Published : Sep-2017
No. of Pages : 118
1 Table of Contents 2
1.1 List of Tables 4
1.2 List of Figures 6
2 Introduction 7
2.1 Tissue Heart Valves Overview 7
3 Products under Development 8
3.1 Tissue Heart Valves - Pipeline Products by Stage of Development 8
3.2 Tissue Heart Valves - Pipeline Products by Segment 9
3.3 Tissue Heart Valves - Pipeline Products by Territory 10
3.4 Tissue Heart Valves - Pipeline Products by Regulatory Path 11
3.5 Tissue Heart Valves - Pipeline Products by Estimated Approval Date 12
3.6 Tissue Heart Valves - Ongoing Clinical Trials 13
4 Tissue Heart Valves - Pipeline Products under Development by Companies 14
4.1 Tissue Heart Valves Companies - Pipeline Products by Stage of Development 14
4.2 Tissue Heart Valves - Pipeline Products by Stage of Development 15
5 Tissue Heart Valves Companies and Product Overview 16
5.1 Abbott Vascular Inc Company Overview 16
5.1.1 Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 16
5.2 Children's Hospital Boston Company Overview 19
5.2.1 Children's Hospital Boston Pipeline Products & Ongoing Clinical Trials Overview 19
5.3 Colibri Heart Valve, LLC Company Overview 20
5.3.1 Colibri Heart Valve, LLC Pipeline Products & Ongoing Clinical Trials Overview 20
5.4 CorMatrix Cardiovascular Inc Company Overview 22
5.4.1 CorMatrix Cardiovascular Inc Pipeline Products & Ongoing Clinical Trials Overview 22
5.5 CryoLife Inc Company Overview 28
5.5.1 CryoLife Inc Pipeline Products & Ongoing Clinical Trials Overview 28
5.6 Cytograft Tissue Engineering Inc (Inactive) Company Overview 30
5.6.1 Cytograft Tissue Engineering Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 30
5.7 Daidalos Solutions BV Company Overview 31
5.7.1 Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview 31
5.8 Edwards Lifesciences Corp Company Overview 34
5.8.1 Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 34
5.9 Medtronic plc Company Overview 42
5.9.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 42
5.10 Revivicor Inc Company Overview 46
5.10.1 Revivicor Inc Pipeline Products & Ongoing Clinical Trials Overview 46
5.11 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 47
5.11.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 47
5.12 Stellenbosch University Company Overview 48
5.12.1 Stellenbosch University Pipeline Products & Ongoing Clinical Trials Overview 48
5.13 Tissue Regenix Ltd Company Overview 49
5.13.1 Tissue Regenix Ltd Pipeline Products & Ongoing Clinical Trials Overview 49
5.14 University of California Irvine Company Overview 52
5.14.1 University of California Irvine Pipeline Products & Ongoing Clinical Trials Overview 52
5.15 University of Cambridge Company Overview 54
5.15.1 University of Cambridge Pipeline Products & Ongoing Clinical Trials Overview 54
5.16 University of Minnesota Company Overview 55
5.16.1 University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 55
5.17 ValveXchange, Inc. (Inactive) Company Overview 56
5.17.1 ValveXchange, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 56
5.18 VueKlar Cardiovascular Ltd Company Overview 59
5.18.1 VueKlar Cardiovascular Ltd Pipeline Products & Ongoing Clinical Trials Overview 59
6 Tissue Heart Valves- Recent Developments 60
6.1 Aug 23, 2017: OmniGuide Appoints Ajay Bhave as its Chief Technology Officer 60
6.2 Aug 22, 2017: Medtronic Reports First Quarter Financial Results 60
6.3 Aug 09, 2017: LivaNova Reports Second Quarter 2017 Results 63
6.4 Aug 04, 2017: LivaNovas Perceval Sutureless Aortic Heart Valve Awarded New Technology Add-on Payment from the Center for Medicare and Medicaid Services 64
6.5 Aug 02, 2017: Medtronic Expands Heart Valve Portfolio with FDA Approval and CE Mark of the Avalus Surgical Aortic Valve 65
6.6 Jul 24, 2017: CryoLife Reports Second Quarter 2017 Financial Results 65
6.7 Jul 05, 2017: Edward's INSPIRIS RESILIA Valve Receives FDA Approval 67
6.8 Jun 12, 2017: LivaNova Appoints Keyna Skeffington as Senior Vice President and General Counsel 68
6.9 May 25, 2017: Medtronic Reports Fourth Quarter and Fiscal Year 2017 Financial Results 68
