Cardiac Valve Repairs – Medical Devices Pipeline Assessment, 2020

Cardiac valve repair devices are used in the repair of malfunctioning valves. Only mitral valve repair has been covered under this segment. GlobalData's Medical Devices sector report, “Cardiac Valve Repairs-Medical Devices Pipeline Assessment, 2020" provides comprehensive information about the Cardiac Valve Repairs pipeline products with comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

The Cardiac Valve Repairs Pipeline Assessment report provides key information and data related to:

Extensive coverage of the Cardiac Valve Repairs 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 Cardiac Valve Repairs pipeline products.

Review of Recent Developments in the segment / industry

The Cardiac Valve Repairs 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 Cardiac valve repair devices under 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 “Cardiac Valve Repairs- 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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Contact us to discuss the areas of your business where you need external input, and we will work with you to identify the strongest way forward to meet your needs

Scope

– Extensive coverage of the Cardiac Valve Repairs 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 Cardiac Valve Repairs 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 Cardiac Valve Repairs 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 Vascular Inc

Affluent Medical SA

Ample Medical Inc

Anchorvalve

Ancora Heart Inc

Boston Children's Hospital

Cardiac Dimensions Inc

Cardiosolutions Inc

Celyad Oncology

Collplant Biotechnologies Ltd

CoreMedic AG

CUBE SRL

Edwards Lifesciences Corp

Emory University

Georgia Institute of Technology

Hangzhou DeJin Medtech Co Ltd

Kardium Inc

Kekai Life Sciences

Mardil Medical, Inc.

Mayo Clinic

Medfree Inc

MiCardia Corp

Michigan Critical Care Consultants Inc

Micro Interventional Devices, Inc.

Millipede LLC

Mitralign Inc

Mitralix Ltd.

Mitre Medical Corp

MVRx, Inc.

