Published : Oct-2017
No. of Pages : 193
1 Table of Contents 2
1.1 List of Tables 6
1.2 List of Figures 11
2 Introduction 12
2.1 Ventricular Assist Devices Overview 12
3 Products under Development 13
3.1 Ventricular Assist Devices - Pipeline Products by Stage of Development 13
3.2 Ventricular Assist Devices - Pipeline Products by Segment 14
3.3 Ventricular Assist Devices - Pipeline Products by Territory 15
3.4 Ventricular Assist Devices - Pipeline Products by Regulatory Path 16
3.5 Ventricular Assist Devices - Pipeline Products by Estimated Approval Date 17
3.6 Ventricular Assist Devices - Ongoing Clinical Trials 18
4 Ventricular Assist Devices - Pipeline Products under Development by Companies 19
4.1 Ventricular Assist Devices Companies - Pipeline Products by Stage of Development 19
4.2 Ventricular Assist Devices - Pipeline Products by Stage of Development 22
5 Ventricular Assist Devices Companies and Product Overview 25
5.1 Abiomed Inc Company Overview 25
5.1.1 Abiomed Inc Pipeline Products & Ongoing Clinical Trials Overview 25
5.2 Biophan Technologies, Inc. Company Overview 34
5.2.1 Biophan Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
5.3 BioVentrix Inc Company Overview 35
5.3.1 BioVentrix Inc Pipeline Products & Ongoing Clinical Trials Overview 35
5.4 Braile Biomedica Ltda Company Overview 39
5.4.1 Braile Biomedica Ltda Pipeline Products & Ongoing Clinical Trials Overview 39
5.5 Calon Cardio-Technology Ltd Company Overview 40
5.5.1 Calon Cardio-Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 40
5.6 CardiacAssist Inc Company Overview 42
5.6.1 CardiacAssist Inc Pipeline Products & Ongoing Clinical Trials Overview 42
5.7 CARDIAnove Company Overview 43
5.7.1 CARDIAnove Pipeline Products & Ongoing Clinical Trials Overview 43
5.8 Carnegie Mellon University Company Overview 44
5.8.1 Carnegie Mellon University Pipeline Products & Ongoing Clinical Trials Overview 44
5.9 Cleveland Clinic Hospital Company Overview 45
5.9.1 Cleveland Clinic Hospital Pipeline Products & Ongoing Clinical Trials Overview 45
5.10 Cleveland Heart Inc Company Overview 46
5.10.1 Cleveland Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 46
5.11 Corinnova Inc Company Overview 47
5.11.1 Corinnova Inc Pipeline Products & Ongoing Clinical Trials Overview 47
5.12 CorWave Company Overview 52
5.12.1 CorWave Pipeline Products & Ongoing Clinical Trials Overview 52
5.13 Drexel University Company Overview 55
5.13.1 Drexel University Pipeline Products & Ongoing Clinical Trials Overview 55
5.14 DUALIS MedTech GmbH Company Overview 56
5.14.1 DUALIS MedTech GmbH Pipeline Products & Ongoing Clinical Trials Overview 56
5.15 Duke University Company Overview 57
5.15.1 Duke University Pipeline Products & Ongoing Clinical Trials Overview 57
5.16 Ension, Inc. Company Overview 58
5.16.1 Ension, Inc. Pipeline Products & Ongoing Clinical Trials Overview 58
5.17 Evaheart Inc Company Overview 59
5.17.1 Evaheart Inc Pipeline Products & Ongoing Clinical Trials Overview 59
5.18 Everheart Systems, LLC Company Overview 60
5.18.1 Everheart Systems, LLC Pipeline Products & Ongoing Clinical Trials Overview 60
5.19 FineHeart Company Overview 61
5.19.1 FineHeart Pipeline Products & Ongoing Clinical Trials Overview 61
5.20 Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon Company Overview 62
5.20.1 Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon Pipeline Products & Ongoing Clinical Trials Overview 62
5.21 Gold Medical Technologies, Inc. Company Overview 63
5.21.1 Gold Medical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 63
5.22 HeartWare International Inc Company Overview 64
5.22.1 HeartWare International Inc Pipeline Products & Ongoing Clinical Trials Overview 64