6.10 May 16, 2017: LivaNova Announces Thad Huston as Chief Financial Officer 71
6.11 May 04, 2017: LivaNova Announces New Data Reaffirming Value of Perceval for Aortic Valve Replacement in Aortic Stenosis Patients 71
6.12 May 03, 2017: LivaNova Reports First Quarter 2017 Results 73
6.13 Apr 28, 2017: LivaNova to Unveil New Data Further Demonstrating the Perceval Sutureless Valve is a Safe and Effective Aortic Valve Replacement for Patients 74
6.14 Apr 26, 2017: CryoLife Reports First Quarter 2017 Financial Results 75
6.15 Apr 25, 2017: Edwards Lifesciences Reports First Quarter Results 76
6.16 Mar 31, 2017: LivaNova Announces Chief Financial Officer Resignation 77
6.17 Mar 31, 2017: LivaNova Reiterates Full-Year 2017 Guidance 78
6.18 Mar 14, 2017: Medtronic Melody Transcatheter Pulmonary Valve First of Its Kind to Receive FDA Approval for Implantation in Failed Surgical Pulmonary Heart Valves 78
6.19 Mar 01, 2017: LivaNova Reports Fourth Quarter and Full-Year 2016 Results 79
6.20 Feb 23, 2017: LivaNova Announces Its Intent to Delist from London Stock Exchange 81
6.21 Feb 21, 2017: Medtronic Reports Third Quarter Financial Results 81
6.22 Feb 15, 2017: CryoLife Reports Fourth Quarter and Full Year 2016 Financial Results 84
6.23 Feb 06, 2017: Medtronic Awarded U.S. Department of Veterans Affairs National Contracts for Home Telehealth Technologies, with Three Other Vendors 85
6.24 Feb 01, 2017: Edwards Lifesciences Reports Fourth Quarter Results 86
6.25 Jan 27, 2017: New Data Reinforce the Clinical Value of the Perceval Sutureless Valve as a Safe and Effective Bioprosthesis for Patients in Need of Aortic Valve Replacement 87
6.26 Dec 08, 2016: Edwards Lifesciences Outlines Growth Strategy At Annual Investor Conference 88
6.27 Nov 22, 2016: Medtronic Reports Second Quarter Financial Results 90
6.28 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 92
6.29 Nov 15, 2016: CEVA to work with Medtronic for distribution facility construction 93
6.30 Nov 02, 2016: LivaNova Announces CEO Transition: Damien McDonald to Succeed Andre-Michel Ballester 94
6.31 Nov 02, 2016: LivaNova Reports Third Quarter 2016 Results 94
6.32 Nov 01, 2016: Early And Sustained Quality Of Life Improvements Seen For Intermediate Risk Patients Treated With Edwards Transcatheter Valves 96
6.33 Oct 31, 2016: EDWARDS INTUITY Elite Rapid Deployment Valve Approved In Canada 96
6.34 Oct 26, 2016: CryoLife Reports Third Quarter 2016 Financial Results 97
6.35 Oct 25, 2016: James W. Bullock Joins CryoLife Board of Directors 98
6.36 Oct 25, 2016: Edwards Lifesciences Reports Third Quarter Results 98
6.37 Oct 19, 2016: St. Jude Medical Reports Third Quarter 2016 Results 100
6.38 Oct 03, 2016: Medtronic Avalus Surgical Aortic Valve Shows Positive Outcomes in One-Year Clinical Trial Results 101
6.39 Sep 29, 2016: Edwards INSPIRIS RESILIA Valve Receives CE Mark 102
6.40 Sep 29, 2016: LivaNova Announces Half-Year Financial Report 103
6.41 Sep 28, 2016: Northwestern Medicine First in Illinois to Implant New FDA-Approved Aortic Valve 111
6.42 Sep 27, 2016: Artificial Blood Vessels Developed in the Lab can Grow with the Recipient 112
6.43 Sep 15, 2016: Medtronic Names Mark Ploof Senior Vice President of Global Operations and Business Services 113
7 Appendix 115
7.1 Methodology 115
7.2 About GlobalData 118
7.3 Contact Us 118
7.4 Disclaimer 118
1.1 List of Tables
Table 1: Tissue Heart Valves - Pipeline Products by Stage of Development 8
Table 2: Tissue Heart Valves - Pipeline Products by Segment 9
Table 3: Tissue Heart Valves - Pipeline Products by Territory 10
Table 4: Tissue Heart Valves - Pipeline Products by Regulatory Path 11
Table 5: Tissue Heart Valves - Pipeline Products by Estimated Approval Date 12
Table 6: Tissue Heart Valves - Ongoing Clinical Trials 13
Table 7: Tissue Heart Valves Companies - Pipeline Products by Stage of Development 14
Table 8: Tissue Heart Valves - Pipeline Products by Stage of Development 15
Table 9: Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 16
