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Tissue Heart Valves - Medical Devices Pipeline Assessment, 2018

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Tissue Heart Valves - Medical Devices Pipeline Assessment, 2018
Published: June 8, 2018 Content info: 123 Pages
Description

GlobalData's Medical Devices sector report, "Tissue Heart Valves - Medical Devices Pipeline Assessment, 2018" 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
Table of Contents
Product Code: GDME0600EPD

Table of Contents

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 17

  • 5.1 Abbott Vascular Inc Company Overview 17
  • 5.2 Children's Hospital Boston Company Overview 20
  • 5.3 Colibri Heart Valve, LLC Company Overview 21
  • 5.4 CorMatrix Cardiovascular Inc Company Overview 23
  • 5.5 CryoLife Inc Company Overview 28
  • 5.6 Cytograft Tissue Engineering Inc (Inactive) Company Overview 30
  • 5.7 Daidalos Solutions BV Company Overview 31
  • 5.8 Edwards Lifesciences Corp Company Overview 34
  • 5.9 Hancock Jaffe Laboratories Inc Company Overview 42
  • 5.10 LivaNova PLC Company Overview 44
  • 5.11 Medtronic plc Company Overview 52
  • 5.12 Revivicor Inc Company Overview 54
  • 5.13 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 55
  • 5.14 Stellenbosch University Company Overview 56
  • 5.15 Tissue Regenix Ltd Company Overview 57
  • 5.16 University of California Irvine Company Overview 59
  • 5.17 University of Cambridge Company Overview 61
  • 5.18 University of Minnesota Company Overview 62
  • 5.19 University of Zurich Company Overview 63
  • 5.20 ValveXchange, Inc. (Inactive) Company Overview 64
  • 5.21 VueKlar Cardiovascular Ltd (Inactive) Company Overview 67

