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Prosthetic Heart Valves - Medical Devices Pipeline Assessment, 2018

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Prosthetic Heart Valves-Medical Devices Pipeline Assessment, 2018

Summary

GlobalData's Medical Devices sector report, Prosthetic Heart Valves-Medical Devices Pipeline Assessment, 2018 provides an overview of Prosthetic 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 Prosthetic 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 Prosthetic 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 Prosthetic 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 Prosthetic 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

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Table Of Content

Scope

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 8

1.2 List of Figures 21

2 Introduction 22

2.1 Prosthetic Heart Valves Overview 22

3 Products under Development 24

3.1 Prosthetic Heart Valves-Pipeline Products by Stage of Development 24

3.2 Prosthetic Heart Valves-Pipeline Products by Segment 25

3.3 Prosthetic Heart Valves-Pipeline Products by Territory 26

3.4 Prosthetic Heart Valves-Pipeline Products by Regulatory Path 28

3.5 Prosthetic Heart Valves-Pipeline Products by Estimated Approval Date 29

3.6 Prosthetic Heart Valves-Ongoing Clinical Trials 30

4 Prosthetic Heart Valves-Pipeline Products under Development by Companies 31

4.1 Prosthetic Heart Valves Companies-Pipeline Products by Stage of Development 31

4.2 Prosthetic Heart Valves-Pipeline Products by Stage of Development 35

5 Prosthetic Heart Valves Companies and Product Overview 41

5.1 4C Medical Technologies Inc Company Overview 41

5.2 Abbott Vascular Inc Company Overview 42

5.3 Admedus Ltd Company Overview 45

5.4 Aegis Surgical Limited Company Overview 46

5.5 Annulon Company Overview 47

5.6 AorTech International Plc Company Overview 48

5.7 AorTx, Inc. Company Overview 49

5.8 Arbor Surgical Technologies, Inc. Company Overview 50

5.9 Boston Children's Hospital Company Overview 51

5.10 Boston Scientific Corp Company Overview 52

5.11 Carena Healthcare Ltd Company Overview 75

5.12 Cephea Valve Technologies, Inc. Company Overview 76

5.13 Children's Hospital Boston Company Overview 77

5.14 Clemson University Company Overview 79

5.15 Colibri Heart Valve, LLC Company Overview 80

5.16 Collagen Solutions Plc Company Overview 89

5.17 Colorado State University Company Overview 90

5.18 CorMatrix Cardiovascular Inc Company Overview 91

5.19 CryoLife Inc Company Overview 97

5.20 Cytograft Tissue Engineering Inc (Inactive) Company Overview 99

5.21 Daidalos Solutions BV Company Overview 100

5.22 Direct Flow Medical Inc (Inactive) Company Overview 104

5.23 DSM Dyneema BV Company Overview 108

5.24 Dura LLC Company Overview 109

5.25 Edwards Lifesciences Corp Company Overview 111

5.26 Emory University Company Overview 139

5.27 Endoluminal Technology Research, LLC Company Overview 140

5.28 Florida International University Company Overview 142

5.29 Georgia Institute of Technology Company Overview 144

5.30 Hancock Jaffe Laboratories Inc Company Overview 145

5.31 HighLife SAS Company Overview 147

5.32 HLT, Inc. Company Overview 150

5.33 Hocor Cardiovascular Technologies, LLC Company Overview 153

5.34 Innovia LLC Company Overview 154

5.35 JC Medical, Inc. Company Overview 156

5.36 JenaValve Technology GmbH Company Overview 161

5.37 Leman Cardiovascular SA Company Overview 164

5.38 LivaNova PLC Company Overview 165

5.39 Mayo Clinic Company Overview 175

5.40 Medi-Line S.A. Company Overview 176

5.41 Medtronic plc Company Overview 177

5.42 Meril Life Sciences Pvt Ltd Company Overview 191

5.43 Micro Interventional Devices, Inc. Company Overview 192

5.44 MicroPort Scientific Corp Company Overview 193

5.45 Mitralix Ltd. Company Overview 197

5.46 MitrAssist Ltd. Company Overview 198

5.47 Mitricares Company Overview 199

5.48 MValve Technologies Ltd. Company Overview 200

5.49 NaviGate Cardiac Structures, Inc. Company Overview 203

5.50 Neovasc Inc Company Overview 207

5.51 Peca Labs, Inc. Company Overview 210

5.52 PolyNova Cardiovascular LLC (Inactive) Company Overview 211

5.53 Polyvascular Corp Company Overview 212

5.54 Rambam Health Care Campus Company Overview 213

5.55 RegenaGraft Company Overview 214

5.56 ReValve Med Inc Company Overview 215

5.57 Revivicor Inc Company Overview 216

5.58 SAS Cormove Company Overview 217

5.59 Sino Medical Sciences Technology Inc Company Overview 218

5.60 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 219

5.61 St. Jude Medical LLC Company Overview 220

5.62 Stellenbosch University Company Overview 226

5.63 Strait Access Technologies (Pty) Ltd Company Overview 227

5.64 Symetis SA Company Overview 229

5.65 Thoratec Corp Company Overview 242

5.66 Thubrikar Aortic Valve, Inc. Company Overview 243

5.67 Tissue Regenix Ltd Company Overview 245

5.68 Trinity College Dublin Company Overview 247

5.69 TTK Healthcare Ltd Company Overview 248

5.70 University College London Company Overview 249

5.71 University of Arizona Company Overview 252

5.72 University of California Company Overview 253

5.73 University of California Irvine Company Overview 254

5.74 University of California San Francisco Company Overview 256

5.75 University of Cambridge Company Overview 257

5.76 University of Colorado Company Overview 259

5.77 University of Florida Company Overview 260

5.78 University of Iowa Company Overview 261

5.79 University of Minnesota Company Overview 263

5.80 University of Pennsylvania Company Overview 264

5.81 University of South Florida Company Overview 267

5.82 University of Zurich Company Overview 268

5.83 Valtech Cardio Ltd Company Overview 269

5.84 ValveXchange, Inc. (Inactive) Company Overview 272

5.85 Vascular Concepts Ltd Company Overview 275

5.86 Venus MedTech Company Overview 276

5.87 VueKlar Cardiovascular Ltd (Inactive) Company Overview 283

5.88 Xeltis AG Company Overview 284

6 Prosthetic Heart Valves- Recent Developments 289

6.1 Jun 05, 2018: Medtronic Presents Strategic Growth Roadmap at 2018 Investor Day; Outlines Plan to Create Shareholder Value 289

6.2 May 31, 2018: JC Medical Announces First-in-Human Treatment with the Unique Transfemoral J-Valve TAVI Device for Aortic Regurgitation 289

6.3 May 24, 2018: Medtronic Reports Fourth Quarter And Fiscal Year 2018 Financial Results 290

6.4 May 23, 2018: Abbott's Investigational Tendyne Device for Mitral Valve Replacement Demonstrates Positive Outcomes at 30 Days in Global Study 292

6.5 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 294

6.6 May 22, 2018: Real-World Evidence Confirms Clinical Trial Outcomes For Patients Treated With Edwards SAPIEN 3 Valve 295

