経カテーテル心臓弁の世界市場:医療機器パイプライン分析2017

◆英語タイトル:Transcatheter Heart Valves - Medical Devices Pipeline Assessment, 2017
◆商品コード:GDME0481EPD
◆発行会社(調査会社):GlobalData
◆発行日:2017年10月11日
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◆レポート言語:英語
◆レポート形式:PDF
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当調査レポートでは、世界における経カテーテル心臓弁の製品パイプライン動向について調査・分析し、以下の構成でお届けいたします。
・経カテーテル心臓弁の概要
・経カテーテル心臓弁の開発動向:開発段階別分析
・経カテーテル心臓弁の開発動向:セグメント別分析
・経カテーテル心臓弁の開発動向:領域別分析
・経カテーテル心臓弁の開発動向:規制Path別分析
・経カテーテル心臓弁の開発動向:承認日(推定)別分析
・企業別経カテーテル心臓弁の開発動向(パイプライン製品、進行中の治験)
・経カテーテル心臓弁の最近動向
【レポートの概要】

Transcatheter Heart Valves – Medical Devices Pipeline Assessment, 2017

Summary

GlobalData’s Medical Devices sector report, “Transcatheter Heart Valves – Medical Devices Pipeline Assessment, 2017″ provides an overview of Transcatheter 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 Transcatheter 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 Transcatheter 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 Transcatheter 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 Transcatheter 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

【レポートの目次】

1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 16
2 Introduction 17
2.1 Transcatheter Heart Valves Overview 17
3 Products under Development 18
3.1 Transcatheter Heart Valves – Pipeline Products by Stage of Development 18
3.2 Transcatheter Heart Valves – Pipeline Products by Segment 19
3.3 Transcatheter Heart Valves – Pipeline Products by Territory 20
3.4 Transcatheter Heart Valves – Pipeline Products by Regulatory Path 21
3.5 Transcatheter Heart Valves – Pipeline Products by Estimated Approval Date 22
3.6 Transcatheter Heart Valves – Ongoing Clinical Trials 23
4 Transcatheter Heart Valves – Pipeline Products under Development by Companies 24
4.1 Transcatheter Heart Valves Companies – Pipeline Products by Stage of Development 24
4.2 Transcatheter Heart Valves – Pipeline Products by Stage of Development 26
5 Transcatheter Heart Valves Companies and Product Overview 29
5.1 4C Medical Technologies Inc Company Overview 29
5.1.1 4C Medical Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 29
5.2 Admedus Ltd Company Overview 30
5.2.1 Admedus Ltd Pipeline Products & Ongoing Clinical Trials Overview 30
5.3 Aegis Surgical Limited Company Overview 31
5.3.1 Aegis Surgical Limited Pipeline Products & Ongoing Clinical Trials Overview 31
5.4 Annulon Company Overview 32
5.4.1 Annulon Pipeline Products & Ongoing Clinical Trials Overview 32
5.5 AorTech International Plc Company Overview 33
5.5.1 AorTech International Plc Pipeline Products & Ongoing Clinical Trials Overview 33
5.6 Arbor Surgical Technologies, Inc. Company Overview 34
5.6.1 Arbor Surgical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
5.7 Boston Scientific Corp Company Overview 35
5.7.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 35
5.8 Celyad SA Company Overview 65
5.8.1 Celyad SA Pipeline Products & Ongoing Clinical Trials Overview 65
5.9 Cephea Valve Technologies, Inc. Company Overview 66
5.9.1 Cephea Valve Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 66
5.10 Children’s Hospital Boston Company Overview 67
5.10.1 Children’s Hospital Boston Pipeline Products & Ongoing Clinical Trials Overview 67
5.11 Clemson University Company Overview 68
5.11.1 Clemson University Pipeline Products & Ongoing Clinical Trials Overview 68
5.12 Colibri Heart Valve, LLC Company Overview 69
5.12.1 Colibri Heart Valve, LLC Pipeline Products & Ongoing Clinical Trials Overview 69
5.13 Daidalos Solutions BV Company Overview 74
5.13.1 Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview 74
5.14 Direct Flow Medical Inc Company Overview 76
5.14.1 Direct Flow Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 76
