Cardiac Assist Devices - Medical Devices Pipeline Assessment, 2015

Table Of Contents
1 Table of Contents 2
1.1 List of Tables 6
1.2 List of Figures 15
2 Introduction 16
2.1 Cardiac Assist Devices Overview 16
3 Products under Development 18
3.1 Cardiac Assist Devices - Pipeline Products by Stage of Development 18
3.2 Cardiac Assist Devices - Pipeline Products by Segment 19
3.3 Cardiac Assist Devices - Pipeline Products by Territory 20
3.4 Cardiac Assist Devices - Pipeline Products by Regulatory Path 21
3.5 Cardiac Assist Devices - Pipeline Products by Estimated Approval Date 22
3.6 Cardiac Assist Devices - Ongoing Clinical Trials 23
4 Cardiac Assist Devices - Pipeline Products under Development by Companies 24
4.1 Cardiac Assist Devices Companies - Pipeline Products by Stage of Development 24
4.2 Cardiac Assist Devices - Pipeline Products by Stage of Development 27
5 Cardiac Assist Devices Companies and Product Overview 31
5.1 Abiomed, Inc. Company Overview 31
5.1.1 Abiomed, Inc. Pipeline Products & Ongoing Clinical Trials Overview 31
5.2 Acorn Cardiovascular, Inc. Company Overview 37
5.2.1 Acorn Cardiovascular, Inc. Pipeline Products & Ongoing Clinical Trials Overview 37
5.3 Arrow International Cr, A.S. Company Overview 40
5.3.1 Arrow International Cr, A.S. Pipeline Products & Ongoing Clinical Trials Overview 40
5.4 Biophan Technologies, Inc. Company Overview 41
5.4.1 Biophan Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 41
5.5 BioQ Devices Pty Ltd Company Overview 43
5.5.1 BioQ Devices Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 43
5.6 BioVentrix, Inc. Company Overview 44
5.6.1 BioVentrix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 44
5.7 BiVacor Pty Ltd Company Overview 48
5.7.1 BiVacor Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 48
5.8 Braile Biomedica Ltda. Company Overview 49
5.8.1 Braile Biomedica Ltda. Pipeline Products & Ongoing Clinical Trials Overview 49
5.9 Calon Cardio-Technology Ltd Company Overview 50
5.9.1 Calon Cardio-Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 50
5.10 Cardiac Power Inc. Company Overview 53
5.10.1 Cardiac Power Inc. Pipeline Products & Ongoing Clinical Trials Overview 53
5.11 CardiacAssist, Inc. Company Overview 54
5.11.1 CardiacAssist, Inc. Pipeline Products & Ongoing Clinical Trials Overview 54
5.12 Cardiak Ltd. Company Overview 57
5.12.1 Cardiak Ltd. Pipeline Products & Ongoing Clinical Trials Overview 57
5.13 CARDIAnove Company Overview 58
5.13.1 CARDIAnove Pipeline Products & Ongoing Clinical Trials Overview 58
5.14 Cardio Vox, Inc. Company Overview 59
5.14.1 Cardio Vox, Inc. Pipeline Products & Ongoing Clinical Trials Overview 59
5.15 CardioBridge GmbH Company Overview 60
5.15.1 CardioBridge GmbH Pipeline Products & Ongoing Clinical Trials Overview 60
5.16 CardioKinetix, Inc. Company Overview 63
5.16.1 CardioKinetix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 63
5.17 CardioPlus, Inc. Company Overview 67
5.17.1 CardioPlus, Inc. Pipeline Products & Ongoing Clinical Trials Overview 67
5.18 Carmat SAS Company Overview 68
5.18.1 Carmat SAS Pipeline Products & Ongoing Clinical Trials Overview 68
5.19 Charite - Universitatsmedizin Berlin Company Overview 72
5.19.1 Charite - Universitatsmedizin Berlin Pipeline Products & Ongoing Clinical Trials Overview 72
5.20 Cleveland Heart, Inc. Company Overview 73
5.20.1 Cleveland Heart, Inc. Pipeline Products & Ongoing Clinical Trials Overview 73
5.21 CorasMedical Company Overview 76
5.21.1 CorasMedical Pipeline Products & Ongoing Clinical Trials Overview 76
5.22 CorAssist Cardiovascular Ltd. Company Overview 77
5.22.1 CorAssist Cardiovascular Ltd. Pipeline Products & Ongoing Clinical Trials Overview 77
5.23 CorInnova, Inc. Company Overview 81
5.23.1 CorInnova, Inc. Pipeline Products & Ongoing Clinical Trials Overview 81
5.24 CorWave Company Overview 86
