Left Ventricular Assist Devices – Medical Devices Pipeline Assessment, 2020

An implantable left ventricular assist device is a ventricular assist system intended for the treatment of end-stage heart failure. GlobalData's Medical Devices sector report, “Left Ventricular Assist Devices – Medical Devices Pipeline Assessment, 2020" provides comprehensive information about the Left Ventricular Assist Devices pipeline products with comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

The Left Ventricular Assist Devices Pipeline Assessment report provides key information and data related to:

Extensive coverage of the Left Ventricular Assist Devices under development

Review details of major pipeline products which include product description, licensing and collaboration details and other developmental activities including pipeline territories, regulatory paths and estimated approval dates

Reviews of major players involved in the pipeline product development.

Provides key clinical trial data related to ongoing clinical trials such as trial phase, trial status, trial start and end dates, and, the number of trials of the major Left Ventricular Assist Devices pipeline products.

Review of Recent Developments in the segment / industry

The Left Ventricular Assist Devices Pipeline Assessment report enables you to:

Access significant competitor information, analysis, and insights to improve your 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 Glaucoma Drainage Device sunder development

Formulate market-entry and market expansion strategies

Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline

The major companies covered in the “Left Ventricular Assist Devices- Medical Devices Pipeline Assessment, 2020” report:

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.

The GlobalData Differentiation

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

The data and analysis within this report are driven by GlobalData Medical Intelligence Center (GDMIC) database. GDMIC gives you the key information required to drive sales, investment and deal-making activity in your business. It includes the following:

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Scope

– Extensive coverage of the Left 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 Left 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 Left 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

Companies mentioned

Abbott Laboratories

Abiomed Inc

Arrow International Cr, A.S.

BioVentrix Inc

Calon Cardio-Technology Ltd

CardiacBooster BV

CARDIAnove Inc

Carnegie Mellon University

Cleveland Clinic Hospital

Cleveland Heart Inc

CorAssist Cardiovascular Ltd

CorWave

Duke University

Evaheart Inc

Everheart Systems, LLC

FineHeart

HeartWare International Inc

Inspired Therapeutics LLC

Jarvik Heart Inc

LaunchPoint Technologies Inc

Leviticus Cardio Ltd

Levram Medical Systems Ltd

Lonestar Heart Inc

Mayo Clinic

Medtronic Plc

Nipro Corp

Perfusion Solution Inc

PlugMed Heart SAS

Procyrion Inc

ReliantHeart, Inc.

Sree Chitra Tirunal Institute for Medical Sciences & Technology

Sunshine Heart Company, Pty. Ltd.

Terumo Corp

Thoratec LLC

Tokyo Medical and Dental University

U.S. Stem Cell Inc

University of Virginia

VASCOR Inc

Windmill Cardiovascular Systems, Inc.