5.15 DSM Dyneema B.V. Company Overview 81
5.15.1 DSM Dyneema B.V. Pipeline Products & Ongoing Clinical Trials Overview 81
5.16 Dura LLC Company Overview 82
5.16.1 Dura LLC Pipeline Products & Ongoing Clinical Trials Overview 82
5.17 Edwards Lifesciences Corp Company Overview 85
5.17.1 Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 85
5.18 Emory University Company Overview 103
5.18.1 Emory University Pipeline Products & Ongoing Clinical Trials Overview 103
5.19 Endoluminal Technology Research, LLC Company Overview 104
5.19.1 Endoluminal Technology Research, LLC Pipeline Products & Ongoing Clinical Trials Overview 104
5.20 Florida International University Company Overview 106
5.20.1 Florida International University Pipeline Products & Ongoing Clinical Trials Overview 106
5.21 Hansen Medical Inc Company Overview 107
5.21.1 Hansen Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 107
5.22 HighLife SAS Company Overview 108
5.22.1 HighLife SAS Pipeline Products & Ongoing Clinical Trials Overview 108
5.23 HLT, Inc. Company Overview 111
5.23.1 HLT, Inc. Pipeline Products & Ongoing Clinical Trials Overview 111
5.24 InterVene Inc. Company Overview 114
5.24.1 InterVene Inc. Pipeline Products & Ongoing Clinical Trials Overview 114
5.25 JC Medical, Inc. Company Overview 117
5.25.1 JC Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 117
5.26 JenaValve Technology GmbH Company Overview 120
5.26.1 JenaValve Technology GmbH Pipeline Products & Ongoing Clinical Trials Overview 120
5.27 LivaNova PLC Company Overview 123
5.27.1 LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 123
5.28 Mayo Clinic US Company Overview 126
5.28.1 Mayo Clinic US Pipeline Products & Ongoing Clinical Trials Overview 126
5.29 Medtronic plc Company Overview 127
5.29.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 127
5.30 Meril Life Sciences Pvt Ltd Company Overview 137
5.30.1 Meril Life Sciences Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 137
5.31 Micro Interventional Devices, Inc. Company Overview 138
5.31.1 Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 138
5.32 MicroPort Scientific Corp Company Overview 139
5.32.1 MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 139
5.33 Mitralix Ltd. Company Overview 142
5.33.1 Mitralix Ltd. Pipeline Products & Ongoing Clinical Trials Overview 142
5.34 MitrAssist Ltd. Company Overview 143
5.34.1 MitrAssist Ltd. Pipeline Products & Ongoing Clinical Trials Overview 143
5.35 MValve Technologies Ltd. Company Overview 144
5.35.1 MValve Technologies Ltd. Pipeline Products & Ongoing Clinical Trials Overview 144
5.36 NaviGate Cardiac Structures, Inc. Company Overview 147
5.36.1 NaviGate Cardiac Structures, Inc. Pipeline Products & Ongoing Clinical Trials Overview 147
5.37 Neovasc Inc Company Overview 151
5.37.1 Neovasc Inc Pipeline Products & Ongoing Clinical Trials Overview 151
5.38 PolyNova Cardiovascular LLC Company Overview 154
5.38.1 PolyNova Cardiovascular LLC Pipeline Products & Ongoing Clinical Trials Overview 154
5.39 RegenaGraft Company Overview 155
5.39.1 RegenaGraft Pipeline Products & Ongoing Clinical Trials Overview 155
5.40 SAS Cormove Company Overview 156
5.40.1 SAS Cormove Pipeline Products & Ongoing Clinical Trials Overview 156
5.41 Sino Medical Sciences Technology Inc Company Overview 157
5.41.1 Sino Medical Sciences Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 157
5.42 St. Jude Medical LLC Company Overview 158
5.42.1 St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 158
5.43 Symetis AG Company Overview 162
5.43.1 Symetis AG Pipeline Products & Ongoing Clinical Trials Overview 162
5.44 Thubrikar Aortic Valve, Inc. Company Overview 173
