Summary
GlobalData's Medical Devices sector report, “Tissue Heart Valves - Medical Devices Pipeline Assessment, 2016" provides an overview of Tissue Heart Valves currently in pipeline stage.
The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The report reviews major players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates and the number of trials for the key Tissue Heart Valves pipeline products.
This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData's team of industry experts.
*Note: Certain sections in the report may be removed or altered based on the availability and relevance of data in relation to the equipment type.
Scope
- Extensive coverage of the Tissue Heart Valves under development
- The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities
- The report reviews the major players involved in the development of Tissue Heart Valves and list all their pipeline projects
- The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage
- The report provides key clinical trial data of ongoing trials specific to pipeline products
- Recent developments in the segment / industry
Reasons to buy
The report enables you to -
- Formulate significant competitor information, analysis, and insights to improve R&D strategies
- Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage
- Identify and understand important and diverse types of Tissue Heart Valves under development
- Develop market-entry and market expansion strategies
- Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline
- In-depth analysis of the product’s current stage of development, territory and estimated launch date
Companies Mentioned
Children's Hospital Boston
Colibri Heart Valve, LLC
CorMatrix Cardiovascular, Inc.
CryoLife, Inc.
Cytograft Tissue Engineering, Inc.
Edwards Lifesciences Corporation
LivaNova PLC
Medtronic plc
Revivicor, Inc.
Sree Chitra Tirunal Institute for Medical Sciences & Technology
Stellenbosch University
Tendyne Medical, Inc.
Tissue Regenix Ltd
University of California, Irvine
University of Cambridge
University of Minnesota
ValveXchange, Inc.
VueKlar Cardiovascular Ltd.
'
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 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 Children's Hospital Boston Company Overview 16
5.1.1 Children's Hospital Boston Pipeline Products & Ongoing Clinical Trials Overview 16
5.2 Colibri Heart Valve, LLC Company Overview 17
5.2.1 Colibri Heart Valve, LLC Pipeline Products & Ongoing Clinical Trials Overview 17
5.3 CorMatrix Cardiovascular, Inc. Company Overview 19
5.3.1 CorMatrix Cardiovascular, Inc. Pipeline Products & Ongoing Clinical Trials Overview 19
5.4 CryoLife, Inc. Company Overview 21
5.4.1 CryoLife, Inc. Pipeline Products & Ongoing Clinical Trials Overview 21
5.5 Cytograft Tissue Engineering, Inc. Company Overview 23
5.5.1 Cytograft Tissue Engineering, Inc. Pipeline Products & Ongoing Clinical Trials Overview 23
5.6 Edwards Lifesciences Corporation Company Overview 24
5.6.1 Edwards Lifesciences Corporation Pipeline Products & Ongoing Clinical Trials Overview 24
5.7 LivaNova PLC Company Overview 27
5.7.1 LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 27
5.8 Medtronic plc Company Overview 29
5.8.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 29
5.9 Revivicor, Inc. Company Overview 31
5.9.1 Revivicor, Inc. Pipeline Products & Ongoing Clinical Trials Overview 31
5.10 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 32
5.10.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 32
5.11 Stellenbosch University Company Overview 33
5.11.1 Stellenbosch University Pipeline Products & Ongoing Clinical Trials Overview 33
5.12 Tendyne Medical, Inc. Company Overview 34
5.12.1 Tendyne Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
5.13 Tissue Regenix Ltd Company Overview 37
5.13.1 Tissue Regenix Ltd Pipeline Products & Ongoing Clinical Trials Overview 37
5.14 University of California, Irvine Company Overview 40
5.14.1 University of California, Irvine Pipeline Products & Ongoing Clinical Trials Overview 40
5.15 University of Cambridge Company Overview 43
5.15.1 University of Cambridge Pipeline Products & Ongoing Clinical Trials Overview 43
5.16 University of Minnesota Company Overview 44
5.16.1 University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 44
5.17 ValveXchange, Inc. (Inactive) Company Overview 45