5.23 Indiana University Company Overview 76
5.23.1 Indiana University Pipeline Products & Ongoing Clinical Trials Overview 76
5.24 Jarvik Heart Inc Company Overview 77
5.24.1 Jarvik Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 77
5.25 LaunchPoint Technologies, Inc. Company Overview 82
5.25.1 LaunchPoint Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 82
5.26 Leviticus Cardio Ltd Company Overview 84
5.26.1 Leviticus Cardio Ltd Pipeline Products & Ongoing Clinical Trials Overview 84
5.27 Levram Medical Systems Ltd Company Overview 85
5.27.1 Levram Medical Systems Ltd Pipeline Products & Ongoing Clinical Trials Overview 85
5.28 Lonestar Heart Inc Company Overview 86
5.28.1 Lonestar Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 86
5.29 Mayo Clinic US Company Overview 89
5.29.1 Mayo Clinic US Pipeline Products & Ongoing Clinical Trials Overview 89
5.30 Medtronic plc Company Overview 91
5.30.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 91
5.31 MyoCardioCare, Inc. Company Overview 92
5.31.1 MyoCardioCare, Inc. Pipeline Products & Ongoing Clinical Trials Overview 92
5.32 NeoCardial Technologies, LLC Company Overview 94
5.32.1 NeoCardial Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 94
5.33 Nipro Corp Company Overview 95
5.33.1 Nipro Corp Pipeline Products & Ongoing Clinical Trials Overview 95
5.34 NuPulse Inc Company Overview 96
5.34.1 NuPulse Inc Pipeline Products & Ongoing Clinical Trials Overview 96
5.35 PlugMed Heart SAS Company Overview 97
5.35.1 PlugMed Heart SAS Pipeline Products & Ongoing Clinical Trials Overview 97
5.36 Procyrion Company Overview 98
5.36.1 Procyrion Pipeline Products & Ongoing Clinical Trials Overview 98
5.37 Purdue University Company Overview 99
5.37.1 Purdue University Pipeline Products & Ongoing Clinical Trials Overview 99
5.38 ReliantHeart, Inc. Company Overview 100
5.38.1 ReliantHeart, Inc. Pipeline Products & Ongoing Clinical Trials Overview 100
5.39 Rutgers The State University of New Jersey Company Overview 105
5.39.1 Rutgers The State University of New Jersey Pipeline Products & Ongoing Clinical Trials Overview 105
5.40 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 106
5.40.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 106
5.41 St. Jude Medical LLC Company Overview 107
5.41.1 St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 107
5.42 Sunshine Heart Company, Pty. Ltd. Company Overview 109
5.42.1 Sunshine Heart Company, Pty. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 109
5.43 Syncardia Systems LLC Company Overview 113
5.43.1 Syncardia Systems LLC Pipeline Products & Ongoing Clinical Trials Overview 113
5.44 Teleflex Inc Company Overview 116
5.44.1 Teleflex Inc Pipeline Products & Ongoing Clinical Trials Overview 116
5.45 Terumo Corp Company Overview 117
5.45.1 Terumo Corp Pipeline Products & Ongoing Clinical Trials Overview 117
5.46 The Artificial Heart Laboratory of Foundation for Cardiac Surgery Development Company Overview 118
5.46.1 The Artificial Heart Laboratory of Foundation for Cardiac Surgery Development Pipeline Products & Ongoing Clinical Trials Overview 118
5.47 The Pennsylvania State University Company Overview 119
5.47.1 The Pennsylvania State University Pipeline Products & Ongoing Clinical Trials Overview 119
5.48 Thoratec Corp Company Overview 120
5.48.1 Thoratec Corp Pipeline Products & Ongoing Clinical Trials Overview 120
5.49 Tokyo Medical and Dental University Company Overview 127
5.49.1 Tokyo Medical and Dental University Pipeline Products & Ongoing Clinical Trials Overview 127
5.50 U.S. Stem Cell Inc Company Overview 128
5.50.1 U.S. Stem Cell Inc Pipeline Products & Ongoing Clinical Trials Overview 128
5.51 University of Florida Company Overview 129
