Ventricular Assist Devices - Medical Devices Pipeline Assessment, 2018

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	Market Research Report Ventricular Assist Devices - Medical Devices Pipeline Assessment, 2018
Published by	GlobalData			Product code	217932
Published	June 1, 2018	Content info	193 Pages Delivery time: 1-2 business days
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Description

GlobalData's Medical Devices sector report, "Ventricular Assist Devices - Medical Devices Pipeline Assessment, 2018" provides an overview of Ventricular Assist Devices currently in pipeline stage.

The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The report reviews major players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Ventricular Assist Devices pipeline products.

This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData's team of industry experts.

Note: Certain sections in the report may be removed or altered based on the availability and relevance of data in relation to the equipment type.

Scope

Extensive coverage of the Ventricular Assist Devices under development
The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities
The report reviews the major players involved in the development of Ventricular Assist Devices and list all their pipeline projects
The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage
The report provides key clinical trial data of ongoing trials specific to pipeline products
Recent developments in the segment / industry.

Reasons to buy

The report enables you to -

Formulate significant competitor information, analysis, and insights to improve R&D strategies
Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage
Identify and understand important and diverse types of Ventricular Assist Devices under development
Develop market-entry and market expansion strategies
Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline
In-depth analysis of the product's current stage of development, territory and estimated launch date.

Table of Contents

Product Code: GDME0563EPD

1 Table of Contents

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
5.2 BioVentrix Inc Company Overview 33
5.3 Braile Biomedica Ltda Company Overview 36
5.4 Calon Cardio-Technology Ltd Company Overview 37
5.5 CardiacAssist Inc Company Overview 39
5.6 CARDIAnove Company Overview 40
5.7 Carnegie Mellon University Company Overview 41
5.8 Cleveland Clinic Hospital Company Overview 42
5.9 Cleveland Heart Inc Company Overview 43
5.10 CorAssist Cardiovascular Ltd Company Overview 44
5.11 Corinnova Inc Company Overview 48
5.12 CorWave Company Overview 53
5.13 Drexel University Company Overview 55
5.14 DUALIS MedTech GmbH Company Overview 56
5.15 Duke University Company Overview 57
5.16 Ension, Inc. Company Overview 58
5.17 Evaheart Inc Company Overview 59
5.18 Everheart Systems, LLC Company Overview 60
5.19 FineHeart Company Overview 61
5.20 Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon Company Overview 62
5.21 Harvard University Company Overview 63
5.22 HeartWare International Inc Company Overview 64
5.23 Indiana University Company Overview 72
5.24 Jarvik Heart Inc Company Overview 73
5.25 LaunchPoint Technologies, Inc. Company Overview 78
5.26 Leviticus Cardio Ltd Company Overview 80
5.27 Levram Medical Systems Ltd Company Overview 81
5.28 Medtronic plc Company Overview 82
5.29 Michigan Critical Care Consultants, Inc. Company Overview 83
5.30 MyoCardioCare, Inc. Company Overview 84
5.31 Myotech, LLC (Inactive) Company Overview 86
5.32 NeoCardial Technologies, LLC Company Overview 87
5.33 Nipro Corp Company Overview 88
5.34 Novapump GmbH Company Overview 89
5.35 NuPulseCV Company Overview 91
5.36 Pennsylvania State University Company Overview 92
5.37 Perfusion Solution Inc Company Overview 93
5.38 PlugMed Heart SAS Company Overview 95
5.39 Procyrion Company Overview 96
5.40 Purdue University Company Overview 97
5.41 ReliantHeart, Inc. Company Overview 98
5.42 Rutgers The State University of New Jersey Company Overview 103
5.43 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 104
5.44 St. Jude Medical LLC Company Overview 105
5.45 Sunshine Heart Company, Pty. Ltd. Company Overview 107
5.46 Syncardia Systems LLC Company Overview 108
5.47 Teleflex Inc Company Overview 110
5.48 Terumo Corp Company Overview 111
5.49 The Artificial Heart Laboratory of Foundation for Cardiac Surgery Development Company Overview 112
5.50 Thoratec Corp Company Overview 113
5.51 Tokyo Medical and Dental University Company Overview 120
5.52 U.S. Stem Cell Inc Company Overview 121
5.53 University of Louisville Company Overview 122
5.54 University of Michigan Company Overview 123
5.55 Vadovations, Inc. Company Overview 124
5.56 Windmill Cardiovascular Systems, Inc. Company Overview 125
5.57 Yale University Company Overview 126

