Transcatheter Mitral Valves (TMVI) - Medical Devices Pipeline Assessment, 2017

Published : Nov-2017

No. of Pages : 90

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1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 4
1.2 List of Figures 6
2 Introduction 7
2.1 Transcatheter Mitral Valves (TMVI) Overview 7
3 Products under Development 8
3.1 Transcatheter Mitral Valves (TMVI) - Pipeline Products by Stage of Development 8
3.2 Transcatheter Mitral Valves (TMVI) - Pipeline Products by Territory 9
3.3 Transcatheter Mitral Valves (TMVI) - Pipeline Products by Regulatory Path 10
3.4 Transcatheter Mitral Valves (TMVI) - Pipeline Products by Estimated Approval Date 11
3.5 Transcatheter Mitral Valves (TMVI) - Ongoing Clinical Trials 12
4 Transcatheter Mitral Valves (TMVI) - Pipeline Products under Development by Companies 13
4.1 Transcatheter Mitral Valves (TMVI) Companies - Pipeline Products by Stage of Development 13
4.2 Transcatheter Mitral Valves (TMVI) - Pipeline Products by Stage of Development 14
5 Transcatheter Mitral Valves (TMVI) Companies and Product Overview 15
5.1 4C Medical Technologies Inc Company Overview 15
5.1.1 4C Medical Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 15
5.2 Annulon Company Overview 16
5.2.1 Annulon Pipeline Products & Ongoing Clinical Trials Overview 16
5.3 Celyad SA Company Overview 17
5.3.1 Celyad SA Pipeline Products & Ongoing Clinical Trials Overview 17
5.4 Cephea Valve Technologies, Inc. Company Overview 18
5.4.1 Cephea Valve Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 18
5.5 Daidalos Solutions BV Company Overview 19
5.5.1 Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview 19
5.6 Direct Flow Medical Inc Company Overview 20
5.6.1 Direct Flow Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 20
5.7 Edwards Lifesciences Corp Company Overview 21
5.7.1 Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 21
5.8 Emory University Company Overview 30
5.8.1 Emory University Pipeline Products & Ongoing Clinical Trials Overview 30
5.9 HighLife SAS Company Overview 31
5.9.1 HighLife SAS Pipeline Products & Ongoing Clinical Trials Overview 31
5.10 LivaNova PLC Company Overview 34
5.10.1 LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 34
5.11 Medtronic plc Company Overview 37
5.11.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 37
5.12 Micro Interventional Devices, Inc. Company Overview 42
5.12.1 Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 42
5.13 Mitralix Ltd. Company Overview 43
5.13.1 Mitralix Ltd. Pipeline Products & Ongoing Clinical Trials Overview 43
5.14 MitrAssist Ltd. Company Overview 44
5.14.1 MitrAssist Ltd. Pipeline Products & Ongoing Clinical Trials Overview 44
5.15 MValve Technologies Ltd. Company Overview 45
5.15.1 MValve Technologies Ltd. Pipeline Products & Ongoing Clinical Trials Overview 45
5.16 NaviGate Cardiac Structures, Inc. Company Overview 48
5.16.1 NaviGate Cardiac Structures, Inc. Pipeline Products & Ongoing Clinical Trials Overview 48
5.17 Neovasc Inc Company Overview 51
5.17.1 Neovasc Inc Pipeline Products & Ongoing Clinical Trials Overview 51
5.18 Sino Medical Sciences Technology Inc Company Overview 54
5.18.1 Sino Medical Sciences Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 54
5.19 Trinity College Dublin Company Overview 55
5.19.1 Trinity College Dublin Pipeline Products & Ongoing Clinical Trials Overview 55
5.20 University College London Company Overview 56
5.20.1 University College London Pipeline Products & Ongoing Clinical Trials Overview 56
5.21 Valtech Cardio Ltd Company Overview 57
5.21.1 Valtech Cardio Ltd Pipeline Products & Ongoing Clinical Trials Overview 57
5.22 Venus MedTech Company Overview 58
5.22.1 Venus MedTech Pipeline Products & Ongoing Clinical Trials Overview 58
6 Transcatheter Mitral Valves (TMVI)- Recent Developments 59
6.1 Oct 24, 2017: 4C Medicals Novel Mitral Regurgitation Therapy to be Presented at TCT 2017 Shark Tank Innovation Competition 59