Neochord Inc

Rambam Health Care Campus

Strait Access Technologies (Pty) Ltd

Symetis SA

Tel Aviv Sourasky Medical Center

TransCardiac Therapeutics, LLC

Transmural systems LLC

TTK Healthcare Ltd

University of Manitoba

Valcare Medical

valsculp

Valtech Cardio Ltd

Vesalius Cardiovascular Inc

Viacor Inc

Table of Contents

1 Table of Contents 2

1.1 List of Tables 5

1.2 List of Figures 9

2 Introduction 11

2.1 Cardiac Valve Repairs Overview 11

3 Products under Development 12

3.1 Cardiac Valve Repairs – Pipeline Products by Stage of Development 12

3.2 Cardiac Valve Repairs – Pipeline Products by Segment 13

3.3 Cardiac Valve Repairs – Pipeline Products by Territory 14

3.4 Cardiac Valve Repairs – Pipeline Products by Regulatory Path 15

3.5 Cardiac Valve Repairs – Pipeline Products by Estimated Approval Date 16

3.6 Cardiac Valve Repairs – Ongoing Clinical Trials 17

4 Cardiac Valve Repairs – Pipeline Products under Development by Companies 18

4.1 Cardiac Valve Repairs Companies – Pipeline Products by Stage of Development 18

4.2 Cardiac Valve Repairs – Pipeline Products by Stage of Development 20

5 Cardiac Valve Repairs Companies and Product Overview 22

5.1 Abbott Vascular Inc Company Overview 22

5.1.1 Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 22

5.2 Affluent Medical SA Company Overview 25

5.2.1 Affluent Medical SA Pipeline Products & Ongoing Clinical Trials Overview 25

5.3 Ample Medical Inc Company Overview 28

5.3.1 Ample Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 28

5.4 Anchorvalve Company Overview 29

5.4.1 Anchorvalve Pipeline Products & Ongoing Clinical Trials Overview 29

5.5 Ancora Heart Inc Company Overview 31

5.5.1 Ancora Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 31

5.6 Boston Children's Hospital Company Overview 35

5.6.1 Boston Children's Hospital Pipeline Products & Ongoing Clinical Trials Overview 35

5.7 Cardiac Dimensions Inc Company Overview 38

5.7.1 Cardiac Dimensions Inc Pipeline Products & Ongoing Clinical Trials Overview 38

5.8 Cardiosolutions Inc Company Overview 41

5.8.1 Cardiosolutions Inc Pipeline Products & Ongoing Clinical Trials Overview 41

5.9 Celyad Oncology Company Overview 42

5.9.1 Celyad Oncology Pipeline Products & Ongoing Clinical Trials Overview 42

5.10 Collplant Biotechnologies Ltd Company Overview 44

5.10.1 Collplant Biotechnologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 44

5.11 CoreMedic AG Company Overview 45

5.11.1 CoreMedic AG Pipeline Products & Ongoing Clinical Trials Overview 45

5.12 CUBE SRL Company Overview 48

5.12.1 CUBE SRL Pipeline Products & Ongoing Clinical Trials Overview 48

5.13 Edwards Lifesciences Corp Company Overview 49

5.13.1 Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 49

5.14 Emory University Company Overview 55

5.14.1 Emory University Pipeline Products & Ongoing Clinical Trials Overview 55

5.15 Georgia Institute of Technology Company Overview 56

5.15.1 Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 56

5.16 Hangzhou DeJin Medtech Co Ltd Company Overview 57

5.16.1 Hangzhou DeJin Medtech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 57

5.17 Kardium Inc Company Overview 59

5.17.1 Kardium Inc Pipeline Products & Ongoing Clinical Trials Overview 59

5.18 Kekai Life Sciences Company Overview 60

5.18.1 Kekai Life Sciences Pipeline Products & Ongoing Clinical Trials Overview 60

5.19 Mardil Medical, Inc. Company Overview 62

5.19.1 Mardil Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 62

5.20 Mayo Clinic Company Overview 65

5.20.1 Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 65

5.21 Medfree Inc Company Overview 66

5.21.1 Medfree Inc Pipeline Products & Ongoing Clinical Trials Overview 66

5.22 MiCardia Corp Company Overview 67

5.22.1 MiCardia Corp Pipeline Products & Ongoing Clinical Trials Overview 67

5.23 Michigan Critical Care Consultants Inc Company Overview 68

5.23.1 Michigan Critical Care Consultants Inc Pipeline Products & Ongoing Clinical Trials Overview 68

5.24 Micro Interventional Devices, Inc. Company Overview 70

5.24.1 Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 70

5.25 Millipede LLC Company Overview 74

5.25.1 Millipede LLC Pipeline Products & Ongoing Clinical Trials Overview 74

5.26 Mitralign Inc Company Overview 77

5.26.1 Mitralign Inc Pipeline Products & Ongoing Clinical Trials Overview 77

5.27 Mitralix Ltd. Company Overview 80

5.27.1 Mitralix Ltd. Pipeline Products & Ongoing Clinical Trials Overview 80

5.28 Mitre Medical Corp Company Overview 83

5.28.1 Mitre Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 83

5.29 MVRx, Inc. Company Overview 87

5.29.1 MVRx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 87

5.30 Neochord Inc Company Overview 90

5.30.1 Neochord Inc Pipeline Products & Ongoing Clinical Trials Overview 90

5.31 Rambam Health Care Campus Company Overview 94

