Transcatheter Heart Valves – Pipeline Products by Stage of Development 28
Transcatheter Heart Valves – Pipeline Products by Segment 29
Transcatheter Heart Valves – Pipeline Products by Territory 30
Transcatheter Heart Valves – Pipeline Products by Regulatory Path 32
Transcatheter Heart Valves – Pipeline Products by Estimated Approval Date 33
Transcatheter Heart Valves – Ongoing Clinical Trials 34
Transcatheter Heart Valves Companies – Pipeline Products by Stage of Development 35
Transcatheter Heart Valves – Pipeline Products by Stage of Development 40
3DT Holdings LLC Pipeline Products & Ongoing Clinical Trials Overview 47
Tissue Heart Valve – Product Status 47
Tissue Heart Valve – Product Description 47
4C Medical Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 48
AltaValve Transcatheter Mitral Valve Replacement Device – Product Status 48
AltaValve Transcatheter Mitral Valve Replacement Device – Product Description 48
Fully Recapturable and Retrievable Transseptal Delivery System – Product Status 49
Fully Recapturable and Retrievable Transseptal Delivery System – Product Description 49
4C Medical Technologies Inc – Ongoing Clinical Trials Overview 50
AltaValve Transcatheter Mitral Valve Replacement Device – AltaValve Early Feasibility Study Protocol 51
Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 52
Tendyne Bioprosthetic Mitral Valve Implantation System – Product Status 52
Tendyne Bioprosthetic Mitral Valve Implantation System – Product Description 52
TriClip Transcatheter Tricuspid Valve Repair System – Product Status 53
TriClip Transcatheter Tricuspid Valve Repair System – Product Description 53
Abbott Vascular Inc – Ongoing Clinical Trials Overview 54
Tendyne Bioprosthetic Mitral Valve Implantation System – Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation 55
Tendyne Bioprosthetic Mitral Valve Implantation System – Expanded Clinical Study of the Tendyne Mitral Valve System 55
Tendyne Bioprosthetic Mitral Valve Implantation System – Feasibility Study of the Tendyne Mitral Valve System for Use in Subjects with Mitral Annular Calcification 55
Tendyne Bioprosthetic Mitral Valve Implantation System – Real World Study of the Tendyne Mitral Valve System to Treat Mitral Regurgitation (RESOLVE-MR) (Tendyne PMCF Study) 56
Tendyne Bioprosthetic Mitral Valve Implantation System – Tendyne European Experience Registry 56
TriClip Transcatheter Tricuspid Valve Repair System – An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated with the Abbott TriClip Device 57
TriClip Transcatheter Tricuspid Valve Repair System – Clinical Trial to Evaluate Cardiovascular Outcomes in Patients Treated with the Tricuspid Valve Repair System Pivotal 57
TriClip Transcatheter Tricuspid Valve Repair System – Evaluation of the Safety, Efficacy and Cost-effectiveness of Transcatheter Tricuspid Valve Repair in Patients With Severe Tricuspid Regurgitation in the Netherlands. 57
TriClip Transcatheter Tricuspid Valve Repair System – Pforzheim Tricuspid Valve Registry: A Real-world Observational Trial Evaluating Outcomes in Patients Treated with the Abbott TriClip Device in Helios Klinikum Pforzheim 58
TriClip Transcatheter Tricuspid Valve Repair System – Trial to Evaluate Treatment with Abbott Transcatheter Clip Repair System in Patients with Moderate or Greater Tricuspid Regurgitation (TRILUMINATE) 58
Aegis Surgical Limited Pipeline Products & Ongoing Clinical Trials Overview 59
pTAo-TAVR – Product Status 59
pTAo-TAVR – Product Description 59
Affluent Medical SASU Pipeline Products & Ongoing Clinical Trials Overview 60
Epygon – Product Status 60
Epygon – Product Description 60
Affluent Medical SASU – Ongoing Clinical Trials Overview 61
Epygon – First-in-human Clinical Study for Treatment of Severe Mitral Valve Insufficiency with Epygon Transcatheter Mitral Valve System (MINERVA FIH) 62
Anchorvalve Pipeline Products & Ongoing Clinical Trials Overview 63
