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Transcatheter Aortic Valves Implantation (TAVI) - Medical Devices Pipeline Assessment, 2018

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Details

Transcatheter Aortic Valves Implantation (TAVI)-Medical Devices Pipeline Assessment, 2018

Summary

GlobalData's Medical Devices sector report, Transcatheter Aortic Valves Implantation (TAVI)-Medical Devices Pipeline Assessment, 2018 provides an overview of Transcatheter Aortic Valves Implantation (TAVI) 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 Transcatheter Aortic Valves Implantation (TAVI) 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 Transcatheter Aortic Valves Implantation (TAVI) 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 Transcatheter Aortic Valves Implantation (TAVI) 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 Transcatheter Aortic Valves Implantation (TAVI) 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

READ MORE

Table Of Content

Scope

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 5

1.2 List of Figures 11

2 Introduction 12

2.1 Transcatheter Aortic Valves Implantation (TAVI) Overview 12

3 Products under Development 13

3.1 Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Stage of Development 13

3.2 Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Territory 14

3.3 Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Regulatory Path 15

3.4 Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Estimated Approval Date 16

3.5 Transcatheter Aortic Valves Implantation (TAVI)-Ongoing Clinical Trials 17

4 Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products under Development by Companies 18

4.1 Transcatheter Aortic Valves Implantation (TAVI) Companies-Pipeline Products by Stage of Development 18

4.2 Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Stage of Development 20

5 Transcatheter Aortic Valves Implantation (TAVI) Companies and Product Overview 22

5.1 Admedus Ltd Company Overview 22

5.2 Aegis Surgical Limited Company Overview 23

5.3 AorTx, Inc. Company Overview 24

5.4 Arbor Surgical Technologies, Inc. Company Overview 25

5.5 Boston Scientific Corp Company Overview 26

5.6 Carena Healthcare Ltd Company Overview 48

5.7 Clemson University Company Overview 49

5.8 Colibri Heart Valve, LLC Company Overview 50

5.9 Daidalos Solutions BV Company Overview 57

5.10 Direct Flow Medical Inc (Inactive) Company Overview 58

5.11 DSM Dyneema BV Company Overview 62

5.12 Dura LLC Company Overview 63

5.13 Edwards Lifesciences Corp Company Overview 64

5.14 HLT, Inc. Company Overview 72

5.15 JC Medical, Inc. Company Overview 75

5.16 JenaValve Technology GmbH Company Overview 80

5.17 Mayo Clinic Company Overview 83

5.18 Medtronic plc Company Overview 84

5.19 Meril Life Sciences Pvt Ltd Company Overview 89

5.20 MicroPort Scientific Corp Company Overview 90

5.21 PolyNova Cardiovascular LLC (Inactive) Company Overview 93

5.22 RegenaGraft Company Overview 94

5.23 ReValve Med Inc Company Overview 95

5.24 SAS Cormove Company Overview 96

5.25 St. Jude Medical LLC Company Overview 97

5.26 Symetis SA Company Overview 101

5.27 Thubrikar Aortic Valve, Inc. Company Overview 112

5.28 University College London Company Overview 113

5.29 University of California San Francisco Company Overview 114

5.30 University of Cambridge Company Overview 115

5.31 University of Iowa Company Overview 116

5.32 Vascular Concepts Ltd Company Overview 117

5.33 Venus MedTech Company Overview 118

5.34 Xeltis AG Company Overview 122

6 Transcatheter Aortic Valves Implantation (TAVI)-Recent Developments 123

6.1 Jun 05, 2018: Medtronic Presents Strategic Growth Roadmap at 2018 Investor Day; Outlines Plan to Create Shareholder Value 123

6.2 May 31, 2018: JC Medical Announces First-in-Human Treatment with the Unique Transfemoral J-Valve TAVI Device for Aortic Regurgitation 123

6.3 May 24, 2018: Medtronic Reports Fourth Quarter And Fiscal Year 2018 Financial Results 124

6.4 May 22, 2018: Treatment with Abbott s Portico Transcatheter Aortic Valve Showed Portico is Safe and Reduces Severe Aortic Stenosis at 30 Days in Real-World Setting 126

6.5 May 22, 2018: Real-World Evidence Confirms Clinical Trial Outcomes For Patients Treated With Edwards SAPIEN 3 Valve 128

6.6 May 22, 2018: Admedus: TAVR Progress Continues With Filing of New Provisional Patents 128

6.7 May 21, 2018: Edwards Announces Key Events For EuroPCR 2018 129

6.8 May 17, 2018: MicroPort CardioFlow Releases One-year Clinical Outcome of VitaFlow 130

6.9 May 17, 2018: MicroPort CardioFlow Attends Fourth China Valve (Hangzhou) Meeting 131

6.10 May 16, 2018: Boston Scientific Announces Schedule of Presentations at EuroPCR 2018 131

6.11 May 16, 2018: Boston Scientific Announces Schedule of Presentations at EuroPCR 2018 132

6.12 May 07, 2018: Medtronic Appoints Mike Weinstein As Senior Vice President Of Strategy 133

6.13 May 04, 2018: Colibri Heart Valve Continues Enrollment in Clinical Feasibility Study of Second-Generation TAVI System 134