W-Z BIOTECH, LLC

Yale University

Table of Contents

1 Table of Contents 2

1.1 List of Tables 5

1.2 List of Figures 8

2 Introduction 9

2.1 Left Ventricular Assist Devices Overview 9

3 Products under Development 10

3.1 Left Ventricular Assist Devices – Pipeline Products by Stage of Development 10

3.2 Left Ventricular Assist Devices – Pipeline Products by Territory 11

3.3 Left Ventricular Assist Devices – Pipeline Products by Regulatory Path 12

3.4 Left Ventricular Assist Devices – Pipeline Products by Estimated Approval Date 13

3.5 Left Ventricular Assist Devices – Ongoing Clinical Trials 14

4 Left Ventricular Assist Devices – Pipeline Products under Development by Companies 15

4.1 Left Ventricular Assist Devices Companies – Pipeline Products by Stage of Development 15

4.2 Left Ventricular Assist Devices – Pipeline Products by Stage of Development 17

5 Left Ventricular Assist Devices Companies and Product Overview 19

5.1 Abbott Laboratories Company Overview 19

5.1.1 Abbott Laboratories Pipeline Products & Ongoing Clinical Trials Overview 19

5.2 Abiomed Inc Company Overview 20

5.2.1 Abiomed Inc Pipeline Products & Ongoing Clinical Trials Overview 20

5.3 Arrow International Cr, A.S. Company Overview 27

5.3.1 Arrow International Cr, A.S. Pipeline Products & Ongoing Clinical Trials Overview 27

5.4 BioVentrix Inc Company Overview 28

5.4.1 BioVentrix Inc Pipeline Products & Ongoing Clinical Trials Overview 28

5.5 Calon Cardio-Technology Ltd Company Overview 29

5.5.1 Calon Cardio-Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 29

5.6 CardiacBooster BV Company Overview 31

5.6.1 CardiacBooster BV Pipeline Products & Ongoing Clinical Trials Overview 31

5.7 CARDIAnove Inc Company Overview 32

5.7.1 CARDIAnove Inc Pipeline Products & Ongoing Clinical Trials Overview 32

5.8 Carnegie Mellon University Company Overview 33

5.8.1 Carnegie Mellon University Pipeline Products & Ongoing Clinical Trials Overview 33

5.9 Cleveland Clinic Hospital Company Overview 34

5.9.1 Cleveland Clinic Hospital Pipeline Products & Ongoing Clinical Trials Overview 34

5.10 Cleveland Heart Inc Company Overview 35

5.10.1 Cleveland Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 35

5.11 CorAssist Cardiovascular Ltd Company Overview 36

5.11.1 CorAssist Cardiovascular Ltd Pipeline Products & Ongoing Clinical Trials Overview 36

5.12 CorWave Company Overview 39

5.12.1 CorWave Pipeline Products & Ongoing Clinical Trials Overview 39

5.13 Duke University Company Overview 41

5.13.1 Duke University Pipeline Products & Ongoing Clinical Trials Overview 41

5.14 Evaheart Inc Company Overview 42

5.14.1 Evaheart Inc Pipeline Products & Ongoing Clinical Trials Overview 42

5.15 Everheart Systems, LLC Company Overview 45

5.15.1 Everheart Systems, LLC Pipeline Products & Ongoing Clinical Trials Overview 45

5.16 FineHeart Company Overview 46

5.16.1 FineHeart Pipeline Products & Ongoing Clinical Trials Overview 46

5.17 HeartWare International Inc Company Overview 47

5.17.1 HeartWare International Inc Pipeline Products & Ongoing Clinical Trials Overview 47

5.18 Inspired Therapeutics LLC Company Overview 54

5.18.1 Inspired Therapeutics LLC Pipeline Products & Ongoing Clinical Trials Overview 54

5.19 Jarvik Heart Inc Company Overview 55

5.19.1 Jarvik Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 55

5.20 LaunchPoint Technologies Inc Company Overview 61

5.20.1 LaunchPoint Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 61

5.21 Leviticus Cardio Ltd Company Overview 63

5.21.1 Leviticus Cardio Ltd Pipeline Products & Ongoing Clinical Trials Overview 63

5.22 Levram Medical Systems Ltd Company Overview 65

5.22.1 Levram Medical Systems Ltd Pipeline Products & Ongoing Clinical Trials Overview 65

5.23 Lonestar Heart Inc Company Overview 66

5.23.1 Lonestar Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 66

5.24 Mayo Clinic Company Overview 70

5.24.1 Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 70

5.25 Medtronic Plc Company Overview 71

5.25.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 71

5.26 Nipro Corp Company Overview 72

5.26.1 Nipro Corp Pipeline Products & Ongoing Clinical Trials Overview 72

5.27 Perfusion Solution Inc Company Overview 73

5.27.1 Perfusion Solution Inc Pipeline Products & Ongoing Clinical Trials Overview 73

5.28 PlugMed Heart SAS Company Overview 74

5.28.1 PlugMed Heart SAS Pipeline Products & Ongoing Clinical Trials Overview 74

5.29 Procyrion Inc Company Overview 75

5.29.1 Procyrion Inc Pipeline Products & Ongoing Clinical Trials Overview 75

5.30 ReliantHeart, Inc. Company Overview 78

5.30.1 ReliantHeart, Inc. Pipeline Products & Ongoing Clinical Trials Overview 78

