1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 15
2 Introduction 16
2.1 Ventricular Assist Devices Overview 16
3 Products under Development 17
3.1 Ventricular Assist Devices – Pipeline Products by Stage of Development 17
3.2 Ventricular Assist Devices – Pipeline Products by Segment 18
3.3 Ventricular Assist Devices – Pipeline Products by Territory 19
3.4 Ventricular Assist Devices – Pipeline Products by Regulatory Path 20
3.5 Ventricular Assist Devices – Pipeline Products by Estimated Approval Date 21
3.6 Ventricular Assist Devices – Ongoing Clinical Trials 22
4 Ventricular Assist Devices – Pipeline Products under Development by Companies 23
4.1 Ventricular Assist Devices Companies – Pipeline Products by Stage of Development 23
4.2 Ventricular Assist Devices – Pipeline Products by Stage of Development 26
5 Ventricular Assist Devices Companies and Product Overview 30
5.1 Abiomed, Inc. Company Overview 30
5.1.1 Abiomed, Inc. Pipeline Products & Ongoing Clinical Trials Overview 30
5.2 Biophan Technologies, Inc. Company Overview 41
5.2.1 Biophan Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 41
5.3 BioVentrix Inc Company Overview 42
5.3.1 BioVentrix Inc Pipeline Products & Ongoing Clinical Trials Overview 42
5.4 Braile Biomedica Ltda Company Overview 45
5.4.1 Braile Biomedica Ltda Pipeline Products & Ongoing Clinical Trials Overview 45
5.5 Calon Cardio-Technology Ltd Company Overview 46
5.5.1 Calon Cardio-Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 46
5.6 CardiacAssist Inc Company Overview 49
5.6.1 CardiacAssist Inc Pipeline Products & Ongoing Clinical Trials Overview 49
5.7 CARDIAnove Company Overview 50
5.7.1 CARDIAnove Pipeline Products & Ongoing Clinical Trials Overview 50
5.8 Cardio Vox, Inc. Company Overview 51
5.8.1 Cardio Vox, Inc. Pipeline Products & Ongoing Clinical Trials Overview 51
5.9 CardioKinetix Inc Company Overview 52
5.9.1 CardioKinetix Inc Pipeline Products & Ongoing Clinical Trials Overview 52
5.10 CardioPlus, Inc. Company Overview 55
5.10.1 CardioPlus, Inc. Pipeline Products & Ongoing Clinical Trials Overview 55
5.11 Carnegie Mellon University Company Overview 56
5.11.1 Carnegie Mellon University Pipeline Products & Ongoing Clinical Trials Overview 56
5.12 Cleveland Clinic Hospital Company Overview 57
5.12.1 Cleveland Clinic Hospital Pipeline Products & Ongoing Clinical Trials Overview 57
5.13 Cleveland Heart Inc Company Overview 58
5.13.1 Cleveland Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 58
5.14 CorAssist Cardiovascular Ltd Company Overview 59
5.14.1 CorAssist Cardiovascular Ltd Pipeline Products & Ongoing Clinical Trials Overview 59
5.15 Corinnova Inc Company Overview 62
5.15.1 Corinnova Inc Pipeline Products & Ongoing Clinical Trials Overview 62
5.16 CorWave Company Overview 66
5.16.1 CorWave Pipeline Products & Ongoing Clinical Trials Overview 66
5.17 Drexel University Company Overview 68
5.17.1 Drexel University Pipeline Products & Ongoing Clinical Trials Overview 68
5.18 DUALIS MedTech GmbH Company Overview 69
5.18.1 DUALIS MedTech GmbH Pipeline Products & Ongoing Clinical Trials Overview 69
5.19 Duke University Company Overview 70
5.19.1 Duke University Pipeline Products & Ongoing Clinical Trials Overview 70
5.20 Ension, Inc. Company Overview 71
5.20.1 Ension, Inc. Pipeline Products & Ongoing Clinical Trials Overview 71
5.21 Evaheart Inc Company Overview 72
5.21.1 Evaheart Inc Pipeline Products & Ongoing Clinical Trials Overview 72
5.22 Everheart Systems, LLC Company Overview 74