Sutureless Trans-Catheter Mitral Valve Replacement (TMVR) – Product Status 63
Sutureless Trans-Catheter Mitral Valve Replacement (TMVR) – Product Description 63
Sutureless Trans-Catheter Tricuspid Valve Replacement (TTVR) – Product Status 64
Sutureless Trans-Catheter Tricuspid Valve Replacement (TTVR) – Product Description 64
Annulon Pipeline Products & Ongoing Clinical Trials Overview 65
Mitral Valve Replacement Device – Product Status 65
Mitral Valve Replacement Device – Product Description 65
Anteris Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 66
DurAVR THV System – Product Status 66
DurAVR THV System – Product Description 66
Anteris Technologies Ltd – Ongoing Clinical Trials Overview 67
DurAVR THV System – Use of DurAVR THV System in Subjects with Severe Aortic Stenosis: First In Human Study 68
AorTx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 69
AorTx Valve – Product Status 69
AorTx Valve – Product Description 69
Arbor Surgical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 70
Trilogy Aortic Valve System – Product Status 70
Trilogy Aortic Valve System – Product Description 70
Atlas Medical Pipeline Products & Ongoing Clinical Trials Overview 71
Endurance Valve – Product Status 71
Endurance Valve – Product Description 71
AVVie GmbH Pipeline Products & Ongoing Clinical Trials Overview 72
Mitral Butterfly – Product Status 72
Mitral Butterfly – Product Description 72
Biotronik AG Pipeline Products & Ongoing Clinical Trials Overview 73
BIOVALVE Resheathable Transcatheter Aortic Valve – Product Status 73
BIOVALVE Resheathable Transcatheter Aortic Valve – Product Description 73
Biotronik AG – Ongoing Clinical Trials Overview 74
BIOVALVE Resheathable Transcatheter Aortic Valve – Safety and Clinical Performance of the Self-expanding Transcatheter BIOVALVE Prosthesis in Subjects with Severe Symptomatic Aortic Stenosis Suitable for Transfemoral Transcatheter Aortic Valve Implantation 75
Boston Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 76
Pulmonary Valve Replacement Device – Product Status 76
Pulmonary Valve Replacement Device – Product Description 76
Two Piece Replacement Heart Valve – Product Status 77
Two Piece Replacement Heart Valve – Product Description 77
Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 78
ACURATE neo2 Transfemoral TAVR System – Product Status 78
ACURATE neo2 Transfemoral TAVR System – Product Description 79
Gen 4 Lotus Valve System – Product Status 79
Gen 4 Lotus Valve System – Product Description 79
Lotus Edge Sheath 15F – Product Status 80
Lotus Edge Sheath 15F – Product Description 80
Lotus Edge Valve System – 21mm – Product Status 80
Lotus Edge Valve System – 21mm – Product Description 81
Lotus Edge Valve System – 29mm – Product Status 81
Lotus Edge Valve System – 29mm – Product Description 82
LOTUS Mantra – Product Status 82
LOTUS Mantra – Product Description 82
Boston Scientific Corp – Ongoing Clinical Trials Overview 83
ACURATE neo2 Transfemoral TAVR System – ACURATE IDE: Transcatheter Replacement of Stenotic Aortic Valve Through Implantation of ACURATE in Subjects InDicatEd for TAVR 84
ACURATE neo2 Transfemoral TAVR System – ACURATE Neo AS Aortic Bioprosthesis for Implantation Using the ACURATE neo AS TF Transfemoral Delivery System in Patients with Severe Aortic Stenosis 84
ACURATE neo2 Transfemoral TAVR System – ACURATE neo2 Post Market Clinical Follow up Study 84
ACURATE neo2 Transfemoral TAVR System – PROVE ACURATE neo2 – Post Market Safety and Performance Surveillance in Aortic Stenosis 85
ACURATE neo2 Transfemoral TAVR System – Randomized Study Comparing Both Latest Generation Self-expanding Valves and Local Anesthesia Vs. Conscious Sedation in Transcatheter Aortic Valve Implantation 85
Cardiac Dimensions Inc Pipeline Products & Ongoing Clinical Trials Overview 86
CARILLON Mitral Contour System – Product Status 86
CARILLON Mitral Contour System – Product Description 86
Cardiac Dimensions Inc – Ongoing Clinical Trials Overview 87