6 Tissue Heart Valves- Recent Developments 68

  • 6.1 Jun 05, 2018: Medtronic Presents Strategic Growth Roadmap at 2018 Investor Day; Outlines Plan to Create Shareholder Value 68
  • 6.2 May 24, 2018: Medtronic Reports Fourth Quarter And Fiscal Year 2018 Financial Results 68
  • 6.3 May 23, 2018: Abbott's Investigational Tendyne Device for Mitral Valve Replacement Demonstrates Positive Outcomes at 30 Days in Global Study 71
  • 6.4 May 09, 2018: Computer-Designed Customized Regenerative Heart Valves 72
  • 6.5 May 07, 2018: Medtronic Appoints Mike Weinstein As Senior Vice President Of Strategy 73
  • 6.6 May 02, 2018: CryoLife Announces First Quarter 2018 Financial Results 74
  • 6.7 Apr 24, 2018: Edwards Lifesciences Announces First Quarter 2018 Financial Results 75
  • 6.8 Apr 10, 2018: SUMMIT Trial (U.S. IDE) of the Tendyne Mitral Valve Received Approval From the FDA 76
  • 6.9 Apr 05, 2018: Dr. Laura Mauri to Join Medtronic as Vice President, Global Clinical Research & Analytics 77
  • 6.10 Mar 26, 2018: Tissue Regenix: Annual results for period ended 31 December 2017 77
  • 6.11 Mar 22, 2018: LivaNova Announces Enrollment for PERFECT Perceval Valve Clinical Trial in China 79
  • 6.12 Mar 08, 2018: Tissue Regenix: Full-year 2017 80
  • 6.13 Mar 07, 2018: CryoLife Reports Fourth Quarter and Full Year 2017 Results 82
  • 6.14 Feb 28, 2018: LivaNova Announces Fourth Quarter and Full-Year 2017 Results 83
  • 6.15 Feb 07, 2018: Caisson Interventional Expanding in Maple Grove 85
  • 6.16 Feb 02, 2018: JenaValve Technology Appoints Laura A. Brenton as Vice President of Clinical and International Market Development 86
  • 6.17 Feb 01, 2018: Edwards Lifesciences Reports Fourth Quarter Results 87
  • 6.18 Jan 30, 2018: Alex Gu Named Senior Vice President and President of Medtronic's Greater China Region 88
  • 6.19 Jan 25, 2018: Edwards' INSPIRIS RESILIA Valve Approved In Canada 89
  • 6.20 Jan 11, 2018: LivaNova Initiates BELIEVE Aortic Heart Valve Study in the U.S. and Canada 89
  • 6.21 Jan 08, 2018: LivaNova Announces Matthew J. Dodds as Senior Vice President, Corporate Development 90
  • 6.22 Dec 19, 2017: Bob White Named Executive Vice President and President of Medtronic's Minimally Invasive Therapies Group; Chris Lee to Assume Leadership of Medtronic's Asia Pacific Region 91
  • 6.23 Dec 07, 2017: Edwards Lifesciences Outlines Growth Strategy At Annual Investor Conference 92
  • 6.24 Dec 01, 2017: Tissue Regenix: Directorate Change 93
  • 6.25 Nov 21, 2017: Medtronic Reports Second Quarter Financial Results 93
  • 6.26 Nov 21, 2017: Vickie Capps Joins OmniGuide's Board of Directors 96
  • 6.27 Nov 08, 2017: Medtronic Announces Preliminary Second Quarter Revenue 97
  • 6.28 Nov 02, 2017: Medtronic Releases Fiscal Year 2017 Integrated Performance Report 98
  • 6.29 Nov 02, 2017: Tissue Regenix: Steve Couldwell appointed Group CEO 99
  • 6.30 Nov 02, 2017: LivaNova Reports Third Quarter 2017 Results 99
  • 6.31 Nov 01, 2017: New tissue-engineered blood vessel replacements closer to human trials 101
  • 6.32 Oct 30, 2017: CryoLife Reports Third Quarter 2017 Results 102
  • 6.33 Oct 24, 2017: Edwards Lifesciences Announces Third Quarter Results 104
  • 6.34 Oct 06, 2017: Medtronic Provides Update on Impact from Hurricane Maria 105
  • 6.35 Oct 02, 2017: Jeffrey H. Burbank Joins CryoLife Board of Directors 106
  • 6.36 Sep 24, 2017: Edwards Announces Key Events For PCR London Valves 2017 107
  • 6.37 Sep 11, 2017: LivaNova Announces Publication of Literature Review Highlighting the Clinical Value and Safety of the Perceval Sutureless Valve for Aortic Valve Replacement 108
  • 6.38 Aug 23, 2017: OmniGuide Appoints Ajay Bhave as its Chief Technology Officer 108
  • 6.39 Aug 22, 2017: Medtronic Reports First Quarter Financial Results 109
  • 6.40 Aug 09, 2017: LivaNova Reports Second Quarter 2017 Results 111
  • 6.41 Aug 04, 2017: LivaNovas Perceval Sutureless Aortic Heart Valve Awarded New Technology Add-on Payment from the Center for Medicare and Medicaid Services 113
  • 6.42 Aug 02, 2017: Medtronic Expands Heart Valve Portfolio with FDA Approval and CE Mark of the Avalus Surgical Aortic Valve 113
  • 6.43 Jul 26, 2017: Edwards Lifesciences Reports Second Quarter Results 114
  • 6.44 Jul 24, 2017: CryoLife Reports Second Quarter 2017 Financial Results 116
  • 6.45 Jul 05, 2017: Edward's INSPIRIS RESILIA Valve Receives FDA Approval 117
  • 6.46 Jun 12, 2017: LivaNova Appoints Keyna Skeffington as Senior Vice President and General Counsel 118

7 Appendix 119

  • 7.1 Methodology 119
  • 7.2 About GlobalData 122
  • 7.3 Contact Us 122
  • 7.4 Disclaimer 122

