MediPoint: Cardiac Rhythm Management - US Analysis and Market Forecasts -





Published: November 2013 | Pages: 229 | Format: PDF

 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. 

Reimbursement in the US continues to be a problem, largely because not all procedures are covered, and because not all patients have insurance. Especially in the wake of the 2008 recession, affordability is a huge concern with patients who don’t have health insurance, and CRM adoption rates have been limited by issues with reimbursement. 

 Scope 

 - An overview of hypertension, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.  

 - Annualized the US 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 the US CRM market. 

 - Realize device preferences of physicians who have performed the tests already. 

 - Access market sizing, forecasts and quantified growth opportunities in the US 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 the US CRM market landscape? Identify, understand and capitalize. 

 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 

 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 41 

 4.1 Overview 41 

 4.2 Clinical Outcomes 41 

 4.2.1 Pacemakers 41 

 4.2.2 ICDs 49 

 4.2.3 CRT-Ps 56 

 4.2.4 CRT-Ds 57 

 4.3 Procedure Trends 58 

 4.3.1 Cost and Appropriateness Still a Concern with Dual-Chamber Devices 58 

 4.3.2 Cardiac Resynchronization Therapy Increasingly Popular Around the World 60 

 4.3.3 Device Reuse Programs to Transform Currently Wasted Resource 61 

 4.3.4 Hospital Market Growth 62 

 4.4 Market Access 62 

 4.4.1 US 62 

 4.4.2 Reimbursement Trends 64 

 4.5 Regulatory Issues/Recalls 67 

 4.5.1 Medtronic Pacemakers Recalled over Failure Risk, 2009 67 

 4.5.2 St. Jude Riata ICD Leads Recalled, 2011 68 

 4.6 Mergers and Acquisitions 68 

 4.6.1 Boston Scientific Acquires C.R. Bard’s Electrophysiology Business 68 

 4.6.2 Sorin Group Closes Further Investment and Option-to-Buy in Enopace Biomedical 68 

 4.7 Key Partnerships 69 

 4.7.1 Leti Forms Partnership with Sorin, TIMA, Cedrat Technologies, Tronics and EASII IC 69 

 4.7.2 St. Jude Medical to Invest in Nanostim 69 

 4.7.3 Sorin Group Signs Supply Agreement for Boston Scientific Corporation Lotus Valve System 71 

 4.8 Economic Impact 71 

 4.8.1 Cost-Effectiveness of Pacemakers 71 

 4.8.2 Cost-Effectiveness of ICDs 72 

 4.8.3 Cost-Effectiveness of Cardiac Resynchronization Therapy 72 

 4.9 Market Drivers 73 

 4.9.1 Rapidly Increasing Patient Populations Suitable for Device Implantation to Drive Sales 73 

 4.9.2 Technological Advances and New Products in Pipeline to Drive Sales 76 

 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 Increased Primary Prevention Procedures 87 

 4.9.7 Increases in Implantation from Positive Clinical Trials 88 

 4.9.8 Antibacterial Envelopes to Reduce Rates of Complication and Increase Device Safety 89 

 4.9.9 Strong Portfolio of Pipeline Products from Key Players to Drive Future Growth of the Market 89 

 4.9.10 Leadless Technology Eliminates Lead-Related Complications 90 

 4.9.11 Diagnostic Rate Improvements Expected to Drive CRM Device Sales 91 

 4.9.12 Increased Device Implantation in Pediatrics 91 

 4.10 Market Barriers 92 

 4.10.1 US Healthcare Reform May Impact US CRM Market Growth Adversely 93 

 4.10.2 Increased Emphasis on Value-Based Payment Programs through Medicare and Cost-Effectiveness Research to Cause Competitive Pricing Pressure 93 