CARILLON Mitral Contour System – An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Function Mitral Regurgitation 88
CARILLON Mitral Contour System – Assessment of the Carillon Mitral Contour System in Treating Heart Failure With at Least Mild Functional Mitral Regurgitation 88
CARILLON Mitral Contour System – European Registry of Transcatheter Repair for Secondary Mitral Regurgitation 88
CARILLON Mitral Contour System – Pivotal Trial for Carillon Mitral Contour System 89
CARILLON Mitral Contour System – The CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation 89
CardioMech AS Pipeline Products & Ongoing Clinical Trials Overview 90
Transcatheter Mitral Valve Repair System – Product Status 90
Transcatheter Mitral Valve Repair System – Product Description 90
CardioMech AS – Ongoing Clinical Trials Overview 91
Transcatheter Mitral Valve Repair System – Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS) 92
Cardiovalve Ltd Pipeline Products & Ongoing Clinical Trials Overview 93
Cardiovalve Transcatheter Tricuspid Valve System – Product Status 93
Cardiovalve Transcatheter Tricuspid Valve System – Product Description 93
Cardiovalve Transfemoral Mitral Valve System – Product Status 94
Cardiovalve Transfemoral Mitral Valve System – Product Description 94
Cardiovalve Ltd – Ongoing Clinical Trials Overview 95
Cardiovalve Transfemoral Mitral Valve System – Cardiovalve Transfemoral Mitral Valve System in Patients at High Surgical Risk with Severe Mitral Regurgitation 96
Cardiovalve Transfemoral Mitral Valve System – Early Feasibility Study of the Cardiovalve System for Tricuspid Regurgitation 96
Cardiovalve Transfemoral Mitral Valve System – Early Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System 96
Cardiovalve Transfemoral Mitral Valve System – European Feasibility Study of High Surgical Risk Patients with Severe Mitral Regurgitation Treated with the Cardiovalve Transfemoral Mitral Valve System: AHEAD Study 97
Cardiovalve Transfemoral Mitral Valve System – Evaluation of a Transcatheter Mitral Valve Replacement System for the Treatment of Severe Mitral Regurgitation with High Surgical Risk: A Chinese Feasibility Study 97
Cardiovalve Transcatheter Tricuspid Valve System – Safety and Performance of the Cardiovalve TR Replacement System for Tricuspid Regurgitation 98
Carena Healthcare Ltd Pipeline Products & Ongoing Clinical Trials Overview 99
Pillar 3D Printed Replacement Heart Valve – Product Status 99
Pillar 3D Printed Replacement Heart Valve – Product Description 99
Cephea Valve Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 100
Cephea Transcatheter Mitral Valve Replacement System – Product Status 100
Cephea Transcatheter Mitral Valve Replacement System – Product Description 100
Chengdu Silara Meditech Inc Pipeline Products & Ongoing Clinical Trials Overview 101
Transcatheter Aortic Valve System – Product Status 101
Transcatheter Aortic Valve System – Product Description 101
Chengdu Silara Meditech Inc – Ongoing Clinical Trials Overview 102
Transcatheter Aortic Valve System – A Prospective, Multi-center, Single-arm Clinical Trial to Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System in Patients with Severe Aortic Stenosis with or without Moderate or Lower Degree Regurgitation 103
Transcatheter Aortic Valve System – To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Symptomatic Aortic Insufficiency 103
Colibri Heart Valve LLC Pipeline Products & Ongoing Clinical Trials Overview 104
Colibri TAVI System – Product Status 104
Colibri TAVI System – Product Description 104
Delta Aortic Heart Valve – Product Status 105
Delta Aortic Heart Valve – Product Description 105
Mitral Valve – Product Status 105
Mitral Valve – Product Description 106
Second-Generation TAVI System – Product Status 106
Second-Generation TAVI System – Product Description 106
Venibri Transcatheter Heart Valve System – Product Status 107
Venibri Transcatheter Heart Valve System – Product Description 107