6.7 May 22, 2018: Admedus: TAVR Progress Continues With Filing of New Provisional Patents 296

6.8 May 21, 2018: Edwards Announces Key Events For EuroPCR 2018 297

6.9 May 21, 2018: NaviGate Cardiac Structures reports excellent valvular function” at 1-year follow-up of first patient to receive GATE tricuspid valved stent via transjugular access 297

6.10 May 17, 2018: MicroPort CardioFlow Releases One-year Clinical Outcome of VitaFlow 299

6.11 May 17, 2018: MicroPort CardioFlow Attends Fourth China Valve (Hangzhou) Meeting 300

6.12 May 17, 2018: Mr. Jonathan Chen Promoted to Chief International Business Officer of MPSC 300

6.13 May 16, 2018: Boston Scientific Announces Schedule of Presentations at EuroPCR 2018 301

6.14 May 16, 2018: Boston Scientific Announces Schedule of Presentations at EuroPCR 2018 302

6.15 May 10, 2018: Neovasc Announces Results for the First Quarter 2018 302

6.16 May 09, 2018: Computer-Designed Customized Regenerative Heart Valves 306

6.17 May 07, 2018: Medtronic Appoints Mike Weinstein As Senior Vice President Of Strategy 307

6.18 May 04, 2018: Colibri Heart Valve Continues Enrollment in Clinical Feasibility Study of Second-Generation TAVI System 307

6.19 May 02, 2018: CryoLife Announces First Quarter 2018 Financial Results 308

7 Appendix 432

7.1 Methodology 432

7.2 About GlobalData 435

7.3 Contact Us 435

7.4 Disclaimer 435


List Of Figure

1.2 List of Figures

Figure 1: Prosthetic Heart Valves-Pipeline Products by Stage of Development 26

Figure 2: Prosthetic Heart Valves-Pipeline Products by Segment 27

Figure 3: Prosthetic Heart Valves-Pipeline Products by Territory 28

Figure 4: Prosthetic Heart Valves-Pipeline Products by Regulatory Path 30

Figure 5: Prosthetic Heart Valves-Pipeline Products by Estimated Approval Date 31

Figure 6: Prosthetic Heart Valves-Ongoing Clinical Trials 32


List Of Table

1.1 List of Tables

Table 1: Prosthetic Heart Valves-Pipeline Products by Stage of Development 26

Table 2: Prosthetic Heart Valves-Pipeline Products by Segment 27

Table 3: Prosthetic Heart Valves-Pipeline Products by Territory 28

Table 4: Prosthetic Heart Valves-Pipeline Products by Regulatory Path 30

Table 5: Prosthetic Heart Valves-Pipeline Products by Estimated Approval Date 31

Table 6: Prosthetic Heart Valves-Ongoing Clinical Trials 32

Table 7: Prosthetic Heart Valves Companies-Pipeline Products by Stage of Development 33

Table 8: Prosthetic Heart Valves-Pipeline Products by Stage of Development 37

Table 9: 4C Medical Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 43

Table 10: AltaValve-Product Status 43

Table 11: AltaValve-Product Description 43

Table 12: Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 44

Table 13: Tendyne Bioprosthetic Mitral Valve Implantation System-Product Status 44

Table 14: Tendyne Bioprosthetic Mitral Valve Implantation System-Product Description 44

Table 15: Abbott Vascular Inc-Ongoing Clinical Trials Overview 45

Table 16: Tendyne Bioprosthetic Mitral Valve Implantation System-Expanded Clinical Study of the Tendyne Mitral Valve System 46

Table 17: Admedus Ltd Pipeline Products & Ongoing Clinical Trials Overview 47

Table 18: Transcatheter Aortic Valve Replacement Device-Product Status 47

Table 19: Transcatheter Aortic Valve Replacement Device-Product Description 47

Table 20: Aegis Surgical Limited Pipeline Products & Ongoing Clinical Trials Overview 48

Table 21: pTAo-TAVR-Product Status 48

Table 22: pTAo-TAVR-Product Description 48

Table 23: Annulon Pipeline Products & Ongoing Clinical Trials Overview 49

Table 24: Mitral Valve Replacement Device-Product Status 49

Table 25: Mitral Valve Replacement Device-Product Description 49

Table 26: AorTech International Plc Pipeline Products & Ongoing Clinical Trials Overview 50

Table 27: AorTech Polymer Valve-Product Status 50

Table 28: AorTech Polymer Valve-Product Description 50

Table 29: AorTx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 51

Table 30: AorTx Valve-Product Status 51

Table 31: AorTx Valve-Product Description 51

Table 32: Arbor Surgical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 52

Table 33: Trilogy Aortic Valve System-Product Status 52

Table 34: Trilogy Aortic Valve System-Product Description 52

Table 35: Boston Children's Hospital Pipeline Products & Ongoing Clinical Trials Overview 53

Table 36: Pulmonary Valve Replacement Device-Product Status 53

Table 37: Pulmonary Valve Replacement Device-Product Description 53

Table 38: Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 54

Table 39: ACURATE TAVR-Product Status 54

Table 40: ACURATE TAVR-Product Description 55

Table 41: Gen 4 Lotus Valve System-Product Status 55

Table 42: Gen 4 Lotus Valve System-Product Description 55

Table 43: Lotus Edge Sheath 15F-Product Status 55

Table 44: Lotus Edge Sheath 15F-Product Description 56

Table 45: Lotus Edge Valve System-21 mm-Product Status 56

Table 46: Lotus Edge Valve System-21 mm-Product Description 56

Table 47: Lotus Edge Valve System-23 mm-Product Status 57

Table 48: Lotus Edge Valve System-23 mm-Product Description 57

Table 49: Lotus Edge Valve System-25 mm-Product Status 57

Table 50: Lotus Edge Valve System-25 mm-Product Description 58

Table 51: Lotus Edge Valve System-27 mm-Product Status 58

Table 52: Lotus Edge Valve System-27 mm-Product Description 58

Table 53: Lotus Edge Valve System-29 mm-Product Status 59

Table 54: Lotus Edge Valve System-29 mm-Product Description 59

Table 55: Lotus Valve System-21 mm-Product Status 59

Table 56: Lotus Valve System-21 mm-Product Description 60

Table 57: Lotus Valve System-23 mm-Product Status 60

Table 58: Lotus Valve System-23 mm-Product Description 61

Table 59: Lotus Valve System-25 mm-Product Status 61

Table 60: Lotus Valve System-25 mm-Product Description 62

Table 61: Lotus Valve System-27 mm-Product Status 62

Table 62: Lotus Valve System-27 mm-Product Description 62

Table 63: Lotus Valve System-29 mm-Product Status 63

Table 64: Lotus Valve System-29 mm-Product Description 63

Table 65: Transaortic Sheath-Product Status 63

Table 66: Transaortic Sheath-Product Description 64

Table 67: Boston Scientific Corp-Ongoing Clinical Trials Overview 65

Table 68: Lotus Valve System-23 mm-Experience with Percutaneous Transcatheter Aortic Valve Implantation in Patients with Symptomatic Aortic Valve Disease in Two German Centers 67

Table 69: Lotus Valve System-23 mm-Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 67

Table 70: Lotus Valve System-23 mm-Re-positionable Lotus Valve System-Post Market Evaluation of Real World Clinical Outcomes: RESPOND 67