6.2 Oct 24, 2017: Edwards Lifesciences Announces Third Quarter Results 59
6.3 Oct 23, 2017: First Patient Treated in Landmark Transcatheter Mitral Valve Replacement Pivotal Trial 61
6.4 Oct 06, 2017: Medtronic Provides Update on Impact from Hurricane Maria 62
6.5 Sep 12, 2017: Neovasc Provides Tiara Clinical Update 63
6.6 Sep 01, 2017: Decision from Appeals Court upholds lower court decisions but denies injunction 64
6.7 Aug 22, 2017: Medtronic Reports First Quarter Financial Results 64
6.8 Aug 03, 2017: 4C Medical's Novel Mitral Regurgitation Therapy Highlighted at CVI 2017 Innovation Summit 67
6.9 Jun 16, 2017: Neovasc Announces German Court Ruling 67
6.10 Jun 15, 2017: Neovasc Tiara Featured in TVT 2017 Presentation 68
6.11 Jun 15, 2017: 4C Medical's Novel Mitral Regurgitation Therapy Highlighted at TVT Innovation Forum 68
6.12 May 25, 2017: Medtronic Reports Fourth Quarter and Fiscal Year 2017 Financial Results 69
6.13 Apr 25, 2017: Edwards Lifesciences Reports First Quarter Results 72
6.14 Feb 21, 2017: Medtronic Reports Third Quarter Financial Results 73
6.15 Feb 06, 2017: Medtronic Awarded U.S. Department of Veterans Affairs National Contracts for Home Telehealth Technologies, with Three Other Vendors 76
6.16 Feb 01, 2017: Edwards Lifesciences Reports Fourth Quarter Results 77
6.17 Jan 19, 2017: LHSC First in Ontario to Implant Canadian made Mitral Valve Device 78
6.18 Dec 23, 2016: Neovasc Announces Update in Litigation with CardiAQ 79
6.19 Dec 08, 2016: Edwards Lifesciences Outlines Growth Strategy At Annual Investor Conference 79
6.20 Dec 06, 2016: Neovasc Provides Update On Its Tiara Mitral Valve Clinical Program 81
6.21 Nov 28, 2016: Neovasc Receives Regulatory Approval To Initiate TIARA II CE Mark Study 82
6.22 Nov 22, 2016: Medtronic Reports Second Quarter Financial Results 83
6.23 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 85
6.24 Nov 15, 2016: CEVA to work with Medtronic for distribution facility construction 86
7 Appendix 87
7.1 Methodology 87
7.2 About GlobalData 90
7.3 Contact Us 90
7.4 Disclaimer 90

1.1 List of Tables
Table 1: Transcatheter Mitral Valves (TMVI) - Pipeline Products by Stage of Development 8
Table 2: Transcatheter Mitral Valves (TMVI) - Pipeline Products by Territory 9
Table 3: Transcatheter Mitral Valves (TMVI) - Pipeline Products by Regulatory Path 10
Table 4: Transcatheter Mitral Valves (TMVI) - Pipeline Products by Estimated Approval Date 11
Table 5: Transcatheter Mitral Valves (TMVI) - Ongoing Clinical Trials 12
Table 6: Transcatheter Mitral Valves (TMVI) Companies - Pipeline Products by Stage of Development 13
Table 7: Transcatheter Mitral Valves (TMVI) - Pipeline Products by Stage of Development 14
Table 8: 4C Medical Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 15
Table 9: TMVR Implant - Product Status 15
Table 10: TMVR Implant - Product Description 15
Table 11: Annulon Pipeline Products & Ongoing Clinical Trials Overview 16
Table 12: Mitral Valve Replacement Device - Product Status 16
Table 13: Mitral Valve Replacement Device - Product Description 16
Table 14: Celyad SA Pipeline Products & Ongoing Clinical Trials Overview 17
Table 15: Mitral Valve Neo-chordae - Product Status 17
Table 16: Mitral Valve Neo-chordae - Product Description 17
Table 17: Cephea Valve Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 18
Table 18: Mitral Valve Replacement Device - Product Status 18
Table 19: Mitral Valve Replacement Device - Product Description 18
Table 20: Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview 19
Table 21: Sutureless Trans-Catheter Mitral Valve Replacement (TMVR) - Product Status 19
Table 22: Sutureless Trans-Catheter Mitral Valve Replacement (TMVR) - Product Description 19
Table 23: Direct Flow Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 20
Table 24: Direct Flow Medical Transcatheter Mitral Valve - Product Status 20