5.31.1 Rambam Health Care Campus Pipeline Products & Ongoing Clinical Trials Overview 94

5.32 Strait Access Technologies (Pty) Ltd Company Overview 95

5.32.1 Strait Access Technologies (Pty) Ltd Pipeline Products & Ongoing Clinical Trials Overview 95

5.33 Symetis SA Company Overview 96

5.33.1 Symetis SA Pipeline Products & Ongoing Clinical Trials Overview 96

5.34 Tel Aviv Sourasky Medical Center Company Overview 97

5.34.1 Tel Aviv Sourasky Medical Center Pipeline Products & Ongoing Clinical Trials Overview 97

5.35 TransCardiac Therapeutics, LLC Company Overview 98

5.35.1 TransCardiac Therapeutics, LLC Pipeline Products & Ongoing Clinical Trials Overview 98

5.36 Transmural systems LLC Company Overview 99

5.36.1 Transmural systems LLC Pipeline Products & Ongoing Clinical Trials Overview 99

5.37 TTK Healthcare Ltd Company Overview 102

5.37.1 TTK Healthcare Ltd Pipeline Products & Ongoing Clinical Trials Overview 102

5.38 University of Manitoba Company Overview 103

5.38.1 University of Manitoba Pipeline Products & Ongoing Clinical Trials Overview 103

5.39 Valcare Medical Company Overview 104

5.39.1 Valcare Medical Pipeline Products & Ongoing Clinical Trials Overview 104

5.40 valsculp Company Overview 106

5.40.1 valsculp Pipeline Products & Ongoing Clinical Trials Overview 106

5.41 Valtech Cardio Ltd Company Overview 107

5.41.1 Valtech Cardio Ltd Pipeline Products & Ongoing Clinical Trials Overview 107

5.42 Vesalius Cardiovascular Inc Company Overview 115

5.42.1 Vesalius Cardiovascular Inc Pipeline Products & Ongoing Clinical Trials Overview 115

5.43 Viacor Inc Company Overview 116

5.43.1 Viacor Inc Pipeline Products & Ongoing Clinical Trials Overview 116

6 Cardiac Valve Repairs- Recent Developments 117

6.1 Jul 16, 2020: Mentice receives order of total SEK

7.0 million from Edwards Lifesciences 117

6.2 Jul 13, 2020: Abbott agrees to global Transcatheter Litigation Settlement with Edwards Lifesciences 117

6.3 Mar 28, 2020: Edwards pauses enrollments in pivotal mitral, tricuspid trials in response to hospitals' focus on COVID-19 117

6.4 Feb 26, 2020: Mayo Clinic reports 'remarkable growth' in 2019 117

6.5 Feb 24, 2020: Dr. Rajamannan responds to FDA demands of new evidence surrounding harm to patients in an open letter to members of congress, the FDA commissioner Hahn and HHS Secretary Azar 118

6.6 Feb 24, 2020: 2020 Catalyst award winner Medtronic hires Chief Inclusion and Diversity Officer 119

6.7 Feb 24, 2020: 2020 Catalyst Award Winner Medtronic hires Chief Inclusion and Diversity Officer 120

6.8 Feb 18, 2020: Medtronic reports third quarter financial results 2020 121

6.9 Feb 14, 2020: CollPlant Biotechnologies raising $4.45 million in U.S. Private Placement 123

6.10 Feb 10, 2020: CollPlant announces appointment of Roger J. Pomerantz, M.D., F.A.C.P. as Chairman of the Board of Directors 124

6.11 Jan 16, 2020: Expert Alert: Robotic repair offers benefits for many patients with leaky mitral valve 124

6.12 Jan 09, 2020: FDA confirms non-exempt status of medical device but no plans to Inform the patients as confirmed by Dr. Rajamannan in press conference at Most Sacred Heart of Jesus Cardiology and Valvular Institute 125

6.13 Dec 23, 2019: Mayo Clinic names chief digital officer to lead transformative digital strategy, create Center for Digital Health 126

6.14 Dec 04, 2019: Lumeon and Medtronic partner to deliver new models of care in Europe 127

6.15 Dec 03, 2019: Affluent Medical announces first patient implanted in OPTIMISE II pivotal clinical study for KALIOS, the minimally invasive mitral valve repair ring 128

6.16 Dec 03, 2019: Dr. John Halamka named president of Mayo Clinic Platform 129

6.17 Nov 29, 2019: CollPlant reports third quarter 2019 financial results and provides business update 129

6.18 Nov 19, 2019: Medtronic reports second quarter financial results for the year 2019 132

6.19 Nov 14, 2019: Medtronic highlights leadership in inclusion, diversity, and equity in 2019 integrated performance report 134

6.20 Oct 23, 2019: Edwards Lifesciences reports third quarter results 135

6.21 Oct 22, 2019: CollPlant CEO Yehiel Tal appointed to serve on international society for Biofabrication's Industry Relations Committee 138

6.22 Oct 21, 2019: Sean Salmon named executive vice president and group president of Medtronic Diabetes 138

6.23 Oct 10, 2019: CINDE announces Edwards Lifesciences invests $100 million to expand its operations in Costa Rica 139

6.24 Sep 28, 2019: New Data Demonstrate Strong Outcomes for Abbott Device to Repair Leaky Tricuspid Heart Valves 141

6.25 Sep 26, 2019: CollPlant reports second quarter 2019 financial results and provides business update 142

6.26 Sep 25, 2019: Ancora Heart announces positive safety and efficacy data from study of first-of-its-kind investigational heart failure therapy 144