Table 71: Lotus Valve System-23 mm-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in China: REPRISE China 68

Table 72: Lotus Valve System-23 mm-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in Japan: REPRISE Japan 68

Table 73: 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) 68

Table 74: Lotus Valve System-27 mm-Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 69

Table 75: Lotus Valve System-27 mm-Re-positionable Lotus Valve System-Post Market Evaluation of Real World Clinical Outcomes: RESPOND 69

Table 76: Lotus Valve System-27 mm-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in China: REPRISE China 69

Table 77: Lotus Valve System-27 mm-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in Japan: REPRISE Japan 70

Table 78: 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) 70

Table 79: Lotus Valve System-25 mm-Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 71

Table 80: Lotus Valve System-25 mm-Re-positionable Lotus Valve System-Post Market Evaluation of Real World Clinical Outcomes: RESPOND 71

Table 81: Lotus Valve System-25 mm-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in China: REPRISE China 71

Table 82: Lotus Valve System-25 mm-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in Japan: REPRISE Japan 72

Table 83: 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) 72

Table 84: Lotus Valve System-21 mm-Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 73

Table 85: Lotus Valve System-21 mm-Re-positionable Lotus Valve System-Post Market Evaluation of Real World Clinical Outcomes: RESPOND 73

Table 86: 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) 73

Table 87: Lotus Valve System-29 mm-Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 74

Table 88: Lotus Valve System-29 mm-Re-positionable Lotus Valve System-Post Market Evaluation of Real World Clinical Outcomes: RESPOND 74

