Cardiac Assist Devices

Transcription

1 Cardiac Assist Devices Current and Pipeline Products GDME1006FPR / Published March 2013

2 1 Table of Contents 1 Table of Contents List of Tables List of Figures Introduction Catalyst Competitive Assessment Cardiac Assist Device Market, Comparison of Key Marketed Products Ventricular Assist Devices Market, Key Company Share Ventricular Assist Devices, Comparison based on Pump Technology Ventricular Assist Devices Overview First-Generation Devices Second-Generation Devices Third-Generation Devices Fourth-Generation Devices Fifth-Generation Devices Sixth-Generation Devices Seventh-Generation Devices Counterpulsation Devices Adult Primary Implant Breakdown Brand-Specific Training Extracorporeal Ventricular Assist Devices AB5000 (Abiomed, Inc.) CentriMag, PediMag (Thoratec) Delta-Stream DP3 Pump (Medos Medizintechnik AG) Excor (Berlin Heart) Page 2 GDME1006FPR / Published MAR 2013

3 3.5.5 PVAD (Thoratec) RotaFlow (Maquet Cardiovascular) Intracorporeal Ventricular Assist Devices DuraHeart (Terumo) EvaHeart (Sun Medical Technology Research Corporation) Heart Assist 5 (MicroMed Cardiovascular, Inc.) HeartMate II (Thoratec) HVAD (HeartWare) Incor (Berlin Heart) IVAD (Thoratec) Jarvik 2000 (Jarvik Heart) Percutaneous Ventricular Assist Devices Impella (Abiomed, Inc.) Synergy (CircuLite) TandemHeart (Cardiac Assist, Inc.) Intra-Aortic Balloon Pumps Overview AutoCAT 2 Wave (Teleflex) CardioSave (Maquet Cardiovascular) CS300 (Maquet Cardiovascular) ivac (PulseCath) Xemex (Zeon) Extra-Aortic Balloon Pumps C-Pulse (Sunshine Heart) Total Artificial Heart Overview AbioCor (Abiomed) SynCardia (SynCardia Systems, Inc.) Page 3 GDME1006FPR / Published MAR 2013

4 3.11 Extracorporeal Membrane Oxygenation Pipeline Products Overview Ventricular Assist Devices CorAide, DexAide (Teleflex) DuraHeart II (Terumo) HeartMate III (Thoratec) HeartMate X (Thoratec) MiFlow (HeartWare) MiTiHeart LVAD (Mohawk Innovative Technology, Inc.) MVAD (HeartWare) PediaFlow VAD (HeartWare) PediPump (Cleveland Clinic) Revolution (Vadovations, Inc.) s.pump (Medos Medizintechnik AG) Percutaneous Ventricular Assist Devices HeartMate PHP (Thoratec) Reitan Catheter Pump (CardioBridge GmbH) Total Artificial Hearts AbioCor II (Abiomed, Inc.) Carmat TAH (Carmat) Golding TAH (Cleveland Clinic) Beatless Heart (Texas Heart Institute) MagScrew (Cleveland Clinic) ReinHeart (University of Aachen) Other Current and Future Players Company Profiles Page 4 GDME1006FPR / Published MAR 2013

5 5.1.1 Abiomed, Inc Berlin Heart CardiacAssist, Inc CardioBridge Carmat CircuLite HeartWare International, Inc Jarvik Heart Maquet Cardiovascular Medos Medizintechnik AG MicroMed Cardiovascular, Inc MiTiHeart Corporation PulseCath BV Sunshine Heart SynCardia Systems, Inc Teleflex Medical Terumo Thoratec Sun Medical Zeon Medical Other Appendix Abbreviations Bibliography Methodology Forecasting Sources Used Forecast Assumptions and Methods Page 5 GDME1006FPR / Published MAR 2013

6 6.4 Coverage Secondary Research Forecasting Methodology Pricing Assumptions Physicians and Specialists Included in this Study Primary Research About the Authors Analysts Global Head of Healthcare Definitions About GlobalData Contact Us Disclaimer Page 6 GDME1006FPR / Published MAR 2013