7 Appendix 146

7.1 Methodology 146

7.2 About GlobalData 150

7.3 Contact Us 150

7.4 Disclaimer 150

List of Tables

Table 1: Cardiac Valve Repairs – Pipeline Products by Stage of Development 12

Table 2: Cardiac Valve Repairs – Pipeline Products by Segment 13

Table 3: Cardiac Valve Repairs – Pipeline Products by Territory 14

Table 4: Cardiac Valve Repairs – Pipeline Products by Regulatory Path 15

Table 5: Cardiac Valve Repairs – Pipeline Products by Estimated Approval Date 16

Table 6: Cardiac Valve Repairs – Ongoing Clinical Trials 17

Table 7: Cardiac Valve Repairs Companies – Pipeline Products by Stage of Development 18

Table 8: Cardiac Valve Repairs – Pipeline Products by Stage of Development 20

Table 9: Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 22

Table 10: TriClip Transcatheter Tricuspid Valve Repair System – Product Status 22

Table 11: TriClip Transcatheter Tricuspid Valve Repair System – Product Description 22

Table 12: Abbott Vascular Inc – Ongoing Clinical Trials Overview 23

Table 13: TriClip Transcatheter Tricuspid Valve Repair System – An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated with the Abbott TriClip Device 24

Table 14: TriClip Transcatheter Tricuspid Valve Repair System – Clinical Trial to Evaluate Cardiovascular Outcomes in Patients Treated with the Tricuspid Valve Repair System Pivotal 24

Table 15: TriClip Transcatheter Tricuspid Valve Repair System – Trial to Evaluate Treatment with Abbott Transcatheter Clip Repair System in Patients with Moderate or Greater Tricuspid Regurgitation (TRILUMINATE) 24

Table 16: Affluent Medical SA Pipeline Products & Ongoing Clinical Trials Overview 25

Table 17: Kalios – Product Status 25

Table 18: Kalios – Product Description 25

Table 19: Affluent Medical SA – Ongoing Clinical Trials Overview 26

Table 20: Kalios – Optimization of Surgical Repair for Treating Insufficiency of the Mitral Valve – Safety and Effectiveness Evaluation: OPTIMISE II 27

Table 21: Ample Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 28

Table 22: PS3 System – Product Status 28

Table 23: PS3 System – Product Description 28

Table 24: Anchorvalve Pipeline Products & Ongoing Clinical Trials Overview 29

Table 25: Sutureless Mitral Valve Repair Ring – Product Status 29

Table 26: Sutureless Mitral Valve Repair Ring – Product Description 29

Table 27: Sutureless Tricuspid Valve Repair Ring – Product Status 30

Table 28: Sutureless Tricuspid Valve Repair Ring – Product Description 30

Table 29: Ancora Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 31

Table 30: AccuCinch Ventriculoplasty System – Product Status 31

Table 31: AccuCinch Ventriculoplasty System – Product Description 31

Table 32: Ancora Heart Inc – Ongoing Clinical Trials Overview 32

Table 33: AccuCinch Ventriculoplasty System – A Study of Percutaneous Repair of Functional Mitral Regurgitation Using the Ancora Heart, Inc. AccuCinch Ventricular Repair System – The CINCH-2 Study 33

Table 34: AccuCinch Ventriculoplasty System – An Early Feasibility Evaluation of the AccuCinch Ventricular Repair System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF) – The CorCinch-HFrEF Study 33

Table 35: AccuCinch Ventriculoplasty System – An Early Feasibility Study of the AccuCinch Ventricular Repair System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation – The CorCinch-PMVI Study 33

Table 36: AccuCinch Ventriculoplasty System – Early Feasibility Study of the AccuCinch Ventricular Repair System 34

Table 37: AccuCinch Ventriculoplasty System – Safety and Performance Evaluation of the AccuCinch Ventricular Repair System for Functional Mitral Regurgitation Due to Dilated Ischemic or Non-Ischemic Cardiomyopathy – The CorCinch-EU Study 34