5.44.1 Thubrikar Aortic Valve, Inc. Pipeline Products & Ongoing Clinical Trials Overview 173
5.45 Trinity College Dublin Company Overview 174
5.45.1 Trinity College Dublin Pipeline Products & Ongoing Clinical Trials Overview 174
5.46 University College London Company Overview 175
5.46.1 University College London Pipeline Products & Ongoing Clinical Trials Overview 175
5.47 University of California San Francisco Company Overview 177
5.47.1 University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview 177
5.48 University of Cambridge Company Overview 178
5.48.1 University of Cambridge Pipeline Products & Ongoing Clinical Trials Overview 178
5.49 University of Iowa Company Overview 179
5.49.1 University of Iowa Pipeline Products & Ongoing Clinical Trials Overview 179
5.50 Valtech Cardio Ltd Company Overview 181
5.50.1 Valtech Cardio Ltd Pipeline Products & Ongoing Clinical Trials Overview 181
5.51 Vascular Concepts Ltd Company Overview 182
5.51.1 Vascular Concepts Ltd Pipeline Products & Ongoing Clinical Trials Overview 182
5.52 Venus MedTech Company Overview 183
5.52.1 Venus MedTech Pipeline Products & Ongoing Clinical Trials Overview 183
5.53 Xeltis AG Company Overview 190
5.53.1 Xeltis AG Pipeline Products & Ongoing Clinical Trials Overview 190
6 Transcatheter Heart Valves- Recent Developments 191
6.1 Sep 21, 2017: Medtronic Announces Clinical Study to Evaluate the CoreValve Evolut PRO System in ‘Everyday’ Clinical Practice 191
6.2 Sep 12, 2017: Neovasc Provides Tiara Clinical Update 191
6.3 Sep 11, 2017: MPSC Achieves Substantial Growth in 1H 2017 Net Profit Increases 272.4% YOY 192
6.4 Sep 01, 2017: Decision from Appeals Court upholds lower court decisions but denies injunction 194
6.5 Aug 30, 2017: NaviGate Cardiac Structures reports world’s first successful transcatheter implantation of 52-mm tricuspid valve into a transplanted-heart patient 194
6.6 Aug 22, 2017: Medtronic Reports First Quarter Financial Results 196
6.7 Aug 16, 2017: AorTech International: Audited results for the year ended 31 March 2017 198
6.8 Aug 11, 2017: MPSC Issues Positive Profit Alert for 2017 1H Net Profit Expected to Increase 261% 200
6.9 Aug 10, 2017: Neovasc Announces Results for the Second Quarter of 2017 200
6.10 Aug 03, 2017: 4C Medical’s Novel Mitral Regurgitation Therapy Highlighted at CVI 2017 Innovation Summit 203
6.11 Jul 31, 2017: Medtronic Announces CE Mark and European Launch of CoreValve Evolut PRO Transcatheter Valve with Advanced Sealing 204
6.12 Jul 27, 2017: Boston Scientific Announces Results for Second Quarter 2017 205
6.13 Jul 24, 2017: MicroPort Attends EUROPACE-CARDIOSTIM 2017 206
6.14 Jul 10, 2017: Medtronic Expands TAVR Access to More Patients With Symptomatic, Severe Aortic Stenosis Upon Intermediate Risk FDA Approval 207
6.15 Jul 07, 2017: MPSC New COO Glendy Wang on Board 208
6.16 Jun 27, 2017: Boston Scientific Outlines Strategy for Sustained Growth at 2017 Investor Day 208
6.17 Jun 16, 2017: Neovasc Announces German Court Ruling 210
6.18 Jun 15, 2017: Neovasc Tiara Featured in TVT 2017 Presentation 210
6.19 Jun 15, 2017: 4C Medical’s Novel Mitral Regurgitation Therapy Highlighted at TVT Innovation Forum 211
6.20 Jun 06, 2017: First U.S. Patients Enrolled in an Early Feasibility Study of HLT’s New Transcatheter Aortic Valve Replacement System 212
6.21 Jun 05, 2017: FDA expands use of Sapien 3 artificial heart valve for high-risk patients 212
6.22 May 25, 2017: Medtronic Reports Fourth Quarter and Fiscal Year 2017 Financial Results 213
6.23 May 19, 2017: Celyad Announces First Quarter 2017 Business Update 216
6.24 May 17, 2017: Edwards’ Novel Self-Expanding Transcatheter Heart Valve Demonstrates Excellent Early Patient Outcomes 217
