Cardiac Valve Repairs-Medical Devices Pipeline Assessment, 2017

Table of Contents

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 6

1.2 List of Figures 10

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 4tech Cardio Ireland Limited Company Overview 22

5.1.1 4tech Cardio Ireland Limited Pipeline Products & Ongoing Clinical Trials Overview 22

5.2 Admedus Ltd Company Overview 25

5.2.1 Admedus Ltd Pipeline Products & Ongoing Clinical Trials Overview 25

5.3 Agamit Medical Ltd (Inactive) Company Overview 27

5.3.1 Agamit Medical Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 27

5.4 Ample Medical Inc Company Overview 28

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

5.5 Ancora Heart Inc Company Overview 29

5.5.1 Ancora Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 29

5.6 Arbor Surgical Technologies, Inc. Company Overview 32

5.6.1 Arbor Surgical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 32

5.7 BioStable Science & Engineering, Inc. Company Overview 33

5.7.1 BioStable Science & Engineering, Inc. Pipeline Products & Ongoing Clinical Trials Overview 33

5.8 Cardiosolutions Inc Company Overview 34

5.8.1 Cardiosolutions Inc Pipeline Products & Ongoing Clinical Trials Overview 34

5.9 Cardious, Inc. Company Overview 35

5.9.1 Cardious, Inc. Pipeline Products & Ongoing Clinical Trials Overview 35

5.10 Children's Hospital Boston Company Overview 36

5.10.1 Children's Hospital Boston Pipeline Products & Ongoing Clinical Trials Overview 36

5.11 CollPlant Ltd. Company Overview 39

5.11.1 CollPlant Ltd. Pipeline Products & Ongoing Clinical Trials Overview 39

5.12 coramaze technologies GmbH Company Overview 40

5.12.1 coramaze technologies GmbH Pipeline Products & Ongoing Clinical Trials Overview 40