Table 38: Boston Children's Hospital Pipeline Products & Ongoing Clinical Trials Overview 35

Table 39: Endovascular Prosthesis – Product Status 35

Table 40: Endovascular Prosthesis – Product Description 35

Table 41: Mitral Valve Repair Clip – Product Status 36

Table 42: Mitral Valve Repair Clip – Product Description 36

Table 43: Tricuspid Valve Repair Device – Product Status 36

Table 44: Tricuspid Valve Repair Device – Product Description 37

Table 45: Cardiac Dimensions Inc Pipeline Products & Ongoing Clinical Trials Overview 38

Table 46: CARILLON Mitral Contour System – Product Status 38

Table 47: CARILLON Mitral Contour System – Product Description 38

Table 48: Cardiac Dimensions Inc – Ongoing Clinical Trials Overview 39

Table 49: CARILLON Mitral Contour System – An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Function Mitral Regurgitation 40

Table 50: CARILLON Mitral Contour System – Assessment of the Carillon Mitral Contour System in Treating Functional Mitral Regurgitation Associated with Heart Failure 40

Table 51: CARILLON Mitral Contour System – European Registry of Transcatheter Repair for Secondary Mitral Regurgitation 40

Table 52: Cardiosolutions Inc Pipeline Products & Ongoing Clinical Trials Overview 41

Table 53: Mitra-Spacer – Product Status 41

Table 54: Mitra-Spacer – Product Description 41

Table 55: Celyad Oncology Pipeline Products & Ongoing Clinical Trials Overview 42

Table 56: Heart Access Sheath – Mitral Valve Repair – Product Status 42

Table 57: Heart Access Sheath – Mitral Valve Repair – Product Description 42

Table 58: Mitral Valve Neo-chordae – Product Status 43

Table 59: Mitral Valve Neo-chordae – Product Description 43

Table 60: Collplant Biotechnologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 44

Table 61: VergenixHVR – Product Status 44

Table 62: VergenixHVR – Product Description 44

Table 63: CoreMedic AG Pipeline Products & Ongoing Clinical Trials Overview 45

Table 64: ChordArt – Product Status 45

Table 65: ChordArt – Product Description 45

Table 66: CoreMedic AG – Ongoing Clinical Trials Overview 46

Table 67: ChordArt – Chordart System Study for the Treatment of Mitral Regurgitation Due to Leaflet Prolapse or Flail 47

Table 68: CUBE SRL Pipeline Products & Ongoing Clinical Trials Overview 48

Table 69: Mitral-FERCube Ring – Product Status 48

Table 70: Mitral-FERCube Ring – Product Description 48

Table 71: Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 49

Table 72: Coapsys – Product Status 49

Table 73: Coapsys – Product Description 50

Table 74: FORMA Tricuspid Repair System – Product Status 50

Table 75: FORMA Tricuspid Repair System – Product Description 50

Table 76: MOBIUS Leaflet Repair System – Product Status 51

Table 77: MOBIUS Leaflet Repair System – Product Description 51

Table 78: MONARC Mitral Repair System – Product Status 51

Table 79: MONARC Mitral Repair System – Product Description 51

Table 80: Physio Flex Annuloplasty Ring – Product Status 52

Table 81: Physio Flex Annuloplasty Ring – Product Description 52

Table 82: Edwards Lifesciences Corp – Ongoing Clinical Trials Overview 53

Table 83: FORMA Tricuspid Repair System – Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System 54

Table 84: FORMA Tricuspid Repair System – International Multisite Transcatheter Tricuspid Valve Therapies Registry 54

Table 85: FORMA Tricuspid Repair System – Repair of Tricuspid Valve Regurgitation Using the Edwards Tricuspid Transcatheter Repair System: The SPACER Trial 54

Table 86: Emory University Pipeline Products & Ongoing Clinical Trials Overview 55

Table 87: MitraSurg – Product Status 55

Table 88: MitraSurg – Product Description 55

Table 89: Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 56

Table 90: Tricuspid Annuloplasty Rings – Product Status 56

Table 91: Tricuspid Annuloplasty Rings – Product Description 56

Table 92: Hangzhou DeJin Medtech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 57

