Transcatheter Mitral Valve Implantation (TMVI) – Medical Devices Pipeline Assessment, 2019

Transcatheter Mitral Valve Implantation (TMVI) is a artificial heart valve made up of natural tissue (biological material mainly derived from cow or bovine) surrounded by a flexible mesh frame known as stent (made of steel or cobalt-chromium) is placed in a long narrow tube known as a catheter. GlobalData's Medical Devices sector report, “Transcatheter Mitral Valve Implantation (TMVI) – Medical Devices Pipeline Assessment, 2019" provides comprehensive information about the Transcatheter Mitral Valve Implantation (TMVI) pipeline products with comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

The Transcatheter Mitral Valve Implantation (TMVI) Pipeline Assessment report provides key information and data related to:

Extensive coverage of the Transcatheter Mitral Valve Implantation (TMVI) under development

Review details of major pipeline products which include product description, licensing and collaboration details and other developmental activities including pipeline territories, regulatory paths and estimated approval dates

Reviews of major players involved in the pipeline product development.

Provides key clinical trial data related to ongoing clinical trials such as trial phase, trial status, trial start and end dates, and, the number of trials of the major Transcatheter Mitral Valve Implantation (TMVI) pipeline products.

Review of Recent Developments in the segment / industry

The Transcatheter Mitral Valve Implantation (TMVI) Pipeline Assessment report enables you to:

Access significant competitor information, analysis, and insights to improve your 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 Mitral Valve Implantation (TMVI) under development

Formulate market-entry and market expansion strategies

Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline

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.

The GlobalData Differentiation

This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData's team of industry experts.

The data and analysis within this report are driven by GlobalData Medical Intelligence Center (GDMIC) database. GDMIC gives you the key information required to drive sales, investment and deal-making activity in your business. It includes the following:

• 15,000+ data tables showing market size across more than 780 medical equipment segments and 39 countries, from 2009 and forecast to 2023

• 4,500+ industry-leading analysis and procedure reports covering growing sectors, market trends, investment opportunities and competitive landscape

• 56,000+ medical equipment company profiles

• 4,300+ company profiles of medical equipment manufacturers in China and India

• 2,000+ company profiles of medical equipment manufacturers in Japan

• 825+ companies’ revenue splits and market shares

• 1,900+ quarterly and annual medical equipment company financials

• 940+ medical equipment company SWOTs

• 21,500+ pipeline product profiles

• 34,500+ marketed product profiles

• 36,000+ clinical trials

• 36,500+ trial investigators

• 5,400+ reports on companies with products in development

• 33,000+ deals in the medical equipment industry

• 1,300+ surgical and diagnostic procedures by therapy area

• 50+ key healthcare indicators by country

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Contact us to discuss the areas of your business where you need external input, and we will work with you to identify the strongest way forward to meet your needs.

Scope

– Extensive coverage of the Transcatheter Mitral Valve Implantation (TMVI) 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 Mitral Valve Implantation (TMVI) 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 Mitral Valve Implantation (TMVI) 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

4C Medical Technologies Inc

Annulon

CardioMech AS

Cardiovalve Ltd

Cephea Valve Technologies, Inc.

Colibri Heart Valve LLC

Daidalos Solutions BV

Direct Flow Medical Inc (Inactive)

Dura LLC

Edwards Lifesciences Corp

Emory University

Foldax Inc

HighLife SAS

LivaNova PLC

Medtronic plc

Micro Interventional Devices, Inc.

MitrAssist Ltd.

MValve Technologies Ltd.

NaviGate Cardiac Structures, Inc.