6.25 May 16, 2017: Real-World Evidence With Edwards SAPIEN 3 Transcatheter Valve Confirms Beneficial Patient Outcomes From Clinical Trials 218
6.26 May 16, 2017: The Boston Scientific LOTUS Valve System Demonstrated Superior Efficacy to CoreValve in Global REPRISE III Trial at One Year 219
6.27 May 16, 2017: New Data on CoreValve and Evolut R Self-Expanding TAVI Systems Show Excellent Clinical Outcomes in Routine Clinical Practice 219
6.28 May 11, 2017: Analysis shows increased risk of early stroke with new-onset atrial fibrillation post-TAVR 220
6.29 May 10, 2017: Boston Scientific to Present The LOTUS Valve System at EuroPCR 2017 221
6.30 May 10, 2017: Neovasc Announces Results for the First Quarter of 2017 222
6.31 Apr 28, 2017: Venus Medtech’s TAVR Device Is Approved By CFDA, Creating A New Era Of Interventional Cardiology In China English 224
6.32 Apr 27, 2017: Boston Scientific Announces Results For First Quarter 2017 225
6.33 Apr 26, 2017: NaviGate Cardiac Structures Reports First Heterotopic Transcatheter GATE Tricuspid Valved Stent Successful Implantation 226
6.34 Apr 25, 2017: Edwards Lifesciences Reports First Quarter Results 227
6.35 Apr 05, 2017: Aurora Health Care Heart Experts Among First in Nation to Implant New Heart Valve to Treat Aortic Stenosis 229
6.36 Apr 04, 2017: HLT Announces First Patient Enrollments in a Feasibility Study of a New Transcatheter Aortic Valve Replacement System 230
6.37 Mar 30, 2017: MPSC Announces 2016 Annual Results 231
6.38 Mar 23, 2017: Neovasc Announces Results for the Fourth Quarter and Fiscal Year 2016 232
6.39 Mar 22, 2017: Medtronic Receives FDA Approval for CoreValve Evolut Pro Transcatheter Valve with Advanced Sealing 236
6.40 Mar 17, 2017: Landmark SURTAVI Clinical Trial Shows Transcatheter Aortic Valve Replacement with the Self-Expanding Platform Performs as Well as Surgery in Intermediate Risk Severe Aortic Stenosis Patients 237
6.41 Mar 10, 2017: Neovasc Announces TSX Symbol Change to NVCN 238
6.42 Mar 09, 2017: Boston Scientific Receives Favorable Rulings In Edwards Lifesciences Litigation 238
6.43 Mar 03, 2017: Colibri Heart Valve Receives ISO 13485 and EN ISO 13485 Certification 238
6.44 Feb 21, 2017: Medtronic Reports Third Quarter Financial Results 239
6.45 Feb 06, 2017: Medtronic Awarded U.S. Department of Veterans Affairs National Contracts for Home Telehealth Technologies, with Three Other Vendors 242
6.46 Feb 02, 2017: Boston Scientific Announces Results For Fourth Quarter And Full Year Ended December 31, 2016 243
6.47 Feb 01, 2017: Edwards Lifesciences Reports Fourth Quarter Results 244
6.48 Jan 19, 2017: LHSC First in Ontario to Implant Canadian made Mitral Valve Device 246
6.49 Jan 18, 2017: Neovasc Announces Update in Litigation with CardiAQ 246
6.50 Jan 17, 2017: Medtronic Announces CE Mark and European Launch of Recaptureable TAVI System Now Available for Severe Aortic Stenosis Patients with Large Anatomies 247
6.51 Dec 30, 2016: NaviGate Cardiac Structures Reports World’s First Transcatheter Tricuspid Valved Stent is Successfully Implanted 247
6.52 Dec 26, 2016: MicroPort Completes Patient Enrollment of VitaFlow Pre-market Clinical Trial 248
6.53 Dec 23, 2016: Neovasc Announces Update in Litigation with CardiAQ 249
6.54 Dec 21, 2016: AorTech International: Unaudited Interim Results For the six months ended 30 September 2016 249
6.55 Dec 21, 2016: AorTech Shares Dive As Losses And Lawsuit Against Former CEO Continue 251
6.56 Dec 08, 2016: Aurora Heart and Vascular team hits milestone of 1,000th valve replacement procedure at Aurora St. Luke’s 251
6.57 Dec 08, 2016: Edwards Lifesciences Outlines Growth Strategy At Annual Investor Conference 252
6.58 Dec 06, 2016: Neovasc Provides Update On Its Tiara Mitral Valve Clinical Program 254
