MediPoint: Cardiac Assist Devices - EU Analysis and Market Forecasts -





Published: March 2013 | Pages: 240 | Format: PDF

 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 6 

 1.1 List of Tables 13 

 1.2 List of Figures 19 

 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 

 

 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 

 

 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