 4.10.3 Innovative and Next-Generation Drug Therapy May Pose a Challenge to CRM Devices in the Future 94 

 4.10.4 Slow Adoption of Remote Patient Monitoring Could Restrain Market Growth 94 

 4.10.5 Inconsistencies between Various Guidelines Affects Treatment 95 

 4.10.6 Inappropriate Shock Rates May Thwart Potential CRM Patients 96 

 4.10.7 Patient Education to Increase Awareness and Device Adoption 96 

 4.10.8 Declining Average Selling Prices to Adversely Affect CRM Product Revenues 97 

 5 Competitive Assessment 98 

 5.1 Overview 98 

 5.2 Regional Market Share 98 

 5.2.1 Pacemaker and CRT-P Market Company Share in the US 98 

 5.2.2 ICD and CRT-D Market Company Share in the US 100 

 6 Unmet Needs 101 

 6.1 Overview 101 

 6.2 Leads and Electrode Development 101 

 6.2.1 MRI-Compatible Generators and Leads 102 

 6.2.2 Single-Lead Systems with Atrial Diagnostics 104 

 6.3 Power-Supplying Batteries 104 

 6.4 Energy-Harvesting Batteries 105 

 6.5 Rates of Infection 106 

 7 Pipeline Products 107 

 7.1 Overview 107 

 7.2 Pipeline Products by Phase in Development 107 

 7.3 Pacemaker and CRT-P Product Profiles 108 

 7.3.1 Aortic Pacemaker (Hadasit Medical Research Services & Development Ltd.) 108 

 7.3.2 Cardiac Energy Harvesting Pacemaker (University of Michigan) 109 

 7.3.3 Endurance Microgenerator (Endurance Rhythm) 109 

 7.3.4 Implantable Dual-Chamber Pacemaker (MicroPort Scientific) 110 

 7.3.5 Unconditional MRI-Compatible Implantable Pacemaker (Kenergy, Inc.) 110 

 7.3.6 Tissue-Engineered Autonomous Pacemaker (Duke University) 111 

 7.3.7 Wireless Cardiac Stimulation Device (EBR Systems, Inc.) 111 

 7.4 ICD and CRT-D Product Profiles 112 

 7.4.1 Atrial Defibrillator (SmartWave Medical Ltd.) 112 

 7.4.2 CardiaLen (CardiaLen, Inc.) 112 

 7.4.3 Chronicle (Medtronic) 113 

 7.5 Clinical Trials to Watch 114 

 7.5.1 Overview 114 

 7.5.2 SELECT-LV Trial of WiCS-LV System (EBR Systems, Inc.) 114 

 7.5.3 MultiPoint Pacing Clinical Trial of Quadra Assura CRT-D (Medtronic) 116 

 7.5.4 MADIT-ASIA Trial with Invive CRT-P (Boston Scientific) 117 

 7.5.5 MultiPoint Pacing IDE Study of Promote Quadra (St. Jude Medical) 119 

 7.5.6 Post Approval Study of S-ICD System (Boston Scientific) 120 

 7.5.7 ProMRI Study of the Evia/Entovis Pacemaker System 122 

 7.5.8 MIRACLE EF Clinical Study of Consulta CRT-P (Medtronic) 124 

 8 Current and Future Players 127 

 8.1 Overview 127 

 8.2 Trends in Corporate Strategy 127 

 8.3 Biotronik 128 

 8.3.1 Overview 128 

 8.3.2 Portfolio Evaluation 130 

 8.3.3 Commercial Positioning 140 

 8.3.4 Company SWOT Analysis 141 

 8.4 Boston Scientific 141 

 8.4.1 Overview 141 

 8.4.2 Portfolio Evaluation 143 

 8.4.3 Commercial Positioning 152 

 8.4.4 Company SWOT Analysis 153 

 8.5 Impulse Dynamics 153 

 8.5.1 Overview 153 

 8.5.2 Portfolio Evaluation 153 

 8.5.3 Commercial Positioning 154 

 8.5.4 Company SWOT Analysis 154 

 8.6 Medtronic 155 

 8.6.1 Overview 155 

 8.6.2 Portfolio Evaluation 157 

 8.6.3 Marketed Products 159 

 8.6.4 Additional Products 167 

 8.6.5 Commercial Positioning 169 

 8.6.6 Company SWOT Analysis 171 

 8.7 Sorin Group 171 

 8.7.1 Overview 171 

 8.7.2 Portfolio Evaluation 173 

 8.7.3 Marketed Products 174 

 8.7.4 Commercial Positioning 175 

 8.7.5 Company SWOT Analysis 176 

 8.8 St. Jude Medical 176 

 8.8.1 Overview 176 

 8.8.2 Portfolio Evaluation 177 

 8.8.3 Marketed Products 179 

 8.8.4 Commercial Positioning 192 

 8.8.5 Company SWOT Analysis 193 

 9 Market Outlooks and Forecasts 194 

 9.1 Market Outlooks and Forecasts by Geography 194 

 9.1.1 US 194 

 10 Appendix 203 

 10.1 Bibliography 203 

 10.2 Abbreviations 216 

 10.3 Report Methodology 221 

 10.3.1 Overview 221 

 10.3.2 Coverage 221 

 10.3.3 Secondary Research 221 

 10.3.4 Forecasting Methodology 222 

 10.3.5 Primary Research - Key Opinion Leader Interviews 223 

 10.3.6 Expert Panel Validation 224 

 10.4 Physicians and Specialists Included in this Study 224 

 10.5 About the Authors 226 

 10.5.1 Analysts 226 

 10.5.2 Global Head of Healthcare 227 

 10.6 About MediPoint 228 

 10.7 About GlobalData 228 

 10.8 Disclaimer 228 

 