5.13 Coroneo Inc. Company Overview 41

5.13.1 Coroneo Inc. Pipeline Products & Ongoing Clinical Trials Overview 41

5.14 CUBE SRL Company Overview 42

5.14.1 CUBE SRL Pipeline Products & Ongoing Clinical Trials Overview 42

5.15 Daidalos Solutions BV Company Overview 43

5.15.1 Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview 43

5.16 Edwards Lifesciences Corp Company Overview 45

5.16.1 Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 45

5.17 Emory University Company Overview 49

5.17.1 Emory University Pipeline Products & Ongoing Clinical Trials Overview 49

5.18 Lartim Medical Ltd Company Overview 51

5.18.1 Lartim Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 51

5.19 Mardil Medical, Inc. Company Overview 52

5.19.1 Mardil Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 52

5.20 Mayo Clinic US Company Overview 54

5.20.1 Mayo Clinic US Pipeline Products & Ongoing Clinical Trials Overview 54

5.21 Medtentia International Ltd Oy Company Overview 55

5.21.1 Medtentia International Ltd Oy Pipeline Products & Ongoing Clinical Trials Overview 55

5.22 MiCardia Corp Company Overview 57

5.22.1 MiCardia Corp Pipeline Products & Ongoing Clinical Trials Overview 57

5.23 Michigan Critical Care Consultants, Inc. Company Overview 60

5.23.1 Michigan Critical Care Consultants, Inc. Pipeline Products & Ongoing Clinical Trials Overview 60

5.24 Micro Interventional Devices, Inc. Company Overview 62

5.24.1 Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 62

5.25 Millipede LLC Company Overview 65

5.25.1 Millipede LLC Pipeline Products & Ongoing Clinical Trials Overview 65

5.26 Mitral Heal Company Overview 66

5.26.1 Mitral Heal Pipeline Products & Ongoing Clinical Trials Overview 66

5.27 Mitralix Ltd. Company Overview 67

5.27.1 Mitralix Ltd. Pipeline Products & Ongoing Clinical Trials Overview 67

5.28 Mitre Medical Corp. (Inactive) Company Overview 68

5.28.1 Mitre Medical Corp. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 68

5.29 Neochord Inc Company Overview 70

5.29.1 Neochord Inc Pipeline Products & Ongoing Clinical Trials Overview 70

5.30 North Carolina State University Company Overview 74

5.30.1 North Carolina State University Pipeline Products & Ongoing Clinical Trials Overview 74

5.31 Phoenix Cardiac Devices, Inc. Company Overview 75

5.31.1 Phoenix Cardiac Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 75

5.32 QuantumCor Inc. (Inactive) Company Overview 77

5.32.1 QuantumCor Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 77

5.33 Rambam Health Care Campus Company Overview 78

5.33.1 Rambam Health Care Campus Pipeline Products & Ongoing Clinical Trials Overview 78

5.34 ReCor Medical, Inc. Company Overview 79

5.34.1 ReCor Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 79

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

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

5.36 Symetis AG Company Overview 81

5.36.1 Symetis AG Pipeline Products & Ongoing Clinical Trials Overview 81

5.37 TransCardiac Therapeutics, LLC Company Overview 82

5.37.1 TransCardiac Therapeutics, LLC Pipeline Products & Ongoing Clinical Trials Overview 82

5.38 Trinity College Dublin Company Overview 83

5.38.1 Trinity College Dublin Pipeline Products & Ongoing Clinical Trials Overview 83

5.39 Valcare Medical Company Overview 84

5.39.1 Valcare Medical Pipeline Products & Ongoing Clinical Trials Overview 84

5.40 Valtech Cardio Ltd Company Overview 86

5.40.1 Valtech Cardio Ltd Pipeline Products & Ongoing Clinical Trials Overview 86

5.41 Viacor Inc Company Overview 94

5.41.1 Viacor Inc Pipeline Products & Ongoing Clinical Trials Overview 94

6 Cardiac Valve Repairs- Recent Developments 95

6.1 Mar 22, 2017: BioStable Science & Engineering Announces FDA Clearance of the HAART 300 Aortic Annuloplasty Device 95

6.2 Mar 21, 2017: Medtronic Prices Public Offering of 1.7% Notes Due 2019 for USD1 Billion 95

6.3 Mar 21, 2017: Medtronic Prices Public Offering of 3.35% Notes Due 2027 for USD850 Million 96

6.4 Mar 21, 2017: Medtronic Prices Public Offering of 4.625% Notes Due 2045 for USD150 Million 96

6.5 Mar 15, 2017: Corindus Vascular Robotics Reports Fourth Quarter and Full Year 2016 Results 97

6.6 Mar 01, 2017: Micro Interventional Devices Announces Second Successful Tricuspid Annuloplasty Procedure Utilizing MIA, Minimally Invasive Annuloplasty Technology 98

6.7 Feb 23, 2017: AtCor Signs Local Health System Agreement 99

6.8 Feb 21, 2017: Medtronic Reports Third Quarter Financial Results 100

6.9 Feb 07, 2017: Dextera Surgical Reports Fiscal 2017 Second Quarter Financial Results 103

6.10 Feb 06, 2017: Medtronic Awarded U.S. Department of Veterans Affairs National Contracts for Home Telehealth Technologies, with Three Other Vendors 104

6.11 Feb 01, 2017: Edwards Lifesciences Reports Fourth Quarter Results 104

6.12 Jan 23, 2017: NeoChord Names J. Alex Martin Chairman of the Board 106

6.13 Jan 17, 2017: Corindus Vascular Robotics Announces Business Accomplishments for Fourth Quarter and Full Year 2016 and Updates 2017 Financial Guidance 107

6.14 Dec 19, 2016: Micro Interventional Devices Announces First in Human Success Utilizing MIA, Minimally Invasive Annuloplasty Technology 108

