Published : Oct-2017
No. of Pages : 284
1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 16
2 Introduction 17
2.1 Transcatheter Heart Valves Overview 17
3 Products under Development 18
3.1 Transcatheter Heart Valves - Pipeline Products by Stage of Development 18
3.2 Transcatheter Heart Valves - Pipeline Products by Segment 19
3.3 Transcatheter Heart Valves - Pipeline Products by Territory 20
3.4 Transcatheter Heart Valves - Pipeline Products by Regulatory Path 21
3.5 Transcatheter Heart Valves - Pipeline Products by Estimated Approval Date 22
3.6 Transcatheter Heart Valves - Ongoing Clinical Trials 23
4 Transcatheter Heart Valves - Pipeline Products under Development by Companies 24
4.1 Transcatheter Heart Valves Companies - Pipeline Products by Stage of Development 24
4.2 Transcatheter Heart Valves - Pipeline Products by Stage of Development 26
5 Transcatheter Heart Valves Companies and Product Overview 29
5.1 4C Medical Technologies Inc Company Overview 29
5.1.1 4C Medical Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 29
5.2 Admedus Ltd Company Overview 30
5.2.1 Admedus Ltd Pipeline Products & Ongoing Clinical Trials Overview 30
5.3 Aegis Surgical Limited Company Overview 31
5.3.1 Aegis Surgical Limited Pipeline Products & Ongoing Clinical Trials Overview 31
5.4 Annulon Company Overview 32
5.4.1 Annulon Pipeline Products & Ongoing Clinical Trials Overview 32
5.5 AorTech International Plc Company Overview 33
5.5.1 AorTech International Plc Pipeline Products & Ongoing Clinical Trials Overview 33
5.6 Arbor Surgical Technologies, Inc. Company Overview 34
5.6.1 Arbor Surgical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
5.7 Boston Scientific Corp Company Overview 35
5.7.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 35
5.8 Celyad SA Company Overview 65
5.8.1 Celyad SA Pipeline Products & Ongoing Clinical Trials Overview 65
5.9 Cephea Valve Technologies, Inc. Company Overview 66
5.9.1 Cephea Valve Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 66
5.10 Children's Hospital Boston Company Overview 67
5.10.1 Children's Hospital Boston Pipeline Products & Ongoing Clinical Trials Overview 67
5.11 Clemson University Company Overview 68
5.11.1 Clemson University Pipeline Products & Ongoing Clinical Trials Overview 68
5.12 Colibri Heart Valve, LLC Company Overview 69
5.12.1 Colibri Heart Valve, LLC Pipeline Products & Ongoing Clinical Trials Overview 69
5.13 Daidalos Solutions BV Company Overview 74
5.13.1 Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview 74
5.14 Direct Flow Medical Inc Company Overview 76
5.14.1 Direct Flow Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 76
5.15 DSM Dyneema B.V. Company Overview 81
5.15.1 DSM Dyneema B.V. Pipeline Products & Ongoing Clinical Trials Overview 81
5.16 Dura LLC Company Overview 82
5.16.1 Dura LLC Pipeline Products & Ongoing Clinical Trials Overview 82
5.17 Edwards Lifesciences Corp Company Overview 85
5.17.1 Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 85
5.18 Emory University Company Overview 103
5.18.1 Emory University Pipeline Products & Ongoing Clinical Trials Overview 103
5.19 Endoluminal Technology Research, LLC Company Overview 104
5.19.1 Endoluminal Technology Research, LLC Pipeline Products & Ongoing Clinical Trials Overview 104
5.20 Florida International University Company Overview 106
5.20.1 Florida International University Pipeline Products & Ongoing Clinical Trials Overview 106
5.21 Hansen Medical Inc Company Overview 107
5.21.1 Hansen Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 107
