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





Published: March 2013 | Pages: 230 | 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). 

A number of devices have been used in the US over the past 20 years, and many are no longer on the market. There are a number of CAD market drivers that will result in further adoption of the devices, although barriers still remain to be overcome before there is widespread use globally. The largest driver of CAD development is the lack of suitable options for an increasing large elderly CHF population. 

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 US 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 US 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 US CAD Market. 

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

 - Access market sizing, forecasts and quantified growth opportunities in the US 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 US 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 18 

 2 Introduction 19 

 2.1 Catalyst 19 

 3 Disease Overview – Congestive Heart Failure 21 

 3.1 Anatomy and Physiology 21 

 3.2 Pathophysiology 21 

 3.3 Types of Heart Failure 22 

 3.3.1 Classification by Progression 22 

 3.3.2 Classification by Location 23 

 3.3.3 Classification by Pumping Mechanism 23 

 3.4 Etiology 24 

 3.4.1 Conditions That Cause Heart Failure 24 

 3.4.2 Other Risk Factors 25 

 3.5 Clinical Presentation 29 

 3.5.1 Symptoms of Heart Failure 29 

 3.6 Diagnosis of Heart Failure 30 

 3.6.1 Stages of Heart Failure Based on Diagnosis 32 

 3.7 Epidemiology 34 

 3.7.1 US 34 

 3.8 Epidemiology Forecast (2012–2019) 35 

 3.8.1 Prevalent Cases of Congestive Heart Failure 35 

 3.9 Clinical Outcomes 35 

 3.9.1 Prognosis 35 

 3.9.2 Surgical Risk Stratification 36 

 3.10 Treatment Modalities 37 

 3.10.1 Medication 38 

 3.10.2 Surgery 38 

 3.10.3 Cardiac Assistance 39 

 3.10.4 Heart Transplantation 42 

 3.11 Economic Impact 43 

 3.11.1 Individual Costs 43 

 3.11.2 Industry Costs 44 

 4 Competitive Assessment 45 

 4.1 Cardiac Assist Device Market, Comparison of Key Marketed Products 45 

 4.2 Ventricular Assist Devices, Comparison based on Pump Technology 48 

 4.3 Ventricular Assist Devices 49 

 4.3.1 Overview 49 

 4.3.2 First-Generation Devices 50 

 4.3.3 Second-Generation Devices 51 

 4.3.4 Third-Generation Devices 51 

 4.3.5 Fourth-Generation Devices 52 

 4.3.6 Fifth-Generation Devices 52 

 4.3.7 Sixth-Generation Devices 52 

 4.3.8 Seventh-Generation Devices 52 

 4.3.9 Counterpulsation Devices 52 

 4.3.10 Adult Primary Implant Breakdown 53 

 4.3.11 Brand-Specific Training 53 

 4.4 Extracorporeal Ventricular Assist Devices 54 

 4.4.1 AB5000 (Abiomed, Inc.) 54 

 4.4.2 CentriMag, PediMag (Thoratec) 56 

 4.4.3 Delta-Stream DP3 Pump (Medos Medizintechnik AG) 59 

 4.4.4 Excor (Berlin Heart) 60 

 4.4.5 PVAD (Thoratec) 62 

 4.4.6 RotaFlow (Maquet Cardiovascular) 64 

 4.5 Intracorporeal Ventricular Assist Devices 66 

 4.5.1 DuraHeart (Terumo) 67 

 4.5.2 EvaHeart (Sun Medical Technology Research Corporation) 69 

 4.5.3 Heart Assist 5 (MicroMed Cardiovascular, Inc.) 71 

 4.5.4 HeartMate II (Thoratec) 73 

 4.5.5 HVAD (HeartWare) 77 