List of Tables

1.1 List of Tables

  • Table 1: Tissue Heart Valves - Pipeline Products by Stage of Development 9
  • Table 2: Tissue Heart Valves - Pipeline Products by Segment 10
  • Table 3: Tissue Heart Valves - Pipeline Products by Territory 11
  • Table 4: Tissue Heart Valves - Pipeline Products by Regulatory Path 12
  • Table 5: Tissue Heart Valves - Pipeline Products by Estimated Approval Date 13
  • Table 6: Tissue Heart Valves - Ongoing Clinical Trials 14
  • Table 7: Tissue Heart Valves Companies - Pipeline Products by Stage of Development 15
  • Table 8: Tissue Heart Valves - Pipeline Products by Stage of Development 16
  • Table 9: Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 18
  • Table 10: Tendyne Bioprosthetic Mitral Valve Implantation System - Product Status 18
  • Table 11: Tendyne Bioprosthetic Mitral Valve Implantation System - Product Description 18
  • Table 12: Abbott Vascular Inc - Ongoing Clinical Trials Overview 19
  • Table 13: Tendyne Bioprosthetic Mitral Valve Implantation System - Expanded Clinical Study of the Tendyne Mitral Valve System 20
  • Table 14: Children's Hospital Boston Pipeline Products & Ongoing Clinical Trials Overview 21
  • Table 15: Heart Valve Leaflet - Product Status 21
  • Table 16: Heart Valve Leaflet - Product Description 21
  • Table 17: Colibri Heart Valve, LLC Pipeline Products & Ongoing Clinical Trials Overview 22
  • Table 18: Pulmonary Valve - Product Status 22
  • Table 19: Pulmonary Valve - Product Description 22
  • Table 20: Sutureless Surgical Aortic Valve - Product Status 23
  • Table 21: Sutureless Surgical Aortic Valve - Product Description 23
  • Table 22: CorMatrix Cardiovascular Inc Pipeline Products & Ongoing Clinical Trials Overview 24
  • Table 23: CorMatrix ECM - Heart Valve Repair - Product Status 24
  • Table 24: CorMatrix ECM - Heart Valve Repair - Product Description 24
  • Table 25: CorMatrix ECM - Heart Valve Replacement - Product Status 25
  • Table 26: CorMatrix ECM - Heart Valve Replacement - Product Description 25
  • Table 27: CorMatrix ECM Tricuspid Heart Valve - Product Status 25
  • Table 28: CorMatrix ECM Tricuspid Heart Valve - Product Description 26
  • Table 29: Regenerating Tubular Mitral Valve - Product Status 26
  • Table 30: Regenerating Tubular Mitral Valve - Product Description 26
  • Table 31: CorMatrix Cardiovascular Inc - Ongoing Clinical Trials Overview 27
  • Table 32: CorMatrix ECM Tricuspid Heart Valve - CorMatrix ECM Tricuspid Valve Replacement Safety and Early Feasibility 28
  • Table 33: CryoLife Inc Pipeline Products & Ongoing Clinical Trials Overview 29
  • Table 34: CryoValve SGAV - Product Status 29
  • Table 35: CryoValve SGAV - Product Description 29
  • Table 36: Synergraft Xenograft Heart Valve - Product Status 30
  • Table 37: Synergraft Xenograft Heart Valve - Product Description 30
  • Table 38: Cytograft Tissue Engineering Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 31
  • Table 39: Cytograft Valve - Product Status 31
  • Table 40: Cytograft Valve - Product Description 31
  • Table 41: Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview 32
  • Table 42: Sutureless Aortic valve Prosthesis - Product Status 32
  • Table 43: Sutureless Aortic valve Prosthesis - Product Description 32
  • Table 44: Sutureless Mitral Valve Prostheses - Product Status 33
  • Table 45: Sutureless Mitral Valve Prostheses - Product Description 33
  • Table 46: Sutureless Tricuspid Valve Prostheses - Product Status 33
  • Table 47: Sutureless Tricuspid Valve Prostheses - Product Description 34
  • Table 48: Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 35
  • Table 49: GLX Aortic Conduit - Product Status 35
  • Table 50: GLX Aortic Conduit - Product Description 35
  • Table 51: INSPIRIS RESILIA Aortic Valve - Product Status 36
  • Table 52: INSPIRIS RESILIA Aortic Valve - Product Description 36
  • Table 53: INTUITY Valve System - Product Status 36
  • Table 54: INTUITY Valve System - Product Description 37
  • Table 55: KONECT Conduit - Product Status 37