5.51.1 University of Florida Pipeline Products & Ongoing Clinical Trials Overview 129
5.52 University of Louisville Company Overview 130
5.52.1 University of Louisville Pipeline Products & Ongoing Clinical Trials Overview 130
5.53 University of Michigan Company Overview 131
5.53.1 University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 131
5.54 Vadovations, Inc. Company Overview 132
5.54.1 Vadovations, Inc. Pipeline Products & Ongoing Clinical Trials Overview 132
5.55 Vienna University of Technology Company Overview 133
5.55.1 Vienna University of Technology Pipeline Products & Ongoing Clinical Trials Overview 133
5.56 Windmill Cardiovascular Systems, Inc. Company Overview 134
5.56.1 Windmill Cardiovascular Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 134
5.57 Yale University Company Overview 135
5.57.1 Yale University Pipeline Products & Ongoing Clinical Trials Overview 135
6 Ventricular Assist Devices- Recent Developments 137
6.1 Sep 20, 2017: Abiomed Receives FDA PMA Approval for Impella RP for Right Heart Failure 137
6.2 Aug 28, 2017: Abbott Introduces HeartMate 3 Left Ventricular Assist System - The Latest Milestone In Therapy For Advanced Heart Failure Patients 138
6.3 Aug 28, 2017: Abiomed Announces Resignation of Chief Financial Officer and Welcomes Back Former Chief Financial Officer as Consultant 139
6.4 Aug 28, 2017: U.S. Stem Cell Clinic Acknowledges Warning Letter By The FDA and Responds 140
6.5 Aug 11, 2017: Micron Solutions Reports 2017 Second Quarter Results 140
6.6 Aug 09, 2017: U.S. Stem Cell Reports Most Successful Financial Performance in the Company's History 142
6.7 Aug 03, 2017: Teleflex Reports Second Quarter 2017 Results 142
6.8 Jul 27, 2017: Abiomed Announces Q1 FY 2018 Revenue of $132.5 Million, Up 29% Over Prior Year 144
6.9 Jul 24, 2017: Micron Solutions Appoints Rodd E. Friedman to its Board of Directors 145
6.10 Jul 06, 2017: CARMAT Appoints Wenzel Hurtak, Previously Business Director New Products at Contract Medical International GmbH, as Director of Manufacturing 146
6.11 Jun 30, 2017: New Study with Abiomed's Impella 2.5 Heart Pump Demonstrates Potential Survival with Pre-PCI Insertion in Heart Attacks with the Left Main Coronary Artery 146
6.12 May 22, 2017: BioVentrix announces the 1st Revivent TC TransCatheter Ventricular Enhancement procedure for Ischemic Cardiomyopathy treatment at Deutsches Herzzentrum Berlin in Germany English 148
6.13 May 09, 2017: Abiomed Introduces 3rd Generation Impella CP Heart Pumps at SCAI 2017 148
6.14 May 09, 2017: Procyrion Chosen to Present at Europcr 2017 in Paris 150
6.15 May 04, 2017: Abiomed Announces First Patient Enrolled in STEMI DTU Feasibility Study 150
6.16 May 04, 2017: Abiomed Announces Q4 FY 2017 Revenue of $124.7 Million, Up 33% Over Prior Year and Total Year Revenue of $445.3 Million, Up 35% Over Prior Year 151
6.17 May 04, 2017: Teleflex Reports First Quarter 2017 Results 152
6.18 May 04, 2017: Medtronic Mechanical Circulatory Support (formerly HeartWare) Expands Recall for Ventricular Assist Device Controllers and DC Adapter 154
6.19 Apr 18, 2017: FDA Designates Medtronic Worldwide Voluntary Field Action on HVAD System Controllers and DC Adapters as Class I Recall 155
6.20 Apr 06, 2017: Clinical Trial of Medtronic Heart Pump Delivers Positive Results with Less-Invasive Implant Procedure 156
6.21 Apr 06, 2017: Patients on HeartMate 3 have fewer blood-related events than those on HeartMate II 157
6.22 Apr 05, 2017: Study Shows Medtronic Left Ventricular Assist Devices Have Positive Results at One Year in Patients Seeking Long-Term LVAD Therapy 158
6.23 Apr 05, 2017: First-in-Canada successful implant of cardiac-assist device in high-risk heart patient 159
