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MediPoint: Electrophysiology - South America Analysis and Market Forecasts

Summary

Still in its infancy, the electrophysiology (EP) device market has seen significant adoption; as more physicians become experienced in diagnostic and ablation techniques, increasing numbers of hospitals purchase supportive equipment, device price-points fall, and efficacy improves. This continued growth is also driven by technological advancements including the emergence of next-generation ablation technologies, improvements in catheter diagnostics, and advancements in lab systems. Further, as imaging modalities improve, patients are exposed to less radiation than ever before, which will only further drive diagnostics.

Training for EP device use is severely limited in Brazil, and although it has been improving over time, it is still not ideal. While manufacturers are willing to sell devices in Brazil, support for device use has been inadequate compared with the US or countries in Europe. As a result, many physicians learn as they go, developing the skills necessary to perform complex ablation from their experiences gained using the devices during simpler procedures.

Scope

- An overview of electrophysiology, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized South America electrophysiology market revenue from 2005 to 2013, forecast for 7 years to 2020.
- Investigation of current and future market competition for electrophysiology
- 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 electrophysiology sector through market impact analysis, future market scenario and company analysis.
- Direct quotes from Key Opinion Leaders (KOL)

Reasons to buy

- Understand the trends shaping and driving South America electrophysiology market.
- Realize device preferences of physicians who have performed the tests already.
- Access market sizing, forecasts and quantified growth opportunities in the South America electrophysiology market through 2020.
- 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 the South America electrophysiology market landscape? Identify, understand and capitalize.

Table Of Contents

MediPoint: Electrophysiology - South America Analysis and Market Forecasts
1 Table of Contents