5.31 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 80

5.31.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 80

5.32 Sunshine Heart Company, Pty. Ltd. Company Overview 81

5.32.1 Sunshine Heart Company, Pty. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 81

5.33 Terumo Corp Company Overview 82

5.33.1 Terumo Corp Pipeline Products & Ongoing Clinical Trials Overview 82

5.34 Thoratec LLC Company Overview 84

5.34.1 Thoratec LLC Pipeline Products & Ongoing Clinical Trials Overview 84

5.35 Tokyo Medical and Dental University Company Overview 85

5.35.1 Tokyo Medical and Dental University Pipeline Products & Ongoing Clinical Trials Overview 85

5.36 U.S. Stem Cell Inc Company Overview 86

5.36.1 U.S. Stem Cell Inc Pipeline Products & Ongoing Clinical Trials Overview 86

5.37 University of Virginia Company Overview 87

5.37.1 University of Virginia Pipeline Products & Ongoing Clinical Trials Overview 87

5.38 VASCOR Inc Company Overview 88

5.38.1 VASCOR Inc Pipeline Products & Ongoing Clinical Trials Overview 88

5.39 Windmill Cardiovascular Systems, Inc. Company Overview 89

5.39.1 Windmill Cardiovascular Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 89

5.40 W-Z BIOTECH, LLC Company Overview 91

5.40.1 W-Z BIOTECH, LLC Pipeline Products & Ongoing Clinical Trials Overview 91

5.41 Yale University Company Overview 92

5.41.1 Yale University Pipeline Products & Ongoing Clinical Trials Overview 92

6 Left Ventricular Assist Devices- Recent Developments 93

6.1 Mar 04, 2020: Study of 21,848 high-risk PCI patients demonstrates lower risk of death and complications in patients who receive PVADs (Impella) 93

6.2 Feb 26, 2020: Mayo Clinic reports 'remarkable growth' in 2019 94

6.3 Feb 20, 2020: Teleflex reports fourth quarter and full year 2019 results; provides 2020 guidance 94

6.4 Feb 11, 2020: CorWave appoints Jim Schuermann as an Independent Director 96

6.5 Feb 06, 2020: Abiomed announces Q3 FY 2020 revenue of $222 million and

31.7% operating margin 97

6.6 Feb 05, 2020: Abbott's implantable heart pump system gets FDA approval 98

6.7 Jan 23, 2020: Class 1 device recall HeartWare HVAD System battery charger AC adapter 99

6.8 Jan 13, 2020: Abiomed announces preliminary Q3 FY 2020 revenue of $222 million, up 10% over prior year 99

6.9 Jan 08, 2020: Abbott receives FDA approval for heart pump implant procedure 100

6.10 Dec 23, 2019: Mayo Clinic names chief digital officer to lead transformative digital strategy, create Center for Digital Health 101

6.11 Dec 16, 2019: First patient enrolls in STEMI DTU randomized controlled FDA trial; study aims to further demonstrate Impella’s safety and effectiveness 102

6.12 Dec 16, 2019: First patient enrolls in STEMI DTU randomized controlled FDA trial; study aims to further demonstrate impella’s safety and effectiveness 103

6.13 Dec 03, 2019: Dr. John Halamka named president of Mayo Clinic Platform 104

6.14 Nov 19, 2019: Impella heart pumps associated with complications after stent procedure 105

6.15 Nov 19, 2019: Abiomed Medical Office completes review of Observational Analysis of Impella Presented at AHA 106

6.16 Nov 19, 2019: Improving the odds for patients with heart pumps 109

6.17 Nov 14, 2019: Clinical review demonstrates cost-effectiveness of Impella in high-risk PCI and Cardiogenic Shock 110

6.18 Oct 31, 2019: First U.S. patients treated with Impella

5.5 with SmartAssist, a minimally invasive, forward flow heart pump 112

6.19 Oct 31, 2019: Teleflex reports third quarter 2019 results 113

6.20 Oct 31, 2019: Abiomed announces Q2 FY 2020 revenue of $205 million and

29.4% operating margin 115

6.21 Oct 30, 2019: FDA grants breakthrough status to Medtronic heart device 117

6.22 Oct 28, 2019: Hackensack University Medical Center first in U.S. to perform cardiovascular procedures using pioneering Impella

5.5 heart pump device 117

6.23 Oct 07, 2019: Abiomed announces 1,000th patient treated with impella in Japan 119

6.24 Sep 27, 2019: Study demonstrates early use of Impella can increase survival in cardiogenic shock; Escalation protocols initiated 120

6.25 Sep 26, 2019: Abiomed gets pre-market approval for Impella

5.5 in US 122

6.26 Sep 26, 2019: PROTECT III presented at TCT 2019 – Clinical data demonstrates protected PCI with Impella is associated with improved outcomes 123

7 Appendix 125

7.1 Methodology 125

7.2 About GlobalData 129

7.3 Contact Us 129

7.4 Disclaimer 129

List of Tables

Table 1: Left Ventricular Assist Devices – Pipeline Products by Stage of Development 10

Table 2: Left Ventricular Assist Devices – Pipeline Products by Territory 11

Table 3: Left Ventricular Assist Devices – Pipeline Products by Regulatory Path 12

