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Ventricular Assist Devices-Medical Devices Pipeline Assessment, 2016

Ventricular Assist Devices-Medical Devices Pipeline Assessment, 2016


  • Products Id :- GDME0295EPD
  • |
  • Pages: 218
  • |
  • December 2016
  • |
  • |
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Executive Summary

Ventricular Assist Devices-Medical Devices Pipeline Assessment, 2016

Summary

GlobalData's Medical Devices sector report, "Ventricular Assist Devices-Medical Devices Pipeline Assessment, 2016" 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



Contact Us:
Ken Research
Ankur Gupta, Head Marketing & Communications
ankur [@] kenresearch.com
+91-9015378249
www.kenresearch.com

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: ReliantHearts 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

1.2 List of Figures

Figure 1: Ventricular Assist Devices-Pipeline Products by Stage of Development 17

Figure 2: Ventricular Assist Devices-Pipeline Products by Segment 18

Figure 3: Ventricular Assist Devices-Pipeline Products by Territory 19

Figure 4: Ventricular Assist Devices-Pipeline Products by Regulatory Path 20

Figure 5: Ventricular Assist Devices-Pipeline Products by Estimated Approval Date 21

Figure 6: Ventricular Assist Devices-Ongoing Clinical Trials 22

1.1 List of Tables

Table 1: Ventricular Assist Devices-Pipeline Products by Stage of Development 17

Table 2: Ventricular Assist Devices-Pipeline Products by Segment 18

Table 3: Ventricular Assist Devices-Pipeline Products by Territory 19

Table 4: Ventricular Assist Devices-Pipeline Products by Regulatory Path 20

Table 5: Ventricular Assist Devices-Pipeline Products by Estimated Approval Date 21

Table 6: Ventricular Assist Devices-Ongoing Clinical Trials 22

Table 7: Ventricular Assist Devices Companies-Pipeline Products by Stage of Development 23

Table 8: Ventricular Assist Devices-Pipeline Products by Stage of Development 26

Table 9: Abiomed, Inc. Pipeline Products & Ongoing Clinical Trials Overview 30

Table 10: Impella 2.5-Cardiogenic Shock-Product Status 31

Table 11: Impella 2.5-Cardiogenic Shock-Product Description 31

Table 12: Impella 2.5 System-Product Status 31

Table 13: Impella 2.5 System-Product Description 32

Table 14: Impella 5.0-Cardiogenic Shock-Product Status 32

Table 15: Impella 5.0-Cardiogenic Shock-Product Description 33

Table 16: Impella 5.5-Product Status 33

Table 17: Impella 5.5-Product Description 33

Table 18: Impella BTR-Product Status 34

Table 19: Impella BTR-Product Description 34

Table 20: Impella CP-Product Status 34

Table 21: Impella CP-Product Description 35

Table 22: Impella CP-Cardiogenic Shock-Product Status 35

Table 23: Impella CP-Cardiogenic Shock-Product Description 36

Table 24: Impella ECP-Product Status 36

Table 25: Impella ECP-Product Description 36

Table 26: Impella RP-Product Status 37

Table 27: Impella RP-Product Description 37

Table 28: Next Generation Impella CP-STEMI-Product Status 37

Table 29: Next Generation Impella CP-STEMI-Product Description 38

Table 30: Abiomed, Inc.-Ongoing Clinical Trials Overview 38

Table 31: Impella RP-The Use of Impella RP Support System in Patients With Right Heart Failure: A Clinical and Probable Benefit Study 39

Table 32: Impella CP-Effects of Advanced Mechanical Circulatory Support in Patients With ST Segment Elevation Myocardial Infarction Complicated by Cardiogenic Shock. The Danish Cardiogenic Shock Trial 39

Table 33: Next Generation Impella CP-STEMI-Door to Unloading (DTU) with Impella CP System in Acute Myocardial Infarction to Reduce Infarct Size 40

Table 34: Biophan Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 41

Table 35: Myotech Circulatory Support System-Product Status 41

Table 36: Myotech Circulatory Support System-Product Description 41

Table 37: BioVentrix Inc Pipeline Products & Ongoing Clinical Trials Overview 42

Table 38: Next Generation Revivent-TC System-Product Status 42

Table 39: Next Generation Revivent-TC System-Product Description 42

Table 40: PliCath HF-Product Status 43

Table 41: PliCath HF-Product Description 43

Table 42: BioVentrix Inc-Ongoing Clinical Trials Overview 44

Table 43: PliCath HF-Phase II Study of the BioVentrix PliCath HF System for the Treatment of Ischemic Cardiomyopathy 44

