MediPoint: Cardiac Rhythm Management - South America Analysis and Market Forecasts

Summary

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.

The medical devices market in Brazil is the largest in South America. Currently, about half of the demand for medical devices in Brazil is met through imports. Over the past few years, a general easing of the import bureaucracy and the requirement to improve the quality and quantity of healthcare services available in Brazil has led to an increased adoption of advanced medical technologies, such as CRM.

Scope

- An overview of hypertension, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized South America CRM market revenue and future forecasts from 2009 to 2011, forecast for 7 years to 2018.
- Investigation of current and future market competition for CRM
- Insightful review of the key industry drivers, restraints and challenges as well as predicted impact of key events.
- Competitor assessment including device approval analysis and device sales forecasts.
- Marketed and pipeline product profiles covering efficiency, safety, clinical study details, device approvals, product positioning and device sales forecast.
- Analysis of unmet needs within the market and opportunities for future players.
- Technology trends evaluation to assess strength of pipeline.
- An overview of all devices in development including clinical study details, design and material selection considerations, efficacy reports, and device approval timelines.
- Company profiles including business description, financial overview and SWOT analysis.
- Coverage of key market players.
- Strategic assessment of the CRM sector through market impact analysis, future market scenario and company analysis.
- Direct quotes from Key Opinion Leaders (KOL) as well as cardiologists

Reasons to buy

- Understand the trends shaping and driving South America CRM market.
- Realize device preferences of physicians who have performed the tests already.
- Access market sizing, forecasts and quantified growth opportunities in South America CRM market through 2018.
- Quantify candidate patient populations to better design product pricing & launch plans.
- Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape.
- Perform benchmarking analysis of growth opportunities against currently marketed products.
- Assess competitiveness of products in market by understanding the strengths and weaknesses of current competition.
- Take a comprehensive look at the market’s device pipeline and identify promising, paradigm-shifting products.
- Create an effective counter-strategy to gain a competitive advantage against those currently in the market.
- Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for growth.
- What’s the next big thing in South America CRM market landscape? Identify, understand and capitalize.