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Products and Companies

Products

4C Medical Technologies Inc, AltaValve; Abbott Vascular Inc, Tendyne Bioprosthetic Mitral Valve Implantation System; Admedus Ltd, Transcatheter Aortic Valve Replacement Device; Aegis Surgical Limited, pTAo-TAVR; Annulon, Mitral Valve Replacement Device; AorTech International Plc, AorTech Polymer Valve; AorTx, Inc., AorTx Valve; Arbor Surgical Technologies, Inc., Trilogy Aortic Valve System; Boston Children's Hospital, Pulmonary Valve Replacement Device; 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; Boston Scientific Corp, Transaortic Sheath; Carena Healthcare Ltd, PILLAR 3D Printed Replacement Heart Valve; Cephea Valve Technologies, Inc., Mitral Valve Replacement Device; Children's Hospital Boston, Heart Valve Leaflet; Children's Hospital Boston, Two Piece 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, Custom Delivery System; Colibri Heart Valve, LLC, Delta Aortic Heart Valve; Colibri Heart Valve, LLC, Mitral Valve; Colibri Heart Valve, LLC, Pulmonary Valve; Colibri Heart Valve, LLC, Sutureless Surgical Aortic Valve; Colibri Heart Valve, LLC, Venibri Transcatheter Heart Valve System; Collagen Solutions Plc, Heart Valve Device; Colorado State University, BioPoly Heart Valve; CorMatrix Cardiovascular Inc, CorMatrix ECM - Heart Valve Repair; CorMatrix Cardiovascular Inc, CorMatrix ECM - Heart Valve Replacement; CorMatrix Cardiovascular Inc, CorMatrix ECM Tricuspid Heart Valve; CorMatrix Cardiovascular Inc, Pediatric Prosthetic Trileaflet Valve; CorMatrix Cardiovascular Inc, Regenerating Tubular Mitral Valve; CryoLife Inc, CryoValve SGAV; CryoLife Inc, Synergraft Xenograft Heart Valve; Cytograft Tissue Engineering Inc (Inactive), Cytograft Valve; Daidalos Solutions BV, Sutureless Aortic valve Prosthesis; Daidalos Solutions BV, Sutureless Mitral Valve Prostheses; Daidalos Solutions BV, Sutureless Trans-Catheter Aortic Valve Replacement (TAVR); Daidalos Solutions BV, Sutureless Trans-Catheter Mitral Valve Replacement (TMVR); Daidalos Solutions BV, Sutureless Trans-Catheter Tricuspid Valve Replacement (TTVR); Daidalos Solutions BV, Sutureless Tricuspid Valve Prostheses; Direct Flow Medical Inc (Inactive), 18F Direct Flow Medical Transcatheter Aortic Valve System; Direct Flow Medical Inc (Inactive), 22F Percutaneous Aortic Valve System; Direct Flow Medical Inc (Inactive), Direct Flow Medical Transcatheter Mitral Valve; DSM Dyneema BV, Dyneema Purity - Transcatheter Heart Valve; Dura LLC, LowPro Valve; Dura LLC, Transcatheter Pulmonary Valve Device; Edwards Lifesciences Corp, Cardiaq Mitral Valve; Edwards Lifesciences Corp, Carpentier-Edwards BioPhysio Aortic Valve; Edwards Lifesciences Corp, Edwards CENTERA Valve; Edwards Lifesciences Corp, Edwards SAPIEN 3 Transcatheter Heart Valve - Low Risk; Edwards Lifesciences Corp, FORTIS Mitral Transcatheter Heart Valve; Edwards Lifesciences Corp, GLX Aortic Conduit; Edwards Lifesciences Corp, INSPIRIS RESILIA Aortic Valve; Edwards Lifesciences Corp, INTUITY Valve System; Edwards Lifesciences Corp, KONECT Conduit; Edwards Lifesciences Corp, Magna EASE Surgical Valve With GLX; Edwards Lifesciences Corp, Next Gen CENTERA; Edwards Lifesciences Corp, Next Gen SAPIEN; Edwards Lifesciences Corp, Next Generation Mitral Heart Valve; Edwards Lifesciences Corp, PASCAL Transcatheter Mitral Valve Repair System; Edwards Lifesciences Corp, Sapien 3 Heart Valve - Heart Failure; Edwards Lifesciences Corp, Sapien 3 Heart Valve - Mitral Annular Calcification; Edwards Lifesciences Corp, Sapien 3 Heart Valve - Pulmonic; Edwards Lifesciences Corp, Sapien 3 Ultra Delivery System; Edwards Lifesciences Corp, Sapien Evolutionary Transcatheter Heart Valve; Edwards Lifesciences Corp, SAPIEN M3; Edwards Lifesciences Corp, Sapien Revolutionary Transcatheter Heart Valve; Edwards Lifesciences Corp, Second Generation Transapical Transcatheter Mitral Valve; Emory University, MitraCath; Endoluminal Technology Research, LLC, Balloon Expandable Paniagua Heart Valve; Endoluminal Technology Research, LLC, Self Expandable Paniagua Heart Valve; Florida International University, Percutaneous Aortic Heart Valve; Florida International University, Percutaneous Heart Valve Delivery System; Georgia Institute of Technology, Replaceable Heart Valve Prosthesis; Hancock Jaffe Laboratories Inc, Bioprosthetic Aortic Heart Valve; Hancock Jaffe Laboratories Inc, Bioprosthetic Mitral Heart Valve; HighLife SAS, Transcatheter Mitral Valve Replacement System; HLT, Inc., HLT Transcatheter Valve System; Hocor Cardiovascular Technologies, LLC, HOCOR System; Innovia LLC, Minimally Invasive Synthetic Tri - Leaflet Heart Valve; Innovia LLC, Percutaneous Synthetic Tri - Leaflet Heart Valve; Innovia LLC, Sutured In Synthetic Tri - Leaflet Heart Valve; JC Medical, Inc., J-Valve TAVI System - Transapical; JC Medical, Inc., J-Valve TAVI System - Transfemoral; JenaValve Technology GmbH, JenaValve Pericardial TAVR System; Leman Cardiovascular SA, Kalangos Valve; LivaNova PLC , Caisson TMVR System; LivaNova PLC , Perceval S - Extended Indications; LivaNova PLC , Perceval Sutureless Aortic Valve - XL Version; LivaNova PLC , Perceval Sutureless Heart Valve; Mayo Clinic, Percutaneous Aortic Valve; Medi-Line S.A., AVATAR² Device; Medtronic plc, Closed-Chest Aortic Tissue Valve; Medtronic plc, CoreValve Evolut PRO - 34 mm; Medtronic plc, CoreValve Evolut R Recapturable System - Low-Risk Aortic Stenosis; Medtronic plc, Enable Valve-Beating Heart Procedure; Medtronic plc, Harmony Transcatheter Pulmonary Valve; Medtronic plc, Intrepid Transcatheter Mitral Valve Replacement; Medtronic plc, Native Outflow Tract Transcatheter Pulmonary Valve; Medtronic plc, Next Generation TCV; Medtronic plc, TCV - Aortic; Medtronic plc, TCV - Mitral; Medtronic plc, TCV - Pulmonic; Medtronic plc, Twelve Transcatheter Mitral Valve Replacement System; Meril Life Sciences Pvt Ltd, Myval Transcatheter Aortic Valve Replacement System; Micro Interventional Devices, Inc., Endovalve; MicroPort Scientific Corp, Biomaterial Replacement Heart Valve; MicroPort Scientific Corp, Vitaflow Transcatheter Aortic Valve; Mitralix Ltd., MAESTRO; MitrAssist Ltd., MitrAssist Valve; Mitricares, MITRICARES Device; MValve Technologies Ltd., MValve Docking System; NaviGate Cardiac Structures, Inc., Gate Tricuspid Valved Stent; NaviGate Cardiac Structures, Inc., Navi Mitral Valved Stent; Neovasc Inc, Tiara Transcatheter Mitral Valve; Peca Labs, Inc., Masa Valve; PolyNova Cardiovascular LLC (Inactive), Trileaflet Polymeric Prosthetic Heart Valve; Polyvascular Corp, Pediatric Valve Device; Rambam Health Care Campus, Prosthetic Heart Valve; RegenaGraft, Synthetic Heart Valve; ReValve Med Inc, Removable Transcatheter Aortic Valve; Revivicor Inc, Heart Valve; SAS Cormove, CORMOVE Percutaneous Aortic Valve; Sino Medical Sciences Technology Inc, AccuFit Transapical Mitral Valve Replacement Device; Sree Chitra Tirunal Institute for Medical Sciences &; Technology, Tissue Based Cardiac Valve; St. Jude Medical LLC, Next Generation - Portico Valve; St. Jude Medical LLC, Portico Subclavian Delivery System; St. Jude Medical LLC, Portico Transcatheter Aortic Valve Implantation System; St. Jude Medical LLC, Transapical Mitral Valve Delivery System; St. Jude Medical LLC, Transeptal Mitral Valve Delivery System; St. Jude Medical LLC, Transfemoral Mitral Valve Delivery System; Stellenbosch University, Percutaneous Heart Valve; Strait Access Technologies (Pty) Ltd, Heart Valve; Strait Access Technologies (Pty) Ltd, Transcatheter Valve Delivery Device; Symetis SA, ACURATE - Size Matrix Expansion; Symetis SA, ACURATE neo Aortic Bioprosthesis; Symetis SA, ACURATE neo AS Aortic Bioprosthesis - Transfemoral Delivery; Symetis SA, ACURATE TA LP Transapical Delivery System; Symetis SA, ACURATE TAo; Symetis SA, Acurate TF; Thoratec Corp, Next Generation Device For TAVI; Thubrikar Aortic Valve, Inc., Optimum TAV Delivery Catheter; Thubrikar Aortic Valve, Inc., Optimum TAVI System; Tissue Regenix Ltd, Cardiopure - Aortic Heart Valve; Tissue Regenix Ltd, Cardiopure - Pulmonary Heart Valve; Trinity College Dublin, MiVaR Device; TTK Healthcare Ltd, Second Generation TTK-Chitra Heart valve; University College London, Percutaneous Heart Valve Delivery Device; University College London, Percutaneous Mitral Valve Device; University College London, TRISKELE Aortic Valve; University of Arizona, Polymeric Heart Valve; University of California Irvine, Bileaflet Bioprosthetic Mitral Valve; University of California Irvine, Heart Valve Leaflets; University of California Irvine, Tubular Scaffold Heart Valves; University of California San Francisco, Transcatheter Aortic Valve; University of California, Atrioventricular Heart Valves Delivery System; University of Cambridge, Polymeric Heart Valve; University of Cambridge, Removable Transcatheter Valve; University of Colorado, Prosthetic Valve; University of Florida, Replacement Heart Valve; University of Iowa, Cellulose Based Aortic Heart Valve; University of Iowa, Expandable Transcatheter Flutter Valve; University of Minnesota, Tissue-Engineered Vessel Graft; University of Pennsylvania, Peripheral Mitral Valve Delivery System; University of Pennsylvania, Sutureless Mitral Valve Replacement Device; University of Pennsylvania, Thoracotomy Mitral Valve Delivery System; University of Pennsylvania, Transatrial Mitral Valve Delivery System; University of South Florida, Ascending Aortic Prosthesis; University of Zurich, Prostheses Heart Valve; Valtech Cardio Ltd, Valtech Cardiovalve; ValveXchange, Inc. (Inactive), Pulmonic Pediatric Valve; ValveXchange, Inc. (Inactive), Vanguard System; ValveXchange, Inc. (Inactive), Vitality Exchangeable Valve System; ValveXchange, Inc. (Inactive), VXi Vanguard II; Vascular Concepts Ltd, TAVI (Transcatheter Aortic Valve Replacement); Venus MedTech, Transapical Trinity Aortic Valve Implantation System; Venus MedTech, Transfemoral Trinity Aortic Valve Implantation System; Venus MedTech, Tresillo System; Venus MedTech, Venus A-Valve; Venus MedTech, Venus P-Valve; VueKlar Cardiovascular Ltd (Inactive), MR-Enhancing Percutaneous Heart Valve; Xeltis AG, Transcatheter Aortic Heart Valve; Xeltis AG, Xeltis Pulmonary Valve


Companies

4C Medical Technologies Inc

Abbott Vascular Inc

Admedus Ltd

Aegis Surgical Limited

Annulon

AorTech International Plc

AorTx, Inc.

Arbor Surgical Technologies, Inc.

Boston Children's Hospital

Boston Scientific Corp

Carena Healthcare Ltd

Cephea Valve Technologies, Inc.