5.24.1 CorWave Pipeline Products & Ongoing Clinical Trials Overview 86
5.25 Drexel University Company Overview 87
5.25.1 Drexel University Pipeline Products & Ongoing Clinical Trials Overview 87
5.26 DUALIS MedTech GmbH Company Overview 88
5.26.1 DUALIS MedTech GmbH Pipeline Products & Ongoing Clinical Trials Overview 88
5.27 Ension, Inc. Company Overview 90
5.27.1 Ension, Inc. Pipeline Products & Ongoing Clinical Trials Overview 90
5.28 Evaheart, Inc. Company Overview 91
5.28.1 Evaheart, Inc. Pipeline Products & Ongoing Clinical Trials Overview 91
5.29 Everheart Systems, LLC Company Overview 95
5.29.1 Everheart Systems, LLC Pipeline Products & Ongoing Clinical Trials Overview 95
5.30 Foster-Miller, Inc. (Inactive) Company Overview 96
5.30.1 Foster-Miller, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 96
5.31 Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon Company Overview 97
5.31.1 Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon Pipeline Products & Ongoing Clinical Trials Overview 97
5.32 Gold Medical Technologies, Inc. Company Overview 98
5.32.1 Gold Medical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 98
5.33 Harvard University Company Overview 99
5.33.1 Harvard University Pipeline Products & Ongoing Clinical Trials Overview 99
5.34 HeartWare International, Inc. Company Overview 100
5.34.1 HeartWare International, Inc. Pipeline Products & Ongoing Clinical Trials Overview 100
5.35 Jarvik Heart, Inc. Company Overview 122
5.35.1 Jarvik Heart, Inc. Pipeline Products & Ongoing Clinical Trials Overview 122
5.36 LaunchPoint Technologies, Inc. Company Overview 126
5.36.1 LaunchPoint Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 126
5.37 Leviticus Cardio Ltd. Company Overview 127
5.37.1 Leviticus Cardio Ltd. Pipeline Products & Ongoing Clinical Trials Overview 127
5.38 Levram Medical Systems Ltd Company Overview 129
5.38.1 Levram Medical Systems Ltd Pipeline Products & Ongoing Clinical Trials Overview 129
5.39 Lonestar Heart, Inc. Company Overview 130
5.39.1 Lonestar Heart, Inc. Pipeline Products & Ongoing Clinical Trials Overview 130
5.40 Mayo Clinic. Company Overview 135
5.40.1 Mayo Clinic. Pipeline Products & Ongoing Clinical Trials Overview 135
5.41 MicroMed Cardiovascular, Inc. Company Overview 137
5.41.1 MicroMed Cardiovascular, Inc. Pipeline Products & Ongoing Clinical Trials Overview 137
5.42 Microstim GmbH Company Overview 138
5.42.1 Microstim GmbH Pipeline Products & Ongoing Clinical Trials Overview 138
5.43 MyoCardioCare, Inc. Company Overview 139
5.43.1 MyoCardioCare, Inc. Pipeline Products & Ongoing Clinical Trials Overview 139
5.44 MyoPowers Medical Technologies SA Company Overview 142
5.44.1 MyoPowers Medical Technologies SA Pipeline Products & Ongoing Clinical Trials Overview 142
5.45 NeoCardial Technologies, LLC Company Overview 143
5.45.1 NeoCardial Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 143
5.46 New Heart Company Overview 144
5.46.1 New Heart Pipeline Products & Ongoing Clinical Trials Overview 144
5.47 Nipro Corporation Company Overview 145
5.47.1 Nipro Corporation Pipeline Products & Ongoing Clinical Trials Overview 145
5.48 NuVascular Technologies Inc Company Overview 147
5.48.1 NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 147
5.49 Orqis Medical Corporation Company Overview 148
5.49.1 Orqis Medical Corporation Pipeline Products & Ongoing Clinical Trials Overview 148
5.50 Penn State Milton S. Hershey Medical Center Company Overview 150
5.50.1 Penn State Milton S. Hershey Medical Center Pipeline Products & Ongoing Clinical Trials Overview 150
5.51 Perfusion Solutions Company Overview 152
5.51.1 Perfusion Solutions Pipeline Products & Ongoing Clinical Trials Overview 152
5.52 PlugMed Heart SAS Company Overview 153
5.52.1 PlugMed Heart SAS Pipeline Products & Ongoing Clinical Trials Overview 153
5.53 Procyrion Company Overview 154