6 Ventricular Assist Devices- Recent Developments 128

6.1 May 22, 2018: Abbott Recalls the HeartMate 3 Left Ventricular Assist System Due to Potential Malfunction that may Lead to Graft Occlusion 128
6.2 May 15, 2018: Micron Solutions Reports 2018 First Quarter Results 128
6.3 May 14, 2018: Autologous Stem Cell Therapy May Hold Key to Regeneration 129
6.4 May 11, 2018: Terumo Appoints its U.S.-based Subsidiary's Associate as the Fifth Terumo Fellow 130
6.5 May 11, 2018: Teleflex: Reaffirms 2018 Guidance and Provides 3-Year Financial Goals and Objectives 130
6.6 May 09, 2018: U.S. Stem Cell Reports First Quarter Results 131
6.7 May 04, 2018: Abbott Implements Corrective Action for HeartMate 3 Heart Pump 132
6.8 May 03, 2018: Abiomed Announces Q4 FY 2018 Revenue of $174 Million, Up 40%, and Total Year Revenue of $594 Million, Up 33%, Over Prior Year 132
6.9 May 03, 2018: Teleflex Reports First Quarter 2018 Results 133
6.10 Apr 30, 2018: Procyrion Appoints Clinical Operations Pro Tara Burt As Associate Director Of Clinical Affairs 136
6.11 Apr 16, 2018: USRM Reports 2017 Financial Results 136
6.12 Apr 10, 2018: Leviticus Cardio Confirms the Successful Completion of a Long-term Chronic Animal Study 137
6.13 Apr 09, 2018: Medtronic to Unveil Additional Clinical Data on HVAD System at ISHLT 2018 138
6.14 Apr 04, 2018: Abiomed Announces European Approval (CE Marking) for Impella 5.5 and First Patient Treated at University Heart Center Hamburg 139
6.15 Apr 02, 2018: Abiomed Receives FDA Approval for Impella CP with SmartAssist and Optical Sensor 140
6.16 Mar 30, 2018: Abiomed to Appoint New Chief Financial Officer Todd A. Trapp 141
6.17 Mar 26, 2018: Micron Solutions Reports 2017 Fourth Quarter and Year End Results 142
6.18 Mar 21, 2018: Procyrion Names Elisabeth Neely Senior Vice President Of Clinical And Regulatory Affairs, Formerly With Abbott 143
6.19 Mar 14, 2018: Baylor College of Medicine approved for $489,000 in funding for LVAD treatment decision support 144
6.20 Mar 13, 2018: UR Medicine Leads U.S. in Minimally Invasive Surgery for Newest LVAD Heart Pump 145
6.21 Mar 11, 2018: New Long-term Data Show Improved Survival and Lower Rates of Stroke and Pump Thrombosis for Abbott's Heartmate 3 Heart Pump 147
6.22 Mar 01, 2018: Palmetto Health is first facility in state to implant HeartMate 3 LVAD outside of research trials 148
6.23 Feb 26, 2018: Successful Outcomes Seen in First-in-Human Trial of NuPulseCV''s Intravascular Ventricular Assist System (iVAS) 149
6.24 Feb 22, 2018: Teleflex Reports Fourth Quarter and Full Year 2017 Results; Provides 2018 Guidance 149
6.25 Feb 14, 2018: Abiomed Receives Approval for Expanded FDA Indication for High Risk Percutaneous Coronary Intervention (PCI) Procedures 152
6.26 Feb 13, 2018: Abiomed Receives Approval for Expanded FDA Indication for Cardiomyopathy with Cardiogenic Shock 153
6.27 Feb 13, 2018: Abiomed Announces Peripartum and Postpartum Cardiomyopathy Approval and Women's Initiative for Heart Recovery 154
6.28 Feb 13, 2018: Carmat: 2017 Annual Results 155
6.29 Feb 08, 2018: Terumo Revises the Full-Year Results Forecast for FY 2017 157
6.30 Feb 06, 2018: USRM Seeing Explosive Increase in Demand for Stem Cell Therapy 157
6.31 Feb 01, 2018: Abiomed Announces Q3 FY 2018 Record Revenue of $154 Million, Up 34% Over Prior Year 158
6.32 Jan 25, 2018: Terumo Announces Change of Directors and Executive Officers 159
6.33 Jan 08, 2018: Abiomed Announces Preliminary Q3 FY 2018 Revenue of $154M, Up 34% Over Prior Year 161
6.34 Jan 04, 2018: Apollo Hospitals, Hyderguda successfully implanted the LVAD Heart Mate 3 to give a new lease of life for a 70-year-old heart failure patient. 161
6.35 Jan 02, 2018: Teleflex Completes Previously Announced CEO Transition 162