Table 93: Second Generation Mitral Valve Repair Device – Product Status 57

Table 94: Second Generation Mitral Valve Repair Device – Product Description 57

Table 95: Tricuspid Repair Device – Product Status 58

Table 96: Tricuspid Repair Device – Product Description 58

Table 97: Kardium Inc Pipeline Products & Ongoing Clinical Trials Overview 59

Table 98: Percutaneous Mitral Valve Regurgitation Device – Product Status 59

Table 99: Percutaneous Mitral Valve Regurgitation Device – Product Description 59

Table 100: Kekai Life Sciences Pipeline Products & Ongoing Clinical Trials Overview 60

Table 101: FlexClamp – Product Status 60

Table 102: FlexClamp – Product Description 60

Table 103: FlexClip – Product Status 61

Table 104: FlexClip – Product Description 61

Table 105: SuperClip – Product Status 61

Table 106: SuperClip – Product Description 61

Table 107: Mardil Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 62

Table 108: VenTouch Triad Targeted Ventricular Reshaping System – Product Status 62

Table 109: VenTouch Triad Targeted Ventricular Reshaping System – Product Description 62

Table 110: Mardil Medical, Inc. – Ongoing Clinical Trials Overview 63

Table 111: VenTouch Triad Targeted Ventricular Reshaping System – Evaluation of the Minimally Invasive VenTouch System in the Treatment of Functional Mitral Valve Regurgitation (FMR): First-in-man Continuation Study 64

Table 112: VenTouch Triad Targeted Ventricular Reshaping System – Evaluation of The Minimally Invasive VenTouch System in The Treatment of Functional Mitral Valve Regurgitation (FMR): OUS Feasibility Study 64

Table 113: Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 65

Table 114: Catheter-Based Mitral Valve Repair Device – Product Status 65

Table 115: Catheter-Based Mitral Valve Repair Device – Product Description 65

Table 116: Medfree Inc Pipeline Products & Ongoing Clinical Trials Overview 66

Table 117: MEDFREE Valve Repair System – Product Status 66

Table 118: MEDFREE Valve Repair System – Product Description 66

Table 119: MiCardia Corp Pipeline Products & Ongoing Clinical Trials Overview 67

Table 120: enCorTC – Product Status 67

Table 121: enCorTC – Product Description 67

Table 122: Michigan Critical Care Consultants Inc Pipeline Products & Ongoing Clinical Trials Overview 68

Table 123: Millipede Percutaneous Annuloplasty Ring – Product Status 68

Table 124: Millipede Percutaneous Annuloplasty Ring – Product Description 68

Table 125: Percutaneous Mitral Annuloplasty Ring – Product Status 69

Table 126: Percutaneous Mitral Annuloplasty Ring – Product Description 69

Table 127: Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 70

Table 128: MIA System – Mitral Valve Repair – Product Status 70

Table 129: MIA System – Mitral Valve Repair – Product Description 70

Table 130: MIA System – Tricuspid Valve Repair – Product Status 71

Table 131: MIA System – Tricuspid Valve Repair – Product Description 71

Table 132: Micro Interventional Devices, Inc. – Ongoing Clinical Trials Overview 72

Table 133: MIA System – Tricuspid Valve Repair – Study of Transcatheter Tricuspid Annular Repair 73

Table 134: Millipede LLC Pipeline Products & Ongoing Clinical Trials Overview 74

Table 135: IRIS Transcatheter Annuloplasty Ring – Product Status 74

Table 136: IRIS Transcatheter Annuloplasty Ring – Product Description 74

Table 137: Millipede LLC – Ongoing Clinical Trials Overview 75

Table 138: IRIS Transcatheter Annuloplasty Ring – A Study to Evaluate the Feasibility and Safety of the Millipede Transcatheter Annuloplasty Ring System in Patients with Functional Mitral Regurgitation: (Millipede Feasibility Study) 76

Table 139: Mitralign Inc Pipeline Products & Ongoing Clinical Trials Overview 77

Table 140: Trialign Percutaneous Tricuspid Valve Annuloplasty System – Product Status 77

Table 141: Trialign Percutaneous Tricuspid Valve Annuloplasty System – Product Description 77