6.59 Dec 01, 2016: Medtronic Announces Reimbursement Approval and Launch of CoreValve Evolut R System in Japan 255
6.60 Nov 28, 2016: Neovasc Receives Regulatory Approval To Initiate TIARA II CE Mark Study 256
6.61 Nov 22, 2016: Medtronic Reports Second Quarter Financial Results 256
6.62 Nov 18, 2016: Celyad Announces Third Quarter 2016 Business Update 259
6.63 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 261
6.64 Nov 15, 2016: CEVA to work with Medtronic for distribution facility construction 261
6.65 Nov 14, 2016: Neovasc Reports Third Quarter Results for 2016 262
6.66 Nov 03, 2016: Study Deems Transcaval Valve Replacement Pioneered at Henry Ford Hospital ‘Successful’ 264
6.67 Nov 01, 2016: Medtronic Harmony Transcatheter Pulmonary Valve Demonstrates Positive Early Clinical Outcomes At One Year 265
6.68 Nov 01, 2016: Edwards Sapien Valves Demonstrate Excellent Durability In 5-Year Echo Study 266
6.69 Nov 01, 2016: Neovasc Announces Update in Litigation with CardiAQ 266
6.70 Nov 01, 2016: Patients with Severe Aortic Stenosis and Intermediate Surgical Risk Show Similar Late Quality of Life Outcomes Following Either Transcatheter or Surgical Aortic Valve replacement 267
6.71 Nov 01, 2016: Xeltis Announces Multidisciplinary Scientific Advisory Board of Global Leading Experts 268
6.72 Nov 01, 2016: Early And Sustained Quality Of Life Improvements Seen For Intermediate Risk Patients Treated With Edwards Transcatheter Valves 268
6.73 Oct 31, 2016: New Data on Medtronic Evolut R TAVR System Show Excellent ‘Real-World’ Outcomes in Global Patient Population 269
6.74 Oct 31, 2016: New method for performing aortic valve replacement proves successful in high risk patients 270
6.75 Oct 27, 2016: The Successful Worldwide First in Human Implantation of an Innovative Aortic Valve from Colibri Heart Valve and Venus Medtech with Disruptive “Dry Tissue” Technology Conducted 271
6.76 Oct 26, 2016: Neovasc to Present Tiara Data at TCT in Washington DC 272
6.77 Oct 26, 2016: Medtronic Announces FDA Approval of New Recaptureable TAVR System Available for Severe Aortic Stenosis Patients with Large Anatomies 273
6.78 Oct 26, 2016: Boston Scientific Announces Results For Third Quarter 2016 273
6.79 Oct 25, 2016: Edwards Lifesciences Reports Third Quarter Results 275
6.80 Oct 24, 2016: Boston Scientific announced key Presentations on Lotus Valve System at Transcatheter Cardiovascular Therapeutics 2016 277
6.81 Oct 19, 2016: St. Jude Medical Reports Third Quarter 2016 Results 278
6.82 Oct 14, 2016: AorTech International Announces Board Changes 279
6.83 Oct 10, 2016: Professor Ian Meredith To Join Boston Scientific As Executive Vice President And Global Chief Medical Officer 280
7 Appendix 281
7.1 Methodology 281
7.2 About GlobalData 284
7.3 Contact Us 284
7.4 Disclaimer 284

1.1 List of Tables
Table 1: Transcatheter Heart Valves - Pipeline Products by Stage of Development 18
Table 2: Transcatheter Heart Valves - Pipeline Products by Segment 19
Table 3: Transcatheter Heart Valves - Pipeline Products by Territory 20
Table 4: Transcatheter Heart Valves - Pipeline Products by Regulatory Path 21
Table 5: Transcatheter Heart Valves - Pipeline Products by Estimated Approval Date 22
Table 6: Transcatheter Heart Valves - Ongoing Clinical Trials 23
Table 7: Transcatheter Heart Valves Companies - Pipeline Products by Stage of Development 24
Table 8: Transcatheter Heart Valves - Pipeline Products by Stage of Development 26
Table 9: 4C Medical Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 29
Table 10: TMVR Implant - Product Status 29
Table 11: TMVR Implant - Product Description 29
Table 12: Admedus Ltd Pipeline Products & Ongoing Clinical Trials Overview 30
Table 13: Transcatheter Aortic Valve Replacement - Product Status 30