Table Of Contents

Table of Contents

1 Table of Contents 7
1.1 List of Tables 14
1.2 List of Figures 19
2 Introduction 20
2.1 Catalyst 20
2.2 Related Reports 21
2.3 Upcoming Related Reports 21
3 Disease Overview 22
3.1 Anatomy and Physiology 22
3.1.1 Risk Factors 23
3.1.2 Etiology 25
3.2 Pathophysiology 26
3.2.1 Cardiac Arrhythmias 26
3.3 Clinical Presentation 32
3.3.1 Symptoms 32
3.4 Diagnosis 33
3.4.1 Blood and Urine Diagnostic Procedures 33
3.4.2 Electrocardiography-Based Diagnostic Procedures 34
3.4.3 Computerized Tomographic Angiography 35
3.4.4 Electrophysiological Testing 35
3.4.5 Electromechanical Wave Imaging 35
3.4.6 Echocardiography 36
3.4.7 Tilt-Table Testing 36
3.4.8 Diagnostic and Electrophysiological Studies 36
3.4.9 New York Heart Association Scale 36
3.4.10 American College of Cardiology Scale 37
3.4.11 Level of Evidence 37
3.5 Epidemiology 38
3.5.1 Prevalence 38
4 Industry Overview 42
4.1 Overview 42
4.2 Clinical Outcomes 42
4.2.1 Pacemakers 42
4.2.2 ICDs 50
4.2.3 CRT-Ps 57
4.2.4 CRT-Ds 58
4.3 Procedure Trends 59
4.3.1 Single-Chamber Devices More Popular than Dual-Chamber Devices in Developing Economies 59
4.3.2 Cardiac Resynchronization Therapy Increasingly Popular Around the World 62
4.3.3 Device Reuse Programs to Transform Currently Wasted Resource 62
4.3.4 Hospital Market Growth 63
4.4 Market Access 63
4.4.1 South America 63
4.4.2 Reimbursement Trends 64
4.5 Regulatory Issues/Recalls 66
4.5.1 Medtronic Pacemakers Recalled over Failure Risk, 2009 66
4.5.2 St. Jude Riata ICD Leads Recalled, 2011 67
4.6 Mergers and Acquisitions 67
4.6.1 Boston Scientific Acquires C.R. Bard’s Electrophysiology Business 67
4.6.2 Sorin Group Closes Further Investment and Option-to-Buy in Enopace Biomedical 67
4.7 Key Partnerships 68
4.7.1 Leti Forms Partnership with Sorin, TIMA, Cedrat Technologies, Tronics and EASII IC 68
4.7.2 St. Jude Medical to Invest in Nanostim 68
4.7.3 Sorin Group Signs Supply Agreement for Boston Scientific Corporation Lotus Valve System 70
4.8 Economic Impact 70
4.8.1 Cost-Effectiveness of Pacemakers 70
4.8.2 Cost-Effectiveness of ICDs 71
4.8.3 Cost-Effectiveness of Cardiac Resynchronization Therapy 71
4.9 Market Drivers 72
4.9.1 Rapidly Increasing Patient Populations Suitable for Device Implantation to Drive Sales 72
4.9.2 Technological Advances and New Products in Pipeline to Drive Sales 77
4.9.3 Evolving Indications for Cardiac Rhythm Management Therapy 81
4.9.4 Imaging Guided Placement of Leads 84
4.9.5 Cost-Saving Benefits of Remote Home Monitoring 85
4.9.6 Growing Adoption of Device Use in Emerging Markets 87
4.9.7 Increases in Implantation from Positive Clinical Trials 89
4.9.8 Antibacterial Envelopes to Reduce Rates of Complication and Increase Device Safety 90
4.9.9 Strong Portfolio of Pipeline Products from Key Players to Drive Future Growth of the Market 90
4.9.10 Leadless Technology Eliminates Lead-Related Complications 91
4.9.11 Diagnostic Rate Improvements Expected to Drive CRM Device Sales 92
4.9.12 Increased Device Implantation in Pediatrics 93
4.10 Market Barriers 94
4.10.1 US Healthcare Reform May Impact US CRM Market Growth Adversely 95
4.10.2 Increased Emphasis on Value-Based Payment Programs through Medicare and Cost-Effectiveness Research to Cause Competitive Pricing Pressure 95
4.10.3 Innovative and Next-Generation Drug Therapy May Pose a Challenge to CRM Devices in the Future 96
4.10.4 Slow Adoption of Remote Patient Monitoring Could Restrain Market Growth 96
4.10.5 Lacking Reimbursement for Costly Devices in Emerging Markets 97