Table 142: Mitralign Inc – Ongoing Clinical Trials Overview 78

Table 143: Trialign Percutaneous Tricuspid Valve Annuloplasty System – Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation 79

Table 144: Trialign Percutaneous Tricuspid Valve Annuloplasty System – International Multisite Transcatheter Tricuspid Valve Therapies Registry 79

Table 145: Trialign Percutaneous Tricuspid Valve Annuloplasty System – Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation 79

Table 146: Mitralix Ltd. Pipeline Products & Ongoing Clinical Trials Overview 80

Table 147: Mistral – Product Status 80

Table 148: Mistral – Product Description 80

Table 149: Mitralix Ltd. – Ongoing Clinical Trials Overview 81

Table 150: Mistral – MATTERS II – Mistral Percutaneous Tricuspid Valve Repair FIM Study 82

Table 151: Mistral – MATTERS Study – Mistral Percutaneous Tricuspid Valve Repair FIM Study 82

Table 152: Mistral – MERIT Study – Mistral Percutaneous Mitral Valve Repair FIM Study 82

Table 153: Mitre Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 83

Table 154: Mitral Touch – Product Status 83

Table 155: Mitral Touch – Product Description 83

Table 156: Next Generation Mitral Touch – Product Status 84

Table 157: Next Generation Mitral Touch – Product Description 84

Table 158: Mitre Medical Corp – Ongoing Clinical Trials Overview 85

Table 159: Mitral Touch – ENRAPTUS Epicardial Mitral Touch System for Mitral Insufficiency 86

Table 160: MVRx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 87

Table 161: ARTO System – Product Status 87

Table 162: ARTO System – Product Description 87

Table 163: MVRx, Inc. – Ongoing Clinical Trials Overview 88

Table 164: ARTO System – Mitral Valve Repair Clinical Trial (MAVERIC Trial) – United States 89

Table 165: ARTO System – Mitral Valve Repair Clinical Trial: MAVERIC Trial 89

Table 166: Neochord Inc Pipeline Products & Ongoing Clinical Trials Overview 90

Table 167: NeoChord DS1000 – Product Status 90

Table 168: NeoChord DS1000 – Product Description 90

Table 169: Neochord Inc – Ongoing Clinical Trials Overview 91

Table 170: NeoChord DS1000 – Evaluate the efficacy of NeoChord in the Treatment of Mitral Valve Regurgitation 92

Table 171: NeoChord DS1000 – Hemodynamic Monitorization Using Pulse Counter Vigileo-Flotrac Cardiac Output System in Transapical Off-pump Minimally Invasive Mitral Valve Repair 92

Table 172: NeoChord DS1000 – Randomized Trial of the NeoChord DS1000 System Versus Open Surgical Repair 92

Table 173: NeoChord DS1000 – The AcChord Study: A Multicenter Post-market Observational Registry of the NeoChord Artificial Chordae Delivery System 93

Table 174: Rambam Health Care Campus Pipeline Products & Ongoing Clinical Trials Overview 94

Table 175: Adjustable Annuloplasty Apparatus – Product Status 94

Table 176: Adjustable Annuloplasty Apparatus – Product Description 94

Table 177: Strait Access Technologies (Pty) Ltd Pipeline Products & Ongoing Clinical Trials Overview 95

Table 178: Mitral Clip – Product Status 95

Table 179: Mitral Clip – Product Description 95

Table 180: Symetis SA Pipeline Products & Ongoing Clinical Trials Overview 96

Table 181: Middle Peak Mitral Implant – Product Status 96

Table 182: Middle Peak Mitral Implant – Product Description 96

Table 183: Tel Aviv Sourasky Medical Center Pipeline Products & Ongoing Clinical Trials Overview 97

Table 184: Mitral Valve Implantation Device – Product Status 97

Table 185: Mitral Valve Implantation Device – Product Description 97

Table 186: TransCardiac Therapeutics, LLC Pipeline Products & Ongoing Clinical Trials Overview 98

Table 187: MitraFlex – Product Status 98

Table 188: MitraFlex – Product Description 98

Table 189: Transmural systems LLC Pipeline Products & Ongoing Clinical Trials Overview 99

