Prosthetic Heart Valves - Pipeline Review, 2015 … Meril Life Sciences Pvt. Ltd. Company Overview...

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Prosthetic Heart Valves - Pipeline Review, 2015 Reference Code: GDME0006EPD

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Prosthetic Heart Valves - Pipeline Review, 2015

Reference Code: GDME0006EPD

Publication Date: April 2015

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1 Table of Contents

1 Table of Contents ........................................................................................................................................................................ 2

1.1 List of Tables..................................................................................................................................................................... 6

1.2 List of Figures ................................................................................................................................................................. 16

2 Introduction ............................................................................................................................................................................... 17

2.1 Prosthetic Heart Valves Overview ................................................................................................................................... 17

3 Products under Development .................................................................................................................................................... 18

3.1 Prosthetic Heart Valves - Pipeline Products by Stage of Development .......................................................................... 18

3.2 Prosthetic Heart Valves - Pipeline Products by Segment ............................................................................................... 19

3.3 Prosthetic Heart Valves - Pipeline Products by Territory ................................................................................................ 20

3.4 Prosthetic Heart Valves - Pipeline Products by Regulatory Path .................................................................................... 21

3.5 Prosthetic Heart Valves - Pipeline Products by Estimated Approval Date ...................................................................... 22

3.6 Prosthetic Heart Valves - Ongoing Clinical Trials............................................................................................................ 23

4 Prosthetic Heart Valves - Pipeline Products under Development by Companies ...................................................................... 24

4.1 Prosthetic Heart Valves Companies - Pipeline Products by Stage of Development ....................................................... 24

4.2 Prosthetic Heart Valves - Pipeline Products by Stage of Development .......................................................................... 27

5 Prosthetic Heart Valves Companies and Product Overview ...................................................................................................... 31

5.1 Aegis Surgical Limited Company Overview .................................................................................................................... 31

5.1.1 Aegis Surgical Limited Pipeline Products & Ongoing Clinical Trials Overview ........................................................... 31

5.2 AorTech International plc Company Overview ................................................................................................................ 32

5.2.1 AorTech International plc Pipeline Products & Ongoing Clinical Trials Overview ....................................................... 32

5.3 Apica Cardiovascular Limited Company Overview ......................................................................................................... 34

5.3.1 Apica Cardiovascular Limited Pipeline Products & Ongoing Clinical Trials Overview ................................................ 34

5.4 Boston Children's Hospital Company Overview .............................................................................................................. 35

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

5.5 Boston Scientific Corporation Company Overview .......................................................................................................... 37

5.5.1 Boston Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview ................................................. 37

5.6 Braile Biomedica Ltda. Company Overview .................................................................................................................... 46

5.6.1 Braile Biomedica Ltda. Pipeline Products & Ongoing Clinical Trials Overview ........................................................... 46

5.7 Caisson Interventional, LLC Company Overview ............................................................................................................ 48

5.7.1 Caisson Interventional, LLC Pipeline Products & Ongoing Clinical Trials Overview ................................................... 48

5.8 Cardiac Dimensions, Inc. Company Overview ................................................................................................................ 49

5.8.1 Cardiac Dimensions, Inc. Pipeline Products & Ongoing Clinical Trials Overview ....................................................... 49

5.9 CardiAQ Valve Technologies, Inc. Company Overview .................................................................................................. 53

5.9.1 CardiAQ Valve Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview ......................................... 53

5.10 Cardio3 BioSciences SA Company Overview ................................................................................................................. 59

5.10.1 Cardio3 BioSciences SA Pipeline Products & Ongoing Clinical Trials Overview ........................................................ 59

5.11 Cephea Valve Technologies, Inc. Company Overview ................................................................................................... 60

5.11.1 Cephea Valve Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview .......................................... 60

5.12 Clemson University Company Overview ......................................................................................................................... 61

5.12.1 Clemson University Pipeline Products & Ongoing Clinical Trials Overview ................................................................ 61

5.13 Colibri Heart Valve, LLC Company Overview ................................................................................................................. 62

5.13.1 Colibri Heart Valve, LLC Pipeline Products & Ongoing Clinical Trials Overview ........................................................ 62

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5.14 CorMatrix Cardiovascular, Inc. Company Overview ........................................................................................................ 70

5.14.1 CorMatrix Cardiovascular, Inc. Pipeline Products & Ongoing Clinical Trials Overview ............................................... 70

5.15 CryoLife, Inc. Company Overview ................................................................................................................................... 75

5.15.1 CryoLife, Inc. Pipeline Products & Ongoing Clinical Trials Overview .......................................................................... 75

5.16 Cytograft Tissue Engineering, Inc. Company Overview .................................................................................................. 77

5.16.1 Cytograft Tissue Engineering, Inc. Pipeline Products & Ongoing Clinical Trials Overview ......................................... 77

5.17 Direct Flow Medical, Inc. Company Overview ................................................................................................................. 78

5.17.1 Direct Flow Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview ........................................................ 78

5.18 Dura Biotech Company Overview ................................................................................................................................... 83

5.18.1 Dura Biotech Pipeline Products & Ongoing Clinical Trials Overview .......................................................................... 83

5.19 Edwards Lifesciences Corporation Company Overview ................................................................................................. 85

5.19.1 Edwards Lifesciences Corporation Pipeline Products & Ongoing Clinical Trials Overview ........................................ 85

5.20 Emory University Company Overview ........................................................................................................................... 106

5.20.1 Emory University Pipeline Products & Ongoing Clinical Trials Overview .................................................................. 106

5.21 HighLife SAS Company Overview ................................................................................................................................ 108

5.21.1 HighLife SAS Pipeline Products & Ongoing Clinical Trials Overview ....................................................................... 108

5.22 HLT, Inc. Company Overview ....................................................................................................................................... 109

5.22.1 HLT, Inc. Pipeline Products & Ongoing Clinical Trials Overview .............................................................................. 109

5.23 Innovia LLC Company Overview ................................................................................................................................... 112

5.23.1 Innovia LLC Pipeline Products & Ongoing Clinical Trials Overview .......................................................................... 112

5.24 JenaValve Technology GmbH Company Overview ...................................................................................................... 115

5.24.1 JenaValve Technology GmbH Pipeline Products & Ongoing Clinical Trials Overview ............................................. 115

5.25 Leman Cardiovascular Company Overview .................................................................................................................. 120

5.25.1 Leman Cardiovascular Pipeline Products & Ongoing Clinical Trials Overview ......................................................... 120

5.26 Mayo Clinic Company Overview ................................................................................................................................... 121

5.26.1 Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview .......................................................................... 121

5.27 Medi-Line S.A. Company Overview .............................................................................................................................. 122

5.27.1 Medi-Line S.A. Pipeline Products & Ongoing Clinical Trials Overview ..................................................................... 122

5.28 Medtronic plc Company Overview ................................................................................................................................ 123

5.28.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview ....................................................................... 123

5.29 Meril Life Sciences Pvt. Ltd. Company Overview .......................................................................................................... 135

5.29.1 Meril Life Sciences Pvt. Ltd. Pipeline Products & Ongoing Clinical Trials Overview ................................................. 135

5.30 Micro Interventional Devices, Inc. Company Overview ................................................................................................. 136

5.30.1 Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview ........................................ 136

5.31 MicroPort Scientific Corporation Company Overview ................................................................................................... 138

5.31.1 MicroPort Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview .......................................... 138

5.32 Mitralix Ltd. Company Overview ................................................................................................................................... 142

5.32.1 Mitralix Ltd. Pipeline Products & Ongoing Clinical Trials Overview .......................................................................... 142

5.33 MitrAssist Ltd. Company Overview ............................................................................................................................... 143

5.33.1 MitrAssist Ltd. Pipeline Products & Ongoing Clinical Trials Overview ...................................................................... 143

5.34 Mitricares Company Overview ...................................................................................................................................... 144

5.34.1 Mitricares Pipeline Products & Ongoing Clinical Trials Overview ............................................................................. 144

5.35 NaviGate Cardiac Structures, Inc. Company Overview ................................................................................................ 145

5.35.1 NaviGate Cardiac Structures, Inc. Pipeline Products & Ongoing Clinical Trials Overview ....................................... 145

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5.36 Neovasc Inc. Company Overview ................................................................................................................................. 146