Table 14: Transcatheter Aortic Valve Replacement - Product Description 30
Table 15: Aegis Surgical Limited Pipeline Products & Ongoing Clinical Trials Overview 31
Table 16: pTAo-TAVR - Product Status 31
Table 17: pTAo-TAVR - Product Description 31
Table 18: Annulon Pipeline Products & Ongoing Clinical Trials Overview 32
Table 19: Mitral Valve Replacement Device - Product Status 32
Table 20: Mitral Valve Replacement Device - Product Description 32
Table 21: AorTech International Plc Pipeline Products & Ongoing Clinical Trials Overview 33
Table 22: AorTech Polymer Valve - Product Status 33
Table 23: AorTech Polymer Valve - Product Description 33
Table 24: Arbor Surgical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 34
Table 25: Trilogy Aortic Valve System - Product Status 34
Table 26: Trilogy Aortic Valve System - Product Description 34
Table 27: Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 35
Table 28: ACURATE TAVR - Product Status 36
Table 29: ACURATE TAVR - Product Description 36
Table 30: Gen 4 Lotus Valve System - Product Status 36
Table 31: Gen 4 Lotus Valve System - Product Description 36
Table 32: Lotus Edge Sheath 15F - Product Status 37
Table 33: Lotus Edge Sheath 15F - Product Description 37
Table 34: Lotus Edge Valve System - 21 mm - Product Status 37
Table 35: Lotus Edge Valve System - 21 mm - Product Description 38
Table 36: Lotus Edge Valve System - 23 mm - Product Status 38
Table 37: Lotus Edge Valve System - 23 mm - Product Description 38
Table 38: Lotus Edge Valve System - 25 mm - Product Status 39
Table 39: Lotus Edge Valve System - 25 mm - Product Description 39
Table 40: Lotus Edge Valve System - 27 mm - Product Status 39
Table 41: Lotus Edge Valve System - 27 mm - Product Description 40
Table 42: Lotus Edge Valve System - 29 mm - Product Status 40
Table 43: Lotus Edge Valve System - 29 mm - Product Description 40
Table 44: Lotus Valve System - 21 mm - Product Status 41
Table 45: Lotus Valve System - 21 mm - Product Description 41
Table 46: Lotus Valve System - 23 mm - Product Status 41
Table 47: Lotus Valve System - 23 mm - Product Description 42
Table 48: Lotus Valve System - 25 mm - Product Status 42
Table 49: Lotus Valve System - 25 mm - Product Description 43
Table 50: Lotus Valve System - 27 mm - Product Status 43
Table 51: Lotus Valve System - 27 mm - Product Description 43
Table 52: Lotus Valve System - 29 mm - Product Status 44
Table 53: Lotus Valve System - 29 mm - Product Description 44
Table 54: Transaortic Sheath - Product Status 44
Table 55: Transaortic Sheath - Product Description 45
Table 56: Boston Scientific Corp - Ongoing Clinical Trials Overview 46
Table 57: Lotus Valve System - 23 mm - Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage 49
Table 58: Lotus Valve System - 23 mm - Experience with Percutaneous Transcatheter Aortic Valve Implantation in Patients with Symptomatic Aortic Valve Disease in Two German Centers 49
Table 59: Lotus Valve System - 23 mm - Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 49
Table 60: Lotus Valve System - 23 mm - Re-positionable Lotus Valve System - Post Market Evaluation of Real World Clinical Outcomes: RESPOND 50
Table 61: Lotus Valve System - 23 mm - Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System - Clinical Evaluation in China: REPRISE China 50
Table 62: Lotus Valve System - 23 mm - Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System - Clinical Evaluation in Japan: REPRISE Japan 50
Table 63: Lotus 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 51
Table 64: 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) 51
Table 65: Lotus Valve System - 27 mm - Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage 52