5.17.1 ValveXchange, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 45
5.18 VueKlar Cardiovascular Ltd. Company Overview 48
5.18.1 VueKlar Cardiovascular Ltd. Pipeline Products & Ongoing Clinical Trials Overview 48
6 Tissue Heart Valves- Recent Developments 50
6.1 Jul 20, 2016: St. Jude Medical Reports Second Quarter 2016 Results 50
6.2 Jul 06, 2016: LivaNova Sets Operating Model and Supporting Organization 51
6.3 Jun 30, 2016: NuVasive Agrees to Settle Patent Litigation With Medtronic 52
6.4 Jun 06, 2016: Medtronic Outlines Future Growth Vision at Investor Day 52
6.5 May 31, 2016: Medtronic Reports Fourth Quarter and Fiscal Year 2016 Financial Results 53
6.6 May 16, 2016: St. Jude Medical Furthers the Company’s Legacy of Heart Valve Excellence With US Launch of the Trifecta Surgical Valve With Glide Technology 55
6.7 Apr 07, 2016: St. Jude Medical Announces the European Launch of the Trifecta Surgical Valve with Glide Technology to Improve Options for Patients in Need of Aortic Valve Replacement 56
6.8 Apr 06, 2016: Cardiothoracic and Vascular Surgeons, In Collaboration with Heart Hospital of Austin, First in Texas to Implant Sutureless Valve For Aortic Valve Replacement Surgery 57
6.9 Apr 04, 2016: LivaNova Announces the First Patient Enrolled in the PERSIST-AVR Trial 57
6.10 Mar 08, 2016: LivaNova Announces the First U.S. Implants of Perceval, the Only Sutureless Valve for Aortic Valve Replacement Surgery 58
6.11 Feb 29, 2016: LivaNova Receives Regulatory Approval in Japan for the Solo Smart Stentless Tissue Aortic Valve 59
6.12 Feb 02, 2016: Edwards Lifesciences Reports Fourth Quarter Results 59
6.13 Feb 01, 2016: LivaNova Announces FDA Approval of Stented Heart Valve CROWN PRT for Aortic Valve Disease 60
6.14 Jan 11, 2016: LivaNova Announces Approval of Perceval 61
6.15 Nov 17, 2015: New 10-Year Study Demonstrates Freedom Solo Stentless Aortic Valve Excellent Hemodynamic Performance and Long-term Durability 61
6.16 Oct 26, 2015: Edwards Lifesciences Reports Third Quarter Results-2015 62
6.17 Oct 08, 2015: MValve Technologies Raises Additional Funds through Private Placement of Shares 64
6.18 Oct 05, 2015: Sorin Group Starts First Randomized, Controlled Trial Comparing the Perceval Sutureless Valve to Standard Bioprostheses 64
6.19 Sep 01, 2015: Max Page Receives a New Heart Pacemaker Pulse Generator from Children’s Hospital Los Angeles 64
6.20 Aug 27, 2015: Children’s Hospital Los Angeles Cardiologists Perform Melody Heart Valve Implant in Child Actor Max Page, the Little Darth Vader in the 2011 VW Super Bowl Commercial 65
6.21 Aug 05, 2015: Health Canada Grants Approval For Sorin’s Perceval Sutureless Aortic Valve 67
6.22 Jul 30, 2015: Abbott Labs Acquires Remaining Stake in Tendyne for USD250 Million 67
6.23 Jul 30, 2015: Abbott Labs Enters into Option Agreement to Acquire Cephea Valve Technologies 68
6.24 Jul 28, 2015: Edwards Lifesciences Reports Second Quarter Results 68
7 Appendix 70
7.1 Methodology 70
7.2 About GlobalData 72
7.3 Contact Us 72
7.4 Disclaimer 73
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: Children's Hospital Boston Pipeline Products & Ongoing Clinical Trials Overview 16
Table 10: Heart Valve Leaflet - Product Status 16
Table 11: Heart Valve Leaflet - Product Description 16
Table 12: Colibri Heart Valve, LLC Pipeline Products & Ongoing Clinical Trials Overview 17
Table 13: Pulmonary Valve - Product Status 17
Table 14: Pulmonary Valve - Product Description 17
Table 15: Sutureless Surgical Aortic Valve - Product Status 18
Table 16: Sutureless Surgical Aortic Valve - Product Description 18
Table 17: CorMatrix Cardiovascular, Inc. Pipeline Products & Ongoing Clinical Trials Overview 19
Table 18: CorMatrix ECM - Heart Valve Repair - Product Status 19
Table 19: CorMatrix ECM - Heart Valve Repair - Product Description 20
Table 20: CorMatrix ECM - Heart Valve Replacement - Product Status 20
Table 21: CorMatrix ECM - Heart Valve Replacement - Product Description 20
Table 22: CryoLife, Inc. Pipeline Products & Ongoing Clinical Trials Overview 21
Table 23: CryoValve SGAV - Product Status 21
Table 24: CryoValve SGAV - Product Description 22
Table 25: Synergraft Xenograft Heart Valve - Product Status 22
Table 26: Synergraft Xenograft Heart Valve - Product Description 22
Table 27: Cytograft Tissue Engineering, Inc. Pipeline Products & Ongoing Clinical Trials Overview 23