7 Appendix 189

7.1 Methodology 189
7.2 About GlobalData 192
7.3 Contact Us 192
7.4 Disclaimer 192

List of Tables

1.1 List of Tables

Table 1: Ventricular Assist Devices - Pipeline Products by Stage of Development 14
Table 2: Ventricular Assist Devices - Pipeline Products by Segment 15
Table 3: Ventricular Assist Devices - Pipeline Products by Territory 16
Table 4: Ventricular Assist Devices - Pipeline Products by Regulatory Path 17
Table 5: Ventricular Assist Devices - Pipeline Products by Estimated Approval Date 18
Table 6: Ventricular Assist Devices - Ongoing Clinical Trials 19
Table 7: Ventricular Assist Devices Companies - Pipeline Products by Stage of Development 20
Table 8: Ventricular Assist Devices - Pipeline Products by Stage of Development 23
Table 9: Abiomed Inc Pipeline Products & Ongoing Clinical Trials Overview 26
Table 10: Impella BTR - Product Status 26
Table 11: Impella BTR - Product Description 27
Table 12: Impella CP (Cardiac Power) - Product Status 27
Table 13: Impella CP (Cardiac Power) - Product Description 27
Table 14: Impella ECP - Product Status 28
Table 15: Impella ECP - Product Description 28
Table 16: Impella RP - Product Status 28
Table 17: Impella RP - Product Description 29
Table 18: Next Generation Impella CP - STEMI - Product Status 29
Table 19: Next Generation Impella CP - STEMI - Product Description 29
Table 20: Abiomed Inc - Ongoing Clinical Trials Overview 30
Table 21: 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 22: 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 23: 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 24: Impella CP (Cardiac Power) - Pulsecath mechanicaL Support Evaluation (PULSE) - Trial 32
Table 25: 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 26: BioVentrix Inc Pipeline Products & Ongoing Clinical Trials Overview 34
Table 27: PliCath HF - Product Status 34
Table 28: PliCath HF - Product Description 34
Table 29: BioVentrix Inc - Ongoing Clinical Trials Overview 35
Table 30: PliCath HF - Phase II Study of the BioVentrix PliCath HF System for the Treatment of Ischemic Cardiomyopathy 36
Table 31: Braile Biomedica Ltda Pipeline Products & Ongoing Clinical Trials Overview 37
Table 32: Blood Pump - Product Status 37
Table 33: Blood Pump - Product Description 37
Table 34: Calon Cardio-Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 38
Table 35: Calon MiniVAD - Product Status 38
Table 36: Calon MiniVAD - Product Description 38
Table 37: CathVAD - Product Status 39
Table 38: CathVAD - Product Description 39
Table 39: MicroVAD - Product Status 39
Table 40: MicroVAD - Product Description 39
Table 41: CardiacAssist Inc Pipeline Products & Ongoing Clinical Trials Overview 40
Table 42: Pediatric pVAD - Product Status 40
Table 43: Pediatric pVAD - Product Description 40
Table 44: CARDIAnove Pipeline Products & Ongoing Clinical Trials Overview 41
Table 45: CARDIAnove Pump - Product Status 41
Table 46: CARDIAnove Pump - Product Description 41
Table 47: Carnegie Mellon University Pipeline Products & Ongoing Clinical Trials Overview 42
Table 48: tVAD - Heart Failure - Product Status 42
Table 49: tVAD - Heart Failure - Product Description 42
Table 50: Cleveland Clinic Hospital Pipeline Products & Ongoing Clinical Trials Overview 43
Table 51: PediPump - Product Status 43
Table 52: PediPump - Product Description 43
Table 53: Cleveland Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 44
Table 54: SmartHeart LVAD - Product Status 44
Table 55: SmartHeart LVAD - Product Description 44
Table 56: CorAssist Cardiovascular Ltd Pipeline Products & Ongoing Clinical Trials Overview 45
Table 57: CORolla - Product Status 45