Neovasc Inc

Polares Medical SA

Sino Medical Sciences Technology Inc

Trinity College Dublin

University College London

Venus MedTech

Table of Contents

1 Table of Contents 2

1.1 List of Tables 4

1.2 List of Figures 7

2 Introduction 8

2.1 Transcatheter Mitral Valve Implantation (TMVI) Overview 8

3 Products under Development 9

3.1 Transcatheter Mitral Valve Implantation (TMVI) – Pipeline Products by Stage of Development 9

3.2 Transcatheter Mitral Valve Implantation (TMVI) – Pipeline Products by Territory 10

3.3 Transcatheter Mitral Valve Implantation (TMVI) – Pipeline Products by Regulatory Path 11

3.4 Transcatheter Mitral Valve Implantation (TMVI) – Pipeline Products by Estimated Approval Date 12

3.5 Transcatheter Mitral Valve Implantation (TMVI) – Ongoing Clinical Trials 13

4 Transcatheter Mitral Valve Implantation (TMVI) – Pipeline Products under Development by Companies 14

4.1 Transcatheter Mitral Valve Implantation (TMVI) Companies – Pipeline Products by Stage of Development 14

4.2 Transcatheter Mitral Valve Implantation (TMVI) – Pipeline Products by Stage of Development 15

5 Transcatheter Mitral Valve Implantation (TMVI) Companies and Product Overview 17

5.1 4C Medical Technologies Inc Company Overview 17

5.1.1 4C Medical Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 17

5.2 Annulon Company Overview 20

5.2.1 Annulon Pipeline Products & Ongoing Clinical Trials Overview 20

5.3 CardioMech AS Company Overview 21

5.3.1 CardioMech AS Pipeline Products & Ongoing Clinical Trials Overview 21

5.4 Cardiovalve Ltd Company Overview 22

5.4.1 Cardiovalve Ltd Pipeline Products & Ongoing Clinical Trials Overview 22

5.5 Cephea Valve Technologies, Inc. Company Overview 26

5.5.1 Cephea Valve Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 26

5.6 Colibri Heart Valve LLC Company Overview 29

5.6.1 Colibri Heart Valve LLC Pipeline Products & Ongoing Clinical Trials Overview 29

5.7 Daidalos Solutions BV Company Overview 30

5.7.1 Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview 30

5.8 Direct Flow Medical Inc (Inactive) Company Overview 31

5.8.1 Direct Flow Medical Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 31

5.9 Dura LLC Company Overview 32

5.9.1 Dura LLC Pipeline Products & Ongoing Clinical Trials Overview 32

5.10 Edwards Lifesciences Corp Company Overview 33

5.10.1 Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 33

5.11 Emory University Company Overview 46

5.11.1 Emory University Pipeline Products & Ongoing Clinical Trials Overview 46

5.12 Foldax Inc Company Overview 47

5.12.1 Foldax Inc Pipeline Products & Ongoing Clinical Trials Overview 47

5.13 HighLife SAS Company Overview 48

5.13.1 HighLife SAS Pipeline Products & Ongoing Clinical Trials Overview 48

5.14 LivaNova PLC Company Overview 51

5.14.1 LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 51

5.15 Medtronic plc Company Overview 55

5.15.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 55

5.16 Micro Interventional Devices, Inc. Company Overview 60

5.16.1 Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 60

5.17 MitrAssist Ltd. Company Overview 61

5.17.1 MitrAssist Ltd. Pipeline Products & Ongoing Clinical Trials Overview 61

5.18 MValve Technologies Ltd. Company Overview 62

5.18.1 MValve Technologies Ltd. Pipeline Products & Ongoing Clinical Trials Overview 62

5.19 NaviGate Cardiac Structures, Inc. Company Overview 65

5.19.1 NaviGate Cardiac Structures, Inc. Pipeline Products & Ongoing Clinical Trials Overview 65

5.20 Neovasc Inc Company Overview 68

5.20.1 Neovasc Inc Pipeline Products & Ongoing Clinical Trials Overview 68

5.21 Polares Medical SA Company Overview 72

5.21.1 Polares Medical SA Pipeline Products & Ongoing Clinical Trials Overview 72

5.22 Sino Medical Sciences Technology Inc Company Overview 73

5.22.1 Sino Medical Sciences Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 73

5.23 Trinity College Dublin Company Overview 74

5.23.1 Trinity College Dublin Pipeline Products & Ongoing Clinical Trials Overview 74

5.24 University College London Company Overview 75

5.24.1 University College London Pipeline Products & Ongoing Clinical Trials Overview 75

5.25 Venus MedTech Company Overview 76

5.25.1 Venus MedTech Pipeline Products & Ongoing Clinical Trials Overview 76

6 Transcatheter Mitral Valve Implantation (TMVI)- Recent Developments 77

6.1 Nov 21, 2019: LivaNova to revamp heart valve division to affect 150 jobs 77

6.2 Nov 19, 2019: Medtronic reports second quarter financial results for the year 2019 77

6.3 Oct 23, 2019: Edwards Lifesciences reports third quarter results 80

6.4 Oct 21, 2019: Sean Salmon named executive vice president and group president of Medtronic Diabetes 83

6.5 Oct 15, 2019: Neovasc announces Notice of US Patent Granted for TiaraTranscatheter Device for treatment of severe mitral regurgitation 84

6.6 Oct 10, 2019: CINDE announces Edwards Lifesciences invests $100 million to expand its operations in Costa Rica 84

6.7 Sep 30, 2019: AltaValve, 4C Medical's Novel Transcatheter Mitral Regurgitation Device Highlighted at TCT 2019 86

6.8 Sep 27, 2019: Medtronic announces early feasibility Trial for Intrepid Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal approach 86

6.9 Aug 28, 2019: Medtronic announces planned leadership succession 87

6.10 Aug 20, 2019: Medtronic reports first quarter financial results for 2019 89

6.11 Jul 24, 2019: Former Medtronic Executive Sean Ginney named VP of Sales at Current Health 91

6.12 Jul 23, 2019: Edwards Lifesciences reports second quarter results for the year 2019 92

6.13 Jun 17, 2019: Tiara featured in presentation at 11th Annual TVT 2019 English 94

6.14 May 23, 2019: Medtronic announces fiscal year and fourth quarter 2019 financial results 94

6.15 May 22, 2019: Edwards announces milestones for Transcatheter Mitral Program 97

6.16 May 20, 2019: Novel technique reduces obstruction risk in heart valve replacement 98

6.17 Apr 23, 2019: Edwards Lifesciences announces first quarter results 99

6.18 Apr 17, 2019: Neovasc announces resolution of last remaining active litigation 100

6.19 Mar 25, 2019: Medtronic launches Medtech Innovation Accelerator in Shanghai 101

6.20 Mar 21, 2019: Neovasc wins German court appeal; announces german court's Decision to dismiss CardiAQ's claim to co-inventorship of a European patent for Tiara 102