Table 44: Braile Biomedica Ltda Pipeline Products & Ongoing Clinical Trials Overview 45

Table 45: Blood Pump-Product Status 45

Table 46: Blood Pump-Product Description 45

Table 47: Calon Cardio-Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 46

Table 48: BridgeVAD-Product Status 46

Table 49: BridgeVAD-Product Description 46

Table 50: Calon MiniVAD-Product Status 47

Table 51: Calon MiniVAD-Product Description 47

Table 52: CathVAD-Product Status 48

Table 53: CathVAD-Product Description 48

Table 54: CardiacAssist Inc Pipeline Products & Ongoing Clinical Trials Overview 49

Table 55: Pediatric pVAD-Product Status 49

Table 56: Pediatric pVAD-Product Description 49

Table 57: CARDIAnove Pipeline Products & Ongoing Clinical Trials Overview 50

Table 58: CARDIAnove Pump-Product Status 50

Table 59: CARDIAnove Pump-Product Description 50

Table 60: Cardio Vox, Inc. Pipeline Products & Ongoing Clinical Trials Overview 51

Table 61: Transcatheter Ventricular Assist Device-Product Status 51

Table 62: Transcatheter Ventricular Assist Device-Product Description 51

Table 63: CardioKinetix Inc Pipeline Products & Ongoing Clinical Trials Overview 52

Table 64: Parachute Ventricular Partitioning Device-Product Status 52

Table 65: Parachute Ventricular Partitioning Device-Product Description 52

Table 66: CardioKinetix Inc-Ongoing Clinical Trials Overview 53

Table 67: Parachute Ventricular Partitioning Device-A Dual-Arm, Open-Label, Multi-Center Registry Designed To Evaluate The Parachute Implant in Ischemic Heart Failure Patients 54

Table 68: Parachute Ventricular Partitioning Device-Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease 54

Table 69: Parachute Ventricular Partitioning Device-Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease. A German Trial to Evaluate the Improvement in Quality of Life and Cardiac Output Following Implanting of the Parachute Implant System : PARACHUTE V 54

Table 70: CardioPlus, Inc. Pipeline Products & Ongoing Clinical Trials Overview 55

Table 71: CardioPlus-Product Status 55

Table 72: CardioPlus-Product Description 55

Table 73: Carnegie Mellon University Pipeline Products & Ongoing Clinical Trials Overview 56

Table 74: tVAD-Heart Failure-Product Status 56

Table 75: tVAD-Heart Failure-Product Description 56

Table 76: Cleveland Clinic Hospital Pipeline Products & Ongoing Clinical Trials Overview 57

Table 77: PediPump-Product Status 57

Table 78: PediPump-Product Description 57

Table 79: Cleveland Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 58

Table 80: SmartHeart LVAD-Product Status 58

Table 81: SmartHeart LVAD-Product Description 58

Table 82: CorAssist Cardiovascular Ltd Pipeline Products & Ongoing Clinical Trials Overview 59

Table 83: CORolla-Product Status 59

Table 84: CORolla-Product Description 59

Table 85: ImCardia-Product Status 60

Table 86: ImCardia-Product Description 60

Table 87: CorAssist Cardiovascular Ltd-Ongoing Clinical Trials Overview 60

Table 88: CORolla-CORolla TAA for Heart Failure and Preserved Ejection Fraction and Diastolic Dysfunction 61

Table 89: CORolla-CORolla TAA for Heart Failure with Preserved Ejection Fraction (HFpEF) and Diastolic Dysfunction (DD) Safety and Feasibility 61