7 1.1 List of Tables Table 1: Cardiac Assist Devices by Launch Table 2: Ventricular Assist Devices Market, Global, Company Share ($m), Table 3: Cardiac Assist Devices by Type Table 4: Product Profile AB Table 5: AB5000 SWOT Analysis, Table 6: Product Profile CentriMag, PediMag Table 7: CentriMag, PediMag SWOT Analysis, Table 8: Product Profile Delta-Stream DP3 Pump Table 9: Delta-Stream DP3 SWOT Analysis, Table 10: Product Profile Excor Table 11: Excor SWOT Analysis, Table 12: Product Profile PVAD Table 13: PVAD SWOT Analysis, Table 14: Product Profile RotaFlow Table 15: RotaFlow SWOT Analysis, Table 16: Product Profile DuraHeart Table 17: DuraHeart SWOT Analysis, Table 18: Product Profile EvaHeart Table 19: EvaHeart SWOT Analysis, Table 20: EvaHeart US Pivotal BTT Trial Table 21: Product Profile HeartAssist Table 22: HeartAssist 5 SWOT Analysis, Table 23: Product Profile HeartMate II Table 24: HeartMate II SWOT Analysis, Table 25: REVIVE-IT Table 26: ROADMAP Table 27: REMATCH Page 7 GDME1006FPR / Published MAR 2013

8 Table 28: Product Profile HVAD Table 29: HVAD SWOT Analysis, Table 30: ENDURANCE Table 31: ADVANCE Table 32: Product Profile Incor Table 33: Incor SWOT Analysis, Table 34: Product Profile IVAD Table 35: IVAD SWOT Analysis, Table 36: Product Profile Jarvik Table 37: Jarvik 2000 SWOT Analysis, Table 38: Jarvik 2000 US Pivotal DT Trial Table 39: Product Profile Impella Table 40: Impella SWOT Analysis, Table 41: Product Profile Synergy Table 42: Synergy SWOT Analysis, Table 43: Synergy CE Mark EU Trial Table 44: Product Profile TandemHeart Table 45: TandemHeart SWOT Analysis, Table 46: TandemHeart to Reduce Infarct Size (TRIS) Table 47: Product Profile AutoCAT 2 Wave Table 48: AutoCAT 2 SWOT Analysis, Table 49: Product Profile CardioSave Table 50: CardioSave SWOT Analysis, Table 51: Product Profile CS Table 52: CS300 SWOT Analysis, Table 53: Product Profile ivac Table 54: ivac SWOT Analysis, Table 55: Product Profile Xemex Page 8 GDME1006FPR / Published MAR 2013

9 Table 56: Xemex SWOT Analysis, Table 57: Comparing Leading CAD Products Table 58: Product Profile C-Pulse Table 59: C-Pulse SWOT Analysis, Table 60: C-Pulse US Pivotal Trial Table 61: Product Profile AbioCor Table 62: AbioCor SWOT Analysis, Table 63: Product Profile SynCardia Table 64: SynCardia SWOT Analysis, Table 65: Cardiac Assist Devices in Pipeline Table 66: Product Profile CorAide, DexAide Table 67: CorAide, DexAide SWOT Analysis, Table 68: Product Profile DuraHeart II Table 69: DuraHeart II SWOT Analysis, Table 70: Product Profile HeartMate III Table 71: HeartMate III SWOT Analysis, Table 72: Product Profile HeartMate X Table 73: HeartMate X SWOT Analysis, Table 74: Product Profile MiFlow Table 75: MiFlow SWOT Analysis, Table 76: Product Profile MiTiHeart Corporation Table 77: MiTiHeart SWOT Analysis, Table 78: Product Profile MVAD Table 79: MVAD SWOT Analysis, Table 80: Product Profile PediaFlow Table 81: PediaFlow SWOT Analysis, Table 82: Product Profile PediPump Table 83: PediPump SWOT Analysis, Page 9 GDME1006FPR / Published MAR 2013

10 Table 84: Product Profile Revolution Table 85: Revolution SWOT Analysis, Table 86: Product Profile s.pump Table 87: s.pump SWOT Analysis, Table 88: Product Profile HeartMate PHP Table 89: HeartMate PHP SWOT Analysis, Table 90: Product Profile Reitan Catheter Pump Table 91: Reitan Catheter Pump SWOT Analysis, Table 92: Product Profile AbioCor II Table 93: AbioCor II SWOT Analysis, Table 94: Product Profile Carmat Table 95: Carmat SWOT Analysis, Table 96: Product Profile Golding TAH Table 97: Golding TAH SWOT Analysis, Table 98: Product Profile Beatless Heart Table 99: Beatless Heart SWOT Analysis, Table 100: Product Profile MagScrew Table 101: MagScrew SWOT Analysis, Table 102: Product Profile ReinHeart Table 103: ReinHeart SWOT Analysis, Table 104: Company Profile Abiomed, Inc Table 105: Abiomed SWOT Analysis, Table 106: Company Profile Berlin Heart Table 107: Berlin Heart SWOT Analysis, Table 108: Company Profile Cardiac Assist Table 109: Cardiac Assist SWOT Analysis, Table 110: Company Profile - CardioBridge Table 111: CardioBridge SWOT Analysis, Page 10 GDME1006FPR / Published MAR 2013