 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, US, Ages ? 45 Years, Men and Women (n), 2012-2019 40 

 Table 5: Pacemaker Implantation Classification Guideline 43 

 Table 6: Patient Post-Operative Condition with ICD Implantation, 2012 50 

 Table 7: Level of Evidence Guidelines 54 

 Table 8: CRT-P versus Conventional Pacemakers, Sales Volume Comparison, US, 2012 60 

 Table 9: CRT-D versus Conventional ICD Products, Sales Volume Comparison, US, 2012 60 

 Table 10: Healthcare Expenditure by Payer (%) and Healthcare Expenditure per Capita ($), US, 2011 64 

 Table 11: Medicare Standardized Payment Rates for Hospitals for Pacemaker/CRT-P Implantation 65 

 Table 12: Medicare Standardized Payment Rates for Hospitals for Pacemaker/CRT-P Replacement 66 

 Table 13: Medicare Standardized Payment Rates for Hospitals for ICD/CRT-D Implantation 66 

 Table 14: Medicare Standardized Payment Rates for Hospitals for ICD/CRT-D Replacement 67 

 Table 15: Percentage of Population Aged 65 Years and Older, US, 2005-2015 74 

 Table 16: Percentage of Smoking Population by Country (%), US, 2010 74 

 Table 17: Percentage of Overweight and Obese Population (Aged 15 Years and Above), US, 2012 75 

 Table 18: Diabetes Prevalence Rates by Region (%), 20-79 Years, North America, 2007 & 2010 75 

 Table 19: Technological Innovations, Cardiac Rhythm Management Devices 77 

 Table 20: Benefits of Quadripolar Lead Technology 79 

 Table 21: Updated Cardiac Resynchronization Therapy Guidelines 80 

 Table 22: Barriers in Access to Quality Healthcare Leading to Disparities in CRM Treatment 92 

 Table 23: Average Selling Price ($) Comparison, US, 2012 97 

 Table 24: Pacemaker and CRT-P Market, US, Revenue ($) and Company Share (%), 2012 99 