6.14 Apr 25, 2018: Boston Scientific Reports Financial Results For First Quarter 2018 135

6.15 Apr 24, 2018: Edwards Lifesciences Announces First Quarter 2018 Financial Results 137

6.16 Apr 19, 2018: Admedus TAVR Gaining Momentum With New Patent Applications 138

6.17 Apr 10, 2018: Jena Valve Technology Continues CE Mark Study Treating Severe Aortic Stenosis with Next-Generation System; Patient Enrollment and Successful Implantations with the Everdur Pericardial Aortic Valve and Coronatix Delivery Catheter 139

6.18 Apr 05, 2018: Dr. Laura Mauri to Join Medtronic as Vice President, Global Clinical Research & Analytics 140

6.19 Mar 28, 2018: Boston Scientific Prevails In U.K. Edwards Lifesciences Litigation 141

6.20 Mar 23, 2018: JenaValve Technology Appoints Keith D Dawkins MD as Board Member 141

6.21 Mar 19, 2018: Colibri Heart Valve Advances Second-Generation TAVI System into Clinical Feasibility Study 142

6.22 Mar 12, 2018: Admedus TAVR Project Passes Testing Milestone 143

6.23 Mar 10, 2018: Clinical Trials Show Strong Long-Term Performance with the Medtronic CoreValve TAVR System 144

6.24 Feb 15, 2018: Edwards' Self-Expanding Transcatheter Heart Valve Receives CE Mark 145

6.25 Feb 02, 2018: JenaValve Technology Appoints Laura A Brenton as Vice President of Clinical and International Market Development 145

6.26 Feb 01, 2018: Boston Scientific Announces Results for Fourth Quarter and Full Year 2017 146

6.27 Feb 01, 2018: Edwards Lifesciences Reports Fourth Quarter Results 148

6.28 Jan 30, 2018: Alex Gu Named Senior Vice President and President of Medtronic's Greater China Region 149

6.29 Jan 09, 2018: Boston Scientific Announces Preliminary Unaudited Sales For The Fourth Quarter And Full Year Ended December 31, 2017 150

6.30 Jan 08, 2018: MicroPort CardioFlow Attends 2017 PCR-CIT China Chengdu Valves 150

7 Appendix 183

7.1 Methodology 183

7.2 About GlobalData 186

7.3 Contact Us 186

7.4 Disclaimer 186


List Of Figure

1.2 List of Figures

Figure 1: Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Stage of Development 14

Figure 2: Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Territory 15

Figure 3: Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Regulatory Path 16

Figure 4: Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Estimated Approval Date 17

Figure 5: Transcatheter Aortic Valves Implantation (TAVI)-Ongoing Clinical Trials 18


List Of Table

1.1 List of Tables

Table 1: Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Stage of Development 14

Table 2: Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Territory 15

Table 3: Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Regulatory Path 16

Table 4: Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Estimated Approval Date 17

Table 5: Transcatheter Aortic Valves Implantation (TAVI)-Ongoing Clinical Trials 18

Table 6: Transcatheter Aortic Valves Implantation (TAVI) Companies-Pipeline Products by Stage of Development 19

Table 7: Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Stage of Development 21

Table 8: Admedus Ltd Pipeline Products & Ongoing Clinical Trials Overview 23

Table 9: Transcatheter Aortic Valve Replacement Device-Product Status 23

Table 10: Transcatheter Aortic Valve Replacement Device-Product Description 23

Table 11: Aegis Surgical Limited Pipeline Products & Ongoing Clinical Trials Overview 24