6.15 Dec 08, 2016: Edwards Lifesciences Outlines Growth Strategy At Annual Investor Conference 108

6.16 Dec 05, 2016: 4Tech appoints new president and CEO 110

6.17 Nov 26, 2016: Edwards Lifesciences Acquires Valtech Cardio 111

6.18 Nov 22, 2016: Medtronic Reports Second Quarter Financial Results 111

6.19 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 114

6.20 Nov 15, 2016: CEVA to work with Medtronic for distribution facility construction 115

6.21 Nov 09, 2016: First Patient Treated in U.S. Randomized Trial of NeoChord’s, Off-Pump, Minimally Invasive Repair for Degenerative Mitral Regurgitation 116

6.22 Nov 08, 2016: Corindus Vascular Robotics Reports Third Quarter 2016 Results 117

6.23 Nov 07, 2016: Dextera Surgical Reports Fiscal 2017 First Quarter Financial Results 118

6.24 Oct 31, 2016: Guided Delivery Systems Announces Senior Leaders and Company Name Change to Ancora Heart 119

6.25 Oct 28, 2016: NeoChord Passes 500 Patient Treatment Milestone 120

6.26 Oct 28, 2016: 4Tech Elects Ex-Medtronic CEO William (“Bill”) A. Hawkins as its Chairman 121

6.27 Oct 25, 2016: Edwards Lifesciences Reports Third Quarter Results 122

6.28 Oct 20, 2016: Corindus Vascular Robotics Appoints Jeff Lemaster Chief Commercial Officer 123

6.29 Oct 19, 2016: St. Jude Medical Reports Third Quarter 2016 Results 124

6.30 Oct 17, 2016: Clinical study results reveal improved heart condition with Medtentia Annuloplasty Ring (MAR) 125

6.31 Oct 11, 2016: BioStable Science & Engineering Completes Direct De Novo Application to FDA for the HAART 300 Aortic Annuloplasty Device 126

6.32 Sep 27, 2016: Hannu Syrjala Appointed as New Chairman for Medtentia’s Board of Directors 127

6.33 Sep 16, 2016: World’s first Transcatheter Tricuspid Valve Repair (TTVR) has been successfully achieved without use of TEE and General Anesthesia in feasibility study of 4Tech TriCinch at San Raffaele Hospital, Milan, Italy 127

6.34 Sep 16, 2016: Valtech Cardio Presents: Cardioband Tricuspid Successful First in Man Cases and 2-Year Cardioband Mitral Data at PCR London Valves 2016 128

6.35 Sep 15, 2016: Medtronic Names Mark Ploof Senior Vice President of Global Operations and Business Services 129

6.36 Aug 25, 2016: Medtronic Reports First Quarter Financial Results 130

6.37 Aug 22, 2016: Data collection completed for the clinical study evaluating Medtentia Annuloplasty Ring safety and performance 132

6.38 Aug 09, 2016: Dextera Surgical Reports FY 2016 Fourth Quarter Financial Results 133

6.39 Aug 04, 2016: Corindus Vascular Robotics Reports Second Quarter 2016 Results 134

6.40 Jul 26, 2016: Edwards Lifesciences Reports Second Quarter Results 135

6.41 Jul 20, 2016: St. Jude Medical Reports Second Quarter 2016 Results 137

6.42 Jun 30, 2016: NuVasive Agrees to Settle Patent Litigation With Medtronic 139

6.43 Jun 29, 2016: Dextera Surgical Appoints Mark Soberman M.D., Leader in Thoracic Surgery, as Medical Director 139

6.44 Jun 20, 2016: Valcare Medical, an Accelmed Portfolio Company, Announces Successful First-In-Human Procedures of the Amend Catheter Delivered Annuloplasty Ring 140

6.45 Jun 20, 2016: Cardica Changes Company Name to Dextera Surgical 141

6.46 Jun 15, 2016: Transcatheter Tricuspid Valve Repair (TTVR) Has Been Successfully Achieved in Feasibility Study of 4Tech TriCinch at San Raffaele Hospital, Milan, Italy 141

6.47 Jun 06, 2016: Medtronic Outlines Future Growth Vision at Investor Day 142

6.48 May 31, 2016: Medtronic Reports Fourth Quarter and Fiscal Year 2016 Financial Results 143

6.49 May 16, 2016: BioStable Science & Engineering Initiates European Commercialization of the HAART 300 Aortic Annuloplasty Device 146