Table 66: Lotus Valve System - 27 mm - Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 52
Table 67: Lotus Valve System - 27 mm - Re-positionable Lotus Valve System - Post Market Evaluation of Real World Clinical Outcomes: RESPOND 52
Table 68: Lotus Valve System - 27 mm - Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System - Clinical Evaluation in China: REPRISE China 53
Table 69: Lotus Valve System - 27 mm - Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System - Clinical Evaluation in Japan: REPRISE Japan 53
Table 70: Lotus 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 53
Table 71: Lotus Valve System - 27 mm - Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve with the Next Generation Delivery System (REPRISE NGDS) 54
Table 72: 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) 54
Table 73: Lotus Valve System - 25 mm - Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage 55
Table 74: Lotus Valve System - 25 mm - Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 55
Table 75: Lotus Valve System - 25 mm - Re-positionable Lotus Valve System - Post Market Evaluation of Real World Clinical Outcomes: RESPOND 55
Table 76: Lotus Valve System - 25 mm - Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System - Clinical Evaluation in China: REPRISE China 56
Table 77: Lotus Valve System - 25 mm - Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System - Clinical Evaluation in Japan: REPRISE Japan 56
Table 78: 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) 56
Table 79: Lotus Valve System - 21 mm - Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage 57
Table 80: Lotus Valve System - 21 mm - Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 57
Table 81: Lotus Valve System - 21 mm - Re-positionable Lotus Valve System - Post Market Evaluation of Real World Clinical Outcomes: RESPOND 57
Table 82: 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) 58
Table 83: Lotus Valve System - 29 mm - Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage 59
Table 84: Lotus Valve System - 29 mm - Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 59
Table 85: Lotus Valve System - 29 mm - Re-positionable Lotus Valve System - Post Market Evaluation of Real World Clinical Outcomes: RESPOND 59
Table 86: 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) 60
Table 87: Lotus Edge Valve System - 23 mm - Randomized Comparison of Repositionable and Balloon-Expandable Prostheses in Patients Undergoing Trans-catheter Aortic Valve Implantation 61
Table 88: Lotus Edge Valve System - 23 mm - Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve with the Next Generation Delivery System (REPRISE NGDS) 61
Table 89: Lotus Edge Valve System - 23 mm - REPRISE EDGE: REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System - Evaluation of Performance and Safety 61
Table 90: Lotus Edge Valve System - 29 mm - Reprise Edge 29 Mm Eu Study: Repositionable Percutaneous Replacement of Native Stenotic Aortic Valve Through Implantation of Lotus Edge 29 Mm Valve - Evaluation of Safety and Performance 62
Table 91: Lotus Edge Valve System - 25 mm - Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve with the Next Generation Delivery System (REPRISE NGDS) 63
Table 92: Lotus Edge Valve System - 25 mm - REPRISE EDGE: REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System - Evaluation of Performance and Safety 63
Table 93: Lotus Edge Valve System - 27 mm - Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve with the Next Generation Delivery System (REPRISE NGDS) 64
Table 94: Lotus Edge Valve System - 27 mm - REPRISE EDGE: REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System - Evaluation of Performance and Safety 64