Table 12: pTAo-TAVR-Product Status 24

Table 13: pTAo-TAVR-Product Description 24

Table 14: AorTx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 25

Table 15: AorTx Valve-Product Status 25

Table 16: AorTx Valve-Product Description 25

Table 17: Arbor Surgical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 26

Table 18: Trilogy Aortic Valve System-Product Status 26

Table 19: Trilogy Aortic Valve System-Product Description 26

Table 20: Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 27

Table 21: ACURATE TAVR-Product Status 27

Table 22: ACURATE TAVR-Product Description 28

Table 23: Gen 4 Lotus Valve System-Product Status 28

Table 24: Gen 4 Lotus Valve System-Product Description 28

Table 25: Lotus Edge Sheath 15F-Product Status 28

Table 26: Lotus Edge Sheath 15F-Product Description 29

Table 27: Lotus Edge Valve System-21 mm-Product Status 29

Table 28: Lotus Edge Valve System-21 mm-Product Description 29

Table 29: Lotus Edge Valve System-23 mm-Product Status 30

Table 30: Lotus Edge Valve System-23 mm-Product Description 30

Table 31: Lotus Edge Valve System-25 mm-Product Status 30

Table 32: Lotus Edge Valve System-25 mm-Product Description 31

Table 33: Lotus Edge Valve System-27 mm-Product Status 31

Table 34: Lotus Edge Valve System-27 mm-Product Description 31

Table 35: Lotus Edge Valve System-29 mm-Product Status 32

Table 36: Lotus Edge Valve System-29 mm-Product Description 32

Table 37: Lotus Valve System-21 mm-Product Status 32

Table 38: Lotus Valve System-21 mm-Product Description 33

Table 39: Lotus Valve System-23 mm-Product Status 33

Table 40: Lotus Valve System-23 mm-Product Description 34

Table 41: Lotus Valve System-25 mm-Product Status 34

Table 42: Lotus Valve System-25 mm-Product Description 35

Table 43: Lotus Valve System-27 mm-Product Status 35

Table 44: Lotus Valve System-27 mm-Product Description 35

Table 45: Lotus Valve System-29 mm-Product Status 36

Table 46: Lotus Valve System-29 mm-Product Description 36

Table 47: Boston Scientific Corp-Ongoing Clinical Trials Overview 37

Table 48: Lotus Valve System-23 mm-Experience with Percutaneous Transcatheter Aortic Valve Implantation in Patients with Symptomatic Aortic Valve Disease in Two German Centers 39

Table 49: Lotus Valve System-23 mm-Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 39

Table 50: Lotus Valve System-23 mm-Re-positionable Lotus Valve System-Post Market Evaluation of Real World Clinical Outcomes: RESPOND 39

Table 51: Lotus Valve System-23 mm-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in China: REPRISE China 40

Table 52: Lotus Valve System-23 mm-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in Japan: REPRISE Japan 40

Table 53: 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) 40

Table 54: Lotus Valve System-27 mm-Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 41

Table 55: Lotus Valve System-27 mm-Re-positionable Lotus Valve System-Post Market Evaluation of Real World Clinical Outcomes: RESPOND 41

Table 56: Lotus Valve System-27 mm-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in China: REPRISE China 41

Table 57: Lotus Valve System-27 mm-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in Japan: REPRISE Japan 42

Table 58: 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) 42

Table 59: Lotus Valve System-25 mm-Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 43

Table 60: Lotus Valve System-25 mm-Re-positionable Lotus Valve System-Post Market Evaluation of Real World Clinical Outcomes: RESPOND 43

Table 61: Lotus Valve System-25 mm-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in China: REPRISE China 43

Table 62: Lotus Valve System-25 mm-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in Japan: REPRISE Japan 44

Table 63: 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) 44

Table 64: Lotus Valve System-21 mm-Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 45

Table 65: Lotus Valve System-21 mm-Re-positionable Lotus Valve System-Post Market Evaluation of Real World Clinical Outcomes: RESPOND 45

Table 66: 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) 45

Table 67: Lotus Valve System-29 mm-Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 46

Table 68: Lotus Valve System-29 mm-Re-positionable Lotus Valve System-Post Market Evaluation of Real World Clinical Outcomes: RESPOND 46

Table 69: 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) 46

Table 70: Lotus Edge Valve System-23 mm-Randomized Comparison of Repositionable and Balloon-Expandable Prostheses in Patients Undergoing Trans-catheter Aortic Valve Implantation 47

Table 71: Lotus Edge 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 47

Table 72: Lotus Edge 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 48

Table 73: Carena Healthcare Ltd Pipeline Products & Ongoing Clinical Trials Overview 49

Table 74: PILLAR 3D Printed Replacement Heart Valve-Product Status 49

Table 75: PILLAR 3D Printed Replacement Heart Valve-Product Description 49

Table 76: Clemson University Pipeline Products & Ongoing Clinical Trials Overview 50

Table 77: Transcatheter Bioprosthetic Heart Valve-Product Status 50

Table 78: Transcatheter Bioprosthetic Heart Valve-Product Description 50

Table 79: Colibri Heart Valve, LLC Pipeline Products & Ongoing Clinical Trials Overview 51