5.53.1 Procyrion Pipeline Products & Ongoing Clinical Trials Overview 154
5.54 Purdue University Company Overview 155
5.54.1 Purdue University Pipeline Products & Ongoing Clinical Trials Overview 155
5.55 QRS Diagnostic, LLC Company Overview 157
5.55.1 QRS Diagnostic, LLC Pipeline Products & Ongoing Clinical Trials Overview 157
5.56 ReliantHeart, Inc. Company Overview 158
5.56.1 ReliantHeart, Inc. Pipeline Products & Ongoing Clinical Trials Overview 158
5.57 Saint Louis University Company Overview 161
5.57.1 Saint Louis University Pipeline Products & Ongoing Clinical Trials Overview 161
5.58 St. Jude Medical, Inc. Company Overview 163
5.58.1 St. Jude Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 163
5.59 Sunshine Heart Company, Pty. Ltd. Company Overview 176
5.59.1 Sunshine Heart Company, Pty. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 176
5.60 SynCardia Systems, Inc. Company Overview 182
5.60.1 SynCardia Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 182
5.61 Teleflex Incorporated Company Overview 194
5.61.1 Teleflex Incorporated Pipeline Products & Ongoing Clinical Trials Overview 194
5.62 Terumo Corporation Company Overview 196
5.62.1 Terumo Corporation Pipeline Products & Ongoing Clinical Trials Overview 196
5.63 The Artificial Heart Laboratory of Foundation for Cardiac Surgery Development Company Overview 198
5.63.1 The Artificial Heart Laboratory of Foundation for Cardiac Surgery Development Pipeline Products & Ongoing Clinical Trials Overview 198
5.64 The University of Tokyo Company Overview 199
5.64.1 The University of Tokyo Pipeline Products & Ongoing Clinical Trials Overview 199
5.65 U.S. Stem Cell, Inc. Company Overview 201
5.65.1 U.S. Stem Cell, Inc. Pipeline Products & Ongoing Clinical Trials Overview 201
5.66 University of Minnesota Company Overview 203
5.66.1 University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 203
5.67 University of Zurich Company Overview 205
5.67.1 University of Zurich Pipeline Products & Ongoing Clinical Trials Overview 205
5.68 Vadovations, Inc. Company Overview 206
5.68.1 Vadovations, Inc. Pipeline Products & Ongoing Clinical Trials Overview 206
5.69 Vienna University of Technology Company Overview 207
5.69.1 Vienna University of Technology Pipeline Products & Ongoing Clinical Trials Overview 207
5.70 Windmill Cardiovascular Systems, Inc. Company Overview 208
5.70.1 Windmill Cardiovascular Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 208
6 Cardiac Assist Devices- Recent Developments 209
7 Appendix 320
7.1 Methodology 320
7.2 About GlobalData 322
7.3 Contact Us 323
7.4 Disclaimer 323

List Of Tables
1.1 List of Tables
Table 1: Cardiac Assist Devices - Pipeline Products by Stage of Development 18
Table 2: Cardiac Assist Devices - Pipeline Products by Segment 19
Table 3: Cardiac Assist Devices - Pipeline Products by Territory 20
Table 4: Cardiac Assist Devices - Pipeline Products by Regulatory Path 21
Table 5: Cardiac Assist Devices - Pipeline Products by Estimated Approval Date 22
Table 6: Cardiac Assist Devices - Ongoing Clinical Trials 23
Table 7: Cardiac Assist Devices Companies - Pipeline Products by Stage of Development 24
Table 8: Cardiac Assist Devices - Pipeline Products by Stage of Development 27
Table 9: Abiomed, Inc. Pipeline Products & Ongoing Clinical Trials Overview 31
Table 10: AbioCor II - Product Status 32
Table 11: AbioCor II - Product Description 32
Table 12: Impella 5.0/LD - High Risk PCI - Product Status 33
Table 13: Impella 5.0/LD - High Risk PCI - Product Description 33
Table 14: Impella CP - High Risk PCI - Product Status 34
Table 15: Impella CP - High Risk PCI - Product Description 34
Table 16: Impella Pediatric Pump - Product Status 35
Table 17: Impella Pediatric Pump - Product Description 35
Table 18: Symphony Heart Pump - Product Status 36
Table 19: Symphony Heart Pump - Product Description 36