6.24 Mar 30, 2017: Abiomed Marks Grand Opening of Newly-Expanded Headquarters in Danvers, Massachusetts 160
6.25 Mar 14, 2017: SynCardia Names New VP of Manufacturing and Facilities 161
6.26 Mar 09, 2017: New Study Finds Abiomed Impella Heart Pump Reduces Injury to Kidneys During High-Risk Percutaneous Coronary Intervention 162
6.27 Feb 23, 2017: Abiomed Surpasses 50,000 Impella Patients Treated in the United States 163
6.28 Feb 23, 2017: Teleflex Announces Benson Smith to Retire as Chief Executive Officer at End of 2017; Liam Kelly to Succeed Smith as Chief Executive Officer 164
6.29 Feb 23, 2017: Teleflex Reports Fourth Quarter and Full Year 2016 Results; Provides 2017 Guidance 165
6.30 Feb 09, 2017: Terumo Announces Change of Executive Officers 166
6.31 Jan 31, 2017: Terumo Opens a Branch in Yangon 167
6.32 Jan 26, 2017: Abiomed Announces Q3 FY 2017 Revenue of $114.7 Million, Up 34% Over Prior Year 168
6.33 Jan 25, 2017: Two Cardiology Experts Join CARMAT's Board of Directors as Independent Members 168
6.34 Jan 24, 2017: Millar Awarded NIH SBIR Grant to Validate Transcutaneous Energy Transfer Technology with Aortix Cardiac Assist Device 169
6.35 Jan 09, 2017: Abiomed Announces Preliminary Q3 FY 2017 Revenue of $114.7 Million, Up 34% Over Prior Year 170
6.36 Dec 12, 2016: Terumo Formulates 5-Year Mid- to Long-term Growth Strategy 171
6.37 Dec 07, 2016: Abiomed Impella CP Receives Expanded FDA Approval for High-Risk Percutaneous Coronary Intervention Procedures 171
6.38 Nov 30, 2016: Getinge Group's Intra-Aortic Balloon Counterpulsation Technology Validated as First-Line Mechanical Circulatory Support Device 173
6.39 Nov 29, 2016: Medtronic First to Receive European Approval for Less-Invasive HVAD Implant Procedure 173
6.40 Nov 16, 2016: St. Jude Medical HeartMate 3 LVAS Demonstrated Improved Clinical Outcomes for Patients Suffering from Advanced Heart Failure 174
6.41 Nov 09, 2016: Arrhythmia Research Technology Reports 2016 Third Quarter Results 175
6.42 Oct 31, 2016: Abiomed Launches Impella Quality (IQ) Assurance Program and Shares Insight From Largest Database of Real-World Evidence of High-Risk PCI and Cardiogenic Shock Patients 177
6.43 Oct 28, 2016: HeartWare Recalls Ventricular Assist Device Controllers 178
6.44 Oct 27, 2016: Abiomed Receives FDA IDE Approval for Initiation of Door to Unloading (DTU) Prospective Feasibility Study 179
6.45 Oct 27, 2016: Abiomed Announces Q2 FY 2017 Revenue of $103 Million, Up 35% Over Prior Year 180
6.46 Oct 27, 2016: Teleflex Reports Third Quarter 2016 Results 181
6.47 Oct 27, 2016: Amedisys Previews Third Quarter 2016 Results 183
6.48 Oct 21, 2016: Jarvik Heart Receives FDA Approval for Clinical Trial of Miniature Heart Assist Device for Infants and Children 184
6.49 Oct 21, 2016: HeartWare Recalls Ventricular Assist Device Pumps Due to Contamination Causing Electrical Issues 185
6.50 Oct 19, 2016: St. Jude Medical Reports Third Quarter 2016 Results 185
6.51 Oct 04, 2016: Steven Healy appointed as Chairman of the Board of Directors of BioVentrix 187
6.52 Sep 30, 2016: FDA Classifies Two Field Actions Related to HeartWare HVAD System as Class 1 Recalls 188
7 Appendix 190
7.1 Methodology 190
7.2 About GlobalData 193
7.3 Contact Us 193
7.4 Disclaimer 193
1.1 List of Tables
Table 1: Ventricular Assist Devices - Pipeline Products by Stage of Development 13
Table 2: Ventricular Assist Devices - Pipeline Products by Segment 14
Table 3: Ventricular Assist Devices - Pipeline Products by Territory 15
Table 4: Ventricular Assist Devices - Pipeline Products by Regulatory Path 16
Table 5: Ventricular Assist Devices - Pipeline Products by Estimated Approval Date 17
Table 6: Ventricular Assist Devices - Ongoing Clinical Trials 18