5.22 HighLife SAS Company Overview 108
5.22.1 HighLife SAS Pipeline Products & Ongoing Clinical Trials Overview 108
5.23 HLT, Inc. Company Overview 111
5.23.1 HLT, Inc. Pipeline Products & Ongoing Clinical Trials Overview 111
5.24 InterVene Inc. Company Overview 114
5.24.1 InterVene Inc. Pipeline Products & Ongoing Clinical Trials Overview 114
5.25 JC Medical, Inc. Company Overview 117
5.25.1 JC Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 117
5.26 JenaValve Technology GmbH Company Overview 120
5.26.1 JenaValve Technology GmbH Pipeline Products & Ongoing Clinical Trials Overview 120
5.27 LivaNova PLC Company Overview 123
5.27.1 LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 123
5.28 Mayo Clinic US Company Overview 126
5.28.1 Mayo Clinic US Pipeline Products & Ongoing Clinical Trials Overview 126
5.29 Medtronic plc Company Overview 127
5.29.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 127
5.30 Meril Life Sciences Pvt Ltd Company Overview 137
5.30.1 Meril Life Sciences Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 137
5.31 Micro Interventional Devices, Inc. Company Overview 138
5.31.1 Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 138
5.32 MicroPort Scientific Corp Company Overview 139
5.32.1 MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 139
5.33 Mitralix Ltd. Company Overview 142
5.33.1 Mitralix Ltd. Pipeline Products & Ongoing Clinical Trials Overview 142
5.34 MitrAssist Ltd. Company Overview 143
5.34.1 MitrAssist Ltd. Pipeline Products & Ongoing Clinical Trials Overview 143
5.35 MValve Technologies Ltd. Company Overview 144
5.35.1 MValve Technologies Ltd. Pipeline Products & Ongoing Clinical Trials Overview 144
5.36 NaviGate Cardiac Structures, Inc. Company Overview 147
5.36.1 NaviGate Cardiac Structures, Inc. Pipeline Products & Ongoing Clinical Trials Overview 147
5.37 Neovasc Inc Company Overview 151
5.37.1 Neovasc Inc Pipeline Products & Ongoing Clinical Trials Overview 151
5.38 PolyNova Cardiovascular LLC Company Overview 154
5.38.1 PolyNova Cardiovascular LLC Pipeline Products & Ongoing Clinical Trials Overview 154
5.39 RegenaGraft Company Overview 155
5.39.1 RegenaGraft Pipeline Products & Ongoing Clinical Trials Overview 155
5.40 SAS Cormove Company Overview 156
5.40.1 SAS Cormove Pipeline Products & Ongoing Clinical Trials Overview 156
5.41 Sino Medical Sciences Technology Inc Company Overview 157
5.41.1 Sino Medical Sciences Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 157
5.42 St. Jude Medical LLC Company Overview 158
5.42.1 St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 158
5.43 Symetis AG Company Overview 162
5.43.1 Symetis AG Pipeline Products & Ongoing Clinical Trials Overview 162
5.44 Thubrikar Aortic Valve, Inc. Company Overview 173
5.44.1 Thubrikar Aortic Valve, Inc. Pipeline Products & Ongoing Clinical Trials Overview 173
5.45 Trinity College Dublin Company Overview 174
5.45.1 Trinity College Dublin Pipeline Products & Ongoing Clinical Trials Overview 174
5.46 University College London Company Overview 175
5.46.1 University College London Pipeline Products & Ongoing Clinical Trials Overview 175
5.47 University of California San Francisco Company Overview 177
5.47.1 University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview 177
5.48 University of Cambridge Company Overview 178
5.48.1 University of Cambridge Pipeline Products & Ongoing Clinical Trials Overview 178
5.49 University of Iowa Company Overview 179
5.49.1 University of Iowa Pipeline Products & Ongoing Clinical Trials Overview 179