  • Table 56: KONECT Conduit - Product Description 37
  • Table 57: Magna EASE Surgical Valve With GLX - Product Status 38
  • Table 58: Magna EASE Surgical Valve With GLX - Product Description 38
  • Table 59: Edwards Lifesciences Corp - Ongoing Clinical Trials Overview 39
  • Table 60: INTUITY Valve System - Multi-center Experience with the Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement 40
  • Table 61: INTUITY Valve System - Surgical Treatment of Aortic Stenosis with a Next Generation Surgical Aortic Valve 40
  • Table 62: Magna EASE Surgical Valve With GLX - Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese Patients 41
  • Table 63: Magna EASE Surgical Valve With GLX - 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 64: 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 42
  • Table 65: Hancock Jaffe Laboratories Inc Pipeline Products & Ongoing Clinical Trials Overview 43
  • Table 66: Bioprosthetic Aortic Heart Valve - Product Status 43
  • Table 67: Bioprosthetic Aortic Heart Valve - Product Description 43
  • Table 68: Bioprosthetic Mitral Heart Valve - Product Status 44
  • Table 69: Bioprosthetic Mitral Heart Valve - Product Description 44
  • Table 70: LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 45
  • Table 71: Perceval S - Extended Indications - Product Status 45
  • Table 72: Perceval S - Extended Indications - Product Description 46
  • Table 73: Perceval Sutureless Aortic Valve - XL Version - Product Status 46
  • Table 74: Perceval Sutureless Aortic Valve - XL Version - Product Description 46
  • Table 75: Perceval Sutureless Heart Valve - Product Status 47
  • Table 76: Perceval Sutureless Heart Valve - Product Description 47
  • Table 77: LivaNova PLC - Ongoing Clinical Trials Overview 48
  • Table 78: Perceval Sutureless Heart Valve - Behavior of Valve Leaflets and the Incidence of Reduced Mobility Post-surgical Aortic Valve Implant 49
  • Table 79: Perceval Sutureless Heart Valve - Perceval S Valve Clinical Trial for Extended CE Mark 49
  • Table 80: Perceval Sutureless Heart Valve - Perceval Sutureless Implant Versus Standard-aortic Valve Replacement A Controlled Randomized Trial in the Surgical Treatment of Aortic Valve Disease 49
  • Table 81: Perceval Sutureless Heart Valve - Perceval Valve Clinical study for Chinese Registration: PERFECT Trial 50
  • Table 82: Perceval S - Extended Indications - Behavior of Valve Leaflets and the Incidence of Reduced Mobility Post-surgical Aortic Valve Implant 51
  • Table 83: Perceval Sutureless Aortic Valve - XL Version - Behavior of Valve Leaflets and the Incidence of Reduced Mobility Post-surgical Aortic Valve Implant 52
  • Table 84: Perceval Sutureless Aortic Valve - XL Version - Perceval Sutureless Implant Versus Standard-aortic Valve Replacement A Controlled Randomized Trial in the Surgical Treatment of Aortic Valve Disease 52
  • Table 85: Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 53
  • Table 86: Closed-Chest Aortic Tissue Valve - Product Status 53
  • Table 87: Closed-Chest Aortic Tissue Valve - Product Description 53
  • Table 88: Enable Valve-Beating Heart Procedure - Product Status 54
  • Table 89: Enable Valve-Beating Heart Procedure - Product Description 54
  • Table 90: Revivicor Inc Pipeline Products & Ongoing Clinical Trials Overview 55
  • Table 91: Heart Valve - Product Status 55
  • Table 92: Heart Valve - Product Description 55
  • Table 93: Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 56
  • Table 94: Tissue Based Cardiac Valve - Product Status 56

List of Figures

1.2 List of Figures

  • Figure 1: Tissue Heart Valves - Pipeline Products by Stage of Development 9
  • Figure 2: Tissue Heart Valves - Pipeline Products by Segment 10
  • Figure 3: Tissue Heart Valves - Pipeline Products by Territory 11
  • Figure 4: Tissue Heart Valves - Pipeline Products by Regulatory Path 12
  • Figure 5: Tissue Heart Valves - Pipeline Products by Estimated Approval Date 13
  • Figure 6: Tissue Heart Valves - Ongoing Clinical Trials 14
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