Colibri Heart Valve LLC – Ongoing Clinical Trials Overview 108
Colibri TAVI System – A Prospective, Single Arm Clinical Investigation Evaluating Safety and Performance of the Colibri Transcatheter Aortic Heart Valve System for the Treatment of Symptomatic Severe Aortic Stenosis Via Transfemoral Access in High Surgical Risk Patients 109
ContiTech (Beijing) Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 110
Balloon-Expandable Transcatheter Aortic Valve Replacement Device – Product Status 110
Balloon-Expandable Transcatheter Aortic Valve Replacement Device – Product Description 110
coramaze technologies GmbH Pipeline Products & Ongoing Clinical Trials Overview 111
Mitramaze Valve Repair System – Product Status 111
Mitramaze Valve Repair System – Product Description 111
Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview 112
Sutureless Trans-Catheter Aortic Valve Replacement (TAVR) – Product Status 112
Sutureless Trans-Catheter Aortic Valve Replacement (TAVR) – Product Description 112
Direct Flow Medical Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 113
18F Direct Flow Medical Transcatheter Aortic Valve System – Product Status 113
18F Direct Flow Medical Transcatheter Aortic Valve System – Product Description 113
22F Percutaneous Aortic Valve System – Product Status 114
22F Percutaneous Aortic Valve System – Product Description 114
Direct Flow Medical Transcatheter Mitral Valve – Product Status 114
Direct Flow Medical Transcatheter Mitral Valve – Product Description 115
Direct Flow Medical Inc (Inactive) – Ongoing Clinical Trials Overview 116
18F Direct Flow Medical Transcatheter Aortic Valve System – SALUS Trial Transcatheter Aortic Valve Replacement System Pivotal Trial the Safety and Effectiveness of the Direct Flow Medical Tanscatheter Aortic Valve System 117
DSM Dyneema BV Pipeline Products & Ongoing Clinical Trials Overview 118
Dyneema Purity – Transcatheter Heart Valve – Product Status 118
Dyneema Purity – Transcatheter Heart Valve – Product Description 118
Dura LLC Pipeline Products & Ongoing Clinical Trials Overview 119
Joyce Fit TPVR System – Product Status 119
Joyce Fit TPVR System – Product Description 119
LowPro Valve – Product Status 120
LowPro Valve – Product Description 120
Sutra TMVR System – Product Status 120
Sutra TMVR System – Product Description 121
VirtuTAVR System – Product Status 121
VirtuTAVR System – Product Description 121
Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 122
CardiAQ Mitral Valve – Product Status 123
CardiAQ Mitral Valve – Product Description 123
EVOQUE Mitral Eos Valve Replacement Device – Product Status 123
EVOQUE Mitral Eos Valve Replacement Device – Product Description 124
EVOQUE Tricuspid Valve Replacement System – Product Status 124
EVOQUE Tricuspid Valve Replacement System – Product Description 124
FORMA Tricuspid Repair System – Product Status 125
FORMA Tricuspid Repair System – Product Description 125
FORTIS Mitral Transcatheter Heart Valve – Product Status 125
FORTIS Mitral Transcatheter Heart Valve – Product Description 126
Monarc Transcatheter Mitral Repair System – Product Status 126
Monarc Transcatheter Mitral Repair System – Product Description 126
Next Gen CENTERA – Product Status 126
Next Gen CENTERA – Product Description 127
PASCAL Ace Transcatheter Mitral Valve Repair System – Product Status 127
PASCAL Ace Transcatheter Mitral Valve Repair System – Product Description 127
PASCAL Ace Transcatheter Tricuspid Valve Repair System – Product Status 128
PASCAL Ace Transcatheter Tricuspid Valve Repair System – Product Description 128
PASCAL Precision Transcatheter Tricuspid Valve Repair System – Product Status 128
PASCAL Precision Transcatheter Tricuspid Valve Repair System – Product Description 129
PASCAL Precision Transcatheter Valve Repair System – Product Status 129
PASCAL Precision Transcatheter Valve Repair System – Product Description 129
PASCAL STABILX – Product Status 130