Table 90: Corinnova Inc Pipeline Products & Ongoing Clinical Trials Overview 62

Table 91: CardiacSTAR-Bridge To Decision-Product Status 62

Table 92: CardiacSTAR-Bridge To Decision-Product Description 62

Table 93: CardiacSTAR-Bridge To Recovery-Product Status 63

Table 94: CardiacSTAR-Bridge To Recovery-Product Description 63

Table 95: CardiacSTAR-Bridge To Transplant-Product Status 64

Table 96: CardiacSTAR-Bridge To Transplant-Product Description 64

Table 97: CardiacSTAR-Destination Therapy-Product Status 65

Table 98: CardiacSTAR-Destination Therapy-Product Description 65

Table 99: CardiacSTAR-Heart Rehabilitation-Product Status 65

Table 100: CardiacSTAR-Heart Rehabilitation-Product Description 66

Table 101: CorWave Pipeline Products & Ongoing Clinical Trials Overview 66

Table 102: Left Ventricular Assist Device-Product Status 66

Table 103: Left Ventricular Assist Device-Product Description 67

Table 104: Drexel University Pipeline Products & Ongoing Clinical Trials Overview 68

Table 105: Intravascular Blood Pump-Product Status 68

Table 106: Intravascular Blood Pump-Product Description 68

Table 107: DUALIS MedTech GmbH Pipeline Products & Ongoing Clinical Trials Overview 69

Table 108: CAREFLOW Pump-Product Status 69

Table 109: CAREFLOW Pump-Product Description 69

Table 110: Duke University Pipeline Products & Ongoing Clinical Trials Overview 70

Table 111: Para-Aortic Blood Pump-Product Status 70

Table 112: Para-Aortic Blood Pump-Product Description 70

Table 113: Ension, Inc. Pipeline Products & Ongoing Clinical Trials Overview 71

Table 114: CardioFlowPQ-Product Status 71

Table 115: CardioFlowPQ-Product Description 71

Table 116: Evaheart Inc Pipeline Products & Ongoing Clinical Trials Overview 72

Table 117: EVAHEART Left Ventricular Assist System-Product Status 72

Table 118: EVAHEART Left Ventricular Assist System-Product Description 73

Table 119: Everheart Systems, LLC Pipeline Products & Ongoing Clinical Trials Overview 74

Table 120: Fully Implantable Left Ventricular Assist Device-Product Status 74

Table 121: Fully Implantable Left Ventricular Assist Device-Product Description 74

Table 122: FineHeart Pipeline Products & Ongoing Clinical Trials Overview 75

Table 123: ICOMS-Product Status 75

Table 124: ICOMS-Product Description 75

Table 125: Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon Pipeline Products & Ongoing Clinical Trials Overview 76

Table 126: Ventricular Assist Device-Product Status 76

Table 127: Ventricular Assist Device-Product Description 76

Table 128: Gold Medical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 77

Table 129: Magnevad III-Product Status 77

Table 130: Magnevad III-Product Description 77

Table 131: HeartWare International Inc Pipeline Products & Ongoing Clinical Trials Overview 78

Table 132: BiVAD-Product Status 79

Table 133: BiVAD-Product Description 79

Table 134: Fully Implantable VAD System-Product Status 79

Table 135: Fully Implantable VAD System-Product Description 80

Table 136: HeartWare IV-VAD-Product Status 80

Table 137: HeartWare IV-VAD-Product Description 80

Table 138: HeartWare Ventricular Assist Device-Bridge-To-Transplant-Product Status 81

Table 139: HeartWare Ventricular Assist Device-Bridge-To-Transplant-Product Description 81

Table 140: HeartWare Ventricular Assist Device-Destination Therapy-Product Status 82

Table 141: HeartWare Ventricular Assist Device-Destination Therapy-Product Description 82

Table 142: Levacor Rotary VAD-Product Status 83

Table 143: Levacor Rotary VAD-Product Description 83

Table 144: Longhorn-Product Status 83

Table 145: Longhorn-Product Description 84

Table 146: MiFlow VAD-Product Status 84

Table 147: MiFlow VAD-Product Description 84

Table 148: Miniaturized Ventricular Assist Device (MVAD) Pump-Product Status 85

Table 149: Miniaturized Ventricular Assist Device (MVAD) Pump-Product Description 85