 4.5.6 Incor (Berlin Heart) 81 

 4.5.7 IVAD (Thoratec) 83 

 4.5.8 Jarvik 2000 (Jarvik Heart) 85 

 4.6 Percutaneous Ventricular Assist Devices 88 

 4.6.1 Impella (Abiomed, Inc.) 89 

 4.6.2 Synergy (CircuLite) 92 

 4.6.3 TandemHeart (Cardiac Assist, Inc.) 94 

 4.7 Intra-Aortic Balloon Pumps 97 

 4.7.1 Overview 97 

 4.7.2 AutoCAT 2 Wave (Teleflex) 99 

 4.7.3 CardioSave (Maquet Cardiovascular) 101 

 4.7.4 CS300 (Maquet Cardiovascular) 103 

 4.7.5 iVAC (PulseCath) 105 

 4.7.6 Xemex (Zeon) 106 

 4.8 Extra-Aortic Balloon Pumps 107 

 4.8.1 C-Pulse (Sunshine Heart) 109 

 4.9 Total Artificial Heart 113 

 4.9.1 Overview 113 

 4.9.2 AbioCor (Abiomed) 114 

 4.9.3 SynCardia (SynCardia Systems, Inc.) 116 

 4.10 Extracorporeal Membrane Oxygenation 118 

 5 Unmet Needs and Opportunities 119 

 5.1 Unmet Needs 120 

 5.1.1 Transcutaneous Energy Transfer to Reduce Risk of Infection and Improve Lifestyle 120 

 5.1.2 Anti-Coagulation to Reduce Risk of Stroke 122 

 5.1.3 Thromboresistant Coatings 122 

 5.1.4 Noncontact Bearing Design 123 

 5.2 Opportunities 124 

 5.2.1 Reduction of Rehospitalization Rates 124 

 5.2.2 NYHA Class III Patients 126 

 5.2.3 Destination Therapy 127 

 5.2.4 Pediatrics 129 

 5.2.5 Hybrid Combination Therapy 130 

 5.2.6 Mitral Valve Repair 131 

 6 Pipeline Products 132 

 6.1 Overview 132 

 6.2 Ventricular Assist Devices 133 

 6.2.1 CorAide, DexAide (Teleflex) 133 

 6.2.2 DuraHeart II (Terumo) 135 

 6.2.3 HeartMate III (Thoratec) 136 

 6.2.4 HeartMate X (Thoratec) 137 

 6.2.5 MiFlow (HeartWare) 138 

 6.2.6 MiTiHeart LVAD (Mohawk Innovative Technology, Inc.) 139 

 6.2.7 MVAD (HeartWare) 141 

 6.2.8 PediaFlow VAD (HeartWare) 143 

 6.2.9 PediPump (Cleveland Clinic) 144 

 6.2.10 Revolution (Vadovations, Inc.) 145 

 6.2.11 s.pump (Medos Medizintechnik AG) 146 

 6.3 Percutaneous Ventricular Assist Devices 147 

 6.3.1 HeartMate PHP (Thoratec) 147 

 6.3.2 Reitan Catheter Pump (CardioBridge GmbH) 148 

 6.4 Total Artificial Hearts 150 

 6.4.1 AbioCor II (Abiomed, Inc.) 150 

 6.4.2 Carmat TAH (Carmat) 151 

 6.4.3 Golding TAH (Cleveland Clinic) 153 

 6.4.4 Beatless Heart (Texas Heart Institute) 154 

 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 193 

 8.1.3 Extensive Clinical Studies to Improve Adoption 193 

 8.1.4 Growing Patient Awareness and Increasing Numbers of Heart Centers 194 

 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 US 201 

 9.1.1 Overview 201 

 9.1.2 Reimbursement 202 

 9.1.3 Affordable Care Act Rehospitalization Fees 202 

 9.1.4 US CAD Market Revenue, 2010–2019 203 

 10 Appendix 205 

 10.1 Abbreviations 205 

 10.2 Bibliography 206 

 10.3 Methodology 220 

 10.3.1 Forecasting 220 

 10.3.2 Sources Used 220 

 10.3.3 Forecast Assumptions and Methods 221 

 10.4 Coverage 223 

 10.5 Secondary Research 223 

 10.6 Forecasting Methodology 224 

 10.6.1 Pricing Assumptions 224 

 10.7 Physicians and Specialists Included in this Study 225 

 10.8 Primary Research 226 

 10.9 About the Authors 227 

 10.9.1 Analysts 227 

 10.9.2 Global Head of Healthcare 228 

 10.10 Definitions 229 

 10.11 About GlobalData 230 

 10.12 Contact Us 230 

 10.13 Disclaimer 230 

  