Table 80: Colibri Aortic Heart Valve-24mm-Product Status 51

Table 81: Colibri Aortic Heart Valve-24mm-Product Description 51

Table 82: Colibri Aortic Heart Valve-21mm-Product Status 52

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Products and Companies

Products

Admedus Ltd, Transcatheter Aortic Valve Replacement Device; Aegis Surgical Limited, pTAo-TAVR; AorTx, Inc., AorTx Valve; Arbor Surgical Technologies, Inc., Trilogy Aortic Valve System; Boston Scientific Corp, ACURATE TAVR; Boston Scientific Corp, Gen 4 Lotus Valve System; Boston Scientific Corp, Lotus Edge Sheath 15F; Boston Scientific Corp, Lotus Edge Valve System - 21 mm; Boston Scientific Corp, Lotus Edge Valve System - 23 mm; Boston Scientific Corp, Lotus Edge Valve System - 25 mm; Boston Scientific Corp, Lotus Edge Valve System - 27 mm; Boston Scientific Corp, Lotus Edge Valve System - 29 mm; Boston Scientific Corp, Lotus Valve System - 21 mm; Boston Scientific Corp, Lotus Valve System - 23 mm; Boston Scientific Corp, Lotus Valve System - 25 mm; Boston Scientific Corp, Lotus Valve System - 27 mm; Boston Scientific Corp, Lotus Valve System - 29 mm; Carena Healthcare Ltd, PILLAR 3D Printed Replacement Heart Valve; Clemson University, Transcatheter Bioprosthetic Heart Valve; Colibri Heart Valve, LLC, Colibri Aortic Heart Valve - 24mm; Colibri Heart Valve, LLC, Colibri Aortic Heart Valve - 21mm; Colibri Heart Valve, LLC, Colibri Aortic Heart Valve - 27mm; Colibri Heart Valve, LLC, Colibri TAVI System; Colibri Heart Valve, LLC, Delta Aortic Heart Valve; Colibri Heart Valve, LLC, Venibri Transcatheter Heart Valve System; Daidalos Solutions BV, Sutureless Trans-Catheter Aortic Valve Replacement (TAVR); Direct Flow Medical Inc (Inactive), 18F Direct Flow Medical Transcatheter Aortic Valve System; Direct Flow Medical Inc (Inactive), 22F Percutaneous Aortic Valve System; DSM Dyneema BV, Dyneema Purity - Transcatheter Heart Valve; Dura LLC, LowPro Valve; Edwards Lifesciences Corp, Edwards CENTERA Valve; Edwards Lifesciences Corp, Edwards SAPIEN 3 Transcatheter Heart Valve - Low Risk; Edwards Lifesciences Corp, Next Gen CENTERA; Edwards Lifesciences Corp, Next Gen SAPIEN; Edwards Lifesciences Corp, Sapien 3 Heart Valve - Heart Failure; HLT, Inc., HLT Transcatheter Valve System; JC Medical, Inc., J-Valve TAVI System - Transapical; JC Medical, Inc., J-Valve TAVI System - Transfemoral; JenaValve Technology GmbH, JenaValve Pericardial TAVR System; Mayo Clinic, Percutaneous Aortic Valve; Medtronic plc, CoreValve Evolut PRO - 34 mm; Medtronic plc, CoreValve Evolut R Recapturable System - Low-Risk Aortic Stenosis; Medtronic plc, TCV - Aortic; Meril Life Sciences Pvt Ltd, Myval Transcatheter Aortic Valve Replacement System; MicroPort Scientific Corp, Vitaflow Transcatheter Aortic Valve; PolyNova Cardiovascular LLC (Inactive), Trileaflet Polymeric Prosthetic Heart Valve; RegenaGraft, Synthetic Heart Valve; ReValve Med Inc, Removable Transcatheter Aortic Valve; SAS Cormove, CORMOVE Percutaneous Aortic Valve; St. Jude Medical LLC, Next Generation - Portico Valve; St. Jude Medical LLC, Portico Transcatheter Aortic Valve Implantation System; Symetis SA, ACURATE - Size Matrix Expansion; Symetis SA, ACURATE neo Aortic Bioprosthesis; Symetis SA, ACURATE neo AS Aortic Bioprosthesis - Transfemoral Delivery; Symetis SA, ACURATE TAo; Symetis SA, Acurate TF; Thubrikar Aortic Valve, Inc., Optimum TAVI System; University College London, TRISKELE Aortic Valve; University of California San Francisco, Transcatheter Aortic Valve; University of Cambridge, Removable Transcatheter Valve; University of Iowa, Cellulose Based Aortic Heart Valve; Vascular Concepts Ltd, TAVI (Transcatheter Aortic Valve Replacement); Venus MedTech, Transapical Trinity Aortic Valve Implantation System; Venus MedTech, Venus A-Valve; Xeltis AG, Transcatheter Aortic Heart Valve


Companies

Admedus Ltd

Aegis Surgical Limited

AorTx, Inc.

Arbor Surgical Technologies, Inc.

Boston Scientific Corp

Carena Healthcare Ltd

Clemson University

Colibri Heart Valve, LLC

Daidalos Solutions BV

Direct Flow Medical Inc

DSM Dyneema BV

Dura LLC

Edwards Lifesciences Corp

HLT, Inc.

JC Medical, Inc.

JenaValve Technology GmbH

Mayo Clinic

Medtronic plc

Meril Life Sciences Pvt Ltd

MicroPort Scientific Corp

PolyNova Cardiovascular LLC

RegenaGraft

ReValve Med Inc

SAS Cormove

St. Jude Medical LLC

Symetis SA

Thubrikar Aortic Valve, Inc.