Children's Hospital Boston

Clemson University

Colibri Heart Valve, LLC

Collagen Solutions Plc

Colorado State University

CorMatrix Cardiovascular Inc

CryoLife Inc

Cytograft Tissue Engineering Inc

Daidalos Solutions BV

Direct Flow Medical Inc

DSM Dyneema BV

Dura LLC

Edwards Lifesciences Corp

Emory University

Endoluminal Technology Research, LLC

Florida International University

Georgia Institute of Technology

Hancock Jaffe Laboratories Inc

HighLife SAS

HLT, Inc.

Hocor Cardiovascular Technologies, LLC

Innovia LLC

JC Medical, Inc.

JenaValve Technology GmbH

Leman Cardiovascular SA

LivaNova PLC

Mayo Clinic

Medi-Line S.A.

Medtronic plc

Meril Life Sciences Pvt Ltd

Micro Interventional Devices, Inc.

MicroPort Scientific Corp

Mitralix Ltd.

MitrAssist Ltd.

Mitricares

MValve Technologies Ltd.

NaviGate Cardiac Structures, Inc.

Neovasc Inc

Peca Labs, Inc.

PolyNova Cardiovascular LLC

Polyvascular Corp

Rambam Health Care Campus

RegenaGraft

ReValve Med Inc

Revivicor Inc

SAS Cormove

Sino Medical Sciences Technology Inc

Sree Chitra Tirunal Institute for Medical Sciences & Technology

St. Jude Medical LLC

Stellenbosch University

Strait Access Technologies (Pty) Ltd

Symetis SA

Thoratec Corp

Thubrikar Aortic Valve, Inc.

Tissue Regenix Ltd

Trinity College Dublin

TTK Healthcare Ltd

University College London

University of Arizona

University of California

University of California Irvine

University of California San Francisco

University of Cambridge

University of Colorado

University of Florida

University of Iowa

University of Minnesota

University of Pennsylvania

University of South Florida

University of Zurich

Valtech Cardio Ltd

ValveXchange, Inc.

Vascular Concepts Ltd

Venus MedTech

VueKlar Cardiovascular Ltd

Xeltis AG

Prosthetic Heart Valves-Medical Devices Pipeline Assessment, 2018

Summary

GlobalData's Medical Devices sector report, Prosthetic Heart Valves-Medical Devices Pipeline Assessment, 2018 provides an overview of Prosthetic 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 Prosthetic 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 Prosthetic 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 Prosthetic 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 Prosthetic 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

READ MORE

Scope

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 8

1.2 List of Figures 21

2 Introduction 22

2.1 Prosthetic Heart Valves Overview 22

3 Products under Development 24

3.1 Prosthetic Heart Valves-Pipeline Products by Stage of Development 24

3.2 Prosthetic Heart Valves-Pipeline Products by Segment 25

3.3 Prosthetic Heart Valves-Pipeline Products by Territory 26

3.4 Prosthetic Heart Valves-Pipeline Products by Regulatory Path 28

3.5 Prosthetic Heart Valves-Pipeline Products by Estimated Approval Date 29

3.6 Prosthetic Heart Valves-Ongoing Clinical Trials 30

4 Prosthetic Heart Valves-Pipeline Products under Development by Companies 31

4.1 Prosthetic Heart Valves Companies-Pipeline Products by Stage of Development 31

4.2 Prosthetic Heart Valves-Pipeline Products by Stage of Development 35

5 Prosthetic Heart Valves Companies and Product Overview 41

5.1 4C Medical Technologies Inc Company Overview 41

5.2 Abbott Vascular Inc Company Overview 42

5.3 Admedus Ltd Company Overview 45

5.4 Aegis Surgical Limited Company Overview 46

5.5 Annulon Company Overview 47

5.6 AorTech International Plc Company Overview 48

5.7 AorTx, Inc. Company Overview 49

5.8 Arbor Surgical Technologies, Inc. Company Overview 50

5.9 Boston Children's Hospital Company Overview 51

5.10 Boston Scientific Corp Company Overview 52

5.11 Carena Healthcare Ltd Company Overview 75

5.12 Cephea Valve Technologies, Inc. Company Overview 76

5.13 Children's Hospital Boston Company Overview 77

5.14 Clemson University Company Overview 79

5.15 Colibri Heart Valve, LLC Company Overview 80

5.16 Collagen Solutions Plc Company Overview 89

5.17 Colorado State University Company Overview 90

5.18 CorMatrix Cardiovascular Inc Company Overview 91

5.19 CryoLife Inc Company Overview 97

5.20 Cytograft Tissue Engineering Inc (Inactive) Company Overview 99

5.21 Daidalos Solutions BV Company Overview 100

5.22 Direct Flow Medical Inc (Inactive) Company Overview 104

5.23 DSM Dyneema BV Company Overview 108

5.24 Dura LLC Company Overview 109

5.25 Edwards Lifesciences Corp Company Overview 111

5.26 Emory University Company Overview 139

5.27 Endoluminal Technology Research, LLC Company Overview 140

5.28 Florida International University Company Overview 142

5.29 Georgia Institute of Technology Company Overview 144

5.30 Hancock Jaffe Laboratories Inc Company Overview 145

5.31 HighLife SAS Company Overview 147

5.32 HLT, Inc. Company Overview 150

5.33 Hocor Cardiovascular Technologies, LLC Company Overview 153

5.34 Innovia LLC Company Overview 154

5.35 JC Medical, Inc. Company Overview 156

5.36 JenaValve Technology GmbH Company Overview 161

5.37 Leman Cardiovascular SA Company Overview 164

5.38 LivaNova PLC Company Overview 165

5.39 Mayo Clinic Company Overview 175

5.40 Medi-Line S.A. Company Overview 176

5.41 Medtronic plc Company Overview 177

5.42 Meril Life Sciences Pvt Ltd Company Overview 191

5.43 Micro Interventional Devices, Inc. Company Overview 192

5.44 MicroPort Scientific Corp Company Overview 193

5.45 Mitralix Ltd. Company Overview 197

5.46 MitrAssist Ltd. Company Overview 198

5.47 Mitricares Company Overview 199

5.48 MValve Technologies Ltd. Company Overview 200

5.49 NaviGate Cardiac Structures, Inc. Company Overview 203

5.50 Neovasc Inc Company Overview 207

5.51 Peca Labs, Inc. Company Overview 210

5.52 PolyNova Cardiovascular LLC (Inactive) Company Overview 211

5.53 Polyvascular Corp Company Overview 212

5.54 Rambam Health Care Campus Company Overview 213

5.55 RegenaGraft Company Overview 214

5.56 ReValve Med Inc Company Overview 215

5.57 Revivicor Inc Company Overview 216

5.58 SAS Cormove Company Overview 217

5.59 Sino Medical Sciences Technology Inc Company Overview 218

5.60 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 219

5.61 St. Jude Medical LLC Company Overview 220

5.62 Stellenbosch University Company Overview 226

5.63 Strait Access Technologies (Pty) Ltd Company Overview 227

5.64 Symetis SA Company Overview 229

5.65 Thoratec Corp Company Overview 242

5.66 Thubrikar Aortic Valve, Inc. Company Overview 243

5.67 Tissue Regenix Ltd Company Overview 245

5.68 Trinity College Dublin Company Overview 247

5.69 TTK Healthcare Ltd Company Overview 248

5.70 University College London Company Overview 249

5.71 University of Arizona Company Overview 252

5.72 University of California Company Overview 253

5.73 University of California Irvine Company Overview 254

5.74 University of California San Francisco Company Overview 256

5.75 University of Cambridge Company Overview 257

5.76 University of Colorado Company Overview 259

5.77 University of Florida Company Overview 260

5.78 University of Iowa Company Overview 261

5.79 University of Minnesota Company Overview 263

5.80 University of Pennsylvania Company Overview 264

5.81 University of South Florida Company Overview 267

5.82 University of Zurich Company Overview 268

5.83 Valtech Cardio Ltd Company Overview 269

5.84 ValveXchange, Inc. (Inactive) Company Overview 272

5.85 Vascular Concepts Ltd Company Overview 275

5.86 Venus MedTech Company Overview 276

5.87 VueKlar Cardiovascular Ltd (Inactive) Company Overview 283

5.88 Xeltis AG Company Overview 284

6 Prosthetic Heart Valves- Recent Developments 289

6.1 Jun 05, 2018: Medtronic Presents Strategic Growth Roadmap at 2018 Investor Day; Outlines Plan to Create Shareholder Value 289