6.50 May 16, 2016: 4Tech and Dr. Jean-Claude Laborde enter into partnership to accelerate 4Tech R&D and clinical development 146

6.51 May 16, 2016: Otsuka Invests in ReCor Medical 147

6.52 May 13, 2016: NeoChord Receives FDA Approval to begin Clinical Trial for Treatment of Degenerative Mitral Valve Regurgitation 147

6.53 May 12, 2016: ReCor Medical Raises USD10 Million in Venture Financing 148

6.54 Apr 19, 2016: Medtentia’s Board of Directors elected 148

6.55 Apr 08, 2016: Admedus Expands Distribution Agreement With Coroneo 148

6.56 Apr 08, 2016: Admedus Extends Distribution Agreement with Coroneo 149

7 Appendix 150

7.1 Methodology 150

7.2 About GlobalData 153

7.3 Contact Us 153

7.4 Disclaimer 153

List of Figure

1.2 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

List of Table

1.1 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: 4tech Cardio Ireland Limited Pipeline Products & Ongoing Clinical Trials Overview 22

Table 10: TriCinch System-Product Status 22

Table 11: TriCinch System-Product Description 22

Table 12: 4tech Cardio Ireland Limited-Ongoing Clinical Trials Overview 23

Table 13: TriCinch System-Percutaneous Treatment of Tricuspid Valve Regurgitation with the TriCinch System 24

Table 14: Admedus Ltd Pipeline Products & Ongoing Clinical Trials Overview 25

Table 15: Curved Patch-Vessel Reconstructions-Product Status 25

Table 16: Curved Patch-Vessel Reconstructions-Product Description 26

Table 17: Agamit Medical Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 27

Table 18: Mitral Valve Repair Device-Product Status 27

Table 19: Mitral Valve Repair Device-Product Description 27

Table 20: Ample Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 28

Table 21: PS3 System-Product Status 28

Table 22: PS3 System-Product Description 28

Table 23: Ancora Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 29

Table 24: AccuCinch Ventriculoplasty System-Product Status 29

Table 25: AccuCinch Ventriculoplasty System-Product Description 29

Table 26: Ancora Heart Inc-Ongoing Clinical Trials Overview 30

Table 27: AccuCinch Ventriculoplasty System-A Study of Percutaneous Treatment of Mitral Regurgitation Using the AccuCinch System 31

Table 28: AccuCinch Ventriculoplasty System Protocol-A Feasibility Study Using the Accucinch System in the Left Ventricular Reshaping of the Mitral Apparatus to Reduce Functional Mitral Regurgitation and Improve Left Ventricular Function 31

Table 29: Arbor Surgical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 32

Table 30: Trilogy Attachment Clip-Product Status 32

Table 31: Trilogy Attachment Clip-Product Description 32

Table 32: BioStable Science & Engineering, Inc. Pipeline Products & Ongoing Clinical Trials Overview 33

Table 33: HAART 200 Aortic Annuloplasty Device-Product Status 33

Table 34: HAART 200 Aortic Annuloplasty Device-Product Description 33

Table 35: Cardiosolutions Inc Pipeline Products & Ongoing Clinical Trials Overview 34

Table 36: Mitra-Spacer-Product Status 34

Table 37: Mitra-Spacer-Product Description 34

Table 38: Cardious, Inc. Pipeline Products & Ongoing Clinical Trials Overview 35

Table 39: AvA Aortic Valve Bypass Graft System-Product Status 35

Table 40: AvA Aortic Valve Bypass Graft System-Product Description 35

Table 41: Children's Hospital Boston Pipeline Products & Ongoing Clinical Trials Overview 36