University College London

University of California San Francisco

University of Cambridge

University of Iowa

Vascular Concepts Ltd

Venus MedTech

Xeltis AG

Transcatheter Aortic Valves Implantation (TAVI)-Medical Devices Pipeline Assessment, 2018

Summary

GlobalData's Medical Devices sector report, Transcatheter Aortic Valves Implantation (TAVI)-Medical Devices Pipeline Assessment, 2018 provides an overview of Transcatheter Aortic Valves Implantation (TAVI) 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 Transcatheter Aortic Valves Implantation (TAVI) 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 Transcatheter Aortic Valves Implantation (TAVI) 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 Transcatheter Aortic Valves Implantation (TAVI) 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 Transcatheter Aortic Valves Implantation (TAVI) 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

READ MORE

Scope

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 5

1.2 List of Figures 11

2 Introduction 12

2.1 Transcatheter Aortic Valves Implantation (TAVI) Overview 12

3 Products under Development 13

3.1 Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Stage of Development 13

3.2 Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Territory 14

3.3 Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Regulatory Path 15

3.4 Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Estimated Approval Date 16

3.5 Transcatheter Aortic Valves Implantation (TAVI)-Ongoing Clinical Trials 17

4 Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products under Development by Companies 18

4.1 Transcatheter Aortic Valves Implantation (TAVI) Companies-Pipeline Products by Stage of Development 18

4.2 Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Stage of Development 20

5 Transcatheter Aortic Valves Implantation (TAVI) Companies and Product Overview 22

5.1 Admedus Ltd Company Overview 22

5.2 Aegis Surgical Limited Company Overview 23

5.3 AorTx, Inc. Company Overview 24

5.4 Arbor Surgical Technologies, Inc. Company Overview 25

5.5 Boston Scientific Corp Company Overview 26

5.6 Carena Healthcare Ltd Company Overview 48

5.7 Clemson University Company Overview 49

5.8 Colibri Heart Valve, LLC Company Overview 50

5.9 Daidalos Solutions BV Company Overview 57

5.10 Direct Flow Medical Inc (Inactive) Company Overview 58

5.11 DSM Dyneema BV Company Overview 62

5.12 Dura LLC Company Overview 63

5.13 Edwards Lifesciences Corp Company Overview 64

5.14 HLT, Inc. Company Overview 72

5.15 JC Medical, Inc. Company Overview 75

5.16 JenaValve Technology GmbH Company Overview 80

5.17 Mayo Clinic Company Overview 83

5.18 Medtronic plc Company Overview 84

5.19 Meril Life Sciences Pvt Ltd Company Overview 89

5.20 MicroPort Scientific Corp Company Overview 90

5.21 PolyNova Cardiovascular LLC (Inactive) Company Overview 93

5.22 RegenaGraft Company Overview 94

5.23 ReValve Med Inc Company Overview 95

5.24 SAS Cormove Company Overview 96

5.25 St. Jude Medical LLC Company Overview 97

5.26 Symetis SA Company Overview 101

5.27 Thubrikar Aortic Valve, Inc. Company Overview 112

5.28 University College London Company Overview 113

5.29 University of California San Francisco Company Overview 114

5.30 University of Cambridge Company Overview 115

5.31 University of Iowa Company Overview 116

5.32 Vascular Concepts Ltd Company Overview 117

5.33 Venus MedTech Company Overview 118

5.34 Xeltis AG Company Overview 122

6 Transcatheter Aortic Valves Implantation (TAVI)-Recent Developments 123

6.1 Jun 05, 2018: Medtronic Presents Strategic Growth Roadmap at 2018 Investor Day; Outlines Plan to Create Shareholder Value 123

6.2 May 31, 2018: JC Medical Announces First-in-Human Treatment with the Unique Transfemoral J-Valve TAVI Device for Aortic Regurgitation 123

6.3 May 24, 2018: Medtronic Reports Fourth Quarter And Fiscal Year 2018 Financial Results 124

6.4 May 22, 2018: Treatment with Abbott s Portico Transcatheter Aortic Valve Showed Portico is Safe and Reduces Severe Aortic Stenosis at 30 Days in Real-World Setting 126

6.5 May 22, 2018: Real-World Evidence Confirms Clinical Trial Outcomes For Patients Treated With Edwards SAPIEN 3 Valve 128

6.6 May 22, 2018: Admedus: TAVR Progress Continues With Filing of New Provisional Patents 128

6.7 May 21, 2018: Edwards Announces Key Events For EuroPCR 2018 129

6.8 May 17, 2018: MicroPort CardioFlow Releases One-year Clinical Outcome of VitaFlow 130

6.9 May 17, 2018: MicroPort CardioFlow Attends Fourth China Valve (Hangzhou) Meeting 131

6.10 May 16, 2018: Boston Scientific Announces Schedule of Presentations at EuroPCR 2018 131

6.11 May 16, 2018: Boston Scientific Announces Schedule of Presentations at EuroPCR 2018 132

6.12 May 07, 2018: Medtronic Appoints Mike Weinstein As Senior Vice President Of Strategy 133

6.13 May 04, 2018: Colibri Heart Valve Continues Enrollment in Clinical Feasibility Study of Second-Generation TAVI System 134