5.36.1 Neovasc Inc. Pipeline Products & Ongoing Clinical Trials Overview ........................................................................ 146

5.37 Peca Labs, Inc. Company Overview ............................................................................................................................. 150

5.37.1 Peca Labs, Inc. Pipeline Products & Ongoing Clinical Trials Overview .................................................................... 150

5.38 PolyNova Cardiovascular LLC Company Overview ...................................................................................................... 151

5.38.1 PolyNova Cardiovascular LLC Pipeline Products & Ongoing Clinical Trials Overview ............................................. 151

5.39 RegenaGraft Company Overview ................................................................................................................................. 152

5.39.1 RegenaGraft Pipeline Products & Ongoing Clinical Trials Overview ........................................................................ 152

5.40 Revivicor, Inc. Company Overview ............................................................................................................................... 153

5.40.1 Revivicor, Inc. Pipeline Products & Ongoing Clinical Trials Overview ...................................................................... 153

5.41 SAS Cormove Company Overview ............................................................................................................................... 154

5.41.1 SAS Cormove Pipeline Products & Ongoing Clinical Trials Overview ...................................................................... 154

5.42 Scientific and Production Center Amphion, LLC Company Overview ........................................................................... 155

5.42.1 Scientific and Production Center Amphion, LLC Pipeline Products & Ongoing Clinical Trials Overview .................. 155

5.43 Sorin S.p.A. Company Overview ................................................................................................................................... 156

5.43.1 Sorin S.p.A. Pipeline Products & Ongoing Clinical Trials Overview .......................................................................... 156

5.44 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview ................................................. 160

5.44.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview ................................................................................................................................................................................. 160

5.45 St. Jude Medical, Inc. Company Overview ................................................................................................................... 162

5.45.1 St. Jude Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview........................................................... 162

5.46 Stellenbosch University Company Overview................................................................................................................. 175

5.46.1 Stellenbosch University Pipeline Products & Ongoing Clinical Trials Overview ........................................................ 175

5.47 Strait Access Technologies (Pty) Ltd Company Overview ............................................................................................ 176

5.47.1 Strait Access Technologies (Pty) Ltd Pipeline Products & Ongoing Clinical Trials Overview ................................... 176

5.48 Symetis AG Company Overview ................................................................................................................................... 178

5.48.1 Symetis AG Pipeline Products & Ongoing Clinical Trials Overview .......................................................................... 178

5.49 Tendyne Medical, Inc. Company Overview ................................................................................................................... 184

5.49.1 Tendyne Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview .......................................................... 184

5.50 The Tel Aviv Sourasky Medical Center Company Overview ......................................................................................... 187

5.50.1 The Tel Aviv Sourasky Medical Center Pipeline Products & Ongoing Clinical Trials Overview ................................ 187

5.51 Thubrikar Aortic Valve, Inc. Company Overview ........................................................................................................... 188

5.51.1 Thubrikar Aortic Valve, Inc. Pipeline Products & Ongoing Clinical Trials Overview .................................................. 188

5.52 Tissue Regenix Ltd Company Overview ....................................................................................................................... 190

5.52.1 Tissue Regenix Ltd Pipeline Products & Ongoing Clinical Trials Overview .............................................................. 190

5.53 Transcatheter Technologies GmbH Company Overview .............................................................................................. 193

5.53.1 Transcatheter Technologies GmbH Pipeline Products & Ongoing Clinical Trials Overview ..................................... 193

5.54 Twelve, Inc Company Overview .................................................................................................................................... 196

5.54.1 Twelve, Inc Pipeline Products & Ongoing Clinical Trials Overview ........................................................................... 196

5.55 UMC Utrecht Holding BV Company Overview .............................................................................................................. 197

5.55.1 UMC Utrecht Holding BV Pipeline Products & Ongoing Clinical Trials Overview ..................................................... 197

5.56 University College London Company Overview ............................................................................................................ 198

5.56.1 University College London Pipeline Products & Ongoing Clinical Trials Overview ................................................... 198

5.57 University of California, Irvine Company Overview ....................................................................................................... 199

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5.57.1 University of California, Irvine Pipeline Products & Ongoing Clinical Trials Overview .............................................. 199

5.58 University of Pennsylvania Company Overview ............................................................................................................ 202

5.58.1 University of Pennsylvania Pipeline Products & Ongoing Clinical Trials Overview ................................................... 202

5.59 Valtech Cardio Ltd. Company Overview ....................................................................................................................... 204

5.59.1 Valtech Cardio Ltd. Pipeline Products & Ongoing Clinical Trials Overview .............................................................. 204

5.60 ValveXchange, Inc. Company Overview ....................................................................................................................... 205

5.60.1 ValveXchange, Inc. Pipeline Products & Ongoing Clinical Trials Overview .............................................................. 205

5.61 VueKlar Cardiovascular Ltd. Company Overview ......................................................................................................... 208

5.61.1 VueKlar Cardiovascular Ltd. Pipeline Products & Ongoing Clinical Trials Overview ................................................ 208

5.62 Xeltis AG Company Overview ....................................................................................................................................... 210

5.62.1 Xeltis AG Pipeline Products & Ongoing Clinical Trials Overview .............................................................................. 210

6 Prosthetic Heart Valves- Recent Developments ..................................................................................................................... 211

7 Appendix ................................................................................................................................................................................. 306

7.1 Methodology ................................................................................................................................................................. 306

7.2 About GlobalData .......................................................................................................................................................... 308

7.4 Disclaimer ..................................................................................................................................................................... 308

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1.1 List of Tables

Table 1: Prosthetic Heart Valves - Pipeline Products by Stage of Development ............................................................................ 18

Table 2: Prosthetic Heart Valves - Pipeline Products by Segment ................................................................................................. 19

Table 3: Prosthetic Heart Valves - Pipeline Products by Territory .................................................................................................. 20

Table 4: Prosthetic Heart Valves - Pipeline Products by Regulatory Path ...................................................................................... 21

Table 5: Prosthetic Heart Valves - Pipeline Products by Estimated Approval Date ........................................................................ 22

Table 6: Prosthetic Heart Valves - Ongoing Clinical Trials ............................................................................................................. 23

Table 7: Prosthetic Heart Valves Companies - Pipeline Products by Stage of Development ......................................................... 24

Table 8: Prosthetic Heart Valves - Pipeline Products by Stage of Development ............................................................................ 27

Table 9: Aegis Surgical Limited Pipeline Products & Ongoing Clinical Trials Overview ................................................................. 31

Table 10: pTAo-TAVR - Product Status ......................................................................................................................................... 31

Table 11: pTAo-TAVR - Product Description .................................................................................................................................. 31

Table 12: AorTech International plc Pipeline Products & Ongoing Clinical Trials Overview ........................................................... 32

Table 13: AorTech Polymer Valve - Product Status ....................................................................................................................... 32

Table 14: AorTech Polymer Valve - Product Description................................................................................................................ 33

Table 15: Apica Cardiovascular Limited Pipeline Products & Ongoing Clinical Trials Overview .................................................... 34

Table 16: Next Generation Device For TAVI - Product Status ........................................................................................................ 34

Table 17: Next Generation Device For TAVI - Product Description ................................................................................................ 34

Table 18: Boston Children's Hospital Pipeline Products & Ongoing Clinical Trials Overview ......................................................... 35

Table 19: Two Piece Replacement Heart Valve Apparatus - Product Status ................................................................................. 35

Table 20: Two Piece Replacement Heart Valve Apparatus - Product Description ......................................................................... 36

Table 21: Boston Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview..................................................... 37

Table 22: 21 mm Lotus Valve System - Product Status ................................................................................................................. 37

Table 23: 21 mm Lotus Valve System - Product Description .......................................................................................................... 38









Table 32: Boston Scientific Corporation - Ongoing Clinical Trials Overview................................................................................... 42

Table 33: 23 mm Lotus Valve System - Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation

of Lotus Valve System (REPRISE I) ................................................................................................................................................. 43

Table 34: 23 mm Lotus Valve System - REPRISE II: Repositionable Percutaneous Replacement Of Stenotic Aortic Valve

Through Implantation Of Lotus Valve System: Evaluation Of Safety And Performance ................................................................... 43

Table 35: 23 mm Lotus Valve System - RESPOND: Repositionable Lotus Valve System - Post Market Evaluation of Real World