Table 7: Ventricular Assist Devices Companies - Pipeline Products by Stage of Development 19
Table 8: Ventricular Assist Devices - Pipeline Products by Stage of Development 22
Table 9: Abiomed Inc Pipeline Products & Ongoing Clinical Trials Overview 25
Table 10: Impella 5.5 - Product Status 25
Table 11: Impella 5.5 - Product Description 26
Table 12: Impella BTR - Product Status 26
Table 13: Impella BTR - Product Description 26
Table 14: Impella CP (Cardiac Power) - Product Status 27
Table 15: Impella CP (Cardiac Power) - Product Description 27
Table 16: Impella ECP - Product Status 27
Table 17: Impella ECP - Product Description 28
Table 18: Impella RP - Product Status 28
Table 19: Impella RP - Product Description 28
Table 20: Next Generation Impella CP - STEMI - Product Status 29
Table 21: Next Generation Impella CP - STEMI - Product Description 29
Table 22: Abiomed Inc - Ongoing Clinical Trials Overview 30
Table 23: Impella RP - A global Initiative in Percutaneous Circulatory Support from the cVAD Steering Committee on Behalf of All cVAD Investigators (Global cVAD Registry) 31
Table 24: Impella CP (Cardiac Power) - A global Initiative in Percutaneous Circulatory Support from the cVAD Steering Committee on Behalf of All cVAD Investigators (Global cVAD Registry) 32
Table 25: Impella CP (Cardiac Power) - Effects of Advanced Mechanical Circulatory Support in Patients With ST Segment Elevation Myocardial Infarction Complicated by Cardiogenic Shock. The Danish Cardiogenic Shock Trial 32
Table 26: Impella CP (Cardiac Power) - Pulsecath mechanicaL Support Evaluation (PULSE) - Trial 32
Table 27: Next Generation Impella CP - STEMI - Door to Unloading with IMPELLA CP System in Acute Myocardial Infarction to Reduce Infarct Size (DTU): A Prospective Feasibility Study 33
Table 28: Biophan Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
Table 29: Myotech Circulatory Support System - Product Status 34
Table 30: Myotech Circulatory Support System - Product Description 34
Table 31: BioVentrix Inc Pipeline Products & Ongoing Clinical Trials Overview 35
Table 32: Next Generation Revivent-TC System - Product Status 35
Table 33: Next Generation Revivent-TC System - Product Description 35
Table 34: PliCath HF - Product Status 36
Table 35: PliCath HF - Product Description 36
Table 36: BioVentrix Inc - Ongoing Clinical Trials Overview 37
Table 37: PliCath HF - Phase II Study of the BioVentrix PliCath HF System for the Treatment of Ischemic Cardiomyopathy 38
Table 38: Braile Biomedica Ltda Pipeline Products & Ongoing Clinical Trials Overview 39
Table 39: Blood Pump - Product Status 39
Table 40: Blood Pump - Product Description 39
Table 41: Calon Cardio-Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 40
Table 42: Calon MiniVAD - Product Status 40
Table 43: Calon MiniVAD - Product Description 40
Table 44: CathVAD - Product Status 41
Table 45: CathVAD - Product Description 41
Table 46: MicroVAD - Product Status 41
Table 47: MicroVAD - Product Description 41
Table 48: CardiacAssist Inc Pipeline Products & Ongoing Clinical Trials Overview 42
Table 49: Pediatric pVAD - Product Status 42
Table 50: Pediatric pVAD - Product Description 42
Table 51: CARDIAnove Pipeline Products & Ongoing Clinical Trials Overview 43
Table 52: CARDIAnove Pump - Product Status 43
Table 53: CARDIAnove Pump - Product Description 43
Table 54: Carnegie Mellon University Pipeline Products & Ongoing Clinical Trials Overview 44
Table 55: tVAD - Heart Failure - Product Status 44
Table 56: tVAD - Heart Failure - Product Description 44
Table 57: Cleveland Clinic Hospital Pipeline Products & Ongoing Clinical Trials Overview 45
Table 58: PediPump - Product Status 45