4.10.6 Inconsistencies between Various Guidelines Affects Treatment 97
4.10.7 Inappropriate Shock Rates May Thwart Potential CRM Patients 98
4.10.8 Patient Education to Increase Awareness and Device Adoption 98
4.10.9 Declining Average Selling Prices to Adversely Affect CRM Product Revenues 99
5 Unmet Needs 101
5.1 Overview 101
5.2 Leads and Electrode Development 101
5.2.1 MRI-Compatible Generators and Leads 102
5.2.2 Single-Lead Systems with Atrial Diagnostics 104
5.3 Power-Supplying Batteries 104
5.4 Energy-Harvesting Batteries 105
5.5 Rates of Infection 106
6 Pipeline Products 107
6.1 Overview 107
6.2 Pipeline Products by Phase in Development 107
6.3 Pacemaker and CRT-P Product Profiles 108
6.3.1 Aortic Pacemaker (Hadasit Medical Research Services and Development Ltd.) 108
6.3.2 Cardiac Energy Harvesting Pacemaker (University of Michigan) 109
6.3.3 Endurance Microgenerator (Endurance Rhythm) 109
6.3.4 Implantable Dual-Chamber Pacemaker (MicroPort Scientific) 110
6.3.5 Unconditional MRI-Compatible Implantable Pacemaker (Kenergy, Inc.) 110
6.3.6 Tissue-Engineered Autonomous Pacemaker (Duke University) 111
6.3.7 Wireless Cardiac Stimulation Device (EBR Systems, Inc.) 111
6.4 ICD and CRT-D Product Profiles 112
6.4.1 Atrial Defibrillator (SmartWave Medical Ltd.) 112
6.4.2 CardiaLen (CardiaLen, Inc.) 112
6.4.3 Chronicle (Medtronic) 113
6.5 Clinical Trials to Watch 114
6.5.1 Overview 114
6.5.2 SELECT-LV Trial of WiCS-LV System (EBR Systems, Inc.) 114
6.5.3 MultiPoint Pacing Clinical Trial of Quadra Assura CRT-D (Medtronic) 116
6.5.4 MADIT-ASIA Trial with Invive CRT-P (Boston Scientific) 117
6.5.5 MultiPoint Pacing IDE Study of Promote Quadra (St. Jude Medical) 119
6.5.6 Post Approval Study of S-ICD System (Boston Scientific) 120
6.5.7 ProMRI Study of the Evia/Entovis Pacemaker System 122
6.5.8 MIRACLE EF Clinical Study of Consulta CRT-P (Medtronic) 124
7 Current and Future Players 127
7.1 Overview 127
7.2 Trends in Corporate Strategy 127
7.3 Biotronik 128
7.3.1 Overview 128
7.3.2 Portfolio Evaluation 130
7.3.3 Commercial Positioning 140
7.3.4 Company SWOT Analysis 141
7.4 Boston Scientific 141
7.4.1 Overview 141
7.4.2 Portfolio Evaluation 143
7.4.3 Commercial Positioning 152
7.4.4 Company SWOT Analysis 153
7.5 Impulse Dynamics 153
7.5.1 Overview 153
7.5.2 Portfolio Evaluation 153
7.5.3 Commercial Positioning 154
7.5.4 Company SWOT Analysis 154
7.6 Medtronic 155
7.6.1 Overview 155
7.6.2 Portfolio Evaluation 157
7.6.3 Marketed Products 159
7.6.4 Additional Products 167
7.6.5 Commercial Positioning 169
7.6.6 Company SWOT Analysis 171
7.7 Sorin Group 171
7.7.1 Overview 171
7.7.2 Portfolio Evaluation 173
7.7.3 Marketed Products 174
7.7.4 Commercial Positioning 175
7.7.5 Company SWOT Analysis 176
7.8 St. Jude Medical 176
7.8.1 Overview 176
7.8.2 Portfolio Evaluation 177
7.8.3 Marketed Products 179
7.8.4 Commercial Positioning 192
7.8.5 Company SWOT Analysis 193
8 Market Outlooks and Forecasts 194
8.1 Market Outlooks and Forecasts by Geography 194
8.1.1 Brazil 194
9 Appendix 199
9.1 Bibliography 199
9.2 Abbreviations 212
9.3 Report Methodology 217
9.3.1 Overview 217
9.3.2 Coverage 217
9.3.3 Secondary Research 217
9.3.4 Forecasting Methodology 218
9.3.5 Primary Research - Key Opinion Leader Interviews 219
9.3.6 Expert Panel Validation 220
9.4 Physicians and Specialists Included in this Study 221
9.5 About the Authors 223
9.5.1 Analysts 223
9.5.2 Global Head of Healthcare 224
9.6 About MediPoint 225
9.7 About GlobalData 225
9.8 Disclaimer 225