Clinical Outcomes ............................................................................................................................................................................ 43


of Lotus Valve With the Next Generation Delivery System: REPRISE NGDS .................................................................................. 44

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of Lotus Valve System - Randomized Clinical Evaluation (REPRISE III) ......................................................................................... 45

Table 38: Braile Biomedica Ltda. Pipeline Products & Ongoing Clinical Trials Overview ............................................................... 46

Table 39: Inovare Valve - Product Status ....................................................................................................................................... 46

Table 40: Inovare Valve - Product Description ............................................................................................................................... 47

Table 41: Caisson Interventional, LLC Pipeline Products & Ongoing Clinical Trials Overview ....................................................... 48

Table 42: Caisson TMVR - Product Status ..................................................................................................................................... 48

Table 43: Caisson TMVR - Product Description ............................................................................................................................. 48

Table 44: Cardiac Dimensions, Inc. Pipeline Products & Ongoing Clinical Trials Overview ........................................................... 49

Table 45: CARILLON Mitral Contour System - Product Status ....................................................................................................... 49

Table 46: CARILLON Mitral Contour System - Product Description ............................................................................................... 49

Table 47: Enhanced CARILLON Mitral Contour System - Product Status ..................................................................................... 50

Table 48: Enhanced CARILLON Mitral Contour System - Product Description .............................................................................. 50

Table 49: Cardiac Dimensions, Inc. - Ongoing Clinical Trials Overview ......................................................................................... 51

Table 50: CARILLON Mitral Contour System - COMPETENT Pilot Study of the CARILLON Mitral Contour System for Treatment

of Functional Mitral Regurgitation ..................................................................................................................................................... 52

Table 51: CARILLON Mitral Contour System - Evaluation of Safety and Efficacy of The CARILLON Device ................................ 52

Table 52: CARILLON Mitral Contour System - Safety and Efficacy of the CARILLON Mitral Contour System in Reducing

Functional Mitral Regurgitation (FMR) Associated with Heart Failure: The REDUCE FMR Trial ..................................................... 52

Table 53: CardiAQ Valve Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview ............................................. 53

Table 54: Second Generation Transapical Transcatheter Mitral Valve - Product Status ................................................................ 53

Table 55: Second Generation Transapical Transcatheter Mitral Valve - Product Description ........................................................ 53

Table 56: Second Generation Transfemoral Transcatheter Mitral Valve - Product Status ............................................................. 54

Table 57: Second Generation Transfemoral Transcatheter Mitral Valve - Product Description...................................................... 54

Table 58: Transcatheter Mitral Valve Implantation System - Product Status .................................................................................. 55

Table 59: Transcatheter Mitral Valve Implantation System - Product Description .......................................................................... 55

Table 60: CardiAQ Valve Technologies, Inc. - Ongoing Clinical Trials Overview ........................................................................... 56

Table 61: Second Generation Transapical Transcatheter Mitral Valve - Early Feasibility Study Using the CardiAQ Second-

generation Transfemoral (TF) and Transapical (TA) Transcatheter Mitral Valve Implantation (TMVI) Systems ............................... 57

Table 62: Second Generation Transfemoral Transcatheter Mitral Valve - Early Feasibility Study Using the CardiAQ Second-

generation Transfemoral (TF) and Transapical (TA) Transcatheter Mitral Valve Implantation (TMVI) Systems ............................... 58

Table 63: Cardio3 BioSciences SA Pipeline Products & Ongoing Clinical Trials Overview ............................................................ 59

Table 64: Mitral Valve Neo-chordae - Product Status .................................................................................................................... 59

Table 65: Mitral Valve Neo-chordae - Product Description ............................................................................................................. 59

Table 66: Cephea Valve Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview .............................................. 60

Table 67: Mitral Valve Replacement Device - Product Status ........................................................................................................ 60

Table 68: Mitral Valve Replacement Device - Product Description ................................................................................................ 60

Table 69: Clemson University Pipeline Products & Ongoing Clinical Trials Overview .................................................................... 61

Table 70: Mechanical Heart Valve - Product Status ....................................................................................................................... 61

Table 71: Mechanical Heart Valve - Product Description ............................................................................................................... 61

Table 72: Colibri Heart Valve, LLC Pipeline Products & Ongoing Clinical Trials Overview ............................................................ 62

Table 73: Colibri Aortic Heart Valve - 24mm - Product Status ....................................................................................................... 62

Table 74: Colibri Aortic Heart Valve - 24mm - Product Description ............................................................................................... 62

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Table 75: Colibri Aortic Heart Valve - 21mm - Product Status ........................................................................................................ 63

Table 76: Colibri Aortic Heart Valve - 21mm - Product Description ................................................................................................ 63

Table 77: Colibri Aortic Heart Valve - 27mm - Product Status ........................................................................................................ 63

Table 78: Colibri Aortic Heart Valve - 27mm - Product Description ................................................................................................ 64

Table 79: Colibri TAVI Device - Product Status .............................................................................................................................. 64

Table 80: Colibri TAVI Device - Product Description ...................................................................................................................... 64

Table 81: Custom Delivery System - Product Status ...................................................................................................................... 65

Table 82: Custom Delivery System - Product Description .............................................................................................................. 65

Table 83: Delta Aortic Heart Valve - Product Status ....................................................................................................................... 65

Table 84: Delta Aortic Heart Valve - Product Description ............................................................................................................... 66

Table 85: Pulmonary Valve - Product Status .................................................................................................................................. 66

Table 86: Pulmonary Valve - Product Description .......................................................................................................................... 66

Table 87: Sutureless Surgical Aortic Valve - Product Status .......................................................................................................... 67

Table 88: Sutureless Surgical Aortic Valve - Product Description .................................................................................................. 67

Table 89: Colibri Heart Valve, LLC - Ongoing Clinical Trials Overview .......................................................................................... 68

Table 90: Colibri TAVI Device - Colibri TAVI System, First Ready-to-Use Transcatheter Heart Valve System: A Prospective,

Multicenter, Non-Randomized, Investigational Study ....................................................................................................................... 69

Table 91: CorMatrix Cardiovascular, Inc. Pipeline Products & Ongoing Clinical Trials Overview ................................................... 70

Table 92: CorMatrix ECM - Heart Valve Repair - Product Status ................................................................................................... 70

Table 93: CorMatrix ECM - Heart Valve Repair - Product Description ........................................................................................... 70

Table 94: CorMatrix ECM - Heart Valve Replacement - Product Status ........................................................................................ 71

Table 95: CorMatrix ECM - Heart Valve Replacement - Product Description ................................................................................. 71

Table 96: CorMatrix ECM Tricuspid Heart Valve - Product Status ................................................................................................. 71

Table 97: CorMatrix ECM Tricuspid Heart Valve - Product Description ......................................................................................... 72

Table 98: Pediatric Prosthetic Trileaflet Valve - Product Status ..................................................................................................... 72

Table 99: Pediatric Prosthetic Trileaflet Valve - Product Description .............................................................................................. 72

Table 100: CorMatrix Cardiovascular, Inc. - Ongoing Clinical Trials Overview ............................................................................... 73

Table 101: CorMatrix ECM Tricuspid Heart Valve - Early Feasibility and Investigational Device Exemption Study of CorMatrix

ECM Tricuspid Heart Valve .............................................................................................................................................................. 74

Table 102: CryoLife, Inc. Pipeline Products & Ongoing Clinical Trials Overview ............................................................................ 75

Table 103: CryoValve SGAV - Product Status ............................................................................................................................... 75

Table 104: CryoValve SGAV - Product Description ........................................................................................................................ 76

Table 105: Cytograft Tissue Engineering, Inc. Pipeline Products & Ongoing Clinical Trials Overview ........................................... 77

Table 106: Cytograft Valve - Product Status .................................................................................................................................. 77

Table 107: Cytograft Valve - Product Description ........................................................................................................................... 77

Table 108: Direct Flow Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview .......................................................... 78

Table 109: 18F Direct Flow Medical Transcatheter Aortic Valve System - Product Status............................................................. 78

Table 110: 18F Direct Flow Medical Transcatheter Aortic Valve System - Product Description ..................................................... 79

Table 111: 23mm Direct Flow Medical Transcatheter Aortic Valve System - Product Status ......................................................... 79