Table 190: Transmural Cerclage – Product Status 99

Table 191: Transmural Cerclage – Product Description 99

Table 192: Transmural systems LLC – Ongoing Clinical Trials Overview 100

Table 193: Transmural Cerclage – NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study 101

Table 194: TTK Healthcare Ltd Pipeline Products & Ongoing Clinical Trials Overview 102

Table 195: Mitral Annuloplasty Ring – Product Status 102

Table 196: Mitral Annuloplasty Ring – Product Description 102

Table 197: University of Manitoba Pipeline Products & Ongoing Clinical Trials Overview 103

Table 198: Aortic Annular System – Product Status 103

Table 199: Aortic Annular System – Product Description 103

Table 200: Valcare Medical Pipeline Products & Ongoing Clinical Trials Overview 104

Table 201: AMEND Mitral Valve Repair System – Product Status 104

Table 202: AMEND Mitral Valve Repair System – Product Description 104

Table 203: Trivid – Product Status 105

Table 204: Trivid – Product Description 105

Table 205: valsculp Pipeline Products & Ongoing Clinical Trials Overview 106

Table 206: SATAR – Product Status 106

Table 207: SATAR – Product Description 106

Table 208: Valtech Cardio Ltd Pipeline Products & Ongoing Clinical Trials Overview 107

Table 209: Cardinal Adjustable Annuloplasty Ring System – Tricuspid Repair – Product Status 107

Table 210: Cardinal Adjustable Annuloplasty Ring System – Tricuspid Repair – Product Description 107

Table 211: Cardioband Direct Access – Product Status 108

Table 212: Cardioband Direct Access – Product Description 108

Table 213: Cardioband System – Mitral Valve Repair – Product Status 108

Table 214: Cardioband System – Mitral Valve Repair – Product Description 109

Table 215: Cardioband System – Tricuspid Regurgitation – Product Status 109

Table 216: Cardioband System – Tricuspid Regurgitation – Product Description 109

Table 217: V-Chordal-Off Pump – Product Status 110

Table 218: V-Chordal-Off Pump – Product Description 110

Table 219: Valtech Cardio Ltd – Ongoing Clinical Trials Overview 111

Table 220: Cardioband System – Mitral Valve Repair – A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Assess Transcatheter Mitral Valve Repair with Edwards Cardioband System and GDMT Versus GDMT Alone in Patients with FMR and Heart Failure: Annular Reduction for Transcatheter Treatment of Insufficient Mitral Valve (ACTIVE) 112

Table 221: Cardioband System – Mitral Valve Repair – Cardioband Adjustable Annuloplasty System for Minimally Invasive Mitral Valve Repair 112

Table 222: Cardioband System – Mitral Valve Repair – European Registry of Transcatheter Repair for Secondary Mitral Regurgitation 112

Table 223: Cardioband System – Mitral Valve Repair – Transcatheter Repair of Mitral Regurgitation with Cardioband System Post Market Study: A European Prospective, Multicenter Study to Assess Transcatheter Mitral Valve Repair with Edwards Cardioband System in Patients with Symptomatic MR 113

Table 224: Cardioband System – Tricuspid Regurgitation – Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study 114

Table 225: Cardioband System – Tricuspid Regurgitation – International Multisite Transcatheter Tricuspid Valve Therapies Registry 114

Table 226: Vesalius Cardiovascular Inc Pipeline Products & Ongoing Clinical Trials Overview 115

Table 227: Calla Mitral Valve Repair System – Product Status 115

Table 228: Calla Mitral Valve Repair System – Product Description 115

Table 229: Viacor Inc Pipeline Products & Ongoing Clinical Trials Overview 116

Table 230: PTMA System – Product Status 116

Table 231: PTMA System – Product Description 116

Table 232: Glossary 149

List of Figures

Figure 1: Cardiac Valve Repairs – Pipeline Products by Stage of Development 12

Figure 2: Cardiac Valve Repairs – Pipeline Products by Segment 13

Figure 3: Cardiac Valve Repairs – Pipeline Products by Territory 14

Figure 4: Cardiac Valve Repairs – Pipeline Products by Regulatory Path 15

Figure 5: Cardiac Valve Repairs – Pipeline Products by Estimated Approval Date 16

Figure 6: Cardiac Valve Repairs – Ongoing Clinical Trials 17

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