List of Tables

Table 1: New York Heart Association Scale 37
Table 2: American College of Cardiology Scale 37
Table 3: Level of Evidence 38
Table 4: Prevalent Cases of Congestive Heart Failure, All Markets, Ages ?45 Years, Men and Women (n), 2012-2019 41
Table 5: Pacemaker Implantation Classification Guideline 44
Table 6: Patient Post-Operative Condition with ICD Implantation, 2012 51
Table 7: Level of Evidence Guidelines 55
Table 8: Single-Chamber Pacemakers versus Dual-Chamber Pacemakers, Sales Volume Comparison, Brazil, 2012 60
Table 9: Single-Chamber ICDs versus Dual-Chamber ICDs, Sales Volume Comparison, Brazil, 2012 60
Table 10: Healthcare Expenditure by Payer (%) and Healthcare Expenditure per Capita ($), Global, 2011 65
Table 11: Percentage of Population Aged 65 Years and Older, by Country, 2005-2015 73
Table 12: Percentage of Smoking Population by Country (%), Global, 2010 74
Table 13: Percentage of Overweight and Obese Population (Aged 15 Years and Above), by Country, 2012 75
Table 14: Diabetes Prevalence Rates by Region (%), 20-79 Years, Global, 2007 and 2010 76
Table 15: Technological Innovations, Cardiac Rhythm Management Devices 77
Table 16: Benefits of Quadripolar Lead Technology 79
Table 17: Updated Cardiac Resynchronization Therapy Guidelines 80
Table 18: Emerging Market Contribution, Global, 2009-2012 88
Table 19: Primary Prevention Cases (%), ICD, Brazil, 2012 92
Table 20: Barriers in Access to Quality Healthcare Leading to Disparities in CRM Treatment 94
Table 21: Average Selling Price ($) Comparison, by Country, 2012 100
Table 22: Product Profile - Aortic Pacemaker 108
Table 23: Product Profile - Cardiac Energy Harvesting Pacemaker 109
Table 24: Product Profile - Endurance Microgenerator 109
Table 25: Product Profile - MicroPort Pacemaker 110
Table 26: Product Profile - Kenergy Pacemaker 110
Table 27: Product Profile - Tissue-Engineered Autonomous Pacemaker 111
Table 28: Product Profile - Wireless Cardiac Stimulation Device 111
Table 29: Product Profile - Atrial Defibrillator 112
Table 30: Product Profile - CardiaLen 112
Table 31: Product Profile - Chronicle 113
Table 32: Clinical Trial for WiCS-LV System 114
Table 33: Clinical Trial for Quadra Assura CRT-D 116
Table 34: Clinical Trial for Invive CRT-P 117
Table 35: MultiPoint Pacing IDE Study for Promote Quadra 119
Table 36: Post Approval Study of S-ICD System 120
Table 37: ProMRI Study of the Evia/Entovis Pacemaker System 122
Table 38: MIRACLE EF Clinical Study of Consulta CRT-P 124
Table 39: Company Profile - Biotronik 130
Table 40: Product Profile - Cylos 990 133
Table 41: Product Profile - Effecta 134
Table 42: Product Profile - Evia/Entovis 135
Table 43: Product Profile - Estella 136
Table 44: Product Profile - Stratos 137
Table 45: Product Profile - Ilesto 7 137
Table 46: Product Profile - Lumax 140
Table 47: Biotronik SWOT Analysis, 2012 141
Table 48: Company Profile - Boston Scientific 142
Table 49: Product Profile - Advantio 145
Table 50: Product Profile - Altrua 146
Table 51: Product Profile - Cognis 147
Table 52: Product Profile - Energen 148
Table 53: Product Profile - Incepta 148
Table 54: Product Profile - Ingenio 149
Table 55: Product Profile - Invive 150
Table 56: Product Profile - Punctua 151
Table 57: Product Profile - S-ICD System 2.0 151
Table 58: Product Profile - Teligen 152
Table 59: Boston Scientific SWOT Analysis, 2012 153
Table 60: Company Profile - Impulse Dynamics 153
Table 61: Product Profile - Optimizer IVs 154
Table 62: Impulse Dynamics SWOT Analysis, 2012 154
Table 63: Company Profile - Medtronic 156
Table 64: Product Profile - Advisa 159
Table 65: Product Profile - Adapta 160
Table 66: Product Profile - Brava/Viva 161
Table 67: Product Profile - Consulta 162
Table 68: Product Profile - EnPulse 162
Table 69: Product Profile - EnRhythm 163
Table 70: Product Profile - Ensura MRI 163
Table 71: Product Profile - Evera 164
Table 72: Product Profile - Protecta 164
Table 73: Product Profile - Secura 165
Table 74: Product Profile - Syncra 166
Table 75: Product Profile - Revo 166
Table 76: Product Profile - Concerto 167
Table 77: Product Profile - EnTrust 168
Table 78: Product Profile - Maximo II 168
Table 79: Medtronic SWOT Analysis, 2012 171
Table 80: Company Profile - Sorin Group 173
Table 81: Product Profile - Esprit 174
Table 82: Product Profile - Paradym 174
Table 83: Product Profile - Reply 2000 175
Table 84: Sorin Group SWOT Analysis, 2012 176
Table 85: Company Profile - St. Jude Medical 177
Table 86: Product Profile - Accent 180
Table 87: Product Profile - Accent MRI 181
Table 88: Product Profile - Anthem 182
Table 89: Product Profile - Allure Quadra 183
Table 90: Product Profile - AnalyST Accel 183
Table 91: Product Profile - Assurity 184
Table 92: Product Profile - Current Accel 184
Table 93: Product Profile - Current Plus 185
Table 94: Product Profile - Ellipse 185
Table 95: Product Profile - Endurity 186
Table 96: Product Profile - Fortify Assura 186
Table 97: Product Profile - Fortify 187
Table 98: Product Profile - Microny 187
Table 99: Product Profile - Leadless Pacemaker 188
Table 100: Product Profile - Promote Plus 189
Table 101: Product Profile - Quadra Assura 190
Table 102: Product Profile - Unify Assura 190
Table 103: Product Profile - Unify Quadra 191
Table 104: Product Profile - Unify 191
Table 105: Product Profile - Zephyr 192
Table 106: St. Jude Medical SWOT Analysis, 2012 193
Table 107: Brazil Cardiac Rhythm Management Device Implantation 196
Table 108: Pacemakers and Cardiac Resynchronization Therapy Pacemakers, Brazil, Revenue ($m), 2010-2020 197
Table 109: Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Defibrillators Market, Brazil, Revenue ($m), 2010-2020 198