 Table 25: ICD and CRT-D Market, US, Revenue ($) and Company Share (%), 2012 100 

 Table 26: Product Profile - Aortic Pacemaker 108 

 Table 27: Product Profile - Cardiac Energy Harvesting Pacemaker 109 

 Table 28: Product Profile - Endurance Microgenerator 109 

 Table 29: Product Profile - MicroPort Pacemaker 110 

 Table 30: Product Profile - Kenergy Pacemaker 110 

 Table 31: Product Profile - Tissue-Engineered Autonomous Pacemaker 111 

 Table 32: Product Profile - Wireless Cardiac Stimulation Device 111 

 Table 33: Product Profile - Atrial Defibrillator 112 

 Table 34: Product Profile - CardiaLen 112 

 Table 35: Product Profile - Chronicle 113 

 Table 36: Clinical Trial for WiCS-LV System 114 

 Table 37: Clinical Trial for Quadra Assura CRT-D 116 

 Table 38: Clinical Trial for Invive CRT-P 117 

 Table 39: MultiPoint Pacing IDE Study for Promote Quadra 119 

 Table 40: Post Approval Study of S-ICD System 120 

 Table 41: ProMRI Study of the Evia/Entovis Pacemaker System 122 

 Table 42: MIRACLE EF Clinical Study of Consulta CRT-P 124 

 Table 43: Company Profile - Biotronik 130 

 Table 44: Product Profile - Cylos 990 133 

 Table 45: Product Profile - Effecta 134 

 Table 46: Product Profile - Evia/Entovis 135 

 Table 47: Product Profile - Estella 136 

 Table 48: Product Profile - Stratos 137 

 Table 49: Product Profile - Ilesto 7 137 

 Table 50: Product Profile - Lumax 140 

 Table 51: Biotronik SWOT Analysis, 2012 141 

 Table 52: Company Profile - Boston Scientific 142 

 Table 53: Product Profile - Advantio 145 

 Table 54: Product Profile - Altrua 146 

 Table 55: Product Profile - Cognis 147 

 Table 56: Product Profile - Energen 148 

 Table 57: Product Profile - Incepta 148 

 Table 58: Product Profile - Ingenio 149 

 Table 59: Product Profile - Invive 150 

 Table 60: Product Profile - Punctua 151 

 Table 61: Product Profile - S-ICD System 2.0 151 

 Table 62: Product Profile - Teligen 152 

 Table 63: Boston Scientific SWOT Analysis, 2012 153 

 Table 64: Company Profile - Impulse Dynamics 153 

 Table 65: Product Profile - Optimizer IVs 154 

 Table 66: Impulse Dynamics SWOT Analysis, 2012 154 

 Table 67: Company Profile - Medtronic 156 

 Table 68: Product Profile - Advisa 159 

 Table 69: Product Profile - Adapta 160 

 Table 70: Product Profile - Brava/Viva 161 

 Table 71: Product Profile - Consulta 162 

 Table 72: Product Profile - EnPulse 162 

 Table 73: Product Profile - EnRhythm 163 

 Table 74: Product Profile - Ensura MRI 163 

 Table 75: Product Profile - Evera 164 

 Table 76: Product Profile - Protecta 164 

 Table 77: Product Profile - Secura 165 

 Table 78: Product Profile - Syncra 166 

 Table 79: Product Profile - Revo 166 

 Table 80: Product Profile - Concerto 167 

 Table 81: Product Profile - EnTrust 168 

 Table 82: Product Profile - Maximo II 168 

 Table 83: Medtronic SWOT Analysis, 2012 171 

 Table 84: Company Profile - Sorin Group 173 

 Table 85: Product Profile - Esprit 174 

 Table 86: Product Profile - Paradym 174 

 Table 87: Product Profile - Reply 2000 175 

 Table 88: Sorin Group SWOT Analysis, 2012 176 

 Table 89: Company Profile - St. Jude Medical 177 

 Table 90: Product Profile - Accent 180 

 Table 91: Product Profile - Accent MRI 181 

 Table 92: Product Profile - Anthem 182 

 Table 93: Product Profile - Allure Quadra 183 

 Table 94: Product Profile - AnalyST Accel 183 

 Table 95: Product Profile - Assurity 184 

 Table 96: Product Profile - Current Accel 184 

 Table 97: Product Profile - Current Plus 185 

 Table 98: Product Profile - Ellipse 185 

 Table 99: Product Profile - Endurity 186 

 Table 100: Product Profile - Fortify Assura 186 

 Table 101: Product Profile - Fortify 187 

 Table 102: Product Profile - Microny 187 

 Table 103: Product Profile - Leadless Pacemaker 188 

 Table 104: Product Profile - Promote Plus 189 

 Table 105: Product Profile - Quadra Assura 190 

 Table 106: Product Profile - Unify Assura 190 

 Table 107: Product Profile - Unify Quadra 191 

 Table 108: Product Profile - Unify 191 

 Table 109: Product Profile - Zephyr 192 

 Table 110: St. Jude Medical SWOT Analysis, 2012 193 

 Table 111: US Cardiac Rhythm Management Device Implantation 195 

 Table 112: Implantable Cardioverter-Defibrillators Patient Clinical History Breakdown (%), US, 2012 198 

 Table 113: Implanting Physician Training Status (%), US, 2012 199 

 Table 114: Pacemakers and Cardiac Resynchronization Therapy Pacemakers, US, Revenue ($m), 2010-2020 201 

 Table 115: Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Defibrillators Market, US, Revenue ($m), 2010-2020 202 

  

 1.2 List of Figures 

 Figure 1: Types of Arrhythmia 26 

 Figure 2: Generic Pacemaker Code 43 

 Figure 3: Guide for Pacemaker Implantation 44 

 Figure 4: Patient and General Population Preferences for CRM Device Reuse, US 61 

 Figure 5: Evaluating Effectiveness of Remote Home Monitoring 86 

 Figure 6: Pacemaker and CRT-P Market, US, Company Share (%), 2012 98 

 Figure 7: ICD and CRT-D Market, US, Company Share (%), 2012 100 

 Figure 8: CRM Pipeline Products by Phase in Development 107 

 Figure 9: Cardiac Resynchronization Therapy Implantation, US, by Age (%), 2011 197 

 Figure 10: Cardiac Rhythm Management Implantation by Sex (%), US, 2012 198 

 Figure 11: Pacemaker Implantation by Payer, US, 2012 199 

 Figure 12: Pacemaker Implantation by Hospital Size, US, 2012 200 

 Figure 13: Pacemakers and Cardiac Resynchronization Therapy Pacemakers, US, Revenue ($m), 2010-2020 201 

 Figure 14: Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Defibrillators Market, US, Revenue ($m), 2010-2020 202