5.50 Valtech Cardio Ltd Company Overview 181
5.50.1 Valtech Cardio Ltd Pipeline Products & Ongoing Clinical Trials Overview 181
5.51 Vascular Concepts Ltd Company Overview 182
5.51.1 Vascular Concepts Ltd Pipeline Products & Ongoing Clinical Trials Overview 182
5.52 Venus MedTech Company Overview 183
5.52.1 Venus MedTech Pipeline Products & Ongoing Clinical Trials Overview 183
5.53 Xeltis AG Company Overview 190
5.53.1 Xeltis AG Pipeline Products & Ongoing Clinical Trials Overview 190
6 Transcatheter Heart Valves- Recent Developments 191
6.1 Sep 21, 2017: Medtronic Announces Clinical Study to Evaluate the CoreValve Evolut PRO System in 'Everyday' Clinical Practice 191
6.2 Sep 12, 2017: Neovasc Provides Tiara Clinical Update 191
6.3 Sep 11, 2017: MPSC Achieves Substantial Growth in 1H 2017 Net Profit Increases 272.4% YOY 192
6.4 Sep 01, 2017: Decision from Appeals Court upholds lower court decisions but denies injunction 194
6.5 Aug 30, 2017: NaviGate Cardiac Structures reports world's first successful transcatheter implantation of 52-mm tricuspid valve into a transplanted-heart patient 194
6.6 Aug 22, 2017: Medtronic Reports First Quarter Financial Results 196
6.7 Aug 16, 2017: AorTech International: Audited results for the year ended 31 March 2017 198
6.8 Aug 11, 2017: MPSC Issues Positive Profit Alert for 2017 1H Net Profit Expected to Increase 261% 200
6.9 Aug 10, 2017: Neovasc Announces Results for the Second Quarter of 2017 200
6.10 Aug 03, 2017: 4C Medical's Novel Mitral Regurgitation Therapy Highlighted at CVI 2017 Innovation Summit 203
6.11 Jul 31, 2017: Medtronic Announces CE Mark and European Launch of CoreValve Evolut PRO Transcatheter Valve with Advanced Sealing 204
6.12 Jul 27, 2017: Boston Scientific Announces Results for Second Quarter 2017 205
6.13 Jul 24, 2017: MicroPort Attends EUROPACE-CARDIOSTIM 2017 206
6.14 Jul 10, 2017: Medtronic Expands TAVR Access to More Patients With Symptomatic, Severe Aortic Stenosis Upon Intermediate Risk FDA Approval 207
6.15 Jul 07, 2017: MPSC New COO Glendy Wang on Board 208
6.16 Jun 27, 2017: Boston Scientific Outlines Strategy for Sustained Growth at 2017 Investor Day 208
6.17 Jun 16, 2017: Neovasc Announces German Court Ruling 210
6.18 Jun 15, 2017: Neovasc Tiara Featured in TVT 2017 Presentation 210
6.19 Jun 15, 2017: 4C Medical's Novel Mitral Regurgitation Therapy Highlighted at TVT Innovation Forum 211
6.20 Jun 06, 2017: First U.S. Patients Enrolled in an Early Feasibility Study of HLT's New Transcatheter Aortic Valve Replacement System 212
6.21 Jun 05, 2017: FDA expands use of Sapien 3 artificial heart valve for high-risk patients 212
6.22 May 25, 2017: Medtronic Reports Fourth Quarter and Fiscal Year 2017 Financial Results 213
6.23 May 19, 2017: Celyad Announces First Quarter 2017 Business Update 216
6.24 May 17, 2017: Edwards' Novel Self-Expanding Transcatheter Heart Valve Demonstrates Excellent Early Patient Outcomes 217
6.25 May 16, 2017: Real-World Evidence With Edwards SAPIEN 3 Transcatheter Valve Confirms Beneficial Patient Outcomes From Clinical Trials 218
6.26 May 16, 2017: The Boston Scientific LOTUS Valve System Demonstrated Superior Efficacy to CoreValve in Global REPRISE III Trial at One Year 219
6.27 May 16, 2017: New Data on CoreValve and Evolut R Self-Expanding TAVI Systems Show Excellent Clinical Outcomes in Routine Clinical Practice 219
6.28 May 11, 2017: Analysis shows increased risk of early stroke with new-onset atrial fibrillation post-TAVR 220
6.29 May 10, 2017: Boston Scientific to Present The LOTUS Valve System at EuroPCR 2017 221