6.21 Mar 04, 2019: Neovasc's Tiara Mitral Valve replacement technology featured in update presentation at the CRT 2019 Meeting 103

6.22 Feb 25, 2019: 4C Medical's novel mitral regurgitation therapy to be highlighted at CRT 2019 Meeting 104

6.23 Feb 21, 2019: Edwards Lifesciences secures CE-Mark for Pascal system 104

6.24 Feb 21, 2019: Neovasc celebrates 5-year anniversary of Tiara patient as the longest surviving transcatheter mitral valve replacement in the world 105

6.25 Feb 20, 2019: Micro Interventional Devices reaches settlement agreement with Neovasc 106

6.26 Jan 31, 2019: Edwards Lifesciences reports financial results for the quarter ended December 31, 2018 106

6.27 Jan 29, 2019: Neovasc receives approval to proceed with phase 2 of TIARA-II study from clinical regulators in Germany and the UK 108

6.28 Jan 22, 2019: Neovasc Announces Dismissal of Claim brought by Edwards Lifesciences 109

6.29 Jan 15, 2019: Boston Scientific, Edwards Lifesciences agree to global litigation settlement 109

6.30 Jan 09, 2019: Medtronic Foundation Recognizes 12 Bakken Invitation Honorees for Driving Positive Change in Healthcare 109

7 Appendix 111

7.1 Methodology 111

7.2 About GlobalData 114

7.3 Contact Us 114

7.4 Disclaimer 114

List of Tables

Table 1: Transcatheter Mitral Valve Implantation (TMVI) – Pipeline Products by Stage of Development 9

Table 2: Transcatheter Mitral Valve Implantation (TMVI) – Pipeline Products by Territory 10

Table 3: Transcatheter Mitral Valve Implantation (TMVI) – Pipeline Products by Regulatory Path 11

Table 4: Transcatheter Mitral Valve Implantation (TMVI) – Pipeline Products by Estimated Approval Date 12

Table 5: Transcatheter Mitral Valve Implantation (TMVI) – Ongoing Clinical Trials 13

Table 6: Transcatheter Mitral Valve Implantation (TMVI) Companies – Pipeline Products by Stage of Development 14

Table 7: Transcatheter Mitral Valve Implantation (TMVI) – Pipeline Products by Stage of Development 15

Table 8: 4C Medical Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 17

Table 13: Annulon Pipeline Products & Ongoing Clinical Trials Overview 20

Table 16: CardioMech AS Pipeline Products & Ongoing Clinical Trials Overview 21

Table 19: Cardiovalve Ltd Pipeline Products & Ongoing Clinical Trials Overview 22

Table 27: Cephea Valve Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 26

Table 32: Colibri Heart Valve LLC Pipeline Products & Ongoing Clinical Trials Overview 29

Table 35: Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview 30

Table 38: Direct Flow Medical Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 31

Table 41: Dura LLC Pipeline Products & Ongoing Clinical Trials Overview 32

Table 44: Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 33

Table 69: Emory University Pipeline Products & Ongoing Clinical Trials Overview 46

Table 72: Foldax Inc Pipeline Products & Ongoing Clinical Trials Overview 47

Table 75: HighLife SAS Pipeline Products & Ongoing Clinical Trials Overview 48

Table 82: LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 51

Table 89: Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 55

Table 98: Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 60

Table 101: MitrAssist Ltd. Pipeline Products & Ongoing Clinical Trials Overview 61

Table 104: MValve Technologies Ltd. Pipeline Products & Ongoing Clinical Trials Overview 62

Table 109: NaviGate Cardiac Structures, Inc. Pipeline Products & Ongoing Clinical Trials Overview 65

Table 114: Neovasc Inc Pipeline Products & Ongoing Clinical Trials Overview 68

Table 122: Polares Medical SA Pipeline Products & Ongoing Clinical Trials Overview 72

Table 125: Sino Medical Sciences Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 73

Table 128: Trinity College Dublin Pipeline Products & Ongoing Clinical Trials Overview 74

Table 131: University College London Pipeline Products & Ongoing Clinical Trials Overview 75

Table 134: Venus MedTech Pipeline Products & Ongoing Clinical Trials Overview 76

Table 137: Glossary 113

List of Figures

Figure 1: Transcatheter Mitral Valve Implantation (TMVI) – Pipeline Products by Stage of Development 9

Figure 2: Transcatheter Mitral Valve Implantation (TMVI) – Pipeline Products by Territory 10

Figure 3: Transcatheter Mitral Valve Implantation (TMVI) – Pipeline Products by Regulatory Path 11

Figure 4: Transcatheter Mitral Valve Implantation (TMVI) – Pipeline Products by Estimated Approval Date 12

Figure 5: Transcatheter Mitral Valve Implantation (TMVI) – Ongoing Clinical Trials 13

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