Table 112: 23mm Direct Flow Medical Transcatheter Aortic Valve System - Product Description ................................................. 79

Table 113: Direct Flow Medical, Inc. - Ongoing Clinical Trials Overview ........................................................................................ 80

Table 114: 18F Direct Flow Medical Transcatheter Aortic Valve System - A Registry To Evaluate The Direct Flow Medical

Transcatheter Aortic Valve System For The Treatment Of Patients With Severe Aortic Stenosis .................................................... 81

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Table 115: 18F Direct Flow Medical Transcatheter Aortic Valve System - Direct Flow Medical Transcatheter Aortic Valve System

Demonstrates Trial Outcomes in SALUS Trial ................................................................................................................................. 81

Table 116: 18F Direct Flow Medical Transcatheter Aortic Valve System - The Direct Flow Medical Transcatheter Aortic Valve

Replacement System a US Pivotal Trial ........................................................................................................................................... 81

Table 117: 18F Direct Flow Medical Transcatheter Aortic Valve System - The Direct Flow Medical TranScatheter Aortic Valve

RepLacement System US Feasibility Trial ....................................................................................................................................... 82

Table 118: Dura Biotech Pipeline Products & Ongoing Clinical Trials Overview ............................................................................ 83

Table 119: Dura Heart Valve - Product Status ............................................................................................................................... 83

Table 120: Dura Heart Valve - Product Description ........................................................................................................................ 83

Table 121: LowPro Valve - Product Status ..................................................................................................................................... 84

Table 122: LowPro Valve - Product Description ............................................................................................................................. 84

Table 123: Edwards Lifesciences Corporation Pipeline Products & Ongoing Clinical Trials Overview .......................................... 85

Table 124: Edwards CENTERA Valve - Product Status ................................................................................................................. 86

Table 125: Edwards CENTERA Valve - Product Description ......................................................................................................... 86

Table 126: Edwards SAPIEN 3 Valve - Product Status .................................................................................................................. 86

Table 127: Edwards SAPIEN 3 Valve - Product Description .......................................................................................................... 87

Table 128: Edwards SAPIEN Pulmonic Transcatheter Heart Valve - Product Status .................................................................... 87

Table 129: Edwards SAPIEN Pulmonic Transcatheter Heart Valve - Product Description ............................................................. 87

Table 130: Edwards SAPIEN XT Valve - 20mm - Product Status .................................................................................................. 88

Table 131: Edwards SAPIEN XT Valve - 20mm - Product Description .......................................................................................... 88

Table 132: FORTIS Mitral Transcatheter Heart Valve - Product Status ......................................................................................... 88

Table 133: FORTIS Mitral Transcatheter Heart Valve - Product Description.................................................................................. 89

Table 134: GLX Aortic Conduit - Product Status ............................................................................................................................ 89

Table 135: GLX Aortic Conduit - Product Description .................................................................................................................... 89

Table 136: INTUITY ELITE - Product Status .................................................................................................................................. 90

Table 137: INTUITY ELITE - Product Description .......................................................................................................................... 90

Table 138: INTUITY Valve System - Product Status ...................................................................................................................... 90

Table 139: INTUITY Valve System - Product Description .............................................................................................................. 91

Table 140: Magna EASE Surgical Valve With GLX - Product Status ............................................................................................. 91

Table 141: Magna EASE Surgical Valve With GLX - Product Description ..................................................................................... 91

Table 142: Next Gen CENTERA - Product Status .......................................................................................................................... 92

Table 143: Next Gen CENTERA - Product Description .................................................................................................................. 92

Table 144: Next Gen SAPIEN - Product Status .............................................................................................................................. 92

Table 145: Next Gen SAPIEN - Product Description ...................................................................................................................... 93

Table 146: SAPIEN XT – Valve-In-Valve Indication - Product Status ............................................................................................. 93

Table 147: SAPIEN XT – Valve-In-Valve Indication - Product Description ..................................................................................... 93

Table 148: ZETA Platform - Product Status ................................................................................................................................... 94

Table 149: ZETA Platform - Product Description ............................................................................................................................ 94

Table 150: Edwards Lifesciences Corporation - Ongoing Clinical Trials Overview ........................................................................ 95

Table 151: INTUITY Valve System - Multi-center Experience with the Rapid Deployment Edwards INTUITY Valve System for

Aortic Valve Replacement ................................................................................................................................................................ 97

Table 152: INTUITY Valve System - Surgical Treatment of Aortic Stenosis with a Next Generation Surgical Aortic Valve ........... 97

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Table 153: Edwards SAPIEN Pulmonic Transcatheter Heart Valve - Implantation of the SAPIEN Transcatheter Heart Valve (THV)

in the Pulmonic Position ................................................................................................................................................................... 98

Table 154: Edwards SAPIEN Pulmonic Transcatheter Heart Valve - Pulmonic SAPIEN XT THV a Multi-center, Observational

Registry with Retrospective Enrollment of Patients That Underwent Transcatheter Pulmonic Valve Implantation and a

Retrospective or Prospective Follow-up ........................................................................................................................................... 98

Table 155: Edwards SAPIEN 3 Valve - Safety And Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve .... 99

Table 156: Edwards SAPIEN 3 Valve - Secure Transapical Access and Closure Using Permaseal .............................................. 99

Table 157: Edwards SAPIEN 3 Valve - SWISS TAVI Registry: Prospective, National, Multi-center Registry of Patients Undergoing

Transcatheter Aortic Valve Implantation ........................................................................................................................................... 99

Table 158: Edwards SAPIEN 3 Valve - The PARTNER II Trial "Placement of Aortic Transcatheter" Valves Trial" (US) [Edwards

Study 2010-12] ............................................................................................................................................................................... 100

Table 159: Edwards CENTERA Valve - Safety and Performance Study of the Edwards Centera Self-expanding Transcatheter

Heart Valve ..................................................................................................................................................................................... 101

Table 160: Magna EASE Surgical Valve With GLX - Edwards Receives IDE for U.S. Clinical Trial of New Heart Valve Tissue

Treatment Platform ......................................................................................................................................................................... 102

Table 161: SAPIEN XT – Valve-In-Valve Indication - A Randomized Comparison of Transcatheter Heart Valves in High Risk

Patients With Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT (The CHOICE Trial) ........................... 103

Table 162: SAPIEN XT – Valve-In-Valve Indication - Cerebral Protection in Transcatheter Aortic Valve Replacement - The

SENTINEL Study ............................................................................................................................................................................ 103

Table 163: SAPIEN XT – Valve-In-Valve Indication - Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve

Implantation and Surgical Aortic Valve Replacement ..................................................................................................................... 104

Table 164: Edwards SAPIEN XT Valve - 20mm - A Clinical Trial of a 20mm Transcatheter Bioprosthetic Valve for Patients With

Aortic Stenosis ............................................................................................................................................................................... 105

Table 165: Emory University Pipeline Products & Ongoing Clinical Trials Overview .................................................................... 106

Table 166: MitraCath - Product Status ......................................................................................................................................... 106

Table 167: MitraCath - Product Description .................................................................................................................................. 107

Table 168: HighLife SAS Pipeline Products & Ongoing Clinical Trials Overview ......................................................................... 108

Table 169: Transcatheter Mitral Valve Replacement System - Product Status ............................................................................ 108

Table 170: Transcatheter Mitral Valve Replacement System - Product Description .................................................................... 108

Table 171: HLT, Inc. Pipeline Products & Ongoing Clinical Trials Overview ................................................................................ 109

Table 172: HLT Transcatheter Valve System - Product Status .................................................................................................... 109

Table 173: HLT Transcatheter Valve System - Product Description ............................................................................................ 109

Table 174: HLT, Inc. - Ongoing Clinical Trials Overview .............................................................................................................. 110

Table 175: HLT Transcatheter Valve System - HLT Transfemoral Replacement of Aortic Valve via Transcatherterization Canada

....................................................................................................................................................................................................... 111

Table 176: Innovia LLC Pipeline Products & Ongoing Clinical Trials Overview ............................................................................ 112

Table 177: Minimally Invasive Synthetic Tri - Leaflet Heart Valve - Product Status ..................................................................... 112