Table 20: Acorn Cardiovascular, Inc. Pipeline Products & Ongoing Clinical Trials Overview 37
Table 21: CorCap Cardiac Support Device - Product Status 37
Table 22: CorCap Cardiac Support Device - Product Description 37
Table 23: Acorn Cardiovascular, Inc. - Ongoing Clinical Trials Overview 38
Table 24: CorCap Cardiac Support Device - Clinical Evaluation Of Acorn CorCap Cardiac Support Device Concomitant To MVR - A Confirmatory Trial 39
Table 25: Arrow International Cr, A.S. Pipeline Products & Ongoing Clinical Trials Overview 40
Table 26: CorAide Left Ventricular Assist System - Product Status 40
Table 27: CorAide Left Ventricular Assist System - Product Description 40
Table 28: Biophan Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 41
Table 29: Myotech Circulatory Support System - Product Status 42
Table 30: Myotech Circulatory Support System - Product Description 42
Table 31: BioQ Devices Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 43
Table 32: BioQ IntraAortic Counterpulsation Prosthesis - Product Status 43
Table 33: BioQ IntraAortic Counterpulsation Prosthesis - Product Description 43
Table 34: BioVentrix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 44
Table 35: Next Generation Revivent System - Product Status 44
Table 36: Next Generation Revivent System - Product Description 44
Table 37: PliCath HF - Product Status 45
Table 38: PliCath HF - Product Description 45
Table 39: BioVentrix, Inc. - Ongoing Clinical Trials Overview 46
Table 40: PliCath HF - Phase II Study of the BioVentrix PliCath HF System for the Treatment of Ischemic Cardiomyopathy. 47
Table 41: PliCath HF - This Study is a Multi-center, Prospective, Single-armed, Study Designed to Evaluate the Safety and Feasibility of the BioVentrix PliCath HF System for Left Ventricular (LV) Volume and Radius Reduction Through Scar Exclusion in Patients Whose Systolic HF is Due to Ischemic Cardiomyopathy 47
Table 42: BiVacor Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 48
Table 43: BiVACOR Device - Product Status 48
Table 44: BiVACOR Device - Product Description 48
Table 45: Braile Biomedica Ltda. Pipeline Products & Ongoing Clinical Trials Overview 49
Table 46: Blood Pump - Product Status 49
Table 47: Blood Pump - Product Description 49
Table 48: Calon Cardio-Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 50
Table 49: BridgeVAD - Product Status 50
Table 50: BridgeVAD - Product Description 50
Table 51: Calon MiniVAD - Product Status 51
Table 52: Calon MiniVAD - Product Description 51
Table 53: CathVAD - Product Status 52
Table 54: CathVAD - Product Description 52
Table 55: Cardiac Power Inc. Pipeline Products & Ongoing Clinical Trials Overview 53
Table 56: Repower - Product Status 53
Table 57: Repower - Product Description 53
Table 58: CardiacAssist, Inc. Pipeline Products & Ongoing Clinical Trials Overview 54
Table 59: TandemHeart Circulatory Support System - Product Status 54
Table 60: TandemHeart Circulatory Support System - Product Description 54
Table 61: CardiacAssist, Inc. - Ongoing Clinical Trials Overview 55
Table 62: TandemHeart Circulatory Support System - TandemHeart Experiences and Methods (THEME Registry) 56
Table 63: Cardiak Ltd. Pipeline Products & Ongoing Clinical Trials Overview 57
Table 64: Akpulsor - Product Status 57
Table 65: Akpulsor - Product Description 57
Table 66: CARDIAnove Pipeline Products & Ongoing Clinical Trials Overview 58
Table 67: CARDIAnove Pump - Product Status 58
Table 68: CARDIAnove Pump - Product Description 58
Table 69: Cardio Vox, Inc. Pipeline Products & Ongoing Clinical Trials Overview 59
Table 70: Transcatheter Ventricular Assist Device - Product Status 59
Table 71: Transcatheter Ventricular Assist Device - Product Description 59
Table 72: CardioBridge GmbH Pipeline Products & Ongoing Clinical Trials Overview 60
Table 73: 10F RCP System - Product Status 61