PASCAL STABILX – Product Description 130
PASCAL Transcatheter Mitral Valve Repair System – DMR – Product Status 130
PASCAL Transcatheter Mitral Valve Repair System – DMR – Product Description 131
PASCAL Transcatheter Mitral Valve Repair System – FMR – Product Status 131
PASCAL Transcatheter Mitral Valve Repair System – FMR – Product Description 131
SAPIEN 3 THV – Asymptomatic Severe Aortic Stenosis – Product Status 132
SAPIEN 3 THV – Asymptomatic Severe Aortic Stenosis – Product Description 132
SAPIEN 3 THV – Moderate Aortic Stenosis – Product Status 132
SAPIEN 3 THV – Moderate Aortic Stenosis – Product Description 133
Sapien 3 Ultra Evolutionary Transcatheter Heart Valve – Product Status 133
Sapien 3 Ultra Evolutionary Transcatheter Heart Valve – Product Description 133
SAPIEN M3 – Product Status 134
SAPIEN M3 – Product Description 134
SAPIEN X4 – Product Status 134
SAPIEN X4 – Product Description 135
Edwards Lifesciences Corp – Ongoing Clinical Trials Overview 136
FORTIS Mitral Transcatheter Heart Valve – Early Feasibility Study of the Edwards EVOQUE Transcatheter Mitral Valve Replacement System For the Treatment of Moderate to Severe Mitral Regurgitation 138
CardiAQ Mitral Valve – Early Feasibility Study of the Edwards EVOQUE Transcatheter Mitral Valve Replacement System For the Treatment of Moderate to Severe Mitral Regurgitation 139
FORMA Tricuspid Repair System – Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System 140
FORMA Tricuspid Repair System – International Multisite Transcatheter Tricuspid Valve Therapies Registry 140
SAPIEN M3 – SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access 141
SAPIEN M3 – Surgical Implantation of Transcatheter valve in Native Mitral Annular Calcification (SITRAL) Study 141
SAPIEN 3 THV – Moderate Aortic Stenosis – Transcatheter Aortic Valve Replacement to Unload the Left Ventricle in Patients with Advanced Heart Failure: A Randomized Trial (TAVR UNLOAD) 142
PASCAL Transcatheter Mitral Valve Repair System – DMR – Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial (CLASP IID/IIF): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Repair with the Edwards PASCAL Transcatheter Valve Repair System Compared to Abbott MitraClip in Patients with Mitral Regurgitation 143
PASCAL Transcatheter Mitral Valve Repair System – DMR – European Registry of Transcatheter Repair for Secondary Mitral Regurgitation 143
PASCAL Transcatheter Mitral Valve Repair System – DMR – The CLASP Study Edwards PASCAL TranScatheter Mitral Valve Repair System Study 143
EVOQUE Mitral Eos Valve Replacement Device – Early Feasibility Study of the Edwards EVOQUE Transcatheter Mitral Valve Replacement System For the Treatment of Moderate to Severe Mitral Regurgitation 144
EVOQUE Tricuspid Valve Replacement System – Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device 145
EVOQUE Tricuspid Valve Replacement System – Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy After Replacement of Tricuspid Valve with Transcatheter Device 145
PASCAL Transcatheter Mitral Valve Repair System – FMR – Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial (CLASP IID/IIF): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Repair with the Edwards PASCAL Transcatheter Valve Repair System Compared to Abbott MitraClip in Patients with Mitral Regurgitation 146
PASCAL Transcatheter Mitral Valve Repair System – FMR – Transcatheter Repair of Mitral Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post Market Clinical Follow-up (PMCF) 146
Emory University Pipeline Products & Ongoing Clinical Trials Overview 147
MitraCath – Product Status 147
MitraCath – Product Description 147
MitraPlug – Product Status 148
MitraPlug – Product Description 148
Endoluminal Technology Research LLC Pipeline Products & Ongoing Clinical Trials Overview 149
Balloon Expandable Paniagua Heart Valve – Product Status 149
Balloon Expandable Paniagua Heart Valve – Product Description 149