Table 178: Minimally Invasive Synthetic Tri - Leaflet Heart Valve - Product Description .............................................................. 113

Table 179: Percutaneous Synthetic Tri - Leaflet Heart Valve - Product Status ............................................................................ 113

Table 180: Percutaneous Synthetic Tri - Leaflet Heart Valve - Product Description ..................................................................... 113

Table 181: Sutured In Synthetic Tri - Leaflet Heart Valve - Product Status .................................................................................. 114

Table 182: Sutured In Synthetic Tri - Leaflet Heart Valve - Product Description .......................................................................... 114

Table 183: JenaValve Technology GmbH Pipeline Products & Ongoing Clinical Trials Overview ............................................... 115

SAMPLE



Table 184: JenaValve Transaortic TAVI System - Product Status ............................................................................................... 115

Table 185: JenaValve Transaortic TAVI System - Product Description ........................................................................................ 115

Table 186: JenaValve Transapical TAVI System - Product Status ............................................................................................... 116

Table 187: JenaValve Transapical TAVI System - Product Description ....................................................................................... 116

Table 188: JenaValve Transfemoral TAVI System - Product Status ............................................................................................ 117

Table 189: JenaValve Transfemoral TAVI System - Product Description .................................................................................... 117

Table 190: JenaValve Technology GmbH - Ongoing Clinical Trials Overview ............................................................................. 118

Table 191: JenaValve Transapical TAVI System - "The JenaValve" Evaluation of Long Term Performance and Safety in Patients

with Severe Aortic Stenosis ............................................................................................................................................................ 119

Table 192: JenaValve Transapical TAVI System - Efficacy Study Of Jenavalve Transapical TAVI System For The Treatment Of

Severe Stenotic Aortic Valve Disease In Elderly High-Risk Patients .............................................................................................. 119

Table 193: Leman Cardiovascular Pipeline Products & Ongoing Clinical Trials Overview ........................................................... 120

Table 194: Kalangos Valve - Product Status ................................................................................................................................ 120

Table 195: Kalangos Valve - Product Description ........................................................................................................................ 120

Table 196: Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview ............................................................................ 121

Table 197: Percutaneous Aortic Valve - Product Status ............................................................................................................... 121

Table 198: Percutaneous Aortic Valve - Product Description ....................................................................................................... 121

Table 199: Medi-Line S.A. Pipeline Products & Ongoing Clinical Trials Overview ....................................................................... 122

Table 200: AVATAR² Device - Product Status ............................................................................................................................. 122

Table 201: AVATAR² Device - Product Description ...................................................................................................................... 122

Table 202: Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview ......................................................................... 123

Table 203: 23 mm CoreValve Evolut R Transcatheter Valve - Product Status ............................................................................. 124

Table 204: 23 mm CoreValve Evolut R Transcatheter Valve - Product Description ..................................................................... 124





Table 209: CoreValve EnVeo R Delivery Catheter System - Product Status ............................................................................... 126

Table 210: CoreValve EnVeo R Delivery Catheter System - Product Description ........................................................................ 126

Table 211: CoreValve Evolut R Recapturable System - Product Status ...................................................................................... 127

Table 212: CoreValve Evolut R Recapturable System - Product Description ............................................................................... 127

Table 213: Engager Transcatheter Aortic Valve Implantation System - Product Status ............................................................... 127

Table 214: Engager Transcatheter Aortic Valve Implantation System - Product Description ....................................................... 128

Table 215: Native Outflow Tract Transcatheter Pulmonary Valve - Product Status ..................................................................... 128

Table 216: Native Outflow Tract Transcatheter Pulmonary Valve - Product Description .............................................................. 128

Table 217: Next Generation TCV - Product Status ....................................................................................................................... 129

Table 218: Next Generation TCV - Product Description ............................................................................................................... 129

Table 219: Medtronic plc - Ongoing Clinical Trials Overview ....................................................................................................... 130

Table 220: Engager Transcatheter Aortic Valve Implantation System - Catheter-Based Transapical Implantation of the Ventor

Embracer Heart Valve Prosthesis in Patients With Severe Aortic Valve Disease .......................................................................... 131

Table 221: Engager Transcatheter Aortic Valve Implantation System - Engager Direct Aortic Clinical Study: Medtronic Engager

Transcatheter Aortic Valve Implantation System Via Direct Aortic Approach ................................................................................. 131

SAMPLE



Table 222: Engager Transcatheter Aortic Valve Implantation System - Pivotal Trial for Engager Transcatheter Aortic Valve

Implantation System In Patients Suffering From Severe Aortic Stenosis ....................................................................................... 131

Table 223: Engager Transcatheter Aortic Valve Implantation System - The Engager ALIGN Study: To Characterize the Safety

and Clinical Benefit of the Engager Transcatheter Aortic Valve Implantation System in a Real World Environment ..................... 132

Table 224: Engager Transcatheter Aortic Valve Implantation System - Transapical Implantation of the Medtronic Engager

Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial ................................................................ 132

Table 225: Native Outflow Tract Transcatheter Pulmonary Valve - Native Outflow Tract Transcatheter Pulmonary Valve Research

Clinical Study .................................................................................................................................................................................. 133

Table 226: CoreValve Evolut R Recapturable System - Medtronic CoreValve Evolut R United States IDE Clinical Study .......... 134

Table 227: Meril Life Sciences Pvt. Ltd. Pipeline Products & Ongoing Clinical Trials Overview................................................... 135

Table 228: Myval Transcatheter Aortic Valve Replacement System - Product Status ................................................................. 135

Table 229: Myval Transcatheter Aortic Valve Replacement System - Product Description .......................................................... 135

Table 230: Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview .......................................... 136

Table 231: Endovalve - Product Status ........................................................................................................................................ 136

Table 232: Endovalve - Product Description ................................................................................................................................ 137

Table 233: MicroPort Scientific Corporation Pipeline Products & Ongoing Clinical Trials Overview ............................................ 138

Table 234: Biomaterial Replacement Heart Valve - Product Status ............................................................................................. 138

Table 235: Biomaterial Replacement Heart Valve - Product Description ..................................................................................... 139

Table 236: Transcatheter Aortic Valve Implantation System - Product Status ............................................................................. 139

Table 237: Transcatheter Aortic Valve Implantation System - Product Description ...................................................................... 139

Table 238: MicroPort Scientific Corporation - Ongoing Clinical Trials Overview .......................................................................... 140

Table 239: Transcatheter Aortic Valve Implantation System - Clinical Evaluation of the Safety and Performance of the MicroPort's

Transcatheter Aortic Valve and Delivery System for Treatment of Severe Aortic Stenosis ............................................................ 141

Table 240: Mitralix Ltd. Pipeline Products & Ongoing Clinical Trials Overview ............................................................................ 142

Table 241: MAESTRO - Product Status ....................................................................................................................................... 142

Table 242: MAESTRO - Product Description ............................................................................................................................... 142

Table 243: MitrAssist Ltd. Pipeline Products & Ongoing Clinical Trials Overview ........................................................................ 143

Table 244: MitrAssist Valve - Product Status ............................................................................................................................... 143

Table 245: MitrAssist Valve - Product Description ........................................................................................................................ 143

Table 246: Mitricares Pipeline Products & Ongoing Clinical Trials Overview ............................................................................... 144

Table 247: MITRICARES Device - Product Status ....................................................................................................................... 144

Table 248: MITRICARES Device - Product Description ............................................................................................................... 144

Table 249: NaviGate Cardiac Structures, Inc. Pipeline Products & Ongoing Clinical Trials Overview ......................................... 145

Table 250: Transcatheter Mitral Valve - Product Status ............................................................................................................... 145

Table 251: Transcatheter Mitral Valve - Product Description ....................................................................................................... 145

Table 252: Neovasc Inc. Pipeline Products & Ongoing Clinical Trials Overview .......................................................................... 146

Table 253: Tiara Transcatheter Mitral Valve - Product Status ...................................................................................................... 146

Table 254: Tiara Transcatheter Mitral Valve - Product Description .............................................................................................. 147

Table 255: Neovasc Inc. - Ongoing Clinical Trials Overview ........................................................................................................ 148

Table 256: Tiara Transcatheter Mitral Valve - Early Feasibility Study of the Neovasc Tiara Mitral Transcatheter Heart Valve with

the Tiara Transapical Delivery System ........................................................................................................................................... 149