Table 4: Left Ventricular Assist Devices – Pipeline Products by Estimated Approval Date 13

Table 5: Left Ventricular Assist Devices – Ongoing Clinical Trials 14

Table 6: Left Ventricular Assist Devices Companies – Pipeline Products by Stage of Development 15

Table 7: Left Ventricular Assist Devices – Pipeline Products by Stage of Development 17

Table 8: Abbott Laboratories Pipeline Products & Ongoing Clinical Trials Overview 19

Table 9: Fully Implantable Left Ventricular Assist System – Product Status 19

Table 10: Fully Implantable Left Ventricular Assist System – Product Description 19

Table 11: Abiomed Inc Pipeline Products & Ongoing Clinical Trials Overview 20

Table 12: Impella 5.5 With SmartAssist – Product Status 20

Table 13: Impella 5.5 With SmartAssist – Product Description 21

Table 14: Impella BTR – Product Status 21

Table 15: Impella BTR – Product Description 21

Table 16: Impella ECP – Product Status 22

Table 17: Impella ECP – Product Description 22

Table 18: Next Generation Impella CP – STEMI – Product Status 22

Table 19: Next Generation Impella CP – STEMI – Product Description 23

Table 20: Abiomed Inc – Ongoing Clinical Trials Overview 24

Table 21: Impella ECP – Use of the Impella ECP in Patients Undergoing an Elective High-risk Percutaneous Coronary Intervention: An Early Feasibility Study 25

Table 22: Next Generation Impella CP – STEMI – Primary Unloading and Delayed Reperfusion in St-elevation Myocardial Infarction: The STEMI-DTU Trial 26

Table 23: Arrow International Cr, A.S. Pipeline Products & Ongoing Clinical Trials Overview 27

Table 24: CorAide Left Ventricular Assist System – Product Status 27

Table 25: CorAide Left Ventricular Assist System – Product Description 27

Table 26: BioVentrix Inc Pipeline Products & Ongoing Clinical Trials Overview 28

Table 27: PliCath HF – Product Status 28

Table 28: PliCath HF – Product Description 28

Table 29: Calon Cardio-Technology Ltd Pipeline Products & Ongoing Clinical Trials Overview 29

Table 30: Calon MiniVAD – Product Status 29

Table 31: Calon MiniVAD – Product Description 29

Table 32: MicroVAD – Product Status 30

Table 33: MicroVAD – Product Description 30

Table 34: CardiacBooster BV Pipeline Products & Ongoing Clinical Trials Overview 31

Table 35: Percutaneous Ventricular Assist Device – Product Status 31

Table 36: Percutaneous Ventricular Assist Device – Product Description 31

Table 37: CARDIAnove Inc Pipeline Products & Ongoing Clinical Trials Overview 32

Table 38: CARDIAnove Pump – Product Status 32

Table 39: CARDIAnove Pump – Product Description 32

Table 40: Carnegie Mellon University Pipeline Products & Ongoing Clinical Trials Overview 33

Table 41: Non-Blood Contacting Muscle Powered VAD – Product Status 33

Table 42: Non-Blood Contacting Muscle Powered VAD – Product Description 33

Table 43: Cleveland Clinic Hospital Pipeline Products & Ongoing Clinical Trials Overview 34

Table 44: PediPump – Product Status 34

Table 45: PediPump – Product Description 34

Table 46: Cleveland Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 35

Table 47: SmartHeart LVAD – Product Status 35

Table 48: SmartHeart LVAD – Product Description 35

Table 49: CorAssist Cardiovascular Ltd Pipeline Products & Ongoing Clinical Trials Overview 36

Table 50: CORolla – Product Status 36

Table 51: CORolla – Product Description 36

Table 52: CorAssist Cardiovascular Ltd – Ongoing Clinical Trials Overview 37

Table 53: CORolla – CORolla TAA for Heart Failure with Preserved Ejection Fraction (HFpEF) and Diastolic Dysfunction (DD) Safety and Feasibility 38

Table 54: CorWave Pipeline Products & Ongoing Clinical Trials Overview 39

Table 55: CorWave Nemo – Product Status 39

Table 56: CorWave Nemo – Product Description 39

Table 57: CorWave Neptune – Product Status 40

Table 58: CorWave Neptune – Product Description 40

Table 59: Duke University Pipeline Products & Ongoing Clinical Trials Overview 41