Table 150: VCAN Trans-Mitral-Product Status 85

Table 151: VCAN Trans-Mitral-Product Description 86

Table 152: HeartWare International Inc-Ongoing Clinical Trials Overview 86

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Abiomed, Inc., Biophan Technologies, Inc., BioVentrix Inc, Braile Biomedica Ltda, Calon Cardio-Technology Ltd, CardiacAssist Inc, CARDIAnove, Cardio Vox, Inc., CardioKinetix Inc, CardioPlus, Inc., Carnegie Mellon University, Cleveland Clinic Hospital, Cleveland Heart Inc, CorAssist Cardiovascular Ltd, Corinnova Inc, CorWave, Drexel University, DUALIS MedTech GmbH, Duke University, Ension, Inc., Evaheart Inc, Everheart Systems, LLC, FineHeart, Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon, Gold Medical Technologies, Inc., HeartWare International Inc, Indiana University, Jarvik Heart Inc, LaunchPoint Technologies, Inc., Leviticus Cardio Ltd, Levram Medical Systems Ltd, Lonestar Heart Inc, Mayo Clinic US, Medtronic plc, Micro Interventional Devices, Inc., MyoCardioCare, Inc., NeoCardial Technologies, LLC, Nipro Corp, NuPulse Inc, Penn State Milton S Hershey Medical Center, PlugMed Heart SAS, Procyrion, Purdue University, QRS Diagnostic LLC, ReliantHeart, Inc., Rutgers The State University of New Jersey, Sree Chitra Tirunal Institute for Medical Sciences & Technology, St. Jude Medical Inc, Sunshine Heart Company, Pty. Ltd., SynCardia Systems, Inc., Teleflex Inc, The Artificial Heart Laboratory of Foundation for Cardiac Surgery Development, The Pennsylvania State University, Thoratec Corp, Tokyo Medical and Dental University, U.S. Stem Cell Inc, University of Louisville, University of Michigan, University of Minnesota, University of Zurich, Vadovations, Inc., Vienna University of Technology, Windmill Cardiovascular Systems, Inc., Yale University