6.14 Apr 25, 2018: Boston Scientific Reports Financial Results For First Quarter 2018 135

6.15 Apr 24, 2018: Edwards Lifesciences Announces First Quarter 2018 Financial Results 137

6.16 Apr 19, 2018: Admedus TAVR Gaining Momentum With New Patent Applications 138

6.17 Apr 10, 2018: Jena Valve Technology Continues CE Mark Study Treating Severe Aortic Stenosis with Next-Generation System; Patient Enrollment and Successful Implantations with the Everdur Pericardial Aortic Valve and Coronatix Delivery Catheter 139

6.18 Apr 05, 2018: Dr. Laura Mauri to Join Medtronic as Vice President, Global Clinical Research & Analytics 140

6.19 Mar 28, 2018: Boston Scientific Prevails In U.K. Edwards Lifesciences Litigation 141

6.20 Mar 23, 2018: JenaValve Technology Appoints Keith D Dawkins MD as Board Member 141

6.21 Mar 19, 2018: Colibri Heart Valve Advances Second-Generation TAVI System into Clinical Feasibility Study 142

6.22 Mar 12, 2018: Admedus TAVR Project Passes Testing Milestone 143

6.23 Mar 10, 2018: Clinical Trials Show Strong Long-Term Performance with the Medtronic CoreValve TAVR System 144

6.24 Feb 15, 2018: Edwards' Self-Expanding Transcatheter Heart Valve Receives CE Mark 145

6.25 Feb 02, 2018: JenaValve Technology Appoints Laura A Brenton as Vice President of Clinical and International Market Development 145

6.26 Feb 01, 2018: Boston Scientific Announces Results for Fourth Quarter and Full Year 2017 146

6.27 Feb 01, 2018: Edwards Lifesciences Reports Fourth Quarter Results 148

6.28 Jan 30, 2018: Alex Gu Named Senior Vice President and President of Medtronic's Greater China Region 149

6.29 Jan 09, 2018: Boston Scientific Announces Preliminary Unaudited Sales For The Fourth Quarter And Full Year Ended December 31, 2017 150

6.30 Jan 08, 2018: MicroPort CardioFlow Attends 2017 PCR-CIT China Chengdu Valves 150

7 Appendix 183

7.1 Methodology 183

7.2 About GlobalData 186

7.3 Contact Us 186

7.4 Disclaimer 186


List Of Figure

1.2 List of Figures

Figure 1: Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Stage of Development 14

Figure 2: Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Territory 15

Figure 3: Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Regulatory Path 16

Figure 4: Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Estimated Approval Date 17

Figure 5: Transcatheter Aortic Valves Implantation (TAVI)-Ongoing Clinical Trials 18


List Of Table

1.1 List of Tables

Table 1: Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Stage of Development 14

Table 2: Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Territory 15

Table 3: Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Regulatory Path 16

Table 4: Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Estimated Approval Date 17

Table 5: Transcatheter Aortic Valves Implantation (TAVI)-Ongoing Clinical Trials 18

Table 6: Transcatheter Aortic Valves Implantation (TAVI) Companies-Pipeline Products by Stage of Development 19

Table 7: Transcatheter Aortic Valves Implantation (TAVI)-Pipeline Products by Stage of Development 21

Table 8: Admedus Ltd Pipeline Products & Ongoing Clinical Trials Overview 23

Table 9: Transcatheter Aortic Valve Replacement Device-Product Status 23

Table 10: Transcatheter Aortic Valve Replacement Device-Product Description 23

Table 11: Aegis Surgical Limited Pipeline Products & Ongoing Clinical Trials Overview 24