Table 257: Peca Labs, Inc. Pipeline Products & Ongoing Clinical Trials Overview ...................................................................... 150

Table 258: Masa Valve - Product Status ...................................................................................................................................... 150

SAMPLE



Table 259: Masa Valve - Product Description .............................................................................................................................. 150

Table 260: PolyNova Cardiovascular LLC Pipeline Products & Ongoing Clinical Trials Overview ............................................... 151

Table 261: Trileaflet Polymeric Prosthetic Heart Valve - Product Status ...................................................................................... 151

Table 262: Trileaflet Polymeric Prosthetic Heart Valve - Product Description .............................................................................. 151

Table 263: RegenaGraft Pipeline Products & Ongoing Clinical Trials Overview .......................................................................... 152

Table 264: Synthetic Heart Valve - Product Status ...................................................................................................................... 152

Table 265: Synthetic Heart Valve - Product Description ............................................................................................................... 152

Table 266: Revivicor, Inc. Pipeline Products & Ongoing Clinical Trials Overview ........................................................................ 153

Table 267: Heart Valve - Product Status ...................................................................................................................................... 153

Table 268: Heart Valve - Product Description .............................................................................................................................. 153

Table 269: SAS Cormove Pipeline Products & Ongoing Clinical Trials Overview ........................................................................ 154

Table 270: CORMOVE Percutaneous Aortic Valve - Product Status ........................................................................................... 154

Table 271: CORMOVE Percutaneous Aortic Valve - Product Description.................................................................................... 154

Table 272: Scientific and Production Center Amphion, LLC Pipeline Products & Ongoing Clinical Trials Overview .................... 155

Table 273: Artificial Venous Valve - Product Status ..................................................................................................................... 155

Table 274: Artificial Venous Valve - Product Description ............................................................................................................. 155

Table 275: Sorin S.p.A. Pipeline Products & Ongoing Clinical Trials Overview ............................................................................ 156

Table 276: Perceval S Aortic Heart Valve - Product Status .......................................................................................................... 156

Table 277: Perceval S Aortic Heart Valve - Product Description .................................................................................................. 157

Table 278: Percutaneous Mitral Valve Replacement Device - Product Status ............................................................................. 157

Table 279: Percutaneous Mitral Valve Replacement Device - Product Description ..................................................................... 157

Table 280: Sorin S.p.A. - Ongoing Clinical Trials Overview.......................................................................................................... 158

Table 281: Perceval S Aortic Heart Valve - Clinical Investigation of the Perceval S Sutureless Heart Valve ............................... 159

Table 282: Perceval S Aortic Heart Valve - Perceval S Valve Clinical Trial for Extended CE Mark ............................................. 159

Table 283: Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview

....................................................................................................................................................................................................... 160

Table 284: Artificial Heart Valve - Product Status ......................................................................................................................... 160

Table 285: Artificial Heart Valve - Product Description ................................................................................................................. 160

Table 286: Tissue Based Cardiac Valve - Product Status ............................................................................................................ 161

Table 287: Tissue Based Cardiac Valve - Product Description .................................................................................................... 161

Table 288: St. Jude Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview ............................................................ 162

Table 289: Masters HP Series 15mm Mechanical Heart Valve - Product Status ......................................................................... 162

Table 290: Masters HP Series 15mm Mechanical Heart Valve - Product Description .................................................................. 163

Table 291: Portico Transapical Aortic Heart Valve System - 23 mm - Product Status ................................................................. 163

Table 292: Portico Transapical Aortic Heart Valve System - 23 mm - Product Description .......................................................... 163

Table 293: Portico Transcatheter Aortic Valve Implantation System - Product Status ................................................................. 164

Table 294: Portico Transcatheter Aortic Valve Implantation System - Product Description ......................................................... 164

Table 295: Portico Transfemoral Aortic Heart Valve System - 23 mm - Product Status ............................................................... 165

Table 296: Portico Transfemoral Aortic Heart Valve System - 23 mm - Product Description ....................................................... 165

Table 297: Portico Transfemoral Aortic Heart Valve System - 25mm - Product Status ................................................................ 165

Table 298: Portico Transfemoral Aortic Heart Valve System - 25mm - Product Description ........................................................ 166

Table 299: Portico Transfemoral Aortic Heart Valve System - 27 mm - Product Status ............................................................... 166

Table 300: Portico Transfemoral Aortic Heart Valve System - 27 mm - Product Description ....................................................... 167

SAMPLE



Table 301: Portico Transfemoral Aortic Heart Valve System - 29mm - Product Status ................................................................ 167

Table 302: Portico Transfemoral Aortic Heart Valve System - 29mm - Product Description ........................................................ 167

Table 303: Subclavian Delivery System - Product Status............................................................................................................. 168

Table 304: Subclavian Delivery System - Product Description ..................................................................................................... 168

Table 305: St. Jude Medical, Inc. - Ongoing Clinical Trials Overview .......................................................................................... 169

Table 306: Portico Transapical Aortic Heart Valve System - 23 mm - Next-Generation Transcatheter Aortic Valve System

Designed To Offer Increased Functionality For Transfemoral And Transapical Implantation ......................................................... 170

Table 307: Portico Transfemoral Aortic Heart Valve System - 23 mm - Assessment of the St. Jude Medical Portico Transcatheter

Aortic Valve Implant (TAVI) and the SJM TAVI Transfemoral Delivery System (Portico TF EU) .................................................... 171

Table 308: Portico Transfemoral Aortic Heart Valve System - 23 mm - First In Human Experience and Assessment of the 23mm

SJM Transcatheter Aortic Valve Implant and the SJM TAVI Transfemoral Delivery System (SJM TAVI FIH) ............................... 171

Table 309: Portico Transfemoral Aortic Heart Valve System - 23 mm - International International Long-term Follow-up Study Of

Patients Implanted With A Portico Valve ........................................................................................................................................ 171

Table 310: Portico Transfemoral Aortic Heart Valve System - 23 mm - Long Term Follow-up of the 23mm Portico Aortic Valve

Implant and the SJM Transfemoral Delivery System ...................................................................................................................... 172

Table 311: Portico Transfemoral Aortic Heart Valve System - 25mm - Portico Valve System Offers A Minimally Invasive

Treatment For Patients With Severe Aortic Stenosis: A Narrowing Of The Aortic Valve That Obstructs Blood Flow From The Heart

....................................................................................................................................................................................................... 173

Table 312: Masters HP Series 15mm Mechanical Heart Valve - A Single Arm, Prospective, Non-randomized, Multi Center

Investigation of the SJM Master Series 15mm Rotatable Mechanical Heart Valve (HALO Clinical Study) .................................... 174

Table 313: Stellenbosch University Pipeline Products & Ongoing Clinical Trials Overview.......................................................... 175

Table 314: Percutaneous Heart Valve - Product Status .............................................................................................................. 175

Table 315: Percutaneous Heart Valve - Product Description ...................................................................................................... 175

Table 316: Strait Access Technologies (Pty) Ltd Pipeline Products & Ongoing Clinical Trials Overview ..................................... 176

Table 317: SATH Heart Valve - Product Status ............................................................................................................................ 176

Table 318: SATH Heart Valve - Product Description .................................................................................................................... 176

Table 319: Transcatheter Valve Delivery Device - Product Status ............................................................................................... 177

Table 320: Transcatheter Valve Delivery Device - Product Description ....................................................................................... 177

Table 321: Symetis AG Pipeline Products & Ongoing Clinical Trials Overview ............................................................................ 178

Table 322: Acurate TA - Product Status ....................................................................................................................................... 178

Table 323: Acurate TA - Product Description ............................................................................................................................... 178

Table 324: ACURATE TAo - Product Status ................................................................................................................................ 179

Table 325: ACURATE TAo - Product Description ........................................................................................................................ 179

Table 326: Acurate TF - Product Status ....................................................................................................................................... 179

Table 327: Acurate TF - Product Description ............................................................................................................................... 180

Table 328: Symetis AG - Ongoing Clinical Trials Overview .......................................................................................................... 181

Table 329: Acurate TF - Symetis ACURATE Neo Valve Implantation Using TransFemoral Access: SAVI TF Registry .............. 182