6.30 May 10, 2017: Neovasc Announces Results for the First Quarter of 2017 222
6.31 Apr 28, 2017: Venus Medtech's TAVR Device Is Approved By CFDA, Creating A New Era Of Interventional Cardiology In China English 224
6.32 Apr 27, 2017: Boston Scientific Announces Results For First Quarter 2017 225
6.33 Apr 26, 2017: NaviGate Cardiac Structures Reports First Heterotopic Transcatheter GATE Tricuspid Valved Stent Successful Implantation 226
6.34 Apr 25, 2017: Edwards Lifesciences Reports First Quarter Results 227
6.35 Apr 05, 2017: Aurora Health Care Heart Experts Among First in Nation to Implant New Heart Valve to Treat Aortic Stenosis 229
6.36 Apr 04, 2017: HLT Announces First Patient Enrollments in a Feasibility Study of a New Transcatheter Aortic Valve Replacement System 230
6.37 Mar 30, 2017: MPSC Announces 2016 Annual Results 231
6.38 Mar 23, 2017: Neovasc Announces Results for the Fourth Quarter and Fiscal Year 2016 232
6.39 Mar 22, 2017: Medtronic Receives FDA Approval for CoreValve Evolut Pro Transcatheter Valve with Advanced Sealing 236
6.40 Mar 17, 2017: Landmark SURTAVI Clinical Trial Shows Transcatheter Aortic Valve Replacement with the Self-Expanding Platform Performs as Well as Surgery in Intermediate Risk Severe Aortic Stenosis Patients 237
6.41 Mar 10, 2017: Neovasc Announces TSX Symbol Change to NVCN 238
6.42 Mar 09, 2017: Boston Scientific Receives Favorable Rulings In Edwards Lifesciences Litigation 238
6.43 Mar 03, 2017: Colibri Heart Valve Receives ISO 13485 and EN ISO 13485 Certification 238
6.44 Feb 21, 2017: Medtronic Reports Third Quarter Financial Results 239
6.45 Feb 06, 2017: Medtronic Awarded U.S. Department of Veterans Affairs National Contracts for Home Telehealth Technologies, with Three Other Vendors 242
6.46 Feb 02, 2017: Boston Scientific Announces Results For Fourth Quarter And Full Year Ended December 31, 2016 243
6.47 Feb 01, 2017: Edwards Lifesciences Reports Fourth Quarter Results 244
6.48 Jan 19, 2017: LHSC First in Ontario to Implant Canadian made Mitral Valve Device 246
6.49 Jan 18, 2017: Neovasc Announces Update in Litigation with CardiAQ 246
6.50 Jan 17, 2017: Medtronic Announces CE Mark and European Launch of Recaptureable TAVI System Now Available for Severe Aortic Stenosis Patients with Large Anatomies 247
6.51 Dec 30, 2016: NaviGate Cardiac Structures Reports World's First Transcatheter Tricuspid Valved Stent is Successfully Implanted 247
6.52 Dec 26, 2016: MicroPort Completes Patient Enrollment of VitaFlow Pre-market Clinical Trial 248
6.53 Dec 23, 2016: Neovasc Announces Update in Litigation with CardiAQ 249
6.54 Dec 21, 2016: AorTech International: Unaudited Interim Results For the six months ended 30 September 2016 249
6.55 Dec 21, 2016: AorTech Shares Dive As Losses And Lawsuit Against Former CEO Continue 251
6.56 Dec 08, 2016: Aurora Heart and Vascular team hits milestone of 1,000th valve replacement procedure at Aurora St. Luke's 251
6.57 Dec 08, 2016: Edwards Lifesciences Outlines Growth Strategy At Annual Investor Conference 252
6.58 Dec 06, 2016: Neovasc Provides Update On Its Tiara Mitral Valve Clinical Program 254
6.59 Dec 01, 2016: Medtronic Announces Reimbursement Approval and Launch of CoreValve Evolut R System in Japan 255
6.60 Nov 28, 2016: Neovasc Receives Regulatory Approval To Initiate TIARA II CE Mark Study 256
6.61 Nov 22, 2016: Medtronic Reports Second Quarter Financial Results 256
6.62 Nov 18, 2016: Celyad Announces Third Quarter 2016 Business Update 259
6.63 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 261