 List of Tables 

 Table 1: New York Heart Association Scale 33 

 Table 2: American College of Cardiology Scale 33 

 Table 3: Prevalent Cases of Congestive Heart Failure, All Markets, Ages ?45 Years, Men and Women (n), 2012–2019 35 

 Table 4: Device Strategy at Time of Implant in US, 2011 40 

 Table 5: Cardiac Assist Devices by Launch 45 

 Table 6: Cardiac Assist Devices by Type 48 

 Table 7: Product Profile – AB5000 54 

 Table 8: AB5000 SWOT Analysis, 2012 55 

 Table 9: Product Profile – CentriMag, PediMag 57 

 Table 10: CentriMag, PediMag SWOT Analysis, 2012 58 

 Table 11: Product Profile – Delta-Stream DP3 Pump 59 

 Table 12: Delta-Stream DP3 SWOT Analysis, 2012 59 

 Table 13: Product Profile – Excor 60 

 Table 14: Excor SWOT Analysis, 2012 61 

 Table 15: Product Profile – PVAD 62 

 Table 16: PVAD SWOT Analysis, 2012 63 

 Table 17: Product Profile – RotaFlow 64 

 Table 18: RotaFlow SWOT Analysis, 2012 65 

 Table 19: Product Profile – DuraHeart 67 

 Table 20: DuraHeart SWOT Analysis, 2012 68 

 Table 21: Product Profile – EvaHeart 69 

 Table 22: EvaHeart SWOT Analysis, 2012 70 

 Table 23: EvaHeart US Pivotal BTT Trial 70 

 Table 24: Product Profile – HeartAssist 5 72 

 Table 25: HeartAssist 5 SWOT Analysis, 2012 72 

 Table 26: Product Profile – HeartMate II 73 

 Table 27: HeartMate II SWOT Analysis, 2012 74 

 Table 28: REVIVE-IT 75 

 Table 29: ROADMAP 75 

 Table 30: REMATCH 76 

 Table 31: Product Profile – HVAD 77 

 Table 32: HVAD SWOT Analysis, 2012 78 

 Table 33: ENDURANCE 79 

 Table 34: ADVANCE 80 

 Table 35: Product Profile – Incor 81 

 Table 36: Incor SWOT Analysis, 2012 82 

 Table 37: Product Profile – IVAD 83 

 Table 38: IVAD SWOT Analysis, 2012 84 

 Table 39: Product Profile – Jarvik 2000 85 

 Table 40: Jarvik 2000 SWOT Analysis, 2012 86 

 Table 41: Jarvik 2000 US Pivotal DT Trial 87 

 Table 42: Product Profile – Impella 90 

 Table 43: Impella SWOT Analysis, 2012 91 

 Table 44: Product Profile – Synergy 92 

 Table 45: Synergy SWOT Analysis, 2012 93 

 Table 46: Synergy CE Mark EU Trial 93 

 Table 47: Product Profile – TandemHeart 94 

 Table 48: TandemHeart SWOT Analysis, 2012 95 

 Table 49: TandemHeart to Reduce Infarct Size (TRIS) 96 

 Table 50: Product Profile – AutoCAT 2 Wave 99 

 Table 51: AutoCAT 2 SWOT Analysis, 2012 100 

 Table 52: Product Profile – CardioSave 101 

 Table 53: CardioSave SWOT Analysis, 2012 102 

 Table 54: Product Profile – CS300 103 

 Table 55: CS300 SWOT Analysis, 2012 104 

 Table 56: Product Profile – iVAC 105 

 Table 57: iVAC SWOT Analysis, 2012 105 

 Table 58: Product Profile – Xemex 106 

 Table 59: Xemex SWOT Analysis, 2012 106 

 Table 60: Comparing Leading CAD Products 108 

 Table 61: Product Profile – C-Pulse 109 

 Table 62: C-Pulse SWOT Analysis, 2012 111 

 Table 63: C-Pulse US Pivotal Trial 112 

 Table 64: Product Profile – AbioCor 114 