Table 25: Direct Flow Medical Transcatheter Mitral Valve - Product Description 20
Table 26: Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 21
Table 27: Cardiaq Mitral Valve - Product Status 21
Table 28: Cardiaq Mitral Valve - Product Description 22
Table 29: FORTIS Mitral Transcatheter Heart Valve - Product Status 22
Table 30: FORTIS Mitral Transcatheter Heart Valve - Product Description 22
Table 31: PASCAL Transcatheter Mitral Valve Repair System - Product Status 23
Table 32: PASCAL Transcatheter Mitral Valve Repair System - Product Description 23
Table 33: Sapien 3 Heart Valve - Mitral Annular Calcification - Product Status 23
Table 34: Sapien 3 Heart Valve - Mitral Annular Calcification - Product Description 24
Table 35: Second Generation Transapical Transcatheter Mitral Valve - Product Status 24
Table 36: Second Generation Transapical Transcatheter Mitral Valve - Product Description 24
Table 37: Edwards Lifesciences Corp - Ongoing Clinical Trials Overview 25
Table 38: FORTIS Mitral Transcatheter Heart Valve - Early Feasibility Study of the CardiAQ Transcatheter Mitral Valve Implantation (TMVI) System (Transfemoral and Transapical Delivery Systems) For the Treatment of Moderate to Severe Mitral Regurgitation 26
Table 39: Cardiaq Mitral Valve - Early Feasibility Study of the CardiAQ Transcatheter Mitral Valve Implantation (TMVI) System (Transfemoral and Transapical Delivery Systems) For the Treatment of Moderate to Severe Mitral Regurgitation 27
Table 40: Cardiaq Mitral Valve - Reduction or elimination of Mitral Regurgitation in Degenerative or Functional Mitral Regurgitation with the CardiAQ-Edwards Transcatheter Mitral Valve: The RELIEF Trial 27
Table 41: Sapien 3 Heart Valve - Mitral Annular Calcification - Surgical Implantation of Transcatheter valve in Native Mitral Annular Calcification (SITRAL) Study 28
Table 42: Sapien 3 Heart Valve - Mitral Annular Calcification - The Safety and Feasibility of the SAPIEN XT Transcatheter Heart Valve with NovaFlex and Ascendra Delivery Systems and SAPIEN 3 with Commander Delivery System in Patients with Symptomatic Severe Calcific Mitral Valve Disease with Severe Mitral Annular Calcification and Patients with Failing Mitral Surgical Rings or Bioprostheses Who Are Not Candidates for Mitral Valve Surgery. 28
Table 43: PASCAL Transcatheter Mitral Valve Repair System - CE Mark Study of PASCAL Transcatheter Mitral Valve Repair System 29
Table 44: PASCAL Transcatheter Mitral Valve Repair System - The CLASP Study Edwards PASCAL TranScatheter Mitral Valve Repair System Study 29
Table 45: Emory University Pipeline Products & Ongoing Clinical Trials Overview 30
Table 46: MitraCath - Product Status 30
Table 47: MitraCath - Product Description 30
Table 48: HighLife SAS Pipeline Products & Ongoing Clinical Trials Overview 31
Table 49: Transcatheter Mitral Valve Replacement System - Product Status 31
Table 50: Transcatheter Mitral Valve Replacement System - Product Description 31
Table 51: HighLife SAS - Ongoing Clinical Trials Overview 32
Table 52: Transcatheter Mitral Valve Replacement System - HighLife Transcatheter Mitral Valve Replacement System for Severe Mitral Regurgitation in Patients at High Surgical Risk 33
Table 53: LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 34
Table 54: Caisson TMVR System - Product Status 34
Table 55: Caisson TMVR System - Product Description 34
Table 56: LivaNova PLC - Ongoing Clinical Trials Overview 35
Table 57: Caisson TMVR System - Percutaneous Mitral Valve Replacement Evaluation Utilizing IDE Early Feasibility Study (PRELUDE) 36
Table 58: Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 37
Table 59: Intrepid Transcatheter Mitral Valve Replacement - Product Status 37
Table 60: Intrepid Transcatheter Mitral Valve Replacement - Product Description 37
Table 61: TCV - Mitral - Product Status 38
Table 62: TCV - Mitral - Product Description 38
Table 63: Twelve Transcatheter Mitral Valve Replacement System - Product Status 38