Table 330: Acurate TA - Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical

Aortic Valve Replacement .............................................................................................................................................................. 183

Table 331: Tendyne Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview ............................................................ 184

Table 332: Tendyne Bioprosthetic Mitral Valve Implantation System - Product Status ................................................................ 184

Table 333: Tendyne Bioprosthetic Mitral Valve Implantation System - Product Description......................................................... 184

Table 334: Tendyne Medical, Inc. - Ongoing Clinical Trials Overview .......................................................................................... 185

SAMPLE



Table 335: Tendyne Bioprosthetic Mitral Valve Implantation System - Early Feasibility Study of the Tendyne Mitral Valve System

....................................................................................................................................................................................................... 186

Table 336: Tendyne Bioprosthetic Mitral Valve Implantation System - Safety and Efficacy of Tendyne Bioprosthetic Mitral Valve

System in Subjects with Symptomatic Mitral Regurgitation of Degenerative or Functional Etiology .............................................. 186

Table 337: Tendyne Bioprosthetic Mitral Valve Implantation System - Safety and Performance of the Tendyne Transcatheter

Mitral Valve Implantation system (TMVI) in Inoperable Subjects with Mitral Regurgitation (MR) ................................................... 186

Table 338: The Tel Aviv Sourasky Medical Center Pipeline Products & Ongoing Clinical Trials Overview .................................. 187

Table 339: Mitral Valve Implantation Device - Product Status ...................................................................................................... 187

Table 340: Mitral Valve Implantation Device - Product Description .............................................................................................. 187

Table 341: Thubrikar Aortic Valve, Inc. Pipeline Products & Ongoing Clinical Trials Overview .................................................... 188

Table 342: 20F Optimum TAV Delivery Catheter - Product Status ............................................................................................... 188

Table 343: 20F Optimum TAV Delivery Catheter - Product Description ....................................................................................... 188

Table 344: Optimum TAVI System - Product Status .................................................................................................................... 189

Table 345: Optimum TAVI System - Product Description ............................................................................................................. 189

Table 346: Tissue Regenix Ltd Pipeline Products & Ongoing Clinical Trials Overview ................................................................ 190

Table 347: dCELL Bovine Heart Valve - Product Status .............................................................................................................. 190

Table 348: dCELL Bovine Heart Valve - Product Description ....................................................................................................... 190

Table 349: dCELL Porcine Aortic Heart Valve - Product Status ................................................................................................... 191

Table 350: dCELL Porcine Aortic Heart Valve - Product Description ........................................................................................... 191

Table 351: dCELL Porcine Pulmonary Heart Valve - Product Status ........................................................................................... 192

Table 352: dCELL Porcine Pulmonary Heart Valve - Product Description ................................................................................... 192

Table 353: Transcatheter Technologies GmbH Pipeline Products & Ongoing Clinical Trials Overview ....................................... 193

Table 354: Transapical Trinity Aortic Valve Implantation System - Product Status ...................................................................... 193

Table 355: Transapical Trinity Aortic Valve Implantation System - Product Description .............................................................. 193

Table 356: Transfemoral Trinity Aortic Valve Implantation System - Product Status .................................................................... 194

Table 357: Transfemoral Trinity Aortic Valve Implantation System - Product Description ............................................................ 194

Table 358: Tresillo System - Product Status ................................................................................................................................ 195

Table 359: Tresillo System - Product Description ......................................................................................................................... 195

Table 360: Twelve, Inc Pipeline Products & Ongoing Clinical Trials Overview ............................................................................. 196

Table 361: Mitral Valve - Product Status ...................................................................................................................................... 196

Table 362: Mitral Valve - Product Description .............................................................................................................................. 196

Table 363: UMC Utrecht Holding BV Pipeline Products & Ongoing Clinical Trials Overview ....................................................... 197

Table 364: Transcatheter Heart Valve - Product Status ............................................................................................................... 197

Table 365: Transcatheter Heart Valve - Product Description ....................................................................................................... 197

Table 366: University College London Pipeline Products & Ongoing Clinical Trials Overview ..................................................... 198

Table 367: Transcatheter Aortic Valve - Product Status ............................................................................................................... 198

Table 368: Transcatheter Aortic Valve - Product Description ....................................................................................................... 198

Table 369: University of California, Irvine Pipeline Products & Ongoing Clinical Trials Overview ................................................ 199

Table 370: Bileaflet Bioprosthetic Mitral Valve - Product Status ................................................................................................... 199

Table 371: Bileaflet Bioprosthetic Mitral Valve - Product Description ........................................................................................... 200

Table 372: Bovine Pericardium Heart Valve - Product Status ...................................................................................................... 200

Table 373: Bovine Pericardium Heart Valve - Product Description .............................................................................................. 200

Table 374: Heart Valve Leaflets - Product Status ......................................................................................................................... 201

SAMPLE



Table 375: Heart Valve Leaflets - Product Description ................................................................................................................. 201

Table 376: University of Pennsylvania Pipeline Products & Ongoing Clinical Trials Overview ..................................................... 202

Table 377: Peripheral Mitral Valve Delivery System - Product Status .......................................................................................... 202

Table 378: Peripheral Mitral Valve Delivery System - Product Description .................................................................................. 203

Table 379: Valtech Cardio Ltd. Pipeline Products & Ongoing Clinical Trials Overview ................................................................ 204

Table 380: Valtech Cardiovalve - Product Status ......................................................................................................................... 204

Table 381: Valtech Cardiovalve - Product Description ................................................................................................................. 204

Table 382: ValveXchange, Inc. Pipeline Products & Ongoing Clinical Trials Overview ................................................................ 205

Table 383: Vanguard System - Product Status ............................................................................................................................ 205

Table 384: Vanguard System - Product Description ..................................................................................................................... 205

Table 385: Vitality Exchangeable Valve System - Product Status ................................................................................................ 206

Table 386: Vitality Exchangeable Valve System - Product Description ........................................................................................ 206

Table 387: VXi Vanguard II - Product Status ................................................................................................................................ 207

Table 388: VXi Vanguard II - Product Description ........................................................................................................................ 207

Table 389: VueKlar Cardiovascular Ltd. Pipeline Products & Ongoing Clinical Trials Overview .................................................. 208

Table 390: MR-Enhancing Percutaneous Heart Valve - Product Status ...................................................................................... 208

Table 391: MR-Enhancing Percutaneous Heart Valve - Product Description ............................................................................... 209

Table 392: Xeltis AG Pipeline Products & Ongoing Clinical Trials Overview ................................................................................ 210

Table 393: QTIS Heart Valve - Product Status ............................................................................................................................. 210

Table 394: QTIS Heart Valve - Product Description ..................................................................................................................... 210

Table 395: Glossary ..................................................................................................................................................................... 307

1.2 List of Figures

Figure 1: Prosthetic Heart Valves - Pipeline Products by Stage of Development ........................................................................... 18

Figure 2: Prosthetic Heart Valves - Pipeline Products by Segment ................................................................................................ 19

Figure 3: Prosthetic Heart Valves - Pipeline Products by Territory ................................................................................................. 20

Figure 4: Prosthetic Heart Valves - Pipeline Products by Regulatory Path .................................................................................... 21

Figure 5: Prosthetic Heart Valves - Pipeline Products by Estimated Approval Date ....................................................................... 22

Figure 6: Prosthetic Heart Valves - Ongoing Clinical Trials ............................................................................................................ 23

SAMPLE



2 Introduction

2.1 Prosthetic Heart Valves Overview

Prosthetic heart valves have a passive mode of functioning; opening and closing of valves are responses to pressure and flow

changes within the heart. Prosthetic heart valve includes both mechanical and tissue or biological heart valves.

• Mechanical Heart Valves

Mechanical heart valves are generally made of non–physiological materials with a mobile occluder, which is made of rigid

materials.

Mechanical Aortic Valve Replacements

Replacement of the aortic heart valve using a mechanical prosthesis. One unit refers to one mechanical aortic valve.

Mechanical Mitral Valve Replacements

Replacement of the mitral heart valve using a mechanical prosthesis. One unit refers to one mechanical mitral valve

replacement.

• Tissue Heart Valves

Tissue heart valve are a combination of tissue and synthetic biomaterials with the tissue itself being flexible. Bovine and

porcine valves are included here.