11 Table 112: Company Profile - Carmat Table 113: Carmat SWOT Analysis, Table 114: Company Profile - CircuLite Table 115: CircuLite SWOT Analysis, Table 116: Company Profile HeartWare Table 117: HeartWare SWOT Analysis, Table 118: Company Profile Jarvik Heart Table 119: Jarvik Heart SWOT Analysis, Table 120: Company Profile Maquet Cardiovascular Table 121: Maquet Cardiovascular SWOT Analysis, Table 122: Company Profile Medos Medizintechnik AG Table 123: Medos Medizintechnik AG SWOT Analysis, Table 124: Company Profile MicroMed Cardiovascular, Inc Table 125: MicroMed Cardiovascular SWOT Analysis, Table 126: Company Profile MiTiHeart Corporation Table 127: MiTiHeart Corporation SWOT Analysis, Table 128: Company Profile PulseCath Table 129: PulseCath SWOT Analysis, Table 130: Company Profile Sunshine Heart Table 131: Sunshine Heart SWOT Analysis, Table 132: Company Profile SynCardia Systems Table 133: SynCardia Systems SWOT Analysis, Table 134: Company Profile - Teleflex Table 135: Teleflex SWOT Analysis, Table 136: Company Profile Terumo Heart Table 137: Terumo Heart SWOT Analysis, Table 138: Company Profile Thoratec Table 139: Thoratec SWOT Analysis, Page 11 GDME1006FPR / Published MAR 2013

12 Table 140: Company Profile Sun Medical Table 141: Sun Medical SWOT Analysis, Table 142: Company Profile Zeon Medical Table 143: Zeon Medical SWOT Analysis, Table 144: Sources of Epidemiological Data Used for the Forecast Table 145: New York Heart Association (NYHA) Class Distributions Description Page 12 GDME1006FPR / Published MAR 2013

13 1.2 List of Figures Figure 1: Ventricular Assist Devices Market, Global, Company Share (%), Page 13 GDME1006FPR / Published MAR 2013

14 Introduction 2 Introduction 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). These mechanical pumps are typically used for short-term purposes, allowing the heart to rest long enough that it can recuperate and return to normal and independent function. This is especially helpful for treating postcardiotomy cardiogenic shock, as these devices can provide a Bridge-To- Transplantation (BTT) or Bridge-To-Recovery (BTR) option for patients with end-stage heart failure. CADs can also be used for long-term Destination Therapy (DT) treatments in patients who are not surgical candidates for transplant but have severe heart failure. As donor hearts can be extremely difficult to get, CADs offer an alternative option for patients with critical heart failure who are waiting to receive a donor heart. 2.1 Catalyst Significant limitations and unmet needs with heart transplantation have generated considerable, continued interest in the development of CADs that are capable of supporting patients with severe CHF, either until donor hearts become available or as an alternative to heart transplantation for long-term use. These CAD devices include Ventricular Assist Devices, Intra-Aortic Balloon Pumps, and Total Artificial Hearts. While heart transplantation remains the gold standard and preferred treatment option for patients with advanced Congestive Heart Failure (CHF), the number of transplant candidates far exceeds the donor pool. The International Society for Heart and Lung Transplantation Registry 2012 Report notes a worldwide continued decrease in the number of donor hearts available. Advanced CHF patients on inotropic support have a mortality rate of 50% at three months and 94% at one year; cardiac assist devices can support these end-stage patients with significantly better survival rates. Many heart failure patients are ineligible for transplant due to old age or comorbidities; approximately 50% of patients who need a transplant are disqualified due to age. Opportunistic infection, rejection, malignancy, and graft coronary artery disease continue to be limitations to heart transplantation. Page 14 GDME1006FPR / Published MAR 2013

15 Introduction It has been shown that implantation of a CAD earlier on during the CHF progression can significantly slow the worsening of the condition, and in some cases even reverse the process to improve patient condition. CADs can greatly improve organ function. Destination therapy or tandem therapy, with a CAD in combination with cell transplantation, genetic treatment, or drug therapy, may be an alternative option to circumvent the shortage of donor hearts worldwide. Page 15 GDME1006FPR / Published MAR 2013

16 Appendix 6.11 About GlobalData GlobalData is a leading global provider of business intelligence in the Healthcare industry. GlobalData provides its clients with up-to-date information and analysis on the latest developments in medical device research, disease analysis, and clinical research and development. Our integrated business intelligence solutions include a range of interactive online databases, analytical tools, reports and forecasts. Our analysis is supported by a 24/7 client support and analyst team. GlobalData has offices in New York, Boston, London, India and Singapore Disclaimer All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GlobalData. Page 182 GDME1006FPR / Published MAR 2013