 Table 65: AbioCor SWOT Analysis, 2012 115 

 Table 66: Product Profile – SynCardia 117 

 Table 67: SynCardia SWOT Analysis, 2012 118 

 Table 68: Risk Prediction Models 125 

 Table 69: Cardiac Assist Devices in Pipeline 132 

 Table 70: Product Profile – CorAide, DexAide 133 

 Table 71: CorAide, DexAide SWOT Analysis, 2012 134 

 Table 72: Product Profile – DuraHeart II 135 

 Table 73: DuraHeart II SWOT Analysis, 2012 135 

 Table 74: Product Profile – HeartMate III 136 

 Table 75: HeartMate III SWOT Analysis, 2012 136 

 Table 76: Product Profile – HeartMate X 137 

 Table 77: HeartMate X SWOT Analysis, 2012 137 

 Table 78: Product Profile – MiFlow 138 

 Table 79: MiFlow SWOT Analysis, 2012 138 

 Table 80: Product Profile – MiTiHeart Corporation 139 

 Table 81: MiTiHeart SWOT Analysis, 2012 140 

 Table 82: Product Profile – MVAD 141 

 Table 83: MVAD SWOT Analysis, 2012 142 

 Table 84: Product Profile – PediaFlow 143 

 Table 85: PediaFlow SWOT Analysis, 2012 143 

 Table 86: Product Profile – PediPump 144 

 Table 87: PediPump SWOT Analysis, 2012 144 

 Table 88: Product Profile – Revolution 145 

 Table 89: Revolution SWOT Analysis, 2012 145 

 Table 90: Product Profile – s.pump 146 

 Table 91: s.pump SWOT Analysis, 2012 146 

 Table 92: Product Profile – HeartMate PHP 147 

 Table 93: HeartMate PHP SWOT Analysis, 2012 147 

 Table 94: Product Profile – Reitan Catheter Pump 148 

 Table 95: Reitan Catheter Pump SWOT Analysis, 2012 149 

 Table 96: Product Profile – AbioCor II 150 

 Table 97: AbioCor II SWOT Analysis, 2012 150 

 Table 98: Product Profile – Carmat 151 

 Table 99: Carmat SWOT Analysis, 2012 152 

 Table 100: Product Profile – Golding TAH 153 

 Table 101: Golding TAH SWOT Analysis, 2012 153 

 Table 102: Product Profile – Beatless Heart 154 

 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: Heart Failure, Prevalence (% total population, n [millions]), US, 2010–2019 192 

 Table 149: Population Aged 65 Years and Above as Percentage of Overall Population, Global, 1960–2050 195 

 Table 150: Cardiac Assist Devices, Average Selling Price ($),US, 2012 199 

 Table 151: US CAD Revenue ($m), 2010–2019 203 

 Table 152: Sources of Epidemiological Data Used for the Forecast 220 

 Table 153: New York Heart Association (NYHA) Class Distributions Description 222 

  

 List of Figures 

 Figure 1: Classifications of Heart Failure 22 

 Figure 2: Stages of Heart Failure Based on Diagnosis 32 

 Figure 3: Treatment Modalities for Heart Failure 37 

 Figure 4: Cardiac Assist Devices, Market Dynamics 191 

 Figure 5: Heart Failure, Prevalence (million), US, 2010–2019 192 

 Figure 6: Population Aged 65 Years and Above as Percentage of Overall Population, Global, 1960–2050 195 

 Figure 7: US CAD Revenue ($m), 2010–2019 203 

 Figure 8: CAD Purchases vs. Heart Transplants, US (N), 2010–2019 204