Table 42: Endovascular Prosthesis-Product Status 36

Table 43: Endovascular Prosthesis-Product Description 36

Table 44: Mitral Valve Repair Clip-Product Status 37

Table 45: Mitral Valve Repair Clip-Product Description 37

Table 46: Tricuspid Valve Repair Device-Product Status 37

Table 47: Tricuspid Valve Repair Device-Product Description 38

Table 48: CollPlant Ltd. Pipeline Products & Ongoing Clinical Trials Overview 39

Table 49: VergenixHVR-Product Status 39

Table 50: VergenixHVR-Product Description 39

Table 51: coramaze technologies GmbH Pipeline Products & Ongoing Clinical Trials Overview 40

Table 52: Mitramaze Valve Repair System-Product Status 40

Table 53: Mitramaze Valve Repair System-Product Description 40

Table 54: Coroneo Inc. Pipeline Products & Ongoing Clinical Trials Overview 41

Table 55: Extra-Aortic Annuloplasty Ring-Product Status 41

Table 56: Extra-Aortic Annuloplasty Ring-Product Description 41

Table 57: CUBE SRL Pipeline Products & Ongoing Clinical Trials Overview 42

Table 58: Mitral-FERCube Ring-Product Status 42

Table 59: Mitral-FERCube Ring-Product Description 42

Table 60: Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview 43

Table 61: Sutureless Mitral Valve Repair Ring-Product Status 43

Table 62: Sutureless Mitral Valve Repair Ring-Product Description 43

Table 63: Sutureless Tricuspid Valve Repair Ring-Product Status 44

Table 64: Sutureless Tricuspid Valve Repair Ring-Product Description 44

Table 65: Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 45

Table 66: Coapsys-Product Status 45

Table 67: Coapsys-Product Description 45

Table 68: FORMA Tricuspid Repair System-Product Status 46

Table 69: FORMA Tricuspid Repair System-Product Description 46

Table 70: MOBIUS Leaflet Repair System-Product Status 46

Table 71: MOBIUS Leaflet Repair System-Product Description 47

Table 72: Edwards Lifesciences Corp-Ongoing Clinical Trials Overview 47

Table 73: FORMA Tricuspid Repair System-Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System 48

Table 74: FORMA Tricuspid Repair System-The SPACER Trial-Repair of Tricuspid Valve Regurgitation Using the Edwards Tricuspid Transcatheter Repair System 48

Table 75: Emory University Pipeline Products & Ongoing Clinical Trials Overview 49

Table 76: MitraPlug-Product Status 49

Table 77: MitraPlug-Product Description 49

Table 78: MitraSurg-Product Status 50

Table 79: MitraSurg-Product Description 50

Table 80: Lartim Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 51

Table 81: Mitral Valve Repair Device-Product Status 51

Table 82: Mitral Valve Repair Device-Product Description 51

Table 83: Mardil Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 52

Table 84: VenTouch Targeted Ventricular Reshaping System-Product Status 52

Table 85: VenTouch Targeted Ventricular Reshaping System-Product Description 52

Table 86: Mardil Medical, Inc.-Ongoing Clinical Trials Overview 53

Table 87: VenTouch Targeted Ventricular Reshaping System-Evaluation of the Minimally Invasive VenTouch System in the Treatment of Functional Mitral Regurgitation (FMR) a First-in Man Continuation Study 53

Table 88: Mayo Clinic US Pipeline Products & Ongoing Clinical Trials Overview 54

Table 89: Catheter-Based Mitral Valve Repair Device-Product Status 54

Table 90: Catheter-Based Mitral Valve Repair Device-Product Description 54

Table 91: Medtentia International Ltd Oy Pipeline Products & Ongoing Clinical Trials Overview 55

Table 92: CathHELIX-Product Status 55

Table 93: CathHELIX-Product Description 55

Table 94: Double Helix Mitral Annuloplasty System-Product Status 56

Table 95: Double Helix Mitral Annuloplasty System-Product Description 56

Table 96: MiCardia Corp Pipeline Products & Ongoing Clinical Trials Overview 57

Table 97: enCor Mitral Valve Repair System-Product Status 57

Table 98: enCor Mitral Valve Repair System-Product Description 57

Table 99: enCorSQ Mitral Valve Repair System-Product Status 58

Table 100: enCorSQ Mitral Valve Repair System-Product Description 58

Table 101: enCorTC-Product Status 58

Table 102: enCorTC-Product Description 59

Table 103: Michigan Critical Care Consultants, Inc. Pipeline Products & Ongoing Clinical Trials Overview 60