Table 95: Celyad SA Pipeline Products & Ongoing Clinical Trials Overview 65
Table 96: Mitral Valve Neo-chordae - Product Status 65
Table 97: Mitral Valve Neo-chordae - Product Description 65
Table 98: Cephea Valve Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 66
Table 99: Mitral Valve Replacement Device - Product Status 66
Table 100: Mitral Valve Replacement Device - Product Description 66
Table 101: Children's Hospital Boston Pipeline Products & Ongoing Clinical Trials Overview 67
Table 102: Two Piece Replacement Heart Valve - Product Status 67
Table 103: Two Piece Replacement Heart Valve - Product Description 67
Table 104: Clemson University Pipeline Products & Ongoing Clinical Trials Overview 68
Table 105: Transcatheter Bioprosthetic Heart Valve - Product Status 68
Table 106: Transcatheter Bioprosthetic Heart Valve - Product Description 68
Table 107: Colibri Heart Valve, LLC Pipeline Products & Ongoing Clinical Trials Overview 69
Table 108: Colibri Aortic Heart Valve - 24mm - Product Status 69
Table 109: Colibri Aortic Heart Valve - 24mm - Product Description 69
Table 110: Colibri Aortic Heart Valve - 21mm - Product Status 70
Table 111: Colibri Aortic Heart Valve - 21mm - Product Description 70
Table 112: Colibri Aortic Heart Valve - 27mm - Product Status 70
Table 113: Colibri Aortic Heart Valve - 27mm - Product Description 71
Table 114: Colibri TAVI System - Product Status 71
Table 115: Colibri TAVI System - Product Description 71
Table 116: Delta Aortic Heart Valve - Product Status 72
Table 117: Delta Aortic Heart Valve - Product Description 72
Table 118: Venibri Transcatheter Heart Valve System - Product Status 72
Table 119: Venibri Transcatheter Heart Valve System - Product Description 73
Table 120: Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview 74
Table 121: Sutureless Trans-Catheter Aortic Valve Replacement (TAVR) - Product Status 74
Table 122: Sutureless Trans-Catheter Aortic Valve Replacement (TAVR) - Product Description 74
Table 123: Sutureless Trans-Catheter Mitral Valve Replacement (TMVR) - Product Status 75

1.2 List of Figures
Figure 1: Transcatheter Heart Valves - Pipeline Products by Stage of Development 18
Figure 2: Transcatheter Heart Valves - Pipeline Products by Segment 19
Figure 3: Transcatheter Heart Valves - Pipeline Products by Territory 20
Figure 4: Transcatheter Heart Valves - Pipeline Products by Regulatory Path 21
Figure 5: Transcatheter Heart Valves - Pipeline Products by Estimated Approval Date 22
Figure 6: Transcatheter Heart Valves - Ongoing Clinical Trials 23

【掲載企業】

4C Medical Technologies Inc
Admedus Ltd
Aegis Surgical Limited
Annulon
AorTech International Plc
Arbor Surgical Technologies, Inc.
Boston Scientific Corp
Celyad SA
Cephea Valve Technologies, Inc.
Children's Hospital Boston
Clemson University
Colibri Heart Valve, LLC
Daidalos Solutions BV
Direct Flow Medical Inc
DSM Dyneema B.V.
Dura LLC
Edwards Lifesciences Corp
Emory University
Endoluminal Technology Research, LLC
Florida International University
Hansen Medical Inc
HighLife SAS
HLT, Inc.
InterVene Inc.
JC Medical, Inc.
JenaValve Technology GmbH
LivaNova PLC
Mayo Clinic US
Medtronic plc
Meril Life Sciences Pvt Ltd
Micro Interventional Devices, Inc.
MicroPort Scientific Corp
Mitralix Ltd.
MitrAssist Ltd.
MValve Technologies Ltd.
NaviGate Cardiac Structures, Inc.
Neovasc Inc
PolyNova Cardiovascular LLC
RegenaGraft
SAS Cormove
Sino Medical Sciences Technology Inc
St. Jude Medical LLC
Symetis AG
Thubrikar Aortic Valve, Inc.
Trinity College Dublin
University College London
University of California San Francisco
University of Cambridge
University of Iowa
Valtech Cardio Ltd
Vascular Concepts Ltd
Venus MedTech
Xeltis AG

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