursement options. While 15 years ago CRM

products were not programmable, most current devices have 200 parameters, which can be

reprogrammed non-invasively using telemetry, and result in substantial performance differences

between the various brands of CRM products. Despite innovation and new product launches, many

customers are genuinely happy with the performance and features of current devices, and as a

result, the CRM market continues to be troubled by a challenging pricing environment that does not

reward innovation. Companies now must figure out how to add value in different ways, principally

related to device cost effectiveness.



Introduction

The CRT-P and CRT-D markets in the US and EU have experienced significant growth in recent

years despite relatively static pacemaker and ICD sales, while countries such as Japan, India,

China, and Brazil are rapidly increasing their demand for all CRM devices across the board. With

competition tight between just a few major players, added emphasis will be put on affordability,

technology innovation, and distribution networks in the coming years.

Next-generation CRT products have experienced significant adoption in recent years

Pipeline technologies including leadless generators and energy harvesting devices will drive

future device sales

Remote home monitoring telemetry is expected to increase CRM device adoption, especially in

remote areas, including China, India and Brazil

The industry shift from single-chamber to dual-chamber ICDs will drive additional revenue

Pricing headwinds, especially in developing countries, will steadily reduce the average selling

price of CRM products

New distribution channels globally will strengthen market access for EU- and US-based

companies

2.2 Related Reports

MediPoint: Cardiac Assist Devices Global Analysis and Market Forecasts GDME0175MAR /

Published March 2013

MediPoint: Transcatheter Aortic Valve Replacement Global Analysis and Market Forecasts

GDME0165MAR / Published November 2012

2.3 Upcoming Related Reports

MediPoint: EP Ablation Global Analysis and Market Forecasts / To be published February 2014



Appendix

6.6 About MediPoint

MediPoint is the flagship product for GlobalData’s Medical team. Each MediPoint report is built

from the ground-up by our team of healthcare analysts in the US and UK. Each report includes

input from experienced physicians and leading Key Opinion Leaders (KOLs). Running throughout

each report in the series, “What Do Physicians Think” quotes provide a unique insight into how

healthcare professionals are reacting to events within the industry, and what their responses could

mean for industry strategists.

6.7 About GlobalData

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

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

in 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.

6.8 Disclaimer

All Rights Reserved.

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

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

permission of the publisher, GlobalData.

cardiac rhythm management – current and future … · reference code gdme1018fpr | publication...

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