Table 104: Annuloplasty Ring Delivery System-Product Status 60

Table 105: Annuloplasty Ring Delivery System-Product Description 60

Table 106: Millipede Percutaneous Annuloplasty Ring-Product Status 61

Table 107: Millipede Percutaneous Annuloplasty Ring-Product Description 61

Table 108: Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 62

Table 109: MIA Annuloplasty System-Mitral Valve Repair-Product Status 62

Table 110: MIA Annuloplasty System-Mitral Valve Repair-Product Description 62

Table 111: MIA Annuloplasty System-Tricuspid Valve Repair-Product Status 63

Table 112: MIA Annuloplasty System-Tricuspid Valve Repair-Product Description 63

Table 113: Micro Interventional Devices, Inc.-Ongoing Clinical Trials Overview 63

Table 114: MIA Annuloplasty System-Mitral Valve Repair Evaluation of Minimally Invasive Annuloplasty Technology via MIA Implant 64

Table 115: Millipede LLC Pipeline Products & Ongoing Clinical Trials Overview 65

Table 116: Millipede System-Product Status 65

Table 117: Millipede System-Product Description 65

Table 118: Mitral Heal Pipeline Products & Ongoing Clinical Trials Overview 66

Table 119: Off-Pump Transapical Mitral Valve Device-Product Status 66

Table 120: Off-Pump Transapical Mitral Valve Device-Product Description 66

Table 121: Mitralix Ltd. Pipeline Products & Ongoing Clinical Trials Overview 67

Table 122: Mistral-Product Status 67

Table 123: Mistral-Product Description 67

Table 124: Mitre Medical Corp. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 68

Table 125: Mitral Touch-Product Status 68

Table 126: Mitral Touch-Product Description 68

Table 127: Next Generation Mitral Touch-Product Status 69

Table 128: Next Generation Mitral Touch-Product Description 69

Table 129: Neochord Inc Pipeline Products & Ongoing Clinical Trials Overview 70

Table 130: NeoChord DS1000-Product Status 70

Table 131: NeoChord DS1000-Product Description 70

Table 132: Neochord Inc-Ongoing Clinical Trials Overview 71

Table 133: NeoChord DS1000-A European, Multicenter, Randomized Study Comparing the Effectiveness and Safety of Mitral Valve Repair with the NeoChord DS1000 Artificial Chordae Delivery System Versus Conventional Surgery in Patients with Severe Primary Mitral Regurgitation Due to Iso 72

Table 134: NeoChord DS1000 Evaluation of NeoChord DS1000 Artificial Chordae Delivery System for the Correction of Mitral Regurgitation 72

Table 135: NeoChord DS1000-Pivotal Clinical Trial for Treatment of Degenerative Mitral Valve Regurgitation 72

Table 136: NeoChord DS1000-Randomized Trial of the NeoChord DS1000 System Versus Open Surgical Repair 73

Table 137: North Carolina State University Pipeline Products & Ongoing Clinical Trials Overview 74

Table 138: Transapical Mitral Valve Regurgitation Device-Product Status 74

Table 139: Transapical Mitral Valve Regurgitation Device-Product Description 74

Table 140: Phoenix Cardiac Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 75

Table 141: BACE Device-Product Status 75

Table 142: BACE Device-Product Description 75

Table 143: Phoenix Cardiac Devices, Inc.-Ongoing Clinical Trials Overview 76

Table 144: BACE Device-Evaluation of Safety and Efficacy of the Basal Annuloplasty of the Cardia Externally (BACE) (Basal Annuloplasty of the Cardia Externally) Device in the Treatment of Functional Mitral Valve Regurgitation (FMR) 76

Table 145: QuantumCor Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 77

Table 146: Boa Catheter-Product Status 77

Table 147: Boa Catheter-Product Description 77

Table 148: Rambam Health Care Campus Pipeline Products & Ongoing Clinical Trials Overview 78