Endomimetics LLC Pipeline Products & Ongoing Clinical Trials Overview 150
Transcatheter Heart Valve – Product Status 150
Transcatheter Heart Valve – Product Description 150
Enlight Medical Technologies (Shanghai) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 151
NovoClasp Transfemoral Mitral Valve Repair System – Product Status 151
NovoClasp Transfemoral Mitral Valve Repair System – Product Description 151
Second-Generation Mitral Valve Repair System – Product Status 152
Second-Generation Mitral Valve Repair System – Product Description 152
Florida International University Pipeline Products & Ongoing Clinical Trials Overview 153
Percutaneous Aortic Heart Valve – Product Status 153
Percutaneous Aortic Heart Valve – Product Description 153
Folda LLC Pipeline Products & Ongoing Clinical Trials Overview 154
Foldavalve – Product Status 154
Foldavalve – Product Description 154
Foldax Inc Pipeline Products & Ongoing Clinical Trials Overview 155
Tria Transcatheter Aortic Valve Replacement Device – Product Status 155
Tria Transcatheter Aortic Valve Replacement Device – Product Description 155
Tria Transcatheter Mitral Valve Replacement Device – Product Status 156
Tria Transcatheter Mitral Valve Replacement Device – Product Description 156
Tria Transcatheter Tricuspid Valve Replacement Device – Product Status 156
Tria Transcatheter Tricuspid Valve Replacement Device – Product Description 156
Half Moon Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 157
Half Moon TMVr System – Product Status 157
Half Moon TMVr System – Product Description 157
Half Moon Medical Inc – Ongoing Clinical Trials Overview 158
Half Moon TMVr System – Evaluation of the Safety and Performance of the Half Moon Transcatheter Mitral Valve Repair System in High Risk Patients with Severe, Symptomatic Mitral Regurgitation 159
Hangzhou DeJin Medtech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 160
MitralStitch – Product Status 160
MitralStitch – Product Description 160
Hangzhou DeJin Medtech Co Ltd – Ongoing Clinical Trials Overview 161
MitralStitch – A Prospective, Multicenter, Single Group Assignment Study for Evaluating the Safety and Effectiveness of MitralStitch Mitral Valve Repair System in Patients with Moderate to Severe and Severe Mitral Regurgitation 162
MitralStitch – To Evaluate the Effectiveness and Safety of MitralStitch Mitral Valve Repair System – A Clinical Application of New Technology 162
Hangzhou Valgen Medtech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 163
Dragonfly Transcatheter Mitral Valve Clamping System – Product Status 163
Dragonfly Transcatheter Mitral Valve Clamping System – Product Description 163
Hangzhou Valued Medtech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 164
DragonFly – Product Status 164
DragonFly – Product Description 164
Hangzhou Valued Medtech Co Ltd – Ongoing Clinical Trials Overview 165
DragonFly – A Clinical Study of Management of Severe Tricuspid Regurgitation with Transcatheter Mitral Valve Clamping System 166
DragonFly – A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Safety and Effectiveness of Dragonfly Transcatheter Mitral Valve Repair System for the Treatment of Degenerative Mitral Regurgitation (DMR) Subjects 166
DragonFly – A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Safety and Effectiveness of Dragonfly Transcatheter Mitral Valve Repair System for the Treatment of Functional Mitral Regurgitation (FMR) Subjects 166
DragonFly – Dragonfly-M Transcatheter Mitral Valve Repair System Early Feasibility Study 167
HighLife SAS Pipeline Products & Ongoing Clinical Trials Overview 168
Peijia HighLife Transcatheter Mitral Valve Replacement – Product Status 168
Peijia HighLife Transcatheter Mitral Valve Replacement – Product Description 168
HighLife SAS – Ongoing Clinical Trials Overview 169