Table 58: CORolla - Product Description 45
Table 59: ImCardia - Product Status 46
Table 60: ImCardia - Product Description 46
Table 61: CorAssist Cardiovascular Ltd - Ongoing Clinical Trials Overview 47
Table 62: CORolla - CORolla TAA for Heart Failure and Preserved Ejection Fraction and Diastolic Dysfunction 48
Table 63: CORolla - CORolla TAA for Heart Failure with Preserved Ejection Fraction (HFpEF) and Diastolic Dysfunction (DD) Safety and Feasibility 48
Table 64: Corinnova Inc Pipeline Products & Ongoing Clinical Trials Overview 49
Table 65: CardiacSTAR - Bridge To Decision - Product Status 49
Table 66: CardiacSTAR - Bridge To Decision - Product Description 49
Table 67: CardiacSTAR - Bridge To Recovery - Product Status 50
Table 68: CardiacSTAR - Bridge To Recovery - Product Description 50
Table 69: CardiacSTAR - Bridge To Transplant - Product Status 50
Table 70: CardiacSTAR - Bridge To Transplant - Product Description 51
Table 71: CardiacSTAR - Destination Therapy - Product Status 51
Table 72: CardiacSTAR - Destination Therapy - Product Description 51
Table 73: CardiacSTAR - Heart Rehabilitation - Product Status 52
Table 74: CardiacSTAR - Heart Rehabilitation - Product Description 52
Table 75: EpicHeart - Soft Robotic Heart Device - Product Status 52
Table 76: EpicHeart - Soft Robotic Heart Device - Product Description 53
Table 77: CorWave Pipeline Products & Ongoing Clinical Trials Overview 54
Table 78: CorWave Neptune - Product Status 54
Table 79: CorWave Neptune - Product Description 54
Table 80: CorWave Nemo - Product Status 55
Table 81: CorWave Nemo - Product Description 55
Table 82: Drexel University Pipeline Products & Ongoing Clinical Trials Overview 56
Table 83: Intravascular Blood Pump - Product Status 56
Table 84: Intravascular Blood Pump - Product Description 56
Table 85: DUALIS MedTech GmbH Pipeline Products & Ongoing Clinical Trials Overview 57
Table 86: CAREFLOW Pump - Product Status 57
Table 87: CAREFLOW Pump - Product Description 57
Table 88: Duke University Pipeline Products & Ongoing Clinical Trials Overview 58
Table 89: Para-Aortic Blood Pump - Product Status 58
Table 90: Para-Aortic Blood Pump - Product Description 58
Table 91: Ension, Inc. Pipeline Products & Ongoing Clinical Trials Overview 59
Table 92: CardioFlowPQ - Product Status 59
Table 93: CardioFlowPQ - Product Description 59
Table 94: Evaheart Inc Pipeline Products & Ongoing Clinical Trials Overview 60
Table 95: EVAHEART Left Ventricular Assist System - Product Status 60
Table 96: EVAHEART Left Ventricular Assist System - Product Description 60
Table 97: Everheart Systems, LLC Pipeline Products & Ongoing Clinical Trials Overview 61
Table 98: Fully Implantable Left Ventricular Assist Device - Product Status 61
Table 99: Fully Implantable Left Ventricular Assist Device - Product Description 61
Table 100: FineHeart Pipeline Products & Ongoing Clinical Trials Overview 62
Table 101: ICOMS - Product Status 62
Table 102: ICOMS - Product Description 62
Table 103: Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon Pipeline Products & Ongoing Clinical Trials Overview 63
Table 104: Ventricular Assist Device - Product Status 63
Table 105: Ventricular Assist Device - Product Description 63
Table 106: Harvard University Pipeline Products & Ongoing Clinical Trials Overview 64
Table 107: Soft Robotic Sleeve - Product Status 64
Table 108: Soft Robotic Sleeve - Product Description 64
Table 109: HeartWare International Inc Pipeline Products & Ongoing Clinical Trials Overview 65
Table 110: BiVAD - Product Status 65
Table 111: BiVAD - Product Description 65
Table 112: Fully Implantable VAD System - Product Status 66