Table 149: Annuloplasty Apparatus-Product Status 78

Table 150: Annuloplasty Apparatus-Product Description 78

Table 151: ReCor Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 79

Table 152: Ultrasound Catheter-Mitral Regurgitation-Product Status 79

Table 153: Ultrasound Catheter-Mitral Regurgitation-Product Description 79

Table 154: Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 80

Table 155: Mitral Annuloplasty Ring-Product Status 80

Table 156: Mitral Annuloplasty Ring-Product Description 80

Table 157: Symetis AG Pipeline Products & Ongoing Clinical Trials Overview 81

Table 158: Middle Peak Mitral Implant-Product Status 81

Table 159: Middle Peak Mitral Implant-Product Description 81

Table 160: TransCardiac Therapeutics, LLC Pipeline Products & Ongoing Clinical Trials Overview 82

Table 161: MitraFlex-Product Status 82

Table 162: MitraFlex-Product Description 82

Table 163: Trinity College Dublin Pipeline Products & Ongoing Clinical Trials Overview 83

Table 164: MiVaR Device-Product Status 83

Table 165: MiVaR Device-Product Description 83

Table 166: Valcare Medical Pipeline Products & Ongoing Clinical Trials Overview 84

Table 167: AMEND Mitral Valve Repair System-Product Status 84

Table 168: AMEND Mitral Valve Repair System-Product Description 84

Table 169: Valcare Medical-Ongoing Clinical Trials Overview 85

Table 170: AMEND Mitral Valve Repair System-AMEND Mitral Valve Repair System, Annuloplasty Ring Applied in a Transcatheter Method 85

Table 171: Valtech Cardio Ltd Pipeline Products & Ongoing Clinical Trials Overview 86

Table 172: Cardinal Adjustable Annuloplasty Ring System-Tricuspid Repair-Product Status 86

Table 173: Cardinal Adjustable Annuloplasty Ring System-Tricuspid Repair-Product Description 87

Table 174: Cardioband System-Mitral Valve Repair-Product Status 87

Table 175: Cardioband System-Mitral Valve Repair-Product Description 87

Table 176: Cardioband System-Tricuspid Regurgitation-Product Status 88

Table 177: Cardioband System-Tricuspid Regurgitation-Product Description 88

Table 178: Transatrial Cardioband System-Product Status 88

Table 179: Transatrial Cardioband System-Product Description 89

Table 180: V-Chordal System-Transfemoral-Product Status 89

Table 181: V-Chordal System-Transfemoral-Product Description 89

Table 182: V-Chordal-Off-Pump-Product Status 90

Table 183: V-Chordal-Off-Pump-Product Description 90

Table 184: Valtech Cardio Ltd-Ongoing Clinical Trials Overview 91

Table 185: Cardioband System-Mitral Valve Repair-Annular Contraction for Transcatheter Treatment of Insufficient Mitral Valve (ACTIVE): A Multicenter, Randomized, Controlled Pivotal Trial to Assess Transcatheter Mitral Valve Repair with Cardioband and Guideline Directed Medical Therapy (GDMT) Compared to GDMT Alone in Patients with Functional Mitral Regurgitation (FMR) and Heart Failure 92

Table 186: Cardioband System-Mitral Valve Repair-Cardioband Adjustable Annuloplasty System for Minimally Invasive Mitral Valve Repair 92

Table 187: Cardioband System-Mitral Valve Repair-Transcatheter Repair of Mitral Insufficiency with Cardioband System-REPAIR 92

Table 188: Cardioband System-Tricuspid Regurgitation-Randomized Controlled Pilot Study Comparing Healing with Epidermal Fractional Blistergrafting (Cellutome) to Acellular Technique (Membrane or Cream Dressings) in Superficial to Mid-dermal Burn Wounds 93

Table 189: Viacor Inc Pipeline Products & Ongoing Clinical Trials Overview 94

Table 190: PTMA System-Product Status 94

Table 191: PTMA System-Product Description 94

Table 192: Glossary 152