6.64 Nov 15, 2016: CEVA to work with Medtronic for distribution facility construction 261
6.65 Nov 14, 2016: Neovasc Reports Third Quarter Results for 2016 262
6.66 Nov 03, 2016: Study Deems Transcaval Valve Replacement Pioneered at Henry Ford Hospital Successful' 264
6.67 Nov 01, 2016: Medtronic Harmony Transcatheter Pulmonary Valve Demonstrates Positive Early Clinical Outcomes At One Year 265
6.68 Nov 01, 2016: Edwards Sapien Valves Demonstrate Excellent Durability In 5-Year Echo Study 266
6.69 Nov 01, 2016: Neovasc Announces Update in Litigation with CardiAQ 266
6.70 Nov 01, 2016: Patients with Severe Aortic Stenosis and Intermediate Surgical Risk Show Similar Late Quality of Life Outcomes Following Either Transcatheter or Surgical Aortic Valve replacement 267
6.71 Nov 01, 2016: Xeltis Announces Multidisciplinary Scientific Advisory Board of Global Leading Experts 268
6.72 Nov 01, 2016: Early And Sustained Quality Of Life Improvements Seen For Intermediate Risk Patients Treated With Edwards Transcatheter Valves 268
6.73 Oct 31, 2016: New Data on Medtronic Evolut R TAVR System Show Excellent 'Real-World' Outcomes in Global Patient Population 269
6.74 Oct 31, 2016: New method for performing aortic valve replacement proves successful in high risk patients 270
6.75 Oct 27, 2016: The Successful Worldwide First in Human Implantation of an Innovative Aortic Valve from Colibri Heart Valve and Venus Medtech with Disruptive "Dry Tissue" Technology Conducted 271
6.76 Oct 26, 2016: Neovasc to Present Tiara Data at TCT in Washington DC 272
6.77 Oct 26, 2016: Medtronic Announces FDA Approval of New Recaptureable TAVR System Available for Severe Aortic Stenosis Patients with Large Anatomies 273
6.78 Oct 26, 2016: Boston Scientific Announces Results For Third Quarter 2016 273
6.79 Oct 25, 2016: Edwards Lifesciences Reports Third Quarter Results 275
6.80 Oct 24, 2016: Boston Scientific announced key Presentations on Lotus Valve System at Transcatheter Cardiovascular Therapeutics 2016 277
6.81 Oct 19, 2016: St. Jude Medical Reports Third Quarter 2016 Results 278
6.82 Oct 14, 2016: AorTech International Announces Board Changes 279
6.83 Oct 10, 2016: Professor Ian Meredith To Join Boston Scientific As Executive Vice President And Global Chief Medical Officer 280
7 Appendix 281
7.1 Methodology 281
7.2 About GlobalData 284
7.3 Contact Us 284
7.4 Disclaimer 284
1.1 List of Tables
Table 1: Transcatheter Heart Valves - Pipeline Products by Stage of Development 18
Table 2: Transcatheter Heart Valves - Pipeline Products by Segment 19
Table 3: Transcatheter Heart Valves - Pipeline Products by Territory 20
Table 4: Transcatheter Heart Valves - Pipeline Products by Regulatory Path 21
Table 5: Transcatheter Heart Valves - Pipeline Products by Estimated Approval Date 22
Table 6: Transcatheter Heart Valves - Ongoing Clinical Trials 23
Table 7: Transcatheter Heart Valves Companies - Pipeline Products by Stage of Development 24
Table 8: Transcatheter Heart Valves - Pipeline Products by Stage of Development 26
Table 9: 4C Medical Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 29
Table 10: TMVR Implant - Product Status 29
Table 11: TMVR Implant - Product Description 29
Table 12: Admedus Ltd Pipeline Products & Ongoing Clinical Trials Overview 30
Table 13: Transcatheter Aortic Valve Replacement - Product Status 30
Table 14: Transcatheter Aortic Valve Replacement - Product Description 30
Table 15: Aegis Surgical Limited Pipeline Products & Ongoing Clinical Trials Overview 31