5.22.1 Everheart Systems, LLC Pipeline Products & Ongoing Clinical Trials Overview 74
5.23 FineHeart Company Overview 75
5.23.1 FineHeart Pipeline Products & Ongoing Clinical Trials Overview 75
5.24 Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon Company Overview 76
5.24.1 Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon Pipeline Products & Ongoing Clinical Trials Overview 76
5.25 Gold Medical Technologies, Inc. Company Overview 77
5.25.1 Gold Medical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 77
5.26 HeartWare International Inc Company Overview 78
5.26.1 HeartWare International Inc Pipeline Products & Ongoing Clinical Trials Overview 78
5.27 Indiana University Company Overview 90
5.27.1 Indiana University Pipeline Products & Ongoing Clinical Trials Overview 90
5.28 Jarvik Heart Inc Company Overview 91
5.28.1 Jarvik Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 91
5.29 LaunchPoint Technologies, Inc. Company Overview 97
5.29.1 LaunchPoint Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 97
5.30 Leviticus Cardio Ltd Company Overview 99
5.30.1 Leviticus Cardio Ltd Pipeline Products & Ongoing Clinical Trials Overview 99
5.31 Levram Medical Systems Ltd Company Overview 101
5.31.1 Levram Medical Systems Ltd Pipeline Products & Ongoing Clinical Trials Overview 101
5.32 Lonestar Heart Inc Company Overview 102
5.32.1 Lonestar Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 102
5.33 Mayo Clinic US Company Overview 104
5.33.1 Mayo Clinic US Pipeline Products & Ongoing Clinical Trials Overview 104
5.34 Medtronic plc Company Overview 106
5.34.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 106
5.35 Micro Interventional Devices, Inc. Company Overview 108
5.35.1 Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 108
5.36 MyoCardioCare, Inc. Company Overview 109
5.36.1 MyoCardioCare, Inc. Pipeline Products & Ongoing Clinical Trials Overview 109
5.37 NeoCardial Technologies, LLC Company Overview 112
5.37.1 NeoCardial Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 112
5.38 Nipro Corp Company Overview 113
5.38.1 Nipro Corp Pipeline Products & Ongoing Clinical Trials Overview 113
5.39 NuPulse Inc Company Overview 114
5.39.1 NuPulse Inc Pipeline Products & Ongoing Clinical Trials Overview 114
5.40 Penn State Milton S Hershey Medical Center Company Overview 115
5.40.1 Penn State Milton S Hershey Medical Center Pipeline Products & Ongoing Clinical Trials Overview 115
5.41 PlugMed Heart SAS Company Overview 117
5.41.1 PlugMed Heart SAS Pipeline Products & Ongoing Clinical Trials Overview 117
5.42 Procyrion Company Overview 118
5.42.1 Procyrion Pipeline Products & Ongoing Clinical Trials Overview 118
5.43 Purdue University Company Overview 119
5.43.1 Purdue University Pipeline Products & Ongoing Clinical Trials Overview 119
5.44 QRS Diagnostic LLC Company Overview 121
5.44.1 QRS Diagnostic LLC Pipeline Products & Ongoing Clinical Trials Overview 121
5.45 ReliantHeart, Inc. Company Overview 122
5.45.1 ReliantHeart, Inc. Pipeline Products & Ongoing Clinical Trials Overview 122
5.46 Rutgers The State University of New Jersey Company Overview 128
5.46.1 Rutgers The State University of New Jersey Pipeline Products & Ongoing Clinical Trials Overview 128
5.47 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 130
5.47.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 130
5.48 St. Jude Medical Inc Company Overview 131
5.48.1 St. Jude Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 131