Table 59: PediPump - Product Description 45
Table 60: Cleveland Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 46
Table 61: SmartHeart LVAD - Product Status 46
Table 62: SmartHeart LVAD - Product Description 46
Table 63: Corinnova Inc Pipeline Products & Ongoing Clinical Trials Overview 47
Table 64: Biventricular Cardiac Assist Device - Product Status 47
Table 65: Biventricular Cardiac Assist Device - Product Description 47
Table 66: CardiacSTAR - Bridge To Decision - Product Status 48
Table 67: CardiacSTAR - Bridge To Decision - Product Description 48
Table 68: CardiacSTAR - Bridge To Recovery - Product Status 48
Table 69: CardiacSTAR - Bridge To Recovery - Product Description 49
Table 70: CardiacSTAR - Bridge To Transplant - Product Status 49
Table 71: CardiacSTAR - Bridge To Transplant - Product Description 49
Table 72: CardiacSTAR - Destination Therapy - Product Status 50
Table 73: CardiacSTAR - Destination Therapy - Product Description 50
Table 74: CardiacSTAR - Heart Rehabilitation - Product Status 50
Table 75: CardiacSTAR - Heart Rehabilitation - Product Description 51
Table 76: CorWave Pipeline Products & Ongoing Clinical Trials Overview 52
Table 77: CorWave Acute Cardiac Assist LVAD - Product Status 52
Table 78: CorWave Acute Cardiac Assist LVAD - Product Description 52
Table 79: CorWave LVAD - Product Status 53
Table 80: CorWave LVAD - Product Description 53
Table 81: CorWave Partial Flow LVAD - Product Status 53
Table 82: CorWave Partial Flow LVAD - Product Description 54
Table 83: Drexel University Pipeline Products & Ongoing Clinical Trials Overview 55
Table 84: Intravascular Blood Pump - Product Status 55
Table 85: Intravascular Blood Pump - Product Description 55
Table 86: DUALIS MedTech GmbH Pipeline Products & Ongoing Clinical Trials Overview 56
Table 87: CAREFLOW Pump - Product Status 56
Table 88: CAREFLOW Pump - Product Description 56
Table 89: Duke University Pipeline Products & Ongoing Clinical Trials Overview 57
Table 90: Para-Aortic Blood Pump - Product Status 57
Table 91: Para-Aortic Blood Pump - Product Description 57
Table 92: Ension, Inc. Pipeline Products & Ongoing Clinical Trials Overview 58
Table 93: CardioFlowPQ - Product Status 58
Table 94: CardioFlowPQ - Product Description 58
Table 95: Evaheart Inc Pipeline Products & Ongoing Clinical Trials Overview 59
Table 96: EVAHEART Left Ventricular Assist System - Product Status 59
Table 97: EVAHEART Left Ventricular Assist System - Product Description 59
Table 98: Everheart Systems, LLC Pipeline Products & Ongoing Clinical Trials Overview 60
Table 99: Fully Implantable Left Ventricular Assist Device - Product Status 60
Table 100: Fully Implantable Left Ventricular Assist Device - Product Description 60
Table 101: FineHeart Pipeline Products & Ongoing Clinical Trials Overview 61
Table 102: ICOMS - Product Status 61
Table 103: ICOMS - Product Description 61
Table 104: Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon Pipeline Products & Ongoing Clinical Trials Overview 62
Table 105: Ventricular Assist Device - Product Status 62
Table 106: Ventricular Assist Device - Product Description 62
Table 107: Gold Medical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 63
Table 108: Magnevad III - Product Status 63
Table 109: Magnevad III - Product Description 63
Table 110: HeartWare International Inc Pipeline Products & Ongoing Clinical Trials Overview 64
Table 111: BiVAD - Product Status 64
Table 112: BiVAD - Product Description 65
Table 113: Fully Implantable VAD System - Product Status 65
Table 114: Fully Implantable VAD System - Product Description 65
Table 115: HeartWare IV-VAD - Product Status 66
Table 116: HeartWare IV-VAD - Product Description 66