Table 16: pTAo-TAVR - Product Status 31
Table 17: pTAo-TAVR - Product Description 31
Table 18: Annulon Pipeline Products & Ongoing Clinical Trials Overview 32
Table 19: Mitral Valve Replacement Device - Product Status 32
Table 20: Mitral Valve Replacement Device - Product Description 32
Table 21: AorTech International Plc Pipeline Products & Ongoing Clinical Trials Overview 33
Table 22: AorTech Polymer Valve - Product Status 33
Table 23: AorTech Polymer Valve - Product Description 33
Table 24: Arbor Surgical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
Table 25: Trilogy Aortic Valve System - Product Status 34
Table 26: Trilogy Aortic Valve System - Product Description 34
Table 27: Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 35
Table 28: ACURATE TAVR - Product Status 36
Table 29: ACURATE TAVR - Product Description 36
Table 30: Gen 4 Lotus Valve System - Product Status 36
Table 31: Gen 4 Lotus Valve System - Product Description 36
Table 32: Lotus Edge Sheath 15F - Product Status 37
Table 33: Lotus Edge Sheath 15F - Product Description 37
Table 34: Lotus Edge Valve System - 21 mm - Product Status 37
Table 35: Lotus Edge Valve System - 21 mm - Product Description 38
Table 36: Lotus Edge Valve System - 23 mm - Product Status 38
Table 37: Lotus Edge Valve System - 23 mm - Product Description 38
Table 38: Lotus Edge Valve System - 25 mm - Product Status 39
Table 39: Lotus Edge Valve System - 25 mm - Product Description 39
Table 40: Lotus Edge Valve System - 27 mm - Product Status 39
Table 41: Lotus Edge Valve System - 27 mm - Product Description 40
Table 42: Lotus Edge Valve System - 29 mm - Product Status 40
Table 43: Lotus Edge Valve System - 29 mm - Product Description 40
Table 44: Lotus Valve System - 21 mm - Product Status 41
Table 45: Lotus Valve System - 21 mm - Product Description 41
Table 46: Lotus Valve System - 23 mm - Product Status 41
Table 47: Lotus Valve System - 23 mm - Product Description 42
Table 48: Lotus Valve System - 25 mm - Product Status 42
Table 49: Lotus Valve System - 25 mm - Product Description 43
Table 50: Lotus Valve System - 27 mm - Product Status 43
Table 51: Lotus Valve System - 27 mm - Product Description 43
Table 52: Lotus Valve System - 29 mm - Product Status 44
Table 53: Lotus Valve System - 29 mm - Product Description 44
Table 54: Transaortic Sheath - Product Status 44
Table 55: Transaortic Sheath - Product Description 45
Table 56: Boston Scientific Corp - Ongoing Clinical Trials Overview 46
Table 57: Lotus Valve System - 23 mm - Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage 49
Table 58: Lotus Valve System - 23 mm - Experience with Percutaneous Transcatheter Aortic Valve Implantation in Patients with Symptomatic Aortic Valve Disease in Two German Centers 49
Table 59: Lotus Valve System - 23 mm - Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 49
Table 60: Lotus Valve System - 23 mm - Re-positionable Lotus Valve System - Post Market Evaluation of Real World Clinical Outcomes: RESPOND 50
Table 61: Lotus Valve System - 23 mm - Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System - Clinical Evaluation in China: REPRISE China 50
Table 62: Lotus Valve System - 23 mm - Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System - Clinical Evaluation in Japan: REPRISE Japan 50
Table 63: Lotus Valve System - 23 mm - Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve with a Flexible Delivery System - Confirmation of Performance and Safety:REPRISE II FLEX 51
