Cardiac Assist Devices Pipeline Technology and Market Forecasts to 2015

Table of Contents

1 Table Of Contents 2
1.1 List of Tables 6
1.2 List of Figures 8
2 Cardiac Assist Devices Pipeline Technology and Market Forecasts to 2015 9
2.1 Executive Summary 9
3 Cardiac Assist Devices:Role in Treating Heart Failure 10
3.1 Overview 10
3.1.1 Pathogenesis of Heart Failure 10
3.1.2 Role of Cardiac Assist Devices 10
3.2 Timeline 11
3.3 Market Segmentation 11
4 Global Cardiac Assist Devices Market 13
4.1 Cardiac Assist Devices Market Sizing 13
4.2 Cardiac Assist Devices Market Volume 15
4.3 Cardiac Assist Devices Country Comparison 16
4.3.1 US To Remain Key Region in the Future 17
4.3.2 Growth Opportunities Outside the US 18
4.4 Cardiac Assist Devices Market Dynamics 19
4.4.1 Market Drivers 19
4.4.1.1 Large patient population 19
4.4.1.2 Fulfilling the Unmet Need 19
4.4.1.3 Rising Prescription Rates due to Reduced Risks and Increasing Lifespan 19
4.4.2 Market Restraints 19
4.4.2.1 Long Development Time and Clinical Risks 19
4.4.2.2 Low Awareness and Availability in the Developing Economies 19
5 Competitive Landscape 20
5.1 Thoratec Corporation 20
5.1.1 Key Takeaway 20
5.2 Abiomed 21
5.2.1 Overview 21
5.2.1 Key Takeaway 21
5.3 SynCardia Systems, Inc 21
5.3.1 Overview 21
5.3.2 CardioWest temporary Total Artificial Heart – First Movers Advantage 22
5.3.3 Key Takeaway 22
5.4 Berlin Heart, Inc. 22
5.4.1 Overview 22
5.4.2 EXCOR - Leading Therapy Option in Children 22
5.4.3 Key Takeaway 23
6 Cardiac Assist Devices Pipeline Product Landscape 24
6.1 Overview 24
6.2 Cardiac Assist Devices Pipeline Product Analysis 26
6.2.1 Stage I: Meeting Patient Demand 27
6.2.2 Stage II: Effective Clinical Trial Information 27
6.2.3 Stage III: First Movers Advantage 27
6.3 Key Pipeline Product Description 28
6.3.1 AbioCor II 28
6.3.1.1 Product Status 28
6.3.1.2 Product Description 28
6.3.1.3 Product Patent Details 29
6.3.2 Cardiac Assist Devices Heartmate II (DT) 30
6.3.2.1 Product Status 30
6.3.2.2 Product Description 30
6.3.2.3 Heartmate II (DT) Clinical Trial 1 31
6.3.2.4 Heartmate II (DT) Clinical Trial 2 31
6.3.2.5 Heartmate II (DT) Clinical Trial 3 32
6.3.2.6 Heartmate II (DT) Clinical Trial 4 33
6.3.2.7 Product Patent Details 34
6.3.3 VentrAssist BTT 35
6.3.3.1 Product Status 35
6.3.3.2 Product Description 35
6.3.3.3 VentrAssist BTT Clinical Trial 1 36
6.3.3.4 VentrAssist BTT Clinical Trial 2 37
6.3.3.5 entrAssist BTT Clinical Trial 3 38
6.3.3.6 VentrAssist BTT Clinical Trial 4 39
6.3.3.7 VentrAssist BTT Clinical Trial 5 39
6.3.4 Pediatric M-Pump 39
6.3.4.1 Product Status 39
6.3.4.2 Product Description 40
7 New Entrants: Promising Products to Intensify Competition 41
7.1 Ventracor as an Acquisition Target 41
8 Pipeline Product Summary 42
9 Clinical Trial Summary 44
10 Appendix 48
10.1 Definitions 48
10.1.1 Cardiac Assist Devices 48
10.1.2 Intra-Aortic Balloon Pump Catheters 48
10.1.3 Total Artificial Heart 48
10.1.4 Ventricular Assist Devices 48
10.2 Company Information 49
10.2.1 Thoratec Corporation, Company Revenue 49
10.2.2 Thoratec Corporation, Key Events 50
10.2.2.1 Thoratec to Acquire HeartWare International 50
10.2.3 HeartMate II – Bridging the Gap between BTT and DT 50
10.2.4 Abiomed Inc., Company Revenues 51
10.2.5 Impella 2.5 Micro Heart Pump – Providing Competition to IABP 52
10.2.6 Key Strength: Only Total Artificial Heart On The Market 52
10.3 Research Methodology 53
10.4 Coverage 54
10.5 Secondary Research 54
10.6 Primary Research 55
10.7 Models 55
10.8 Forecasts 56
10.9 Expert Panels 56
10.10 GlobalData Consulting 56
10.11 Contact Us 57
10.12 Disclaimer 57