Table 117: HeartWare Ventricular Assist Device - Bridge-To-Transplant - Product Status 66
Table 118: HeartWare Ventricular Assist Device - Bridge-To-Transplant - Product Description 67
Table 119: HeartWare Ventricular Assist Device - Destination Therapy - Product Status 67
Table 120: HeartWare Ventricular Assist Device - Destination Therapy - Product Description 67
Table 121: Levacor Rotary VAD - Product Status 68
Table 122: Levacor Rotary VAD - Product Description 68
Table 123: Longhorn - Product Status 68
Table 124: Longhorn - Product Description 69
Table 125: MiFlow VAD - Product Status 69
Table 126: MiFlow VAD - Product Description 69
Table 127: Miniaturized Ventricular Assist Device (MVAD) Pump - Product Status 70
Table 128: Miniaturized Ventricular Assist Device (MVAD) Pump - Product Description 70
Table 129: VCAN Trans-Mitral - Product Status 70
Table 130: VCAN Trans-Mitral - Product Description 71
Table 131: HeartWare International Inc - Ongoing Clinical Trials Overview 72
Table 132: HeartWare Ventricular Assist Device - Destination Therapy - A Prospective, Randomized, Controlled, Unblinded, Multi-center Clinical Trial to Evaluate the HeartWare Ventricular Assist Device System for Destination Therapy of Advanced Heart Failure 73
Table 133: HeartWare IV-VAD - A Prospective, Randomized, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of the HeartAssist 5 VAD System Compared to the Thoratec HeartMate II VAD and HeartWare HVAD for Left Ventricular Support in Patients Awaiting Cardiac Transplantation 74
Table 134: HeartWare Ventricular Assist Device - Bridge-To-Transplant - A Multi-Center, Post Approval Study Providing Continued Evaluation and Follow-up on Patients Who Received a HeartWare Ventricular Assist System During IDE Trials for the Treatment of Advanced Heart Failure 75
Table 135: HeartWare Ventricular Assist Device - Bridge-To-Transplant - Evaluation of and Safety and efficacy of HeartWare Ventricular Assist Device - Bridge-to-Transplant in Japan 75
Table 136: Indiana University Pipeline Products & Ongoing Clinical Trials Overview 76
Table 137: Bi-Conical Heart Pump - Product Status 76
Table 138: Bi-Conical Heart Pump - Product Description 76
Table 139: Jarvik Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 77
Table 140: Infant Jarvik 2000 - Product Status 77
Table 141: Infant Jarvik 2000 - Product Description 77
Table 142: Jarvik 15mm LVAD System - Product Status 78
Table 143: Jarvik 15mm LVAD System - Product Description 78
Table 144: Jarvik 2000 Heart - Bridge To Transplant - Product Status 78
Table 145: Jarvik 2000 Heart - Bridge To Transplant - Product Description 79
Table 146: Jarvik 2000 Heart - Destination Therapy - Product Status 79
Table 147: Jarvik 2000 Heart - Destination Therapy - Product Description 79
Table 148: Jarvik Heart Inc - Ongoing Clinical Trials Overview 80
Table 149: Jarvik 2000 Heart - Destination Therapy - Evaluation of the Jarvik 2000 Left Ventricular Assist System with Post-auricular Connector--Destination Therapy Study 81
Table 150: LaunchPoint Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 82
Table 151: Pediaflow Pediatric VAD - Product Status 82
Table 152: Pediaflow Pediatric VAD - Product Description 82
Table 153: Streamliner VAD - Product Status 83
1.2 List of Figures
Figure 1: Ventricular Assist Devices - Pipeline Products by Stage of Development 13
Figure 2: Ventricular Assist Devices - Pipeline Products by Segment 14
Figure 3: Ventricular Assist Devices - Pipeline Products by Territory 15
Figure 4: Ventricular Assist Devices - Pipeline Products by Regulatory Path 16
Figure 5: Ventricular Assist Devices - Pipeline Products by Estimated Approval Date 17
Figure 6: Ventricular Assist Devices - Ongoing Clinical Trials 18