Table 64: Lotus Valve System - 23 mm - Safety and Efficacy of Lotus Valve For Transcatheter Aortic Valve Implantation in Patients with Severe Aortic Stenosis in Chinese Population (LOTUS-CHINA) 51
Table 65: Lotus Valve System - 27 mm - Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage 52
Table 66: Lotus Valve System - 27 mm - Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 52
Table 67: Lotus Valve System - 27 mm - Re-positionable Lotus Valve System - Post Market Evaluation of Real World Clinical Outcomes: RESPOND 52
Table 68: Lotus Valve System - 27 mm - Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System - Clinical Evaluation in China: REPRISE China 53
Table 69: Lotus Valve System - 27 mm - Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System - Clinical Evaluation in Japan: REPRISE Japan 53
Table 70: Lotus Valve System - 27 mm - Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve with a Flexible Delivery System - Confirmation of Performance and Safety:REPRISE II FLEX 53
Table 71: Lotus Valve System - 27 mm - Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve with the Next Generation Delivery System (REPRISE NGDS) 54
Table 72: Lotus Valve System - 27 mm - Safety and Efficacy of Lotus Valve For Transcatheter Aortic Valve Implantation in Patients with Severe Aortic Stenosis in Chinese Population (LOTUS-CHINA) 54
Table 73: Lotus Valve System - 25 mm - Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage 55
Table 74: Lotus Valve System - 25 mm - Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 55
Table 75: Lotus Valve System - 25 mm - Re-positionable Lotus Valve System - Post Market Evaluation of Real World Clinical Outcomes: RESPOND 55
Table 76: Lotus Valve System - 25 mm - Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System - Clinical Evaluation in China: REPRISE China 56
Table 77: Lotus Valve System - 25 mm - Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System - Clinical Evaluation in Japan: REPRISE Japan 56
Table 78: Lotus Valve System - 25 mm - Safety and Efficacy of Lotus Valve For Transcatheter Aortic Valve Implantation in Patients with Severe Aortic Stenosis in Chinese Population (LOTUS-CHINA) 56
Table 79: Lotus Valve System - 21 mm - Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage 57
Table 80: Lotus Valve System - 21 mm - Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 57
Table 81: Lotus Valve System - 21 mm - Re-positionable Lotus Valve System - Post Market Evaluation of Real World Clinical Outcomes: RESPOND 57
Table 82: Lotus Valve System - 21 mm - Safety and Efficacy of Lotus Valve For Transcatheter Aortic Valve Implantation in Patients with Severe Aortic Stenosis in Chinese Population (LOTUS-CHINA) 58
Table 83: Lotus Valve System - 29 mm - Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage 59
Table 84: Lotus Valve System - 29 mm - Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 59
Table 85: Lotus Valve System - 29 mm - Re-positionable Lotus Valve System - Post Market Evaluation of Real World Clinical Outcomes: RESPOND 59
Table 86: Lotus Valve System - 29 mm - Safety and Efficacy of Lotus Valve For Transcatheter Aortic Valve Implantation in Patients with Severe Aortic Stenosis in Chinese Population (LOTUS-CHINA) 60
Table 87: Lotus Edge Valve System - 23 mm - Randomized Comparison of Repositionable and Balloon-Expandable Prostheses in Patients Undergoing Trans-catheter Aortic Valve Implantation 61
Table 88: Lotus Edge Valve System - 23 mm - Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve with the Next Generation Delivery System (REPRISE NGDS) 61