Table 113: Fully Implantable VAD System - Product Description 66
Table 114: HeartWare IV-VAD - Product Status 66
Table 115: HeartWare IV-VAD - Product Description 66
Table 116: HeartWare Ventricular Assist Device - Bridge-To-Transplant - Product Status 67
Table 117: HeartWare Ventricular Assist Device - Bridge-To-Transplant - Product Description 67
Table 118: Levacor Rotary VAD - Product Status 67
Table 119: Levacor Rotary VAD - Product Description 68
Table 120: Longhorn - Product Status 68
Table 121: Longhorn - Product Description 68
Table 122: MiFlow VAD - Product Status 69
Table 123: MiFlow VAD - Product Description 69
Table 124: Miniaturized Ventricular Assist Device (MVAD) Pump - Product Status 69
Table 125: Miniaturized Ventricular Assist Device (MVAD) Pump - Product Description 70
Table 126: VCAN Trans-Mitral - Product Status 70
Table 127: VCAN Trans-Mitral - Product Description 70
Table 128: HeartWare International Inc - Ongoing Clinical Trials Overview 71
Table 129: Miniaturized Ventricular Assist Device (MVAD) Pump - Multi Center, Prospective, Non-randomized, Single-arm Trial Evaluating the Clinical Safety and Performance of the HeartWare MVAD System for the Treatment of Advanced Heart Failure 72
Table 130: Indiana University Pipeline Products & Ongoing Clinical Trials Overview 73
Table 131: Bi-Conical Heart Pump - Product Status 73
Table 132: Bi-Conical Heart Pump - Product Description 73
Table 133: Jarvik Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 74
Table 134: Jarvik 15mm LVAD System - Product Status 74
Table 135: Jarvik 15mm LVAD System - Product Description 74
Table 136: Jarvik 2000 Heart - Bridge To Transplant - Product Status 75
Table 137: Jarvik 2000 Heart - Bridge To Transplant - Product Description 75
Table 138: Jarvik 2000 Heart - Destination Therapy - Product Status 75
Table 139: Jarvik 2000 Heart - Destination Therapy - Product Description 76
Table 140: Jarvik Heart Inc - Ongoing Clinical Trials Overview 77
Table 141: Jarvik 2000 Heart - Destination Therapy - Evaluation of the Jarvik 2000 Left Ventricular Assist System with Post-auricular Connector--Destination Therapy Study 78
Table 142: LaunchPoint Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 79
Table 143: Pediaflow Pediatric VAD - Product Status 79
Table 144: Pediaflow Pediatric VAD - Product Description 79
Table 145: Streamliner VAD - Product Status 80
Table 146: Streamliner VAD - Product Description 80
Table 147: Leviticus Cardio Ltd Pipeline Products & Ongoing Clinical Trials Overview 81
Table 148: Coplanar Energy Transfer System - Product Status 81
Table 149: Coplanar Energy Transfer System - Product Description 81
Table 150: Levram Medical Systems Ltd Pipeline Products & Ongoing Clinical Trials Overview 82
Table 151: LEVRAM-Ventricular Assist Device - Product Status 82
Table 152: LEVRAM-Ventricular Assist Device - Product Description 82
Table 153: Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 83
Table 154: HVAD System - Thoracotomy - Product Status 83

List of Figures

1.2 List of Figures

Figure 1: Ventricular Assist Devices - Pipeline Products by Stage of Development 14
Figure 2: Ventricular Assist Devices - Pipeline Products by Segment 15
Figure 3: Ventricular Assist Devices - Pipeline Products by Territory 16
Figure 4: Ventricular Assist Devices - Pipeline Products by Regulatory Path 17
Figure 5: Ventricular Assist Devices - Pipeline Products by Estimated Approval Date 18
Figure 6: Ventricular Assist Devices - Ongoing Clinical Trials 19

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Ventricular Assist Devices - Medical Devices Pipeline Assessment, 2018
Published: June 1, 2018	Content info: 193 Pages