Table 28: Cytograft Valve - Product Status 23
Table 29: Cytograft Valve - Product Description 23
Table 30: Edwards Lifesciences Corporation Pipeline Products & Ongoing Clinical Trials Overview 24
Table 31: GLX Aortic Conduit - Product Status 24
Table 32: GLX Aortic Conduit - Product Description 25
Table 33: INSPIRIS Platform - Product Status 25
Table 34: INSPIRIS Platform - Product Description 25
Table 35: INTUITY ELITE - Product Status 26
Table 36: INTUITY ELITE - Product Description 26
Table 37: LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 27
Table 38: CROWN PRT - Product Status 27
Table 39: CROWN PRT - Product Description 28
Table 40: Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 29
Table 41: Closed-Chest Aortic Tissue Valve - Product Status 29
Table 42: Closed-Chest Aortic Tissue Valve - Product Description 30
Table 43: Revivicor, Inc. Pipeline Products & Ongoing Clinical Trials Overview 31
Table 44: Heart Valve - Product Status 31
Table 45: Heart Valve - Product Description 31
Table 46: Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 32
Table 47: Tissue Based Cardiac Valve - Product Status 32
Table 48: Tissue Based Cardiac Valve - Product Description 32
Table 49: Stellenbosch University Pipeline Products & Ongoing Clinical Trials Overview 33
Table 50: Percutaneous Heart Valve - Product Status 33
Table 51: Percutaneous Heart Valve - Product Description 33
Table 52: Tendyne Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
Table 53: Tendyne Bioprosthetic Mitral Valve Implantation System - Product Status 34
Table 54: Tendyne Bioprosthetic Mitral Valve Implantation System - Product Description 34
Table 55: Tendyne Medical, Inc. - Ongoing Clinical Trials Overview 35
Table 56: Tendyne Bioprosthetic Mitral Valve Implantation System - Early Feasibility Study of the Tendyne Mitral Valve System 36
Table 57: Tendyne Bioprosthetic Mitral Valve Implantation System - Safety and Efficacy of Tendyne Bioprosthetic Mitral Valve System in Subjects with Symptomatic Mitral Regurgitation of Degenerative or Functional Etiology 36
Table 58: 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) 36
Table 59: Tissue Regenix Ltd Pipeline Products & Ongoing Clinical Trials Overview 37
Table 60: Cardiopure - Aortic Heart Valve - Product Status 37
Table 61: Cardiopure - Aortic Heart Valve - Product Description 37
Table 62: Cardiopure - Pulmonary Heart Valve - Product Status 38
Table 63: Cardiopure - Pulmonary Heart Valve - Product Description 38
Table 64: CardioPure HV - Product Status 38
Table 65: CardioPure HV - Product Description 39
Table 66: dCELL Porcine Aortic Heart Valve - Product Status 39
Table 67: dCELL Porcine Aortic Heart Valve - Product Description 39
Table 68: University of California, Irvine Pipeline Products & Ongoing Clinical Trials Overview 40
Table 69: Bileaflet Bioprosthetic Mitral Valve - Product Status 40
Table 70: Bileaflet Bioprosthetic Mitral Valve - Product Description 40
Table 71: Bovine Pericardium Heart Valve - Product Status 41
Table 72: Bovine Pericardium Heart Valve - Product Description 41
Table 73: Heart Valve Leaflets - Product Status 41
Table 74: Heart Valve Leaflets - Product Description 42
Table 75: University of Cambridge Pipeline Products & Ongoing Clinical Trials Overview 43
Table 76: Polymeric Heart Valve - Product Status 43
Table 77: Polymeric Heart Valve - Product Description 43
Table 78: University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 44
Table 79: Tissue-Engineered Paediatric Heart Valve - Product Status 44
Table 80: Tissue-Engineered Paediatric Heart Valve - Product Description 44
Table 81: ValveXchange, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 45
Table 82: Vanguard System - Product Status 45
Table 83: Vanguard System - Product Description 45
Table 84: Vitality Exchangeable Valve System - Product Status 46
Table 85: Vitality Exchangeable Valve System - Product Description 46
Table 86: VXi Vanguard II - Product Status 46
Table 87: VXi Vanguard II - Product Description 47
Table 88: VueKlar Cardiovascular Ltd. Pipeline Products & Ongoing Clinical Trials Overview 48
Table 89: MR-Enhancing Percutaneous Heart Valve - Product Status 48
Table 90: MR-Enhancing Percutaneous Heart Valve - Product Description 49
Table 91: Glossary 71
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
