MediPoint: Cardiac Assist Devices - EU Analysis and Market Forecasts

Summary

Cardiac Assist Devices (CAD) are mechanical pumps that work in conjunction with a patient’s heart to improve the pumping efficiency, increase the cardiac output and restore normal blood circulation. The devices are typically employed in patients suffering from end-stage Congestive Heart Failure (CHF), where the chances of survival through oral medications alone become minimal. The scarcity of donor organs has led to the development of interim interventions that utilize CADs, which comprise three segments: Ventricular Assist Devices (VAD), Intra-Aortic Balloon Pumps (IABP), and Total Artificial Hearts (TAH).

The Cardiac Assist Device (CAD) market, including Intra-Aortic Balloon Pumps (IABP), Ventricular Assist Devices (VAD), and Total Artificial Hearts (TAH), is expected to experience significant growth during the seven-year forecast period in the 5EU market. The report provides insight into the competitive CAD landscape, including new companies entering the market and pipeline products in development. It quantifies the potential of long-term cardiac assist device use in end-stage heart failure patients awaiting transplantation, and examines the impact of this disruptive technology around the world. Included in the report is investigation of the highest growth sectors for CAD, with a focus on next-generation technologies due to enter the market, including transcutaneous energy transfer and fully implantable support systems.

Scope

- An overview of Congestive Heart Failure, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.
- Annualized EU CAD market revenue and future forecasts from 2009 to 2011, forecast for 7 years to 2018.
- Investigation of current and future market competition for CAD
- 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 EU device 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 EU CAD Market.
- Realize device preferences of physicians who have performed the tests already.
- Access market sizing, forecasts and quantified growth opportunities in the EU CAD 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 EU CAD market landscape? Identify, understand and capitalize.