Table 10: Tendyne Bioprosthetic Mitral Valve Implantation System - Product Status 16
Table 11: Tendyne Bioprosthetic Mitral Valve Implantation System - Product Description 16
Table 12: Abbott Vascular Inc - Ongoing Clinical Trials Overview 17
Table 13: Tendyne Bioprosthetic Mitral Valve Implantation System - Early Feasibility Study of the Tendyne Mitral Valve System 18
Table 14: 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) 18
Table 15: Children's Hospital Boston Pipeline Products & Ongoing Clinical Trials Overview 19
Table 16: Heart Valve Leaflet - Product Status 19
Table 17: Heart Valve Leaflet - Product Description 19
Table 18: Colibri Heart Valve, LLC Pipeline Products & Ongoing Clinical Trials Overview 20
Table 19: Pulmonary Valve - Product Status 20
Table 20: Pulmonary Valve - Product Description 20
Table 21: Sutureless Surgical Aortic Valve - Product Status 21
Table 22: Sutureless Surgical Aortic Valve - Product Description 21
Table 23: CorMatrix Cardiovascular Inc Pipeline Products & Ongoing Clinical Trials Overview 22
Table 24: CorMatrix ECM - Heart Valve Repair - Product Status 22
Table 25: CorMatrix ECM - Heart Valve Repair - Product Description 22
Table 26: CorMatrix ECM - Heart Valve Replacement - Product Status 23
Table 27: CorMatrix ECM - Heart Valve Replacement - Product Description 23
Table 28: CorMatrix ECM Tricuspid Heart Valve - Product Status 23
Table 29: CorMatrix ECM Tricuspid Heart Valve - Product Description 24
Table 30: CorMatrix Cardiovascular Inc - Ongoing Clinical Trials Overview 25
Table 31: CorMatrix ECM - Heart Valve Repair - Cardial Infarct Repair Using CorMatrix-ECM: Clinical Feasibility Study 26
Table 32: CorMatrix ECM Tricuspid Heart Valve - CorMatrix ECM Tricuspid Valve Replacement Safety and Early Feasibility 27
Table 33: CryoLife Inc Pipeline Products & Ongoing Clinical Trials Overview 28
Table 34: CryoValve SGAV - Product Status 28
Table 35: CryoValve SGAV - Product Description 28
Table 36: Synergraft Xenograft Heart Valve - Product Status 29
Table 37: Synergraft Xenograft Heart Valve - Product Description 29
Table 38: Cytograft Tissue Engineering Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 30
Table 39: Cytograft Valve - Product Status 30
Table 40: Cytograft Valve - Product Description 30
Table 41: Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview 31
Table 42: Sutureless Aortic valve Prosthesis - Product Status 31
Table 43: Sutureless Aortic valve Prosthesis - Product Description 31
Table 44: Sutureless Mitral Valve Prostheses - Product Status 32
Table 45: Sutureless Mitral Valve Prostheses - Product Description 32
Table 46: Sutureless Tricuspid Valve Prostheses - Product Status 32
Table 47: Sutureless Tricuspid Valve Prostheses - Product Description 33
Table 48: Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 34
Table 49: GLX Aortic Conduit - Product Status 34
Table 50: GLX Aortic Conduit - Product Description 35
Table 51: INSPIRIS RESILIA Aortic Valve - Product Status 35
Table 52: INSPIRIS RESILIA Aortic Valve - Product Description 35
Table 53: INTUITY Valve System - Product Status 36
Table 54: INTUITY Valve System - Product Description 36
Table 55: KONECT Conduit - Product Status 36
Table 56: KONECT Conduit - Product Description 37
Table 57: Magna EASE Surgical Valve With GLX - Product Status 37
Table 58: Magna EASE Surgical Valve With GLX - Product Description 37
Table 59: Edwards Lifesciences Corp - Ongoing Clinical Trials Overview 38
Table 60: INTUITY Valve System - A Randomized Comparison of the EDWARDS INTUITY Valve System and Commercially Available Aortic Bioprostheses in Subjects Undergoing Surgical Aortic Valve Replacement 39
Table 61: INTUITY Valve System - Multi-center Experience with the Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement 39
Table 62: INTUITY Valve System - Surgical Treatment of Aortic Stenosis with a Next Generation Surgical Aortic Valve 39
Table 63: Magna EASE Surgical Valve With GLX - Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese Patients 40