Abiomed, Inc., Impella 2.5-Cardiogenic Shock; Abiomed, Inc., Impella 2.5 System; Abiomed, Inc., Impella 5.0-Cardiogenic Shock; Abiomed, Inc., Impella 5.5; Abiomed, Inc., Impella BTR; Abiomed, Inc., Impella CP; Abiomed, Inc., Impella CP-Cardiogenic Shock; Abiomed, Inc., Impella ECP; Abiomed, Inc., Impella RP; Abiomed, Inc., Next Generation Impella CP-STEMI; Biophan Technologies, Inc., Myotech Circulatory Support System; BioVentrix Inc, Next Generation Revivent-TC System; BioVentrix Inc, PliCath HF; Braile Biomedica Ltda, Blood Pump; Calon Cardio-Technology Ltd, BridgeVAD; Calon Cardio-Technology Ltd, Calon MiniVAD; Calon Cardio-Technology Ltd, CathVAD; CardiacAssist Inc, Pediatric pVAD; CARDIAnove, CARDIAnove Pump; Cardio Vox, Inc., Transcatheter Ventricular Assist Device; CardioKinetix Inc, Parachute Ventricular Partitioning Device; CardioPlus, Inc., CardioPlus; Carnegie Mellon University, tVAD-Heart Failure; Cleveland Clinic Hospital, PediPump; Cleveland Heart Inc, SmartHeart LVAD; CorAssist Cardiovascular Ltd, CORolla; CorAssist Cardiovascular Ltd, ImCardia; Corinnova Inc, CardiacSTAR-Bridge To Decision; Corinnova Inc, CardiacSTAR-Bridge To Recovery; Corinnova Inc, CardiacSTAR-Bridge To Transplant; Corinnova Inc, CardiacSTAR-Destination Therapy; Corinnova Inc, CardiacSTAR-Heart Rehabilitation; CorWave, Left Ventricular Assist Device; Drexel University, Intravascular Blood Pump; DUALIS MedTech GmbH, CAREFLOW Pump; Duke University, Para-Aortic Blood Pump; Ension, Inc., CardioFlowPQ; Evaheart Inc, EVAHEART Left Ventricular Assist System; Everheart Systems, LLC, Fully Implantable Left Ventricular Assist Device; FineHeart, ICOMS; Fundacion para la Investigacion Biomedica del Hospital Gregorio Maranon, Ventricular Assist Device; Gold Medical Technologies, Inc., Magnevad III; HeartWare International Inc, BiVAD; HeartWare International Inc, Fully Implantable VAD System; HeartWare International Inc, HeartWare IV-VAD; HeartWare International Inc, HeartWare Ventricular Assist Device-Bridge-To-Transplant; HeartWare International Inc, HeartWare Ventricular Assist Device-Destination Therapy; HeartWare International Inc, Levacor Rotary VAD; HeartWare International Inc, Longhorn; HeartWare International Inc, MiFlow VAD; HeartWare International Inc, Miniaturized Ventricular Assist Device (MVAD) Pump; HeartWare International Inc, VCAN Trans-Mitral; Indiana University, Bi-Conical Heart Pump; Jarvik Heart Inc, Infant Jarvik 2000; Jarvik Heart Inc, Jarvik 15mm LVAD System; Jarvik Heart Inc, Jarvik 2000 FlowMaker; Jarvik Heart Inc, Jarvik 2000 Heart-Bridge To Transplant; Jarvik Heart Inc, Jarvik 2000 Heart-Destination Therapy; LaunchPoint Technologies, Inc., Pediaflow Pediatric VAD; LaunchPoint Technologies, Inc., Quintessential Ventricular Cannula; Leviticus Cardio Ltd, Coplanar Energy Transfer System; Levram Medical Systems Ltd, LEVRAM-Ventricular Assist Device; Lonestar Heart Inc, Algisyl-LVR Surgical Device; Mayo Clinic US, Device For Diastolic Heart Failure; Mayo Clinic US, Implantable Left Ventricular Assist Device; Medtronic plc, HVAD System; Micro Interventional Devices, Inc., LVAD Cuff; MyoCardioCare, Inc., MCC3000 Heart Pump; MyoCardioCare, Inc., MCC3000 Heart Pump-Pediatrics; NeoCardial Technologies, LLC, eHeart Extra Ventricular Assist Device; Nipro Corp, Implantable Ventricular Assist Device; NuPulse Inc, NuPulseCV iVAS; Penn State Milton S Hershey Medical Center, Fontan Circulatory Assist Device; PlugMed Heart SAS, Implantable Left Ventricular Assist Device; Procyrion, Aortix Device; Purdue University, Viscous Impeller Pump-Infants; QRS Diagnostic LLC, LVA4; ReliantHeart, Inc., aVAD; ReliantHeart, Inc., aVAD-Disconnector Driveline; ReliantHeart, Inc., aVAD Liberty System; ReliantHeart, Inc., HeartAssist 5 Adult VAD; Rutgers The State University of New Jersey, Temporary Percutaneous Ventricular Assist Device; Sree Chitra Tirunal Institute for Medical Sciences &; Technology, Paracorporeal Left Ventricle Assist Device; St. Jude Medical Inc, Fully Implantable Ventricular Assist System; St. Jude Medical Inc, UltraMag Adult Ventricular Assist System; St. Jude Medical Inc, UltraMag Pediatric Ventricular Assist System; Sunshine Heart Company, Pty. Ltd., C-Pulse-Wireless Version; Sunshine Heart Company, Pty. Ltd., C-Pulse Heart Assist System; SynCardia Systems, Inc., 10cc Ventricular Assist Device; SynCardia Systems, Inc., 30cc Ventricular Assist Device; SynCardia Systems, Inc., 60cc Ventricular Assist Device; Teleflex Inc, CorAide Left Ventricular Assist System; The Artificial Heart Laboratory of Foundation for Cardiac Surgery Development, ReligaHeart EXT; The Pennsylvania State University, Pediatric Heart-Assist Device; Thoratec Corp, Apica VAD SIS Device; Thoratec Corp, DuraHeart II; Thoratec Corp, HeartMate III LVAS-Bridge-to-Transplant; Thoratec Corp, HeartMate III LVAS-Destination Therapy; Thoratec Corp, HeartMate X; Tokyo Medical and Dental University, TinyPump; U.S. Stem Cell Inc, SVAD; University of Louisville, Paediatric Heart Pump; University of Michigan, BioVAD; University of Minnesota, Cardiac Ventricular Assist Device; University of Zurich, Sensor-Responsive System; Vadovations, Inc., REVOLUTION; Vienna University of Technology, Pneumatic Heart Catheter Pump; Windmill Cardiovascular Systems, Inc., TORVAD; Yale University, BoLetz Pump; Yale University, CAP RVAD Pump


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