Table 12: pTAo-TAVR-Product Status 24

Table 13: pTAo-TAVR-Product Description 24

Table 14: AorTx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 25

Table 15: AorTx Valve-Product Status 25

Table 16: AorTx Valve-Product Description 25

Table 17: Arbor Surgical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 26

Table 18: Trilogy Aortic Valve System-Product Status 26

Table 19: Trilogy Aortic Valve System-Product Description 26

Table 20: Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 27

Table 21: ACURATE TAVR-Product Status 27

Table 22: ACURATE TAVR-Product Description 28

Table 23: Gen 4 Lotus Valve System-Product Status 28

Table 24: Gen 4 Lotus Valve System-Product Description 28

Table 25: Lotus Edge Sheath 15F-Product Status 28

Table 26: Lotus Edge Sheath 15F-Product Description 29

Table 27: Lotus Edge Valve System-21 mm-Product Status 29

Table 28: Lotus Edge Valve System-21 mm-Product Description 29

Table 29: Lotus Edge Valve System-23 mm-Product Status 30

Table 30: Lotus Edge Valve System-23 mm-Product Description 30

Table 31: Lotus Edge Valve System-25 mm-Product Status 30

Table 32: Lotus Edge Valve System-25 mm-Product Description 31

Table 33: Lotus Edge Valve System-27 mm-Product Status 31

Table 34: Lotus Edge Valve System-27 mm-Product Description 31

Table 35: Lotus Edge Valve System-29 mm-Product Status 32

Table 36: Lotus Edge Valve System-29 mm-Product Description 32

Table 37: Lotus Valve System-21 mm-Product Status 32

Table 38: Lotus Valve System-21 mm-Product Description 33

Table 39: Lotus Valve System-23 mm-Product Status 33

Table 40: Lotus Valve System-23 mm-Product Description 34

Table 41: Lotus Valve System-25 mm-Product Status 34

Table 42: Lotus Valve System-25 mm-Product Description 35

Table 43: Lotus Valve System-27 mm-Product Status 35

Table 44: Lotus Valve System-27 mm-Product Description 35

Table 45: Lotus Valve System-29 mm-Product Status 36

Table 46: Lotus Valve System-29 mm-Product Description 36

Table 47: Boston Scientific Corp-Ongoing Clinical Trials Overview 37

Table 48: Lotus Valve System-23 mm-Experience with Percutaneous Transcatheter Aortic Valve Implantation in Patients with Symptomatic Aortic Valve Disease in Two German Centers 39

Table 49: Lotus Valve System-23 mm-Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 39

Table 50: Lotus Valve System-23 mm-Re-positionable Lotus Valve System-Post Market Evaluation of Real World Clinical Outcomes: RESPOND 39

Table 51: Lotus Valve System-23 mm-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in China: REPRISE China 40

Table 52: Lotus Valve System-23 mm-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in Japan: REPRISE Japan 40

Table 53: 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) 40

Table 54: Lotus Valve System-27 mm-Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 41

Table 55: Lotus Valve System-27 mm-Re-positionable Lotus Valve System-Post Market Evaluation of Real World Clinical Outcomes: RESPOND 41

Table 56: Lotus Valve System-27 mm-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in China: REPRISE China 41

Table 57: Lotus Valve System-27 mm-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in Japan: REPRISE Japan 42

Table 58: 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) 42

Table 59: Lotus Valve System-25 mm-Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 43

Table 60: Lotus Valve System-25 mm-Re-positionable Lotus Valve System-Post Market Evaluation of Real World Clinical Outcomes: RESPOND 43

Table 61: Lotus Valve System-25 mm-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in China: REPRISE China 43

Table 62: Lotus Valve System-25 mm-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in Japan: REPRISE Japan 44

Table 63: 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) 44

Table 64: Lotus Valve System-21 mm-Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 45

Table 65: Lotus Valve System-21 mm-Re-positionable Lotus Valve System-Post Market Evaluation of Real World Clinical Outcomes: RESPOND 45

Table 66: 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) 45

Table 67: Lotus Valve System-29 mm-Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 46

Table 68: Lotus Valve System-29 mm-Re-positionable Lotus Valve System-Post Market Evaluation of Real World Clinical Outcomes: RESPOND 46

Table 69: 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) 46

Table 70: Lotus Edge Valve System-23 mm-Randomized Comparison of Repositionable and Balloon-Expandable Prostheses in Patients Undergoing Trans-catheter Aortic Valve Implantation 47

Table 71: Lotus Edge 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 47

Table 72: Lotus Edge 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 48

Table 73: Carena Healthcare Ltd Pipeline Products & Ongoing Clinical Trials Overview 49

Table 74: PILLAR 3D Printed Replacement Heart Valve-Product Status 49

Table 75: PILLAR 3D Printed Replacement Heart Valve-Product Description 49

Table 76: Clemson University Pipeline Products & Ongoing Clinical Trials Overview 50

Table 77: Transcatheter Bioprosthetic Heart Valve-Product Status 50

Table 78: Transcatheter Bioprosthetic Heart Valve-Product Description 50

Table 79: Colibri Heart Valve, LLC Pipeline Products & Ongoing Clinical Trials Overview 51