6.2 May 31, 2018: JC Medical Announces First-in-Human Treatment with the Unique Transfemoral J-Valve TAVI Device for Aortic Regurgitation 289

6.3 May 24, 2018: Medtronic Reports Fourth Quarter And Fiscal Year 2018 Financial Results 290

6.4 May 23, 2018: Abbott's Investigational Tendyne Device for Mitral Valve Replacement Demonstrates Positive Outcomes at 30 Days in Global Study 292

6.5 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 294

6.6 May 22, 2018: Real-World Evidence Confirms Clinical Trial Outcomes For Patients Treated With Edwards SAPIEN 3 Valve 295

6.7 May 22, 2018: Admedus: TAVR Progress Continues With Filing of New Provisional Patents 296

6.8 May 21, 2018: Edwards Announces Key Events For EuroPCR 2018 297

6.9 May 21, 2018: NaviGate Cardiac Structures reports excellent valvular function” at 1-year follow-up of first patient to receive GATE tricuspid valved stent via transjugular access 297

6.10 May 17, 2018: MicroPort CardioFlow Releases One-year Clinical Outcome of VitaFlow 299

6.11 May 17, 2018: MicroPort CardioFlow Attends Fourth China Valve (Hangzhou) Meeting 300

6.12 May 17, 2018: Mr. Jonathan Chen Promoted to Chief International Business Officer of MPSC 300

6.13 May 16, 2018: Boston Scientific Announces Schedule of Presentations at EuroPCR 2018 301

6.14 May 16, 2018: Boston Scientific Announces Schedule of Presentations at EuroPCR 2018 302

6.15 May 10, 2018: Neovasc Announces Results for the First Quarter 2018 302

6.16 May 09, 2018: Computer-Designed Customized Regenerative Heart Valves 306

6.17 May 07, 2018: Medtronic Appoints Mike Weinstein As Senior Vice President Of Strategy 307

6.18 May 04, 2018: Colibri Heart Valve Continues Enrollment in Clinical Feasibility Study of Second-Generation TAVI System 307

6.19 May 02, 2018: CryoLife Announces First Quarter 2018 Financial Results 308

7 Appendix 432

7.1 Methodology 432

7.2 About GlobalData 435

7.3 Contact Us 435

7.4 Disclaimer 435


List Of Figure

1.2 List of Figures

Figure 1: Prosthetic Heart Valves-Pipeline Products by Stage of Development 26

Figure 2: Prosthetic Heart Valves-Pipeline Products by Segment 27

Figure 3: Prosthetic Heart Valves-Pipeline Products by Territory 28

Figure 4: Prosthetic Heart Valves-Pipeline Products by Regulatory Path 30

Figure 5: Prosthetic Heart Valves-Pipeline Products by Estimated Approval Date 31

Figure 6: Prosthetic Heart Valves-Ongoing Clinical Trials 32


List Of Table

1.1 List of Tables

Table 1: Prosthetic Heart Valves-Pipeline Products by Stage of Development 26

Table 2: Prosthetic Heart Valves-Pipeline Products by Segment 27

Table 3: Prosthetic Heart Valves-Pipeline Products by Territory 28

Table 4: Prosthetic Heart Valves-Pipeline Products by Regulatory Path 30

Table 5: Prosthetic Heart Valves-Pipeline Products by Estimated Approval Date 31

Table 6: Prosthetic Heart Valves-Ongoing Clinical Trials 32

Table 7: Prosthetic Heart Valves Companies-Pipeline Products by Stage of Development 33

Table 8: Prosthetic Heart Valves-Pipeline Products by Stage of Development 37

Table 9: 4C Medical Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 43

Table 10: AltaValve-Product Status 43

Table 11: AltaValve-Product Description 43

Table 12: Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 44

Table 13: Tendyne Bioprosthetic Mitral Valve Implantation System-Product Status 44

Table 14: Tendyne Bioprosthetic Mitral Valve Implantation System-Product Description 44

Table 15: Abbott Vascular Inc-Ongoing Clinical Trials Overview 45

Table 16: Tendyne Bioprosthetic Mitral Valve Implantation System-Expanded Clinical Study of the Tendyne Mitral Valve System 46

Table 17: Admedus Ltd Pipeline Products & Ongoing Clinical Trials Overview 47

Table 18: Transcatheter Aortic Valve Replacement Device-Product Status 47

Table 19: Transcatheter Aortic Valve Replacement Device-Product Description 47

Table 20: Aegis Surgical Limited Pipeline Products & Ongoing Clinical Trials Overview 48

Table 21: pTAo-TAVR-Product Status 48

Table 22: pTAo-TAVR-Product Description 48

Table 23: Annulon Pipeline Products & Ongoing Clinical Trials Overview 49

Table 24: Mitral Valve Replacement Device-Product Status 49

Table 25: Mitral Valve Replacement Device-Product Description 49

Table 26: AorTech International Plc Pipeline Products & Ongoing Clinical Trials Overview 50

Table 27: AorTech Polymer Valve-Product Status 50

Table 28: AorTech Polymer Valve-Product Description 50

Table 29: AorTx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 51

Table 30: AorTx Valve-Product Status 51

Table 31: AorTx Valve-Product Description 51

Table 32: Arbor Surgical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 52

Table 33: Trilogy Aortic Valve System-Product Status 52

Table 34: Trilogy Aortic Valve System-Product Description 52

Table 35: Boston Children's Hospital Pipeline Products & Ongoing Clinical Trials Overview 53