2 Introduction 19
2.1 Catalyst 19
2.2 Related Reports 19
3 Industry Overview 20
3.1 Introduction 20
3.2 Anatomy and Physiology 20
3.2.1 Etiology 21
3.2.2 Risk Factors 22
3.2.3 Types of Arrhythmia 23
3.3 Clinical Presentation 26
3.3.1 Symptoms 26
3.4 Diagnosis 26
3.4.1 Blood and Urine Diagnostic Procedures 27
3.4.2 Electrocardiography-Based Diagnostic Procedures 27
3.4.3 Computerized Tomographic Angiography 28
3.4.4 Electrophysiological Testing 28
3.4.5 Electromechanical Wave Imaging 29
3.4.6 Echocardiography 29
3.4.7 Tilt-Taable Testing 29
3.4.8 Diagnostic and Electrophysiological Studies 30
3.4.9 New York Heart Association Scale 30
3.4.10 American College of Cardiology Scale 30
3.5 Epidemiology 31
3.5.1 Prevalence 31
3.6 Market Segmentation 34
3.6.1 Electrophysiology Diagnostic Catheter 34
3.6.2 Electrophysiology Ablation Catheter 35
3.6.3 Electrophysiology Lab Systems 49
3.7 Treatment Costs, Pricing, and Reimbursement 49
3.7.1 Direct Costs 52
3.7.2 Indirect Costs 54
3.7.3 Pricing of Electrophysiology Devices and Equipment 56
3.7.4 Reimbursement 57
3.8 Market Characterization 59
3.8.1 Growing Patient Population Suitable for Treatment 59
3.8.2 Increasing Prevalence of Arrhythmia with Age 60
3.8.3 Emergence of Remote Catheter Navigation and Ablation Technology 62
3.8.4 Focus on the Development of “Single Shot” Devices 65
3.8.5 Catheter Localization Aided by Novel Mapping and Visualization Techniques 66
3.8.6 Electrophysiology Market Trends in Inorganic Growth through Consolidation 67
3.8.7 Lack of Skilled and Experienced Electrophysiologists to Negatively Impact Procedure Volumes and Hinder Market Growth 67
3.8.8 Awareness and Education to Drive Earlier Intervention 68
3.9 Regulatory Issues and Recalls 69
4 Segment Analysis 70
4.1 Ablation Catheters Market Dynamics 70
4.1.1 Ablation Catheters Market Drivers 70
4.1.2 Ablation Catheters Market Barriers 87
4.2 Diagnostic Catheters Market Dynamics 98
4.2.1 Diagnostic Catheters Market Drivers 98
4.2.2 Diagnostic Catheters Market Barriers 99
4.3 Lab Systems Market Dynamics 102
4.3.1 Lab Systems Market Drivers 102
4.3.2 Lab Systems Market Barriers 104
5 Market Outlooks by Geography 106
5.1 Brazil 106
5.1.1 Overview 106
5.1.2 Market Analysis 106
5.1.3 Market Analysis 108
6 Strategic Competitive Assessment 116
6.1 Key Company Share 116
6.1.1 Brazil 116
7 Current and Future Players 117
7.1 Biosense Webster 117
7.1.1 Overview 117
7.1.2 Portfolio Evaluation 117
7.1.3 Biosense Webster SWOT Analysis 118
7.2 Biotronik 122
7.2.1 Overview 122
7.2.2 Portfolio Evaluation 122
7.2.3 Biotronik SWOT Analysis 123
7.3 Boston Scientific 128
7.3.1 Overview 128
7.3.2 Boston Scientific Acquires Bard EP and Rhythmia Medical 128
7.3.3 Portfolio Evaluation 129
7.3.4 Boston Scientific SWOT Analysis 132
7.4 CardioFocus 138
7.4.1 Overview 138
7.4.2 Portfolio Evaluation 139
7.4.3 Company SWOT Analysis 141
7.5 CardioInsight 144
7.5.1 Overview 144
7.5.2 Portfolio Evaluation 144
7.5.3 CardioInsight SWOT Analysis 145
7.6 Hansen Medical 148
7.6.1 Overview 148
7.6.2 Portfolio Evaluation 149
7.6.3 Company SWOT Analysis 149
7.7 Imricor 152
7.7.1 Overview 152
7.7.2 Portfolio Evaluation 153
7.7.3 Company SWOT Analysis 153
7.8 Japan Lifeline 156
7.8.1 Overview 156
7.8.2 Portfolio Evaluation 157
7.8.3 Company SWOT Analysis 157
7.9 Magnetecs Corporation 160
7.9.1 Overview 160
7.9.2 Portfolio Evaluation 160
7.9.3 Company SWOT Analysis 161
7.10 Medtronic 163
7.10.1 Overview 163
7.10.2 Portfolio Evaluation 164
7.10.3 Company SWOT Analysis 167
7.11 MicroPort Scientific Company 171
7.11.1 Overview 171
7.11.2 Portfolio Evaluation 171
7.11.3 MicroPort Scientific SWOT Analysis 172
7.12 St. Jude Medical 175
7.12.1 Overview 175
7.12.2 Portfolio Evaluation 176
7.12.3 Company SWOT Analysis 178
7.13 Stereotaxis 181
7.13.1 Overview 181
7.13.2 Portfolio Evaluation 181
7.13.3 Commercial Positioning 182
7.13.4 Company SWOT Analysis 183
7.14 Stryker Sustainability Solutions 189
7.14.1 Overview 189
7.14.2 Portfolio Evaluation 190
7.14.3 Company SWOT Analysis 191
7.15 Topera Medical 193
7.15.1 Overview 193
7.15.2 Portfolio Evaluation 194
7.15.3 Company SWOT Analysis 195
8 Pipeline Product Assessment 198
8.1 Pipeline Assessment by Development Stage 198
8.2 Segment Analysis of Pipeline Products 199
8.2.1 Ablation Catheter Pipeline Products 199
8.2.2 Diagnostic Catheter Pipeline Products 205
8.3 Lab Systems 206
8.3.1 Integrated X-Ray and Robotic Catheter System (Hansen Medical, Philips Healthcare) 206
8.3.2 ClearTrace System (MRI Interventions) 207
8.3.3 Robotic Catheter Guidance Lab System (North Carolina State University) 207
8.3.4 Catheter Guidance Lab System (SCR) 208
9 Strategic Deals Analysis 209
9.1 Key Acquisitions 209
9.1.1 Boston Scientific Acquires C.R. Bard's Electrophysiology Business for $275m 209
9.1.2 St. Jude Medical Acquires Endosense for $161m 209
9.1.3 Boston Scientific Acquires Rhythmia Medical for $265m 210
9.2 Key Partnerships 210
9.2.1 Philips and Biosense Webster Technology Integration Agreement 210
9.2.2 Biosense Webster Technology Integration Agreement with GE Healthcare Systems and Siemens Healthcare 210
9.2.3 Abbott and St. Jude Medical Broaden Alliance in US Cardiovascular Device Market 211
10 Appendix 212
10.1 Bibliography 212
10.2 Abbreviations 223
10.3 Report Methodology 228
10.3.1 Overview 228
10.3.2 Coverage 228
10.3.3 Secondary Research 228
10.3.4 Forecasting Methodology 229
10.3.5 Primary Research - Key Opinion Leader Interviews 230
10.3.6 Expert Panel Validation 230
10.4 Physicians Included in this Study 231
10.5 About the Authors 233
10.5.1 Analysts 233
10.5.2 Global Head of Healthcare 234
10.6 About MediPoint 235
10.7 About GlobalData 235
10.8 Disclaimer 235