Tissue Aortic Valve Replacements

Replacement of the aortic heart valve using a biological prosthesis. One unit refers to one tissue aortic valve.

Tissue Mitral Valve Replacements

Replacement of the mitral heart valve using a biological prosthesis. One unit refers to one tissue mitral valve.

• Transcatheter Heart Valves

The transcatheter heart valve is a tissue valve replacement that can be compressed down to the diameter of a pencil. It

can be placed inside a beating heart using a catheter threaded through the patient's circulatory system or through a small

incision between the ribs. Once inside the heart, the valve can then be opened into its natural position by the inflation of a

balloon and deployed within the patient's diseased aortic valve. Only aortic valves replacements are tracked here. One

unit refers to one transcatheter heart valve.

SAMPLE



3 Products under Development

3.1 Prosthetic Heart Valves - Pipeline Products by Stage of Development

Figure 1: Prosthetic Heart Valves - Pipeline Products by Stage of Development

Source: Primary and Secondary Research, GlobalData

As of April, 2015

Table 1: Prosthetic Heart Valves - Pipeline Products by Stage of Development

Stage Of Development Number of Products

Early development

Pre-Clinical

Clinical

In Approval Process

Source: Primary / Secondary Research, GlobalData

As of April, 2015

SAMPLE


Page 20


3.3 Prosthetic Heart Valves - Pipeline Products by Territory

Figure 3: Prosthetic Heart Valves - Pipeline Products by Territory


As of April, 2015

Table 3: Prosthetic Heart Valves - Pipeline Products by Territory

Territory Number of Products

United States

Global

Europe

Japan

Canada

China

Germany

United Kingdom

Austria


As of April, 2015

SAMPLE


Page 21


3.4 Prosthetic Heart Valves - Pipeline Products by Regulatory Path

Figure 4: Prosthetic Heart Valves - Pipeline Products by Regulatory Path


As of April, 2015

Table 4: Prosthetic Heart Valves - Pipeline Products by Regulatory Path

Regulatory Path Number of Products

PMA

CE

Shonin

MDEL

Ninsho

HDE Approvals

IMDRC

510(k)


As of April, 2015

SAMPLE


Page 306


7 Appendix

The data and analysis within this report is driven by GlobalData. GlobalData gives you key information to drive sales, investment and deal making activity in your business.

Our coverage includes 200,000 + reports on 185,000+ companies (including 150,000+ private) across 200+ countries and 29

industries. The key industries include Alternative Energy, Oil & Gas, Clean Technology, Technology and Telecommunication,

Pharmaceutical and Healthcare, Power, Financial Services, Chemical and Metal & Mining.

7.1 Methodology

GlobalData company reports are based on a core set of research techniques which ensure the best possible level of quality and

accuracy of data. The key sources used include:

• Company Websites

• Company Annual Reports

• SEC Filings

• Press Releases

• Proprietary Databases

Taxonomy:

GlobalData has developed an industry-leading four tier (market, category, segment, subsegment) medical devices taxonomy. The

taxonomy is both comprehensive and constantly updated ensuring data quality. The report published is a category based report

where the product taxonomy vary from category level to sub-segment level.

Origination:

GlobalData’s pipeline products and clinical trials data is built using information and data from a number of important sources based

on both internal and external sources to develop a comprehensive and robust view of the medical devices market.

Secondary Research:

Extensive secondary research is done to gather data specific to the pipeline products and clinical trials. We track medical devices

that are in development related to nearly 18 markets (ie, cardiovascular devices, dental devices etc) that we cover.

GlobalData conducts extensive research to gather data specific to pipeline products (product status, current stage of development,

product description, technology and estimation timelines of medical devices) and clinical trials. Hundreds of medical specific live

news sources are monitored on a daily basis.

Primary Research:

Primary research is conducted to validate the product status, stage of development and estimated timelines.

GlobalData’s pool of primary research candidates for the pipeline products enquiries includes marketing / product managers, R&D

director, sales director and key person involving with regulatory process.

SAMPLE


Page 307


Updates:

All pipeline products are updated at least once in a quarter. Products are updated through secondary research sources such as

live news, press releases, company websites, presentations, sec filings, transcripts etc.

GlobalData uses an in house template to estimate product approval date and product launch date in case if data is not obtained

either through secondary or primary research. The template uses various parameters (pipeline territory (region), device class,

stage of development, product source date) to analyze and estimate the product approval/launch date.

A wide range of factors are considered while estimating timelines for the medical devices.

Notes

• Financial information for the company is taken from the most recently published annual reports or SEC filings

• The number of products mentioned in various graphs can be inconsistent due to plotting of different fields

• Pipeline Products by Stage of Development Graph - Displays exact count of pipeline products

• Pipeline Products by Segment Graph - Products tagged directly to sector is not included but its sub-level tagging is shown

• Pipeline Products by Territory Graph - Displays count of all multiple territories tagged to pipeline products

• Pipeline Products by Regulatory Path Graph - Displays only count of territories for which Regulatory Path is defined

• Pipeline Products by Estimated Approval Date Graph - Displays count of all estimated approval dates tagged to multiple

territories

• Only the below mentioned status of Clinical trials are included in the report specific to the pipeline products:

Ongoing, Recruiting

Ongoing, not Recruiting

Ongoing, Recruiting by invitation

Ongoing, not yet recruiting

• Recent Development section covers news posted during last six months

• GlobalData considers regulatory approved (Approved and Issued) products as pipeline in case products are yet to launch in the

market.

Table 395: Glossary

Field Name Definition

Product Name Indicates product name

Developed By Provides information of the company which develops the

product

Product Description Provides information on product (What is the condition, where

it will be used, benefits, technical specifications etc)

Indication Provides information on the therapeutic or diagnostic

conditions where the product is used

Application Indicates the procedure or intervention for which the selected

product is used

Device Class Provides product class information based on their design

complexity, characteristics and risk factors i.e. Class I, II and

III

Highest Stage of Development/Development stage Provides information on the developmental status e.g. early

development, pre-clinicals, clinical, in approval process

Territory A geographic region where the product is currently in pipeline

or will be commercially launched

Estimated Approval Date Provides information on expected product approval date

Market Category/Equipment Type Indicates the classification of a medical device based on

therapy area and application

Regulatory Path Regulatory process through which the product gets marketing

SAMPLE


Page 308


approval by respective regulatory agency

Technology Indicates the core technology used in product

Function Provides information about the mechanism of action of the

device

Early Development Defined when a product is in prototype or design stage of

development

Pre Clinical Defined when a product is tested in animals

Clinical Defined when a product is tested in humans for the safety and

efficacy of the device

In Approval Process Defined when a product is filed for approval with regulatory

body for approval of the product

Issued Defined when a product receives regulatory approval from

European Union

Approved Defined when a product receives regulatory approval from a

country other than Europe

Planned (Ongoing, not yet Recruiting) The participants are not yet to be recruited or enrolled for the

study

Ongoing, Recruiting The participants are currently being recruited or enrolled for

the study

Ongoing, not Recruiting The study is still ongoing. The patients are being treated or

examined or study results are being analyzed for its

endpoints. But enrollment for the study stands completed

Ongoing, Recruiting by invitation The participants are being (or will be) selected from a

predetermined population (as decided in advance by the

researchers)

Global (Pipeline territory) If source does not indicate any specific country as pipeline

region, then Global is added as the pipeline territory


As of April, 2015

7.2 About GlobalData

GlobalData is one of the world’s leading providers of company operational data and strategic analysis, providing detailed

information on tens of thousands of companies globally. Our highly qualified team of Analysts, Researchers, and Solution

Consultants use proprietary data sources and various tools and techniques to gather, analyze and represent the latest and the

most reliable information essential for businesses to sustain a competitive edge. Data is continuously updated and revised by large

teams of research experts, so that it always reflects the latest events and information. With a large dedicated research and

analysis capability, GlobalData employs rigorous primary and secondary research techniques in developing unique data sets and

research material for this series and its other reports. GlobalData offers comprehensive geographic coverage across world’s most

important sectors, focusing particularly on energy and healthcare.

7.4 Disclaimer

All Rights Reserved No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic,

mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GlobalData

The data and analysis within this report is driven by GlobalData from its own primary and secondary research of public and

proprietary sources and does not necessarily represent the views of the company profiled

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