Table 74: 10F RCP System - Product Description 61
Table 75: 14F RCP System - Product Status 62
Table 76: 14F RCP System - Product Description 62
Table 77: CardioKinetix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 63
Table 78: Parachute Ventricular Partitioning Device - Product Status 63
Table 79: Parachute Ventricular Partitioning Device - Product Description 63
Table 80: CardioKinetix, Inc. - Ongoing Clinical Trials Overview 64
Table 81: Parachute Ventricular Partitioning Device - A Dual-Arm, Open-Label, Multi-Center Registry Designed To Evaluate The Parachute Implant in Ischemic Heart Failure Patients 65
Table 82: Parachute Ventricular Partitioning Device - A Multinational Trial To Evaluate the Parachute Implant System: Parachute Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease 65
Table 83: Parachute Ventricular Partitioning Device - PARACHUTE III: A Multinational Trial to Evaluate the Longterm Safety of the Parachute System 65
Table 84: Parachute Ventricular Partitioning Device - Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease 66
Table 85: CardioPlus, Inc. Pipeline Products & Ongoing Clinical Trials Overview 67
Table 86: CardioPlus - Product Status 67
Table 87: CardioPlus - Product Description 67
Table 88: Carmat SAS Pipeline Products & Ongoing Clinical Trials Overview 68
Table 89: Artificial Heart - Product Status 69
Table 90: Artificial Heart - Product Description 69
Table 91: Carmat SAS - Ongoing Clinical Trials Overview 70
Table 92: Artificial Heart - First-in-man CARMAT’s Bioprosthetic Heart Trial For End-stage Heart Failure 71
Table 93: Charite - Universitatsmedizin Berlin Pipeline Products & Ongoing Clinical Trials Overview 72
Table 94: Low - Stress Rotary Blood Pump - Product Status 72
Table 95: Low - Stress Rotary Blood Pump - Product Description 72
Table 96: Cleveland Heart, Inc. Pipeline Products & Ongoing Clinical Trials Overview 73
Table 97: SmartHeart LVAD - Product Status 74
Table 98: SmartHeart LVAD - Product Description 74
Table 99: SmartHeart TAH - Product Status 75
Table 100: SmartHeart TAH - Product Description 75
Table 101: CorasMedical Pipeline Products & Ongoing Clinical Trials Overview 76
Table 102: CORAS Hotor - Product Status 76
Table 103: CORAS Hotor - Product Description 76
Table 104: CorAssist Cardiovascular Ltd. Pipeline Products & Ongoing Clinical Trials Overview 77
Table 105: CORolla - Product Status 77
Table 106: CORolla - Product Description 77
Table 107: ImCardia - Product Status 78
Table 108: ImCardia - Product Description 78
Table 109: CorAssist Cardiovascular Ltd. - Ongoing Clinical Trials Overview 79
Table 110: CORolla - CORolla TAA for Heart Failure and Preserved Ejection Fraction and Diastolic Dysfunction 80
Table 111: CORolla - CORolla TAA for Heart Failure with Preserved Ejection Fraction (HFpEF) and Diastolic Dysfunction (DD) Safety and Feasibility 80
Table 112: CorInnova, Inc. Pipeline Products & Ongoing Clinical Trials Overview 81
Table 113: CardiacSTAR - Bridge To Decision - Product Status 81
Table 114: CardiacSTAR - Bridge To Decision - Product Description 81
Table 115: CardiacSTAR - Bridge To Recovery - Product Status 82
Table 116: CardiacSTAR - Bridge To Recovery - Product Description 82
Table 117: CardiacSTAR - Bridge To Transplant - Product Status 83
Table 118: CardiacSTAR - Bridge To Transplant - Product Description 83

List Of Figures
1.2 List of Figures
Figure 1: Cardiac Assist Devices - Pipeline Products by Stage of Development 18
Figure 2: Cardiac Assist Devices - Pipeline Products by Segment 19
Figure 3: Cardiac Assist Devices - Pipeline Products by Territory 20
Figure 4: Cardiac Assist Devices - Pipeline Products by Regulatory Path 21
Figure 5: Cardiac Assist Devices - Pipeline Products by Estimated Approval Date 22
Figure 6: Cardiac Assist Devices - Ongoing Clinical Trials 23

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