Table Of Contents

1 Table of Contents
1 Table of Contents 6


2 Introduction 20
2.1 Catalyst 20
3 Disease Overview - Congestive Heart Failure 22
3.1 Anatomy and Physiology 22
3.2 Pathophysiology 22
3.3 Types of Heart Failure 23
3.3.1 Classification by Progression 23
3.3.2 Classification by Location 24
3.3.3 Classification by Pumping Mechanism 24
3.4 Etiology 25
3.4.1 Conditions That Cause Heart Failure 25
3.4.2 Other Risk Factors 26
3.5 Clinical Presentation 30
3.5.1 Symptoms of Heart Failure 30
3.6 Diagnosis of Heart Failure 31
3.6.1 Stages of Heart Failure Based on Diagnosis 33
3.7 Epidemiology 35
3.7.1 Global Trends 35
3.7.2 US 35
3.8 Epidemiology Forecast (2012-2019) 36
3.8.1 Prevalent Cases of Congestive Heart Failure 36
3.9 Clinical Outcomes 37
3.9.1 Prognosis 37
3.9.2 Surgical Risk Stratification 38
3.10 Treatment Modalities 39
3.10.1 Medication 40
3.10.2 Surgery 40
3.10.3 Cardiac Assistance 41
3.10.4 Heart Transplantation 44
3.11 Economic Impact 45
3.11.1 Individual Costs 45
3.11.2 Industry Costs 46
4 Competitive Assessment 47
4.1 Cardiac Assist Device Market, Comparison of Key Marketed Products 47
4.2 Ventricular Assist Devices, Comparison based on Pump Technology 50
4.3 Ventricular Assist Devices 51
4.3.1 Overview 51
4.3.2 First-Generation Devices 52
4.3.3 Second-Generation Devices 53
4.3.4 Third-Generation Devices 53
4.3.5 Fourth-Generation Devices 54
4.3.6 Fifth-Generation Devices 54
4.3.7 Sixth-Generation Devices 54
4.3.8 Seventh-Generation Devices 54
4.3.9 Counterpulsation Devices 54
4.3.10 Adult Primary Implant Breakdown 55
4.3.11 Brand-Specific Training 55
4.4 Extracorporeal Ventricular Assist Devices 56
4.4.1 AB5000 (Abiomed, Inc.) 56
4.4.2 CentriMag, PediMag (Thoratec) 58
4.4.3 Delta-Stream DP3 Pump (Medos Medizintechnik AG) 61
4.4.4 Excor (Berlin Heart) 62
4.4.5 PVAD (Thoratec) 64
4.4.6 RotaFlow (Maquet Cardiovascular) 66
4.5 Intracorporeal Ventricular Assist Devices 68
4.5.1 DuraHeart (Terumo) 69
4.5.2 EvaHeart (Sun Medical Technology Research Corporation) 71
4.5.3 Heart Assist 5 (MicroMed Cardiovascular, Inc.) 73
4.5.4 HeartMate II (Thoratec) 75
4.5.5 HVAD (HeartWare) 79
4.5.6 Incor (Berlin Heart) 83
4.5.7 IVAD (Thoratec) 85
4.5.8 Jarvik 2000 (Jarvik Heart) 87
4.6 Percutaneous Ventricular Assist Devices 90
4.6.1 Impella (Abiomed, Inc.) 91
4.6.2 Synergy (CircuLite) 94
4.6.3 TandemHeart (Cardiac Assist, Inc.) 96
4.7 Intra-Aortic Balloon Pumps 99
4.7.1 Overview 99
4.7.2 AutoCAT 2 Wave (Teleflex) 101
4.7.3 CardioSave (Maquet Cardiovascular) 103
4.7.4 CS300 (Maquet Cardiovascular) 105
4.7.5 iVAC (PulseCath) 107
4.7.6 Xemex (Zeon) 108
4.8 Extra-Aortic Balloon Pumps 109
4.8.1 C-Pulse (Sunshine Heart) 111
4.9 Total Artificial Heart 115
4.9.1 Overview 115
4.9.2 AbioCor (Abiomed) 116
4.9.3 SynCardia (SynCardia Systems, Inc.) 118
4.10 Extracorporeal Membrane Oxygenation 120
5 Unmet Needs and Opportunities 121
5.1 Unmet Needs 122
5.1.1 Transcutaneous Energy Transfer to Reduce Risk of Infection and Improve Lifestyle 122
5.1.2 Anti-Coagulation to Reduce Risk of Stroke 124
5.1.3 Thromboresistant Coatings 124
5.1.4 Noncontact Bearing Design 125
5.2 Opportunities 126
5.2.1 Reduction of Rehospitalization Rates 126
5.2.2 NYHA Class III Patients 128
5.2.3 Destination Therapy 129
5.2.4 Pediatrics 131
5.2.5 Hybrid Combination Therapy 132
5.2.6 Mitral Valve Repair 133
6 Pipeline Products 134
6.1 Overview 134
6.2 Ventricular Assist Devices 135
6.2.1 CorAide, DexAide (Teleflex) 135