Table 60: Para-Aortic Blood Pump – Product Status 41

Table 61: Para-Aortic Blood Pump – Product Description 41

Table 62: Evaheart Inc Pipeline Products & Ongoing Clinical Trials Overview 42

Table 63: EVAHEART Left Ventricular Assist System – Product Status 42

Table 64: EVAHEART Left Ventricular Assist System – Product Description 42

Table 65: Evaheart Inc – Ongoing Clinical Trials Overview 43

Table 66: EVAHEART Left Ventricular Assist System – Prospective Multi-Center Randomized Study for Evaluating the EVAHEART2 Left Ventricular Assist System: the COMPETENCE Trial 44

Table 67: Everheart Systems, LLC Pipeline Products & Ongoing Clinical Trials Overview 45

Table 68: Fully Implantable Left Ventricular Assist Device – Product Status 45

Table 69: Fully Implantable Left Ventricular Assist Device – Product Description 45

Table 70: FineHeart Pipeline Products & Ongoing Clinical Trials Overview 46

Table 71: ICOMS – Product Status 46

Table 72: ICOMS – Product Description 46

Table 73: HeartWare International Inc Pipeline Products & Ongoing Clinical Trials Overview 47

Table 74: HVAD System – Destination Therapy – Product Status 47

Table 75: HVAD System – Destination Therapy – Product Description 48

Table 76: Longhorn – Product Status 48

Table 77: Longhorn – Product Description 49

Table 78: Miniaturized Ventricular Assist Device (MVAD) Pump – Product Status 49

Table 79: Miniaturized Ventricular Assist Device (MVAD) Pump – Product Description 49

Table 80: VCAN Trans-Mitral – Product Status 50

Table 81: VCAN Trans-Mitral – Product Description 50

Table 82: HeartWare International Inc – Ongoing Clinical Trials Overview 51

Table 83: 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 52

Table 84: HVAD System – Destination Therapy – Apogee International 53

Table 85: Inspired Therapeutics LLC Pipeline Products & Ongoing Clinical Trials Overview 54

Table 86: INSPIRE System – Product Status 54

Table 87: INSPIRE System – Product Description 54

Table 88: Jarvik Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 55

Table 89: Jarvik 2000 Heart – Bridge To Transplant – Product Status 55

Table 90: Jarvik 2000 Heart – Bridge To Transplant – Product Description 56

Table 91: Jarvik 2000 Heart – Destination Therapy – Product Status 56

Table 92: Jarvik 2000 Heart – Destination Therapy – Product Description 56

Table 93: Jarvik 2015 – Product Status 57

Table 94: Jarvik 2015 – Product Description 57

Table 95: Jarvik Heart Inc – Ongoing Clinical Trials Overview 58

Table 96: Jarvik 2000 Heart – Destination Therapy – Evaluation of the Jarvik 2000 Left Ventricular Assist System with Post-auricular Connector–destination Therapy Study 59

Table 97: Jarvik 2015 – Pumps for Kids, Infants, and Neonates 60

Table 98: LaunchPoint Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 61

Table 99: Pediaflow Pediatric VAD – Product Status 61

Table 100: Pediaflow Pediatric VAD – Product Description 61

Table 101: Streamliner VAD – Product Status 62

Table 102: Streamliner VAD – Product Description 62

Table 103: Leviticus Cardio Ltd Pipeline Products & Ongoing Clinical Trials Overview 63

Table 104: FiVAD System – Product Status 63

Table 105: FiVAD System – Product Description 64

Table 106: Hybrid FILVAS – Product Status 64

Table 107: Hybrid FILVAS – Product Description 64

Table 108: Levram Medical Systems Ltd Pipeline Products & Ongoing Clinical Trials Overview 65

Table 109: LEVRAM-Ventricular Assist Device – Product Status 65

Table 110: LEVRAM-Ventricular Assist Device – Product Description 65

Table 111: Lonestar Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 66

Table 112: Algisyl-LVR Surgical Device – Product Status 66

Table 113: Algisyl-LVR Surgical Device – Product Description 67

Table 114: Lonestar Heart Inc – Ongoing Clinical Trials Overview 68

Table 115: Algisyl-LVR Surgical Device – A Pivotal Trial to Establish the Efficacy and Safety of Algisyl in Patients With Moderate to Severe Heart Failure 69

Table 116: Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 70

Table 117: Implantable Left Ventricular Assist Device – Product Status 70

Table 118: Implantable Left Ventricular Assist Device – Product Description 70

Table 119: Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 71

Table 120: Fully Implantable Left Ventricular Assist Device – Product Status 71

Table 121: Fully Implantable Left Ventricular Assist Device – Product Description 71