1.1 List of Tables

Table 1: New York Heart Association Scale 30
Table 2: American College of Cardiology Scale 31
Table 3: Prevalent Cases of Congestive Heart Failure, Nine Major Markets, Ages ?45 Years, Men and Women (N), 2012-2019 34
Table 4: Atrial Fibrillation Treatment Goals 37
Table 5: Reasons for Lack of Consensus on Site for Ablation 41
Table 6: Techniques for Treatment of Persistent and Permanent Atrial Fibrillation 43
Table 7: Types of Atrial Fibrillation based of Triggers 45
Table 8: Characteristics of Catheter Ablation by Arrhythmia Type (%) 46
Table 9: Rates of Occurrence of Major Complications with Catheter Ablation (%), 2003-2006 47
Table 10: Catheter Ablation Success for the Treatment of Atrial Fibrillation (%), Global, 1995-2002 and 2003-2006 48
Table 11: Catheter Ablation Success by Arrhythmia Type (%), 2009 49
Table 12: Classes of Recommendations 50
Table 13: Level of Evidence 50
Table 14: Estimation of Total Incremental Health Care Costs in Patients with Atrial Fibrillation ($), US, 2008 56
Table 15: Average Selling Price of Electrophysiology Products by Type, South America, 2013 57
Table 16: Percentage of Population Age 65 and Older, by Country, 2010-2015 60
Table 17: Overview of the Applications, Benefits, Limitations, and Future Directions of Remote Navigation Systems in Electrophysiology 64
Table 18: Key Acquisitions in the Electrophysiology Devices Market 67
Table 19: Advantages and Disadvantages of Various Energy Sources Used for Catheter Ablation 78
Table 20: Experimental Theories of How Atrial Fibrillation Perpetuates 85
Table 21: Antiarrhythmic Drug Classification by Mode of Action 89
Table 22: Major Complications Associated with Catheter Ablation 92
Table 23: Complications Associated with Catheter Ablation 92
Table 24: Recently Approved and Investigational Antiarrhythmic Drugs Under Development 93
Table 25: Diagnosed Patient Volume by Disease Type, Diagnosed Patients (N), Brazil, 2013 109
Table 26: Ablation Catheters Market, Brazil, Historic Revenue ($m), 2005-2013 110
Table 27: Ablation Catheters Market, Brazil, Forecast Revenue ($m), 2013-2020 111
Table 28: Diagnostic Catheters Market, Brazil, Historic Revenue ($m), 2005-2013 111
Table 29: Diagnostic Catheters Market, Brazil, Forecast Revenue ($m), 2013-2020 112
Table 30: Lab Systems Market, Brazil, Historic Revenue ($m), 2005-2013 113
Table 31: Lab Systems Market, Brazil, Forecast Revenue ($m), 2013-2020 114
Table 32: Company Share, Brazil, Total Electrophysiology Market Revenue (%), 2012 116
Table 33: Company Profile - Biosense Webster 117
Table 34: Biosense Webster, Electrophysiology Devices Portfolio 118
Table 35: SWOT Analysis - Biosense Webster 118
Table 36: Company Profile - Biotronik 122
Table 37: Biotronik, Electrophysiology Devices Portfolio 123
Table 38: SWOT Analysis - Biotronik 123
Table 39: Company Profile - Boston Scientific 129
Table 40: Boston Scientific, Electrophysiology Devices Portfolio 131
Table 41: SWOT Analysis - Boston Scientific 132
Table 42: Company Profile - CardioFocus 139
Table 43: CardioFocus, Electrophysiology Devices Portfolio 140
Table 44: SWOT Analysis - CardioFocus 141
Table 45: Company Profile - CardioInsight 144
Table 46: CardioInsight, Electrophysiology Devices Portfolio 144
Table 47: SWOT Analysis - CardioInsight 145
Table 48: Company Profile - Hansen Medical 148
Table 49: Hansen Medical, Electrophysiology Devices Portfolio 149
Table 50: SWOT Analysis - Hansen Medical 149
Table 51: Company Profile - Imricor 152
Table 52: SWOT Analysis - Imricor 153