1.2 List of Figures
Figure 1: Types of Arrhythmia 26
Figure 2: Generic Pacemaker Code 44
Figure 3: Guide for Pacemaker Implantation 45
Figure 4: Patient and General Population Preferences for CRM Device Reuse, US 63
Figure 5: Healthcare Expenditure by Payer, Global, 2011 65
Figure 6: Percentage of Population Aged 65 Years and Above, by Country, 2005-2015 73
Figure 7: Diabetes Prevalence Rates, 20-79 Years, by Region, 2007-2010 76
Figure 8: Evaluating Effectiveness of Remote Home Monitoring 86
Figure 9: Emerging Market Contribution, Global, 2009-2012 88
Figure 10: Secondary Prevention Diagnosed Cases by Country (%), ICD, Global, 2012 92
Figure 11: Diagnosed VT and VF Cases Receiving ICD by Country (%), ICD, Global, 2012 93
Figure 12: Average Selling Price ($) Comparison, by Country, 2012 99
Figure 13: CRM Pipeline Products by Phase in Development 107
Figure 14: Pacemakers and Cardiac Resynchronization Therapy Pacemakers, Brazil, Revenue ($m), 2010-2020 197
Figure 15: Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Defibrillators Market, Brazil, Revenue ($m), 2010-2020 198



Companies Mentioned

Biotronik
Boston Scientific
Impulse Dynamics
Medtronic
Sorin Group
St. Jude Medical

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