Table 64: Magna EASE Surgical Valve With GLX - Edwards Receives IDE for U.S. Clinical Trial of New Heart Valve Tissue Treatment Platform 40
Table 65: INSPIRIS RESILIA Aortic Valve - Prospective, Non-randomized, Multicenter Clinical Evaluation of the Edwards Pericardial Aortic and Mitral Bioprostheses (Models 11000a and 11000m) with a New Tissue Treatment Platform: COMMENCE 41
Table 66: Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 42
Table 67: Avalus Surgical Aortic Valve - Product Status 42
Table 68: Avalus Surgical Aortic Valve - Product Description 42
Table 69: Closed-Chest Aortic Tissue Valve - Product Status 43
Table 70: Closed-Chest Aortic Tissue Valve - Product Description 43
Table 71: Enable Valve-Beating Heart Procedure - Product Status 43
Table 72: Enable Valve-Beating Heart Procedure - Product Description 43
Table 73: Medtronic plc - Ongoing Clinical Trials Overview 44
Table 74: Avalus Surgical Aortic Valve - Medtronic Pericardial Surgical Aortic Valve Replacement Pivotal Trial a Multi-center, Non-randomized Trial to Determine the Safety and Effectiveness of the Model 400 Aortic Valve Bioprosthesis in Patients with Aortic Valve Disease 45
Table 75: Revivicor Inc Pipeline Products & Ongoing Clinical Trials Overview 46
Table 76: Heart Valve - Product Status 46
Table 77: Heart Valve - Product Description 46
Table 78: Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 47
Table 79: Tissue Based Cardiac Valve - Product Status 47
Table 80: Tissue Based Cardiac Valve - Product Description 47
Table 81: Stellenbosch University Pipeline Products & Ongoing Clinical Trials Overview 48
Table 82: Percutaneous Heart Valve - Product Status 48
Table 83: Percutaneous Heart Valve - Product Description 48
Table 84: Tissue Regenix Ltd Pipeline Products & Ongoing Clinical Trials Overview 49
Table 85: Cardiopure - Aortic Heart Valve - Product Status 49
Table 86: Cardiopure - Aortic Heart Valve - Product Description 49
Table 87: Cardiopure - Pulmonary Heart Valve - Product Status 50
Table 88: Cardiopure - Pulmonary Heart Valve - Product Description 50
Table 89: CardioPure HV - Product Status 50
Table 90: CardioPure HV - Product Description 51
Table 91: University of California Irvine Pipeline Products & Ongoing Clinical Trials Overview 52
Table 92: Bileaflet Bioprosthetic Mitral Valve - Product Status 52
Table 93: Bileaflet Bioprosthetic Mitral Valve - Product Description 52
Table 94: Heart Valve Leaflets - Product Status 53
Table 95: Heart Valve Leaflets - Product Description 53
Table 96: University of Cambridge Pipeline Products & Ongoing Clinical Trials Overview 54
Table 97: Polymeric Heart Valve - Product Status 54
Table 98: Polymeric Heart Valve - Product Description 54
Table 99: University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 55
Table 100: Tissue-Engineered Vessel Graft - Product Status 55
Table 101: Tissue-Engineered Vessel Graft - Product Description 55
Table 102: ValveXchange, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 56
Table 103: Vanguard System - Product Status 56
Table 104: Vanguard System - Product Description 56
Table 105: Vitality Exchangeable Valve System - Product Status 57
Table 106: Vitality Exchangeable Valve System - Product Description 57
Table 107: VXi Vanguard II - Product Status 57
Table 108: VXi Vanguard II - Product Description 58
Table 109: VueKlar Cardiovascular Ltd Pipeline Products & Ongoing Clinical Trials Overview 59
Table 110: MR-Enhancing Percutaneous Heart Valve - Product Status 59
Table 111: MR-Enhancing Percutaneous Heart Valve - Product Description 59
Table 112: Glossary 117
1.2 List of Figures
Figure 1: Tissue Heart Valves - Pipeline Products by Stage of Development 8
Figure 2: Tissue Heart Valves - Pipeline Products by Segment 9
Figure 3: Tissue Heart Valves - Pipeline Products by Territory 10
Figure 4: Tissue Heart Valves - Pipeline Products by Regulatory Path 11
Figure 5: Tissue Heart Valves - Pipeline Products by Estimated Approval Date 12
Figure 6: Tissue Heart Valves - Ongoing Clinical Trials 13