6.2.2 DuraHeart II (Terumo) 137
6.2.3 HeartMate III (Thoratec) 138
6.2.4 HeartMate X (Thoratec) 139
6.2.5 MiFlow (HeartWare) 140
6.2.6 MiTiHeart LVAD (Mohawk Innovative Technology, Inc.) 141
6.2.7 MVAD (HeartWare) 143
6.2.8 PediaFlow VAD (HeartWare) 145
6.2.9 PediPump (Cleveland Clinic) 146
6.2.10 Revolution (Vadovations, Inc.) 147
6.2.11 s.pump (Medos Medizintechnik AG) 148
6.3 Percutaneous Ventricular Assist Devices 149
6.3.1 HeartMate PHP (Thoratec) 149
6.3.2 Reitan Catheter Pump (CardioBridge GmbH) 150
6.4 Total Artificial Hearts 152
6.4.1 AbioCor II (Abiomed, Inc.) 152
6.4.2 Carmat TAH (Carmat) 153
6.4.3 Golding TAH (Cleveland Clinic) 154
6.4.4 Beatless Heart (Texas Heart Institute) 155
6.4.5 MagScrew (Cleveland Clinic) 156
6.4.6 ReinHeart (University of Aachen) 157
6.4.7 Other 157
7 Current and Future Players 158
7.1 Company Profiles 158
7.1.1 Abiomed, Inc. 158
7.1.2 Berlin Heart 160
7.1.3 CardiacAssist, Inc. 162
7.1.4 CardioBridge 163
7.1.5 Carmat 164
7.1.6 CircuLite 165
7.1.7 HeartWare International, Inc. 166
7.1.8 Jarvik Heart 169
7.1.9 Maquet Cardiovascular 171
7.1.10 Medos Medizintechnik AG 172
7.1.11 MicroMed Cardiovascular, Inc. 173
7.1.12 MiTiHeart Corporation 175
7.1.13 PulseCath BV 176
7.1.14 Sunshine Heart 177
7.1.15 SynCardia Systems, Inc. 179
7.1.16 Teleflex Medical 181
7.1.17 Terumo 182
7.1.18 Thoratec 184
7.1.19 Sun Medical 189
7.1.20 Zeon Medical 190
7.1.21 Other 190
8 Market Drivers, Opportunities, and Barriers 191
8.1 Market Drivers 192
8.1.1 Increasing Heart Failure Population 192
8.1.2 Technological Advancements, Miniaturizations, Leading to Increased Adoption by Physicians 192
8.1.3 Extensive Clinical Studies to Improve Adoption 193
8.1.4 Growing Patient Awareness and Increasing Numbers of Heart Centers 193
8.1.5 Aging Population to Drive Growth in Cardiac Assist Devices Market 195
8.2 Market Opportunities 197
8.2.1 Highly Under-Penetrated Market to Provide Significant Opportunity 197
8.2.2 Shortage of Donor Hearts for Transplantation Creates Opportunity 197
8.3 Market Barriers 198
8.3.1 Complications Associated with CAD 198
8.3.2 High Cost Makes Treatment Unaffordable 198
8.3.3 Alternative Therapies 199
8.3.4 Medical Device Tax Affects Manufacturers 199
8.3.5 Long Research and Development of Devices may Deter New Entrants into the Market 200
8.3.6 Complications Associated with Cardiac Assist Devices might Deter Physicians from Adoption of Their Use 200
8.4 Mergers and Acquisitions 200
8.4.1 Potential Sunshine Acquisition 200
9 Country Outlook and Forecasts 201
9.1 France 201
9.1.1 Overview 201
9.1.2 France CAD Revenue, 2010-2019 202
9.2 Germany 203
9.2.1 Overview 203
9.2.2 Germany CAD Revenue, 2010-2019 204
9.3 Italy 205
9.3.1 Overview 205
9.3.2 Italy CAD Revenue, 2010-2019 205
9.4 Spain 207
9.4.1 Overview 207
9.4.2 Spain CAD Revenue, 2010-2019 208
9.5 UK 209
9.5.1 Overview 209
9.5.2 UK CAD Revenue, 2010-2019 210
10 Appendix 211
10.1 Abbreviations 211
10.2 Bibliography 213
10.3 Methodology 226
10.3.1 Forecasting 226
10.3.2 Sources Used 227
10.3.3 Forecast Assumptions and Methods 230
10.4 Coverage 233
10.5 Secondary Research 233
10.6 Forecasting Methodology 234
10.6.1 Pricing Assumptions 234
10.7 Physicians and Specialists Included in this Study 235
10.8 Primary Research 236
10.9 About the Authors 237
10.9.1 Analysts 237
10.9.2 Global Head of Healthcare 238
10.10 Definitions 239
10.11 About GlobalData 240
10.12 Contact Us 240
10.13 Disclaimer 240