5.49 Sunshine Heart Company, Pty. Ltd. Company Overview 134
5.49.1 Sunshine Heart Company, Pty. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 134
5.50 SynCardia Systems, Inc. Company Overview 139
5.50.1 SynCardia Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 139
5.51 Teleflex Inc Company Overview 142
5.51.1 Teleflex Inc Pipeline Products & Ongoing Clinical Trials Overview 142
5.52 The Artificial Heart Laboratory of Foundation for Cardiac Surgery Development Company Overview 144
5.52.1 The Artificial Heart Laboratory of Foundation for Cardiac Surgery Development Pipeline Products & Ongoing Clinical Trials Overview 144
5.53 The Pennsylvania State University Company Overview 145
5.53.1 The Pennsylvania State University Pipeline Products & Ongoing Clinical Trials Overview 145
5.54 Thoratec Corp Company Overview 146
5.54.1 Thoratec Corp Pipeline Products & Ongoing Clinical Trials Overview 146
5.55 Tokyo Medical and Dental University Company Overview 156
5.55.1 Tokyo Medical and Dental University Pipeline Products & Ongoing Clinical Trials Overview 156
5.56 U.S. Stem Cell Inc Company Overview 157
5.56.1 U.S. Stem Cell Inc Pipeline Products & Ongoing Clinical Trials Overview 157
5.57 University of Louisville Company Overview 159
5.57.1 University of Louisville Pipeline Products & Ongoing Clinical Trials Overview 159
5.58 University of Michigan Company Overview 160
5.58.1 University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 160
5.59 University of Minnesota Company Overview 161
5.59.1 University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 161
5.60 University of Zurich Company Overview 162
5.60.1 University of Zurich Pipeline Products & Ongoing Clinical Trials Overview 162
5.61 Vadovations, Inc. Company Overview 163
5.61.1 Vadovations, Inc. Pipeline Products & Ongoing Clinical Trials Overview 163
5.62 Vienna University of Technology Company Overview 164
5.62.1 Vienna University of Technology Pipeline Products & Ongoing Clinical Trials Overview 164
5.63 Windmill Cardiovascular Systems, Inc. Company Overview 165
5.63.1 Windmill Cardiovascular Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 165
5.64 Yale University Company Overview 166
5.64.1 Yale University Pipeline Products & Ongoing Clinical Trials Overview 166
6 Ventricular Assist Devices- Recent Developments 168
6.1 Nov 30, 2016: Getinge Group’s Intra-Aortic Balloon Counterpulsation Technology Validated as First-Line Mechanical Circulatory Support Device 168
6.2 Nov 29, 2016: Medtronic First to Receive European Approval for Less-Invasive HVAD Implant Procedure 168
6.3 Nov 16, 2016: St. Jude Medical HeartMate 3 LVAS Demonstrated Improved Clinical Outcomes for Patients Suffering from Advanced Heart Failure 169
6.4 Nov 09, 2016: Arrhythmia Research Technology Reports 2016 Third Quarter Results 170
6.5 Nov 04, 2016: Corwave Raises USD17.2 Million in Series B Financing 172
6.6 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 172
6.7 Oct 28, 2016: HeartWare Recalls Ventricular Assist Device Controllers 173
6.8 Oct 27, 2016: Abiomed Receives FDA IDE Approval for Initiation of Door to Unloading (DTU) Prospective Feasibility Study 173
6.9 Oct 27, 2016: Abiomed Announces Q2 FY 2017 Revenue of $103 Million, Up 35% Over Prior Year 175
6.10 Oct 27, 2016: Teleflex Reports Third Quarter 2016 Results 175
6.11 Oct 27, 2016: Amedisys Previews Third Quarter 2016 Results 178
6.12 Oct 21, 2016: Jarvik Heart Receives FDA Approval for Clinical Trial of Miniature Heart Assist Device for Infants and Children 178