Table 80: Colibri Aortic Heart Valve-24mm-Product Status 51

Table 81: Colibri Aortic Heart Valve-24mm-Product Description 51

Table 82: Colibri Aortic Heart Valve-21mm-Product Status 52

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Products

Admedus Ltd, Transcatheter Aortic Valve Replacement Device; Aegis Surgical Limited, pTAo-TAVR; AorTx, Inc., AorTx Valve; Arbor Surgical Technologies, Inc., Trilogy Aortic Valve System; Boston Scientific Corp, ACURATE TAVR; Boston Scientific Corp, Gen 4 Lotus Valve System; Boston Scientific Corp, Lotus Edge Sheath 15F; Boston Scientific Corp, Lotus Edge Valve System - 21 mm; Boston Scientific Corp, Lotus Edge Valve System - 23 mm; Boston Scientific Corp, Lotus Edge Valve System - 25 mm; Boston Scientific Corp, Lotus Edge Valve System - 27 mm; Boston Scientific Corp, Lotus Edge Valve System - 29 mm; Boston Scientific Corp, Lotus Valve System - 21 mm; Boston Scientific Corp, Lotus Valve System - 23 mm; Boston Scientific Corp, Lotus Valve System - 25 mm; Boston Scientific Corp, Lotus Valve System - 27 mm; Boston Scientific Corp, Lotus Valve System - 29 mm; Carena Healthcare Ltd, PILLAR 3D Printed Replacement Heart Valve; Clemson University, Transcatheter Bioprosthetic Heart Valve; Colibri Heart Valve, LLC, Colibri Aortic Heart Valve - 24mm; Colibri Heart Valve, LLC, Colibri Aortic Heart Valve - 21mm; Colibri Heart Valve, LLC, Colibri Aortic Heart Valve - 27mm; Colibri Heart Valve, LLC, Colibri TAVI System; Colibri Heart Valve, LLC, Delta Aortic Heart Valve; Colibri Heart Valve, LLC, Venibri Transcatheter Heart Valve System; Daidalos Solutions BV, Sutureless Trans-Catheter Aortic Valve Replacement (TAVR); Direct Flow Medical Inc (Inactive), 18F Direct Flow Medical Transcatheter Aortic Valve System; Direct Flow Medical Inc (Inactive), 22F Percutaneous Aortic Valve System; DSM Dyneema BV, Dyneema Purity - Transcatheter Heart Valve; Dura LLC, LowPro Valve; Edwards Lifesciences Corp, Edwards CENTERA Valve; Edwards Lifesciences Corp, Edwards SAPIEN 3 Transcatheter Heart Valve - Low Risk; Edwards Lifesciences Corp, Next Gen CENTERA; Edwards Lifesciences Corp, Next Gen SAPIEN; Edwards Lifesciences Corp, Sapien 3 Heart Valve - Heart Failure; HLT, Inc., HLT Transcatheter Valve System; JC Medical, Inc., J-Valve TAVI System - Transapical; JC Medical, Inc., J-Valve TAVI System - Transfemoral; JenaValve Technology GmbH, JenaValve Pericardial TAVR System; Mayo Clinic, Percutaneous Aortic Valve; Medtronic plc, CoreValve Evolut PRO - 34 mm; Medtronic plc, CoreValve Evolut R Recapturable System - Low-Risk Aortic Stenosis; Medtronic plc, TCV - Aortic; Meril Life Sciences Pvt Ltd, Myval Transcatheter Aortic Valve Replacement System; MicroPort Scientific Corp, Vitaflow Transcatheter Aortic Valve; PolyNova Cardiovascular LLC (Inactive), Trileaflet Polymeric Prosthetic Heart Valve; RegenaGraft, Synthetic Heart Valve; ReValve Med Inc, Removable Transcatheter Aortic Valve; SAS Cormove, CORMOVE Percutaneous Aortic Valve; St. Jude Medical LLC, Next Generation - Portico Valve; St. Jude Medical LLC, Portico Transcatheter Aortic Valve Implantation System; Symetis SA, ACURATE - Size Matrix Expansion; Symetis SA, ACURATE neo Aortic Bioprosthesis; Symetis SA, ACURATE neo AS Aortic Bioprosthesis - Transfemoral Delivery; Symetis SA, ACURATE TAo; Symetis SA, Acurate TF; Thubrikar Aortic Valve, Inc., Optimum TAVI System; University College London, TRISKELE Aortic Valve; University of California San Francisco, Transcatheter Aortic Valve; University of Cambridge, Removable Transcatheter Valve; University of Iowa, Cellulose Based Aortic Heart Valve; Vascular Concepts Ltd, TAVI (Transcatheter Aortic Valve Replacement); Venus MedTech, Transapical Trinity Aortic Valve Implantation System; Venus MedTech, Venus A-Valve; Xeltis AG, Transcatheter Aortic Heart Valve


Companies

Admedus Ltd

Aegis Surgical Limited

AorTx, Inc.

Arbor Surgical Technologies, Inc.

Boston Scientific Corp

Carena Healthcare Ltd

Clemson University

Colibri Heart Valve, LLC

Daidalos Solutions BV

Direct Flow Medical Inc

DSM Dyneema BV

Dura LLC

Edwards Lifesciences Corp

HLT, Inc.

JC Medical, Inc.

JenaValve Technology GmbH

Mayo Clinic

Medtronic plc

Meril Life Sciences Pvt Ltd

MicroPort Scientific Corp

PolyNova Cardiovascular LLC

RegenaGraft

ReValve Med Inc

SAS Cormove

St. Jude Medical LLC

Symetis SA

Thubrikar Aortic Valve, Inc.

University College London

University of California San Francisco

University of Cambridge

University of Iowa

Vascular Concepts Ltd

Venus MedTech

Xeltis AG