1.1 List of Tables
Table 1: New York Heart Association Scale 34
Table 2: American College of Cardiology Scale 34
Table 3: Prevalent Cases of Congestive Heart Failure, All Markets, Ages ?45 Years, Men and Women (n), 2012-2019 36
Table 4: Device Strategy at Time of Implant in US, 2011 42
Table 5: Cardiac Assist Devices by Launch 47
Table 6: Cardiac Assist Devices by Type 50
Table 7: Product Profile - AB5000 56
Table 8: AB5000 SWOT Analysis, 2012 57
Table 9: Product Profile - CentriMag, PediMag 59
Table 10: CentriMag, PediMag SWOT Analysis, 2012 60
Table 11: Product Profile - Delta-Stream DP3 Pump 61
Table 12: Delta-Stream DP3 SWOT Analysis, 2012 61
Table 13: Product Profile - Excor 62
Table 14: Excor SWOT Analysis, 2012 63
Table 15: Product Profile - PVAD 64
Table 16: PVAD SWOT Analysis, 2012 65
Table 17: Product Profile - RotaFlow 66
Table 18: RotaFlow SWOT Analysis, 2012 67
Table 19: Product Profile - DuraHeart 69
Table 20: DuraHeart SWOT Analysis, 2012 70
Table 21: Product Profile - EvaHeart 71
Table 22: EvaHeart SWOT Analysis, 2012 72
Table 23: EvaHeart US Pivotal BTT Trial 72
Table 24: Product Profile - HeartAssist 5 74
Table 25: HeartAssist 5 SWOT Analysis, 2012 74
Table 26: Product Profile - HeartMate II 75
Table 27: HeartMate II SWOT Analysis, 2012 76
Table 28: REVIVE-IT 77
Table 29: ROADMAP 77
Table 30: REMATCH 78
Table 31: Product Profile - HVAD 79
Table 32: HVAD SWOT Analysis, 2012 80
Table 33: ENDURANCE 81
Table 34: ADVANCE 82
Table 35: Product Profile - Incor 83
Table 36: Incor SWOT Analysis, 2012 84
Table 37: Product Profile - IVAD 85
Table 38: IVAD SWOT Analysis, 2012 86
Table 39: Product Profile - Jarvik 2000 87
Table 40: Jarvik 2000 SWOT Analysis, 2012 88
Table 41: Jarvik 2000 US Pivotal DT Trial 89
Table 42: Product Profile - Impella 92
Table 43: Impella SWOT Analysis, 2012 93
Table 44: Product Profile - Synergy 94
Table 45: Synergy SWOT Analysis, 2012 95
Table 46: Synergy CE Mark EU Trial 95
Table 47: Product Profile - TandemHeart 96
Table 48: TandemHeart SWOT Analysis, 2012 97
Table 49: TandemHeart to Reduce Infarct Size (TRIS) 98
Table 50: Product Profile - AutoCAT 2 Wave 101
Table 51: AutoCAT 2 SWOT Analysis, 2012 102
Table 52: Product Profile - CardioSave 103
Table 53: CardioSave SWOT Analysis, 2012 104
Table 54: Product Profile - CS300 105
Table 55: CS300 SWOT Analysis, 2012 106
Table 56: Product Profile - iVAC 107
Table 57: iVAC SWOT Analysis, 2012 107
Table 58: Product Profile - Xemex 108
Table 59: Xemex SWOT Analysis, 2012 108
Table 60: Comparing Leading CAD Products 110
Table 61: Product Profile - C-Pulse 111
Table 62: C-Pulse SWOT Analysis, 2012 113
Table 63: C-Pulse US Pivotal Trial 114
Table 64: Product Profile - AbioCor 116
Table 65: AbioCor SWOT Analysis, 2012 117
Table 66: Product Profile - SynCardia 119
Table 67: SynCardia SWOT Analysis, 2012 120
Table 68: Risk Prediction Models 127
Table 69: Cardiac Assist Devices in Pipeline 134
Table 70: Product Profile - CorAide, DexAide 135
Table 71: CorAide, DexAide SWOT Analysis, 2012 136
Table 72: Product Profile - DuraHeart II 137
Table 73: DuraHeart II SWOT Analysis, 2012 137
Table 74: Product Profile - HeartMate III 138
Table 75: HeartMate III SWOT Analysis, 2012 138
Table 76: Product Profile - HeartMate X 139
Table 77: HeartMate X SWOT Analysis, 2012 139
Table 78: Product Profile - MiFlow 140
Table 79: MiFlow SWOT Analysis, 2012 140
Table 80: Product Profile - MiTiHeart Corporation 141
Table 81: MiTiHeart SWOT Analysis, 2012 142
Table 82: Product Profile - MVAD 143
Table 83: MVAD SWOT Analysis, 2012 144
Table 84: Product Profile - PediaFlow 145
Table 85: PediaFlow SWOT Analysis, 2012 145
Table 86: Product Profile - PediPump 146
Table 87: PediPump SWOT Analysis, 2012 146
Table 88: Product Profile - Revolution 147
Table 89: Revolution SWOT Analysis, 2012 147
Table 90: Product Profile - s.pump 148
Table 91: s.pump SWOT Analysis, 2012 148