Table 53: Company Profile - Japan Lifeline 156
Table 54: Japan Lifeline, Electrophysiology Devices Portfolio 157
Table 55: SWOT Analysis - Japan Lifeline 157
Table 56: Company Profile - Magnetecs Corporation 160
Table 57: Magnetecs Corporation, Electrophysiology Devices Portfolio 161
Table 58: SWOT Analysis - Magnetecs Corporation 161
Table 59: Company Profile - Medtronic 164
Table 60: Medtronic, Electrophysiology Devices Portfolio, 2013 166
Table 61: SWOT Analysis - Medtronic 167
Table 62: Company Profile - MicroPort Scientific Company 171
Table 63: MicroPort Scientific, Electrophysiology Devices Portfolio 172
Table 64: SWOT Analysis - MicroPort Scientific 172
Table 65: Company Profile - St. Jude Medical 175
Table 66: St. Jude Medical, Electrophysiology Devices Portfolio 177
Table 67: SWOT Analysis - St. Jude Medical 178
Table 68: Company Profile - Stereotaxis 181
Table 69: Stereotaxis, Electrophysiology Devices Portfolio 183
Table 70: SWOT Analysis - Stereotaxis 184
Table 71: Company Profile - Stryker Sustainability Solutions 190
Table 72: Stryker Sustainability Solutions, Electrophysiology Devices Portfolio 190
Table 73: SWOT Analysis - Stryker Sustainability Solutions 191
Table 74: Company Profile - Topera Medical 194
Table 75: Topera Medical, Electrophysiology Devices Portfolio, 2013 194
Table 76: SWOT Analysis - Topera Medical 195
Table 77: Ablation Catheter Pipeline Products 198
Table 78: Diagnostic Catheter Pipeline Products 198
Table 79: Lab Systems Pipeline Products 198
Table 80: Catheter Ablation Device, Product Status 199
Table 81: Ablation Catheter Device - Transcutaneous Monitoring to Avoid Hypercapnea during Complex Catheter Ablations 200
Table 82: Apama Medical Ablation Catheter, Product Status 201
Table 83: Cooled Tip Catheter, Product Status 201
Table 84: MaPP-CS, Product Status 202
Table 85: ROF-AC, Product Status 202
Table 86: ROF-AS, Product Status 203
Table 87: Vision MR Ablation Catheter, Product Status 203
Table 88: Voyager Irrigated RFA Catheter, Product Status 204
Table 89: Navigation and Ablation Catheter, Product Status 204
Table 90: Hot Balloon Catheter, Product Status 205
Table 91: Lesion Assessment Device, Product Status 206
Table 92: Horizon MR Recording System, Product Status 206
Table 93: Integrated X-Ray and Robotic Catheter System, Product Status 207
Table 94: ClearTrace System, Product Status 207
Table 95: Robotic Catheter Guidance Lab System, Product Status 208
Table 96: Catheter Guidance Lab System, Product Status 208
Table 97: Key Acquisitions in the Electrophysiology Market 209

1.2 List of Figures
Figure 1: Types of Arrhythmia 23
Figure 2: Pulmonary Vein Ablation Procedure 38
Figure 3: Antiarrhythmic Drugs and/or Ablation for Rhythm Control in Atrial Fibrillation 51
Figure 4: Cost Comparison of Ablation versus Antiarrhythmic Drug Therapy, 2009 53
Figure 5: Diagnosed Patient Volume by Disease Type, Diagnosed Patients (%), Brazil, 2013 109
Figure 6: Ablation Catheters Market, Brazil, Historic Revenue ($m), 2005-2013 110
Figure 7: Ablation Catheters Market, Brazil, Forecast Revenue ($m), 2013-2020 111
Figure 8: Diagnostic Catheters Market, Brazil, Historic Revenue ($m), 2005-2013 112
Figure 9: Diagnostic Catheters Market, Brazil, Forecast Revenue ($m), 2013-2020 113
Figure 10: Lab Systems Market, Brazil, Historic Revenue ($m), 2005-2013 114
Figure 11: Lab Systems Market, Brazil, Forecast Revenue ($m), 2013-2020 115
Figure 12: Company Share, Brazil, Total Electrophysiology Market Revenue (%), 2012 116

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