Table 36: Pulmonary Valve Replacement Device-Product Status 53

Table 37: Pulmonary Valve Replacement Device-Product Description 53

Table 38: Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 54

Table 39: ACURATE TAVR-Product Status 54

Table 40: ACURATE TAVR-Product Description 55

Table 41: Gen 4 Lotus Valve System-Product Status 55

Table 42: Gen 4 Lotus Valve System-Product Description 55

Table 43: Lotus Edge Sheath 15F-Product Status 55

Table 44: Lotus Edge Sheath 15F-Product Description 56

Table 45: Lotus Edge Valve System-21 mm-Product Status 56

Table 46: Lotus Edge Valve System-21 mm-Product Description 56

Table 47: Lotus Edge Valve System-23 mm-Product Status 57

Table 48: Lotus Edge Valve System-23 mm-Product Description 57

Table 49: Lotus Edge Valve System-25 mm-Product Status 57

Table 50: Lotus Edge Valve System-25 mm-Product Description 58

Table 51: Lotus Edge Valve System-27 mm-Product Status 58

Table 52: Lotus Edge Valve System-27 mm-Product Description 58

Table 53: Lotus Edge Valve System-29 mm-Product Status 59

Table 54: Lotus Edge Valve System-29 mm-Product Description 59

Table 55: Lotus Valve System-21 mm-Product Status 59

Table 56: Lotus Valve System-21 mm-Product Description 60

Table 57: Lotus Valve System-23 mm-Product Status 60

Table 58: Lotus Valve System-23 mm-Product Description 61

Table 59: Lotus Valve System-25 mm-Product Status 61

Table 60: Lotus Valve System-25 mm-Product Description 62

Table 61: Lotus Valve System-27 mm-Product Status 62

Table 62: Lotus Valve System-27 mm-Product Description 62

Table 63: Lotus Valve System-29 mm-Product Status 63

Table 64: Lotus Valve System-29 mm-Product Description 63

Table 65: Transaortic Sheath-Product Status 63

Table 66: Transaortic Sheath-Product Description 64

Table 67: Boston Scientific Corp-Ongoing Clinical Trials Overview 65

Table 68: Lotus Valve System-23 mm-Experience with Percutaneous Transcatheter Aortic Valve Implantation in Patients with Symptomatic Aortic Valve Disease in Two German Centers 67

Table 69: Lotus Valve System-23 mm-Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 67

Table 70: Lotus Valve System-23 mm-Re-positionable Lotus Valve System-Post Market Evaluation of Real World Clinical Outcomes: RESPOND 67

Table 71: Lotus Valve System-23 mm-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in China: REPRISE China 68

Table 72: Lotus Valve System-23 mm-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in Japan: REPRISE Japan 68

Table 73: 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) 68

Table 74: Lotus Valve System-27 mm-Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 69

Table 75: Lotus Valve System-27 mm-Re-positionable Lotus Valve System-Post Market Evaluation of Real World Clinical Outcomes: RESPOND 69

Table 76: Lotus Valve System-27 mm-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in China: REPRISE China 69

Table 77: Lotus Valve System-27 mm-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in Japan: REPRISE Japan 70

Table 78: 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) 70

Table 79: Lotus Valve System-25 mm-Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 71

Table 80: Lotus Valve System-25 mm-Re-positionable Lotus Valve System-Post Market Evaluation of Real World Clinical Outcomes: RESPOND 71

Table 81: Lotus Valve System-25 mm-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in China: REPRISE China 71

Table 82: Lotus Valve System-25 mm-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in Japan: REPRISE Japan 72

Table 83: 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) 72

Table 84: Lotus Valve System-21 mm-Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 73

Table 85: Lotus Valve System-21 mm-Re-positionable Lotus Valve System-Post Market Evaluation of Real World Clinical Outcomes: RESPOND 73

Table 86: 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) 73

Table 87: Lotus Valve System-29 mm-Mitral Valve Replacement with the MValve Dock and a Percutaneous Transcatheter Heart Valve 74

Table 88: Lotus Valve System-29 mm-Re-positionable Lotus Valve System-Post Market Evaluation of Real World Clinical Outcomes: RESPOND 74