Peijia HighLife Transcatheter Mitral Valve Replacement – A Prospective, Multicentric Clinical Trial Protocol to Evaluate the Safety and Efficacy of the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System for the Treatment of Moderate-severe or Severe Mitral Regurgitation With Single-arm Objective Performance Criteria 170
Peijia HighLife Transcatheter Mitral Valve Replacement – An Early Feasibility Study of the HighLife 28mm Trans-septal Transcatheter Mitral Valve Replacement System 170
Peijia HighLife Transcatheter Mitral Valve Replacement – Feasibility Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients with Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk 170
Peijia HighLife Transcatheter Mitral Valve Replacement – HighLife Transcatheter Mitral Valve Replacement System for Severe Mitral Regurgitation in Patients at High Surgical Risk 171
Peijia HighLife Transcatheter Mitral Valve Replacement – HighLife TSMVR Feasibility Study of the Open Cell CLARITY Valve in Patients with Moderate-severe or Severe MR, High Surgical Risk and with a High Risk for Left Ventricular Outflow Tract Obstruction (LVOTO) 171
Peijia HighLife Transcatheter Mitral Valve Replacement – Study to Evaluate the Efficacy of HighLife Trans-septal Mitral Valve Replacement System in Patients with Mitral Valve Disease 171
HLT, Inc. Pipeline Products & Ongoing Clinical Trials Overview 172
Meridian II Transcatheter Aortic Valve Replacement System – Product Status 172
Meridian II Transcatheter Aortic Valve Replacement System – Product Description 172
HLT, Inc. – Ongoing Clinical Trials Overview 173
Meridian II Transcatheter Aortic Valve Replacement System – Study to Evaluate the Safety and Performance of HLT Meridian TAVR Valve System in the Treatment of Aortic Regurgitation 174
Meridian II Transcatheter Aortic Valve Replacement System – Study to Evaluate the Safety and Performance of HLT Meridian TAVR Valve System in the Treatment of Aortic Stenosis 174
Meridian II Transcatheter Aortic Valve Replacement System – Transfemoral Replacement of Aortic Valve with HLT Meridian Valve Early Feasibility Trial 174
Meridian II Transcatheter Aortic Valve Replacement System – Transfemoral Replacement of Aortic Valve with HLT Meridian Valve Feasibility Trial Canada 175
InnovHeart SRL Pipeline Products & Ongoing Clinical Trials Overview 176
Saturn TMVR Prosthesis – Transapical – Product Status 176
Saturn TMVR Prosthesis – Transapical – Product Description 177
Saturn TMVR Prosthesis – Transeptal – Product Status 177
Saturn TMVR Prosthesis – Transeptal – Product Description 177
Saturn TMVR Prosthesis – Transfemoral – Product Status 178
Saturn TMVR Prosthesis – Transfemoral – Product Description 178
InnovHeart SRL – Ongoing Clinical Trials Overview 179
Saturn TMVR Prosthesis – Transapical – SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation 180
JC Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 181
J-Valve TAVI System – Transapical – Product Status 181
J-Valve TAVI System – Transapical – Product Description 181
J-Valve TAVI System – Transfemoral – Product Status 182
J-Valve TAVI System – Transfemoral – Product Description 182
JC Medical, Inc. – Ongoing Clinical Trials Overview 183
J-Valve TAVI System – Transapical – Efficacy and Safety Evaluation for the Interventional Aortic Valve Bioprosthesis and Delivery System in Patients with Severe Aortic Stenosis and/or Aortic Regurgitation with Elevated Surgical Risk 184
J-Valve TAVI System – Transfemoral – J-Valve Compassionate Use Cases 185
JenaValve Technology GmbH Pipeline Products & Ongoing Clinical Trials Overview 186
JenaValve Pericardial TAVR System – Product Status 186
JenaValve Pericardial TAVR System – Product Description 186
Trilogy Heart Valve System – Product Status 187
Trilogy Heart Valve System – Product Description 187
JenaValve Technology GmbH – Ongoing Clinical Trials Overview 188
JenaValve Pericardial TAVR System – A Study to Assess Safety and Effectiveness of the JenaValve Trilogy Heart Valve System in the Treatment of High Surgical Risk Patients With Symptomatic, Severe Aortic Regurgitation (AR) 189