6.13 Oct 21, 2016: HeartWare Recalls Ventricular Assist Device Pumps Due to Contamination Causing Electrical Issues 179
6.14 Oct 19, 2016: St. Jude Medical Reports Third Quarter 2016 Results 180
6.15 Oct 04, 2016: Steven Healy appointed as Chairman of the Board of Directors of BioVentrix 181
6.16 Sep 30, 2016: FDA Classifies Two Field Actions Related to HeartWare HVAD System as Class 1 Recalls 182
6.17 Sep 27, 2016: Abiomed Impella 5.0 Heart Pump Receive Regulatory Approval From Japan Ministry of Health, Labor & Welfare 183
6.18 Sep 27, 2016: Abiomed Impella 2.5 Heart Pump Receive Regulatory Approval From Japan MHLW 184
6.19 Sep 08, 2016: CARMAT: 2016 half-year results in line with the progress achieved by the Company 185
6.20 Sep 01, 2016: Hazard alert: HeartWare Ventricular Assist Device 186
6.21 Sep 01, 2016: CARMAT announces the departure of Marcello Conviti, CEO 186
6.22 Sep 01, 2016: Stephane Piat, Previously Division Vice President of Abbott in California, Has Been Appointed CEO of CARMAT 186
6.23 Aug 11, 2016: Arrhythmia Research Technology Reports 2016 Second Quarter Results 187
6.24 Aug 11, 2016: Abiomed Outlines Long-Term Growth Strategy and Unveils Future Products at Annual Investor Conference 189
6.25 Aug 03, 2016: U.S. Stem Cell Reports Positive Results for Q2 2016 190
6.26 Aug 02, 2016: ReliantHeart’s aVAD Gets CE Mark 190
6.27 Jul 28, 2016: Teleflex Reports Second Quarter 2016 Results 191
6.28 Jul 28, 2016: HeartWare International Reports $68.7 Million In Second Quarter 2016 Revenue 192
6.29 Jul 28, 2016: Abiomed Announces Q1 FY 2017 Revenue of $103.0 Million, Up 40% Over Prior Year 194
6.30 Jul 25, 2016: LaunchPoint Announces New Analytics Executive 195
6.31 Jul 21, 2016: CardioKinetix Announces the 500th Parachute Heart Failure Device Implantation 195
6.32 Jul 21, 2016: BioVentrix Raises USD1.2 Million in Venture Financing 196
6.33 Jul 20, 2016: St. Jude Medical Reports Second Quarter 2016 Results 196
6.34 Jul 02, 2016: Versa Capital Management Acquires SynCardia Systems 198
6.35 Jun 27, 2016: Medtronic Acquires HeartWare International for USD1.1 Billion 198
6.36 Jun 20, 2016: St. Jude Medical HeartMate 3 Left Ventricular Assist System Wins CARDIOSTIM-EHRA EUROPACE Innovation Award 198
6.37 May 24, 2016: Sunshine Heart Announces OPTIONS HF Clinical Experience 199
6.38 May 11, 2016: Teleflex Raises USD400 Million in Public Offering of 4.875% Notes Due 2026 200
6.39 May 05, 2016: U.S. Stem Cell Reports Positive Results for Q1 2016 200
6.40 May 04, 2016: HeartWare International Reports First Quarter 2016 Financial Results 201
6.41 May 03, 2016: Abiomed Announces Q4 FY 2016 Revenue of $94.0 Million, Up 39% Over Prior Year 202
6.42 Apr 28, 2016: Two Year ROADMAP Data Showcases the Potential Benefits of HeartMate II LVAD in Ambulatory Heart Failure Patients 203
6.43 Apr 28, 2016: HeartMate 3 CE Mark Trial 1-Year Results Presented at ISHLT 36th Annual Meeting and Scientific Sessions in Washington, D.C. 204
6.44 Apr 27, 2016: HeartWare Completes Enrollment In HVAD System LATERAL Study 204
6.45 Apr 20, 2016: HeartWare Announces HVAD System Scientific Presentations At The International Society For Heart And Lung Transplantation 36th Annual Meeting 205
6.46 Apr 07, 2016: Abiomed Impella Therapy Receives FDA Approval for Cardiogenic Shock After Heart Attack or Heart Surgery 207
7 Appendix 215
7.1 Methodology 215
7.2 About GlobalData 218
7.3 Contact Us 218
7.4 Disclaimer 218