Table 64: Twelve Transcatheter Mitral Valve Replacement System - Product Description 38
Table 65: Medtronic plc - Ongoing Clinical Trials Overview 39
Table 66: Twelve Transcatheter Mitral Valve Replacement System - Evaluation of Safety and Performance of the Twelve Transcatheter Mitral Valve Replacement System in Patients with Severe, Symptomatic Mitral Regurgitation 40
Table 67: Intrepid Transcatheter Mitral Valve Replacement - Evaluation of Safety and Efficacy of the Intrepid TMVR System in Patients with Severe, Symptomatic Mitral Valve Regurgitation: APOLLO Trial 41
Table 68: Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 42
Table 69: Endovalve - Product Status 42
Table 70: Endovalve - Product Description 42
Table 71: Mitralix Ltd. Pipeline Products & Ongoing Clinical Trials Overview 43
Table 72: MAESTRO - Product Status 43
Table 73: MAESTRO - Product Description 43
Table 74: MitrAssist Ltd. Pipeline Products & Ongoing Clinical Trials Overview 44
Table 75: MitrAssist Valve - Product Status 44
Table 76: MitrAssist Valve - Product Description 44
Table 77: MValve Technologies Ltd. Pipeline Products & Ongoing Clinical Trials Overview 45
Table 78: MValve Docking System - Product Status 45
Table 79: MValve Docking System - Product Description 45
Table 80: MValve Technologies Ltd. - Ongoing Clinical Trials Overview 46
Table 81: MValve Docking System - Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 47
Table 82: NaviGate Cardiac Structures, Inc. Pipeline Products & Ongoing Clinical Trials Overview 48
Table 83: Navi Mitral Valved Stent - Product Status 48
Table 84: Navi Mitral Valved Stent - Product Description 48
Table 85: NaviGate Cardiac Structures, Inc. - Ongoing Clinical Trials Overview 49
Table 86: Navi Mitral Valved Stent - Navi Valved Stent for Correction of Severe Functional Mitral Regurgitation (FMR) 50
Table 87: Neovasc Inc Pipeline Products & Ongoing Clinical Trials Overview 51
Table 88: Tiara Transcatheter Mitral Valve - Product Status 51
Table 89: Tiara Transcatheter Mitral Valve - Product Description 51
Table 90: Neovasc Inc - Ongoing Clinical Trials Overview 52
Table 91: Tiara Transcatheter Mitral Valve - Early Feasibility Study of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System 53
Table 92: Tiara Transcatheter Mitral Valve - Tiara Transcatheter Mitral Valve Replacement Study: TIARA-II 53
Table 93: Sino Medical Sciences Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 54
Table 94: AccuFit Transapical Mitral Valve Replacement Device - Product Status 54
Table 95: AccuFit Transapical Mitral Valve Replacement Device - Product Description 54
Table 96: Trinity College Dublin Pipeline Products & Ongoing Clinical Trials Overview 55
Table 97: MiVaR Device - Product Status 55
Table 98: MiVaR Device - Product Description 55
Table 99: University College London Pipeline Products & Ongoing Clinical Trials Overview 56
Table 100: Percutaneous Mitral Valve Device - Product Status 56
Table 101: Percutaneous Mitral Valve Device - Product Description 56
Table 102: Valtech Cardio Ltd Pipeline Products & Ongoing Clinical Trials Overview 57
Table 103: Valtech Cardiovalve - Product Status 57
Table 104: Valtech Cardiovalve - Product Description 57
Table 105: Venus MedTech Pipeline Products & Ongoing Clinical Trials Overview 58
Table 106: Tresillo System - Product Status 58
Table 107: Tresillo System - Product Description 58
Table 108: Glossary 89

1.2 List of Figures
Figure 1: Transcatheter Mitral Valves (TMVI) - Pipeline Products by Stage of Development 8
Figure 2: Transcatheter Mitral Valves (TMVI) - Pipeline Products by Territory 9
Figure 3: Transcatheter Mitral Valves (TMVI) - Pipeline Products by Regulatory Path 10
Figure 4: Transcatheter Mitral Valves (TMVI) - Pipeline Products by Estimated Approval Date 11
Figure 5: Transcatheter Mitral Valves (TMVI) - Ongoing Clinical Trials 12

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