Table 89: Lotus Edge Valve System - 23 mm - REPRISE EDGE: REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System - Evaluation of Performance and Safety 61
Table 90: Lotus Edge Valve System - 29 mm - Reprise Edge 29 Mm Eu Study: Repositionable Percutaneous Replacement of Native Stenotic Aortic Valve Through Implantation of Lotus Edge 29 Mm Valve - Evaluation of Safety and Performance 62
Table 91: Lotus Edge Valve System - 25 mm - Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve with the Next Generation Delivery System (REPRISE NGDS) 63
Table 92: Lotus Edge Valve System - 25 mm - REPRISE EDGE: REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System - Evaluation of Performance and Safety 63
Table 93: Lotus Edge Valve System - 27 mm - Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve with the Next Generation Delivery System (REPRISE NGDS) 64
Table 94: Lotus Edge Valve System - 27 mm - REPRISE EDGE: REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System - Evaluation of Performance and Safety 64
Table 95: Celyad SA Pipeline Products & Ongoing Clinical Trials Overview 65
Table 96: Mitral Valve Neo-chordae - Product Status 65
Table 97: Mitral Valve Neo-chordae - Product Description 65
Table 98: Cephea Valve Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 66
Table 99: Mitral Valve Replacement Device - Product Status 66
Table 100: Mitral Valve Replacement Device - Product Description 66
Table 101: Children's Hospital Boston Pipeline Products & Ongoing Clinical Trials Overview 67
Table 102: Two Piece Replacement Heart Valve - Product Status 67
Table 103: Two Piece Replacement Heart Valve - Product Description 67
Table 104: Clemson University Pipeline Products & Ongoing Clinical Trials Overview 68
Table 105: Transcatheter Bioprosthetic Heart Valve - Product Status 68
Table 106: Transcatheter Bioprosthetic Heart Valve - Product Description 68
Table 107: Colibri Heart Valve, LLC Pipeline Products & Ongoing Clinical Trials Overview 69
Table 108: Colibri Aortic Heart Valve - 24mm - Product Status 69
Table 109: Colibri Aortic Heart Valve - 24mm - Product Description 69
Table 110: Colibri Aortic Heart Valve - 21mm - Product Status 70
Table 111: Colibri Aortic Heart Valve - 21mm - Product Description 70
Table 112: Colibri Aortic Heart Valve - 27mm - Product Status 70
Table 113: Colibri Aortic Heart Valve - 27mm - Product Description 71
Table 114: Colibri TAVI System - Product Status 71
Table 115: Colibri TAVI System - Product Description 71
Table 116: Delta Aortic Heart Valve - Product Status 72
Table 117: Delta Aortic Heart Valve - Product Description 72
Table 118: Venibri Transcatheter Heart Valve System - Product Status 72
Table 119: Venibri Transcatheter Heart Valve System - Product Description 73
Table 120: Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview 74
Table 121: Sutureless Trans-Catheter Aortic Valve Replacement (TAVR) - Product Status 74
Table 122: Sutureless Trans-Catheter Aortic Valve Replacement (TAVR) - Product Description 74
Table 123: Sutureless Trans-Catheter Mitral Valve Replacement (TMVR) - Product Status 75
1.2 List of Figures
Figure 1: Transcatheter Heart Valves - Pipeline Products by Stage of Development 18
Figure 2: Transcatheter Heart Valves - Pipeline Products by Segment 19
Figure 3: Transcatheter Heart Valves - Pipeline Products by Territory 20
Figure 4: Transcatheter Heart Valves - Pipeline Products by Regulatory Path 21
Figure 5: Transcatheter Heart Valves - Pipeline Products by Estimated Approval Date 22
Figure 6: Transcatheter Heart Valves - Ongoing Clinical Trials 23