1.1 List of Tables
Table 1: Cardiac Assist Devices Market, Revenue by Segment ($ m), 2001 – 2008 13
Table 2: Cardiac Assist Devices Market, Revenue by Segment ($m), 2008 – 2015 14
Table 3: Cardiac Assist Devices Market, Volume (Units), 2001 – 2008 15
Table 4: Cardiac Assist Devices Market, Volume (Units), 2008 – 2015 15
Table 5: Cardiac Assist Devices, Revenue By Country ($m), 2001 - 2008 17
Table 6: Cardiac Assist Devices, Revenue By Country ($m), 2008 - 2015 17
Table 7: US Cardiac Assist Devices Market Analysis, 2008 17
Table 8: Key Players in the Cardiac Assist Devices Market 20
Table 9: Cardiac Assist Devices, Pipeline Products by Category and Development Stage, 2009 24
Table 10: AbioCor II, Product Status 28
Table 11: AbioCor II, Product Description 28
Table 12: AbioCor II Patent Details 29
Table 13: Heartmate II (DT), Product Status 30
Table 14: Heartmate II (DT), Product Description 30
Table 15: Heartmate II (DT) - Clinical Experience With Sternotomy Versus Subcostal Approach for Exchange of the HeartMate XVE to the HeartMate II Ventricular Assist Device 31
Table 16: Heartmate II (DT) - Fibrinolytic activation during long-term support with the HeartMate II left ventricular assist device. 31
Table 17: Heartmate II (DT) - Initial clinical experience with the HeartMate II axial-flow left ventricular assist device. 32
Table 18: Heartmate II (DT) - The HeartMate II LVAS Pivotal Study Protocol, Destination Therapy 33
Table 19: Heartmate II (DT) Patent Details 34
Table 20: VentrAssist BTT, Product Status 35
Table 21: VentrAssist BTT, Product Description 35
Table 22: VentrAssist BTT - Evaluation of the VentrAssist Left Ventricular Assist Device as a Bridge to Cardiac Transplantation - Feasibility Trial 36
Table 23: VentrAssist BTT - Evaluation of the VentrAssist Left Ventricular Assist Device as a Bridge to Cardiac Transplantation - Pivotal Trial 37
Table 24: VentrAssist BTT - VentrAssist (BTT) - Pilot Trial 38
Table 25: VentrAssist BTT - VentrAssist (BTT) - CE Mark Trial 39
Table 26: VentrAssist BTT - VentrAssist (BTT) - BRACE Trial 39
Table 27: Pediatric M-Pump, Product Status 39
Table 28: Pediatric M-Pump, Product Description 40
Table 29: Cardiac Assist Device Pipeline Products 42
Table 30: Cardiac Assist Devices Clinical Trials 44
Table 31: Thoratec Corporation, Revenues ($m), 2006 – 2008 49
Table 32: HeartWare International, Pipeline Product Portfolio 50
Table 33: Abiomed Inc., Revenues ($m), 2005 – 2009 52

1.2 List of Figures
Figure 1: History of Cardiac Assist Devices 11
Figure 2: Types of Cardiac Assist Devices 12
Figure 3: Cardiac Assist Devices Market, Revenue by Segment ($ m), 2001 – 2008 13
Figure 4: Cardiac Assist Devices Market, Revenue by Segment ($m), 2008 – 2015 14
Figure 5: Cardiac Assist Devices, Revenue By Country ($ m), 2008 and 2015 16
Figure 6: Cardiac Assist Devices, Pipeline Products by Category and Development Stage, 2009 24
Figure 7: Pipeline Product Comparison, Cardiac Assist Devices Market, 2009 26
Figure 8: Thoratec Corporation, Revenues ($m), 2006 – 2008 49
Figure 9: Abiomed Inc., Revenues ($m), 2005 – 2009 51
Figure 10: GlobalData Methodology 53