JenaValve Pericardial TAVR System – JENAVALVE ALIGN-AS TRIAL: Safety and Effectiveness/Performance of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Stenosis (AS) 189
JenaValve Pericardial TAVR System – THE ALIGN-AR TRIAL: Safety and Effectiveness/Performance of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients with Symptomatic Severe Aortic Regurgitation (AR) 189
Trilogy Heart Valve System – Trilogy Heart Valve System for Management of Patients with Aortic Valve Disease: Patient Registry and Post-market Clinical Follow-up Study 190
Jenscare Scientific Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 191
AnchorValve – Product Status 191
AnchorValve – Product Description 192
JensClip – Product Status 192
JensClip – Product Description 192
JensT-Clip – Product Status 193
JensT-Clip – Product Description 193
Ken-Valve – Product Status 193
Ken-Valve – Product Description 194
KenFlex – Product Status 194
KenFlex – Product Description 194
LuX-Valve – Product Status 195
LuX-Valve – Product Description 195
LuX-Valve Plus – Product Status 195
LuX-Valve Plus – Product Description 196
MitraPatch – Product Status 196
MitraPatch – Product Description 196
Jenscare Scientific Co Ltd – Ongoing Clinical Trials Overview 197
LuX-Valve – THE TRAVEL II TRIAL: Transcatheter Right Atrial-ventricular Valve Replacement with LuX-Valve Via Jugular Vein 198
LuX-Valve – The Travel Trial: Transcatheter Right Atrial-ventricular Valve replacement with LuX-valve 198
LuX-Valve Plus – Trial to Evaluate Transvenous Tricuspid Valve Replacement with LuX-Valve Plus System in Patients with Severe or Greater Tricuspid Regurgitation — Safety and Clinical Performance 199
JensClip – A Prospective, Multicenter, Single-group Target Value Clinical Study to Evaluate the Safety and Efficacy of JensClip Transcatheter Valve Repair System in the Treatment of Moderate to Severe Degenerative Mitral Regurgitation 200
JensClip – Clinical Study Protocol of Jensclip Transcatheter Valve Clip and Delivery System for the Treatment of High-risk Patients with Moderate to Severe or Severe Mitral Regurgitation 200
Jiangsu Zhenyi Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 201
Neoblazar Transcatheter Tricuspid Valve Repair System – Product Status 201
Neoblazar Transcatheter Tricuspid Valve Repair System – Product Description 201
Neonova Transcatheter Mitral Valve Repair System – Product Status 202
Neonova Transcatheter Mitral Valve Repair System – Product Description 202
Trudelta Transcatheter Mitral Valve Replacement System – Product Status 202
Trudelta Transcatheter Mitral Valve Replacement System – Product Description 203
Jinshi Biotechnology (Changshu) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 204
Interventional Tricuspid Valve – Product Status 204
Interventional Tricuspid Valve – Product Description 204
Transcatheter Aortic Valve Replacement Device – Product Status 205
Transcatheter Aortic Valve Replacement Device – Product Description 205
Kekai Life Sciences Pipeline Products & Ongoing Clinical Trials Overview 206
Lifeclip – Product Status 206
Lifeclip – Product Description 206
KOKA Lifesciences Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 207
Koka Valve – Product Status 207
Koka Valve – Product Description 207
KOKA Lifesciences Co Ltd – Ongoing Clinical Trials Overview 208
Koka Valve – A Clinical Trial of the Transcatheter Aortic Valve Implantation System With a Prospective, Multi-Center, One-Arm Approach to Evaluate the Efficacy and Safety in the Treatment of Patients With Severe Aortic Stenosis 209
LaPlace Interventional Inc Pipeline Products & Ongoing Clinical Trials Overview 210
Transcatheter Tricuspid Valve Replacement Device – Product Status 210
Transcatheter Tricuspid Valve Replacement Device – Product Description 210
Lepu Medical Technology (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 211
Artificial Heart Valve Wi