Table 92: Product Profile - HeartMate PHP 149
Table 93: HeartMate PHP SWOT Analysis, 2012 149
Table 94: Product Profile - Reitan Catheter Pump 150
Table 95: Reitan Catheter Pump SWOT Analysis, 2012 151
Table 96: Product Profile - AbioCor II 152
Table 97: AbioCor II SWOT Analysis, 2012 152
Table 98: Product Profile - Carmat 153
Table 99: Carmat SWOT Analysis, 2012 153
Table 100: Product Profile - Golding TAH 154
Table 101: Golding TAH SWOT Analysis, 2012 154
Table 102: Product Profile - Beatless Heart 155
Table 103: Beatless Heart SWOT Analysis, 2012 155
Table 104: Product Profile - MagScrew 156
Table 105: MagScrew SWOT Analysis, 2012 156
Table 106: Product Profile - ReinHeart 157
Table 107: ReinHeart SWOT Analysis, 2012 157
Table 108: Company Profile - Abiomed, Inc. 158
Table 109: Abiomed SWOT Analysis, 2012 159
Table 110: Company Profile - Berlin Heart 160
Table 111: Berlin Heart SWOT Analysis, 2012 161
Table 112: Company Profile - Cardiac Assist 162
Table 113: Cardiac Assist SWOT Analysis, 2012 162
Table 114: Company Profile - CardioBridge 163
Table 115: CardioBridge SWOT Analysis, 2012 163
Table 116: Company Profile - Carmat 164
Table 117: Carmat SWOT Analysis, 2012 164
Table 118: Company Profile - CircuLite 165
Table 119: CircuLite SWOT Analysis, 2012 165
Table 120: Company Profile - HeartWare 167
Table 121: HeartWare SWOT Analysis, 2012 168
Table 122: Company Profile - Jarvik Heart 169
Table 123: Jarvik Heart SWOT Analysis, 2012 170
Table 124: Company Profile - Maquet Cardiovascular 171
Table 125: Maquet Cardiovascular SWOT Analysis, 2012 171
Table 126: Company Profile - Medos Medizintechnik AG 172
Table 127: Medos Medizintechnik AG SWOT Analysis, 2012 172
Table 128: Company Profile - MicroMed Cardiovascular, Inc. 173
Table 129: MicroMed Cardiovascular SWOT Analysis, 2012 174
Table 130: Company Profile - MiTiHeart Corporation 175
Table 131: MiTiHeart Corporation SWOT Analysis, 2012 175
Table 132: Company Profile - PulseCath 176
Table 133: PulseCath SWOT Analysis, 2012 176
Table 134: Company Profile - Sunshine Heart 177
Table 135: Sunshine Heart SWOT Analysis, 2012 178
Table 136: Company Profile - SynCardia Systems 179
Table 137: SynCardia Systems SWOT Analysis, 2012 180
Table 138: Company Profile - Teleflex 181
Table 139: Teleflex SWOT Analysis, 2012 181
Table 140: Company Profile - Terumo Heart 182
Table 141: Terumo Heart SWOT Analysis, 2012 183
Table 142: Company Profile - Thoratec 185
Table 143: Thoratec SWOT Analysis, 2012 188
Table 144: Company Profile - Sun Medical 189
Table 145: Sun Medical SWOT Analysis, 2012 189
Table 146: Company Profile - Zeon Medical 190
Table 147: Zeon Medical SWOT Analysis, 2012 190
Table 148: Population Aged 65 Years and Above as Percentage of Overall Population, Global, 1960-2050 195
Table 149: Cardiac Assist Devices, Average Selling Price ($),US, 2012 199
Table 150: France CAD Revenue ($m), 2010-2019 202
Table 151: Germany CAD Revenue ($m), 2010-2019 204
Table 152: Germany CAD Revenue ($m), 2010-2019 206
Table 153: Germany CAD Revenue ($m), 2010-2019 208
Table 154: UK CAD Revenue ($m), 2010-2019 210
Table 155: Sources of Epidemiological Data Used for the Forecast 227
Table 156: New York Heart Association (NYHA) Class Distributions Description 232

1.2 List of Figures
Figure 1: Classifications of Heart Failure 23
Figure 2: Stages of Heart Failure Based on Diagnosis 33
Figure 3: Treatment Modalities for Heart Failure 39
Figure 4: Cardiac Assist Devices, Market Dynamics 191
Figure 5: Population Aged 65 Years and Above as Percentage of Overall Population, Global, 1960-2050 195
Figure 6: France CAD Revenue ($m), 2010-2019 202
Figure 7: Germany CAD Revenue ($m), 2010-2019 204
Figure 8: Italy CAD Revenue ($m), 2010-2019 205
Figure 9: Spain CAD Revenue ($m), 2010-2019 208
Figure 10: UK CAD Revenue ($m), 2010-2019 210

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