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Products

4C Medical Technologies Inc, AltaValve; Abbott Vascular Inc, Tendyne Bioprosthetic Mitral Valve Implantation System; Admedus Ltd, Transcatheter Aortic Valve Replacement Device; Aegis Surgical Limited, pTAo-TAVR; Annulon, Mitral Valve Replacement Device; AorTech International Plc, AorTech Polymer Valve; AorTx, Inc., AorTx Valve; Arbor Surgical Technologies, Inc., Trilogy Aortic Valve System; Boston Children's Hospital, Pulmonary Valve Replacement Device; 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; Boston Scientific Corp, Transaortic Sheath; Carena Healthcare Ltd, PILLAR 3D Printed Replacement Heart Valve; Cephea Valve Technologies, Inc., Mitral Valve Replacement Device; Children's Hospital Boston, Heart Valve Leaflet; Children's Hospital Boston, Two Piece 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, Custom Delivery System; Colibri Heart Valve, LLC, Delta Aortic Heart Valve; Colibri Heart Valve, LLC, Mitral Valve; Colibri Heart Valve, LLC, Pulmonary Valve; Colibri Heart Valve, LLC, Sutureless Surgical Aortic Valve; Colibri Heart Valve, LLC, Venibri Transcatheter Heart Valve System; Collagen Solutions Plc, Heart Valve Device; Colorado State University, BioPoly Heart Valve; CorMatrix Cardiovascular Inc, CorMatrix ECM - Heart Valve Repair; CorMatrix Cardiovascular Inc, CorMatrix ECM - Heart Valve Replacement; CorMatrix Cardiovascular Inc, CorMatrix ECM Tricuspid Heart Valve; CorMatrix Cardiovascular Inc, Pediatric Prosthetic Trileaflet Valve; CorMatrix Cardiovascular Inc, Regenerating Tubular Mitral Valve; CryoLife Inc, CryoValve SGAV; CryoLife Inc, Synergraft Xenograft Heart Valve; Cytograft Tissue Engineering Inc (Inactive), Cytograft Valve; Daidalos Solutions BV, Sutureless Aortic valve Prosthesis; Daidalos Solutions BV, Sutureless Mitral Valve Prostheses; Daidalos Solutions BV, Sutureless Trans-Catheter Aortic Valve Replacement (TAVR); Daidalos Solutions BV, Sutureless Trans-Catheter Mitral Valve Replacement (TMVR); Daidalos Solutions BV, Sutureless Trans-Catheter Tricuspid Valve Replacement (TTVR); Daidalos Solutions BV, Sutureless Tricuspid Valve Prostheses; Direct Flow Medical Inc (Inactive), 18F Direct Flow Medical Transcatheter Aortic Valve System; Direct Flow Medical Inc (Inactive), 22F Percutaneous Aortic Valve System; Direct Flow Medical Inc (Inactive), Direct Flow Medical Transcatheter Mitral Valve; DSM Dyneema BV, Dyneema Purity - Transcatheter Heart Valve; Dura LLC, LowPro Valve; Dura LLC, Transcatheter Pulmonary Valve Device; Edwards Lifesciences Corp, Cardiaq Mitral Valve; Edwards Lifesciences Corp, Carpentier-Edwards BioPhysio Aortic Valve; Edwards Lifesciences Corp, Edwards CENTERA Valve; Edwards Lifesciences Corp, Edwards SAPIEN 3 Transcatheter Heart Valve - Low Risk; Edwards Lifesciences Corp, FORTIS Mitral Transcatheter Heart Valve; Edwards Lifesciences Corp, GLX Aortic Conduit; Edwards Lifesciences Corp, INSPIRIS RESILIA Aortic Valve; Edwards Lifesciences Corp, INTUITY Valve System; Edwards Lifesciences Corp, KONECT Conduit; Edwards Lifesciences Corp, Magna EASE Surgical Valve With GLX; Edwards Lifesciences Corp, Next Gen CENTERA; Edwards Lifesciences Corp, Next Gen SAPIEN; Edwards Lifesciences Corp, Next Generation Mitral Heart Valve; Edwards Lifesciences Corp, PASCAL Transcatheter Mitral Valve Repair System; Edwards Lifesciences Corp, Sapien 3 Heart Valve - Heart Failure; Edwards Lifesciences Corp, Sapien 3 Heart Valve - Mitral Annular Calcification; Edwards Lifesciences Corp, Sapien 3 Heart Valve - Pulmonic; Edwards Lifesciences Corp, Sapien 3 Ultra Delivery System; Edwards Lifesciences Corp, Sapien Evolutionary Transcatheter Heart Valve; Edwards Lifesciences Corp, SAPIEN M3; Edwards Lifesciences Corp, Sapien Revolutionary Transcatheter Heart Valve; Edwards Lifesciences Corp, Second Generation Transapical Transcatheter Mitral Valve; Emory University, MitraCath; Endoluminal Technology Research, LLC, Balloon Expandable Paniagua Heart Valve; Endoluminal Technology Research, LLC, Self Expandable Paniagua Heart Valve; Florida International University, Percutaneous Aortic Heart Valve; Florida International University, Percutaneous Heart Valve Delivery System; Georgia Institute of Technology, Replaceable Heart Valve Prosthesis; Hancock Jaffe Laboratories Inc, Bioprosthetic Aortic Heart Valve; Hancock Jaffe Laboratories Inc, Bioprosthetic Mitral Heart Valve; HighLife SAS, Transcatheter Mitral Valve Replacement System; HLT, Inc., HLT Transcatheter Valve System; Hocor Cardiovascular Technologies, LLC, HOCOR System; Innovia LLC, Minimally Invasive Synthetic Tri - Leaflet Heart Valve; Innovia LLC, Percutaneous Synthetic Tri - Leaflet Heart Valve; Innovia LLC, Sutured In Synthetic Tri - Leaflet Heart Valve; JC Medical, Inc., J-Valve TAVI System - Transapical; JC Medical, Inc., J-Valve TAVI System - Transfemoral; JenaValve Technology GmbH, JenaValve Pericardial TAVR System; Leman Cardiovascular SA, Kalangos Valve; LivaNova PLC , Caisson TMVR System; LivaNova PLC , Perceval S - Extended Indications; LivaNova PLC , Perceval Sutureless Aortic Valve - XL Version; LivaNova PLC , Perceval Sutureless Heart Valve; Mayo Clinic, Percutaneous Aortic Valve; Medi-Line S.A., AVATAR² Device; Medtronic plc, Closed-Chest Aortic Tissue Valve; Medtronic plc, CoreValve Evolut PRO - 34 mm; Medtronic plc, CoreValve Evolut R Recapturable System - Low-Risk Aortic Stenosis; Medtronic plc, Enable Valve-Beating Heart Procedure; Medtronic plc, Harmony Transcatheter Pulmonary Valve; Medtronic plc, Intrepid Transcatheter Mitral Valve Replacement; Medtronic plc, Native Outflow Tract Transcatheter Pulmonary Valve; Medtronic plc, Next Generation TCV; Medtronic plc, TCV - Aortic; Medtronic plc, TCV - Mitral; Medtronic plc, TCV - Pulmonic; Medtronic plc, Twelve Transcatheter Mitral Valve Replacement System; Meril Life Sciences Pvt Ltd, Myval Transcatheter Aortic Valve Replacement System; Micro Interventional Devices, Inc., Endovalve; MicroPort Scientific Corp, Biomaterial Replacement Heart Valve; MicroPort Scientific Corp, Vitaflow Transcatheter Aortic Valve; Mitralix Ltd., MAESTRO; MitrAssist Ltd., MitrAssist Valve; Mitricares, MITRICARES Device; MValve Technologies Ltd., MValve Docking System; NaviGate Cardiac Structures, Inc., Gate Tricuspid Valved Stent; NaviGate Cardiac Structures, Inc., Navi Mitral Valved Stent; Neovasc Inc, Tiara Transcatheter Mitral Valve; Peca Labs, Inc., Masa Valve; PolyNova Cardiovascular LLC (Inactive), Trileaflet Polymeric Prosthetic Heart Valve; Polyvascular Corp, Pediatric Valve Device; Rambam Health Care Campus, Prosthetic Heart Valve; RegenaGraft, Synthetic Heart Valve; ReValve Med Inc, Removable Transcatheter Aortic Valve; Revivicor Inc, Heart Valve; SAS Cormove, CORMOVE Percutaneous Aortic Valve; Sino Medical Sciences Technology Inc, AccuFit Transapical Mitral Valve Replacement Device; Sree Chitra Tirunal Institute for Medical Sciences &; Technology, Tissue Based Cardiac Valve; St. Jude Medical LLC, Next Generation - Portico Valve; St. Jude Medical LLC, Portico Subclavian Delivery System; St. Jude Medical LLC, Portico Transcatheter Aortic Valve Implantation System; St. Jude Medical LLC, Transapical Mitral Valve Delivery System; St. Jude Medical LLC, Transeptal Mitral Valve Delivery System; St. Jude Medical LLC, Transfemoral Mitral Valve Delivery System; Stellenbosch University, Percutaneous Heart Valve; Strait Access Technologies (Pty) Ltd, Heart Valve; Strait Access Technologies (Pty) Ltd, Transcatheter Valve Delivery Device; Symetis SA, ACURATE - Size Matrix Expansion; Symetis SA, ACURATE neo Aortic Bioprosthesis; Symetis SA, ACURATE neo AS Aortic Bioprosthesis - Transfemoral Delivery; Symetis SA, ACURATE TA LP Transapical Delivery System; Symetis SA, ACURATE TAo; Symetis SA, Acurate TF; Thoratec Corp, Next Generation Device For TAVI; Thubrikar Aortic Valve, Inc., Optimum TAV Delivery Catheter; Thubrikar Aortic Valve, Inc., Optimum TAVI System; Tissue Regenix Ltd, Cardiopure - Aortic Heart Valve; Tissue Regenix Ltd, Cardiopure - Pulmonary Heart Valve; Trinity College Dublin, MiVaR Device; TTK Healthcare Ltd, Second Generation TTK-Chitra Heart valve; University College London, Percutaneous Heart Valve Delivery Device; University College London, Percutaneous Mitral Valve Device; University College London, TRISKELE Aortic Valve; University of Arizona, Polymeric Heart Valve; University of California Irvine, Bileaflet Bioprosthetic Mitral Valve; University of California Irvine, Heart Valve Leaflets; University of California Irvine, Tubular Scaffold Heart Valves; University of California San Francisco, Transcatheter Aortic Valve; University of California, Atrioventricular Heart Valves Delivery System; University of Cambridge, Polymeric Heart Valve; University of Cambridge, Removable Transcatheter Valve; University of Colorado, Prosthetic Valve; University of Florida, Replacement Heart Valve; University of Iowa, Cellulose Based Aortic Heart Valve; University of Iowa, Expandable Transcatheter Flutter Valve; University of Minnesota, Tissue-Engineered Vessel Graft; University of Pennsylvania, Peripheral Mitral Valve Delivery System; University of