Table 122: Nipro Corp Pipeline Products & Ongoing Clinical Trials Overview 72

Table 123: BR16010 – Product Status 72

Table 124: BR16010 – Product Description 72

Table 125: Perfusion Solution Inc Pipeline Products & Ongoing Clinical Trials Overview 73

Table 126: Transapical LVAD – Product Status 73

Table 127: Transapical LVAD – Product Description 73

Table 128: PlugMed Heart SAS Pipeline Products & Ongoing Clinical Trials Overview 74

Table 129: Implantable Left Ventricular Assist Device – Product Status 74

Table 130: Implantable Left Ventricular Assist Device – Product Description 74

Table 131: Procyrion Inc Pipeline Products & Ongoing Clinical Trials Overview 75

Table 132: Aortix Device – Product Status 75

Table 133: Aortix Device – Product Description 75

Table 134: Procyrion Inc – Ongoing Clinical Trials Overview 76

Table 135: Aortix Device – An Evaluation of the Safety and Performance of the Aortix System for Intra-aortic Mechanical Circulatory Support in Patients with Cardiorenal Syndrome 77

Table 136: ReliantHeart, Inc. Pipeline Products & Ongoing Clinical Trials Overview 78

Table 137: aVAD Liberty System – Product Status 78

Table 138: aVAD Liberty System – Product Description 78

Table 139: VAD Maintenance System – Product Status 79

Table 140: VAD Maintenance System – Product Description 79

Table 141: Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 80

Table 142: Paracorporeal Left Ventricle Assist Device – Product Status 80

Table 143: Paracorporeal Left Ventricle Assist Device – Product Description 80

Table 144: Sunshine Heart Company, Pty. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 81

Table 145: C-Pulse – Wireless Version – Product Status 81

Table 146: C-Pulse – Wireless Version – Product Description 81

Table 147: Terumo Corp Pipeline Products & Ongoing Clinical Trials Overview 82

Table 148: DuraHeart Destination Therapy Left Ventricular Assist System – Product Status 82

Table 149: DuraHeart Destination Therapy Left Ventricular Assist System – Product Description 83

Table 150: Thoratec LLC Pipeline Products & Ongoing Clinical Trials Overview 84

Table 151: DuraHeart II – Product Status 84

Table 152: DuraHeart II – Product Description 84

Table 153: Tokyo Medical and Dental University Pipeline Products & Ongoing Clinical Trials Overview 85

Table 154: TinyPump – Product Status 85

Table 155: TinyPump – Product Description 85

Table 156: U.S. Stem Cell Inc Pipeline Products & Ongoing Clinical Trials Overview 86

Table 157: SVAD – Product Status 86

Table 158: SVAD – Product Description 86

Table 159: University of Virginia Pipeline Products & Ongoing Clinical Trials Overview 87

Table 160: VADStent – Product Status 87

Table 161: VADStent – Product Description 87

Table 162: VASCOR Inc Pipeline Products & Ongoing Clinical Trials Overview 88

Table 163: Vascor LVAD – Product Status 88

Table 164: Vascor LVAD – Product Description 88

Table 165: Windmill Cardiovascular Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 89

Table 166: Pediatric TORVAD – Product Status 89

Table 167: Pediatric TORVAD – Product Description 89

Table 168: TORVAD – Product Status 90

Table 169: TORVAD – Product Description 90

Table 170: W-Z BIOTECH, LLC Pipeline Products & Ongoing Clinical Trials Overview 91

Table 171: Double Lumen Cannula-Based Left Ventricular Assist Device – Product Status 91

Table 172: Double Lumen Cannula-Based Left Ventricular Assist Device – Product Description 91

Table 173: Yale University Pipeline Products & Ongoing Clinical Trials Overview 92

Table 174: BoLetz Pump – Product Status 92

Table 175: BoLetz Pump – Product Description 92

Table 176: Glossary 128

List of Figures

Figure 1: Left Ventricular Assist Devices – Pipeline Products by Stage of Development 10

Figure 2: Left Ventricular Assist Devices – Pipeline Products by Territory 11

Figure 3: Left Ventricular Assist Devices – Pipeline Products by Regulatory Path 12

Figure 4: Left Ventricular Assist Devices – Pipeline Products by Estimated Approval Date 13

Figure 5: Left Ventricular Assist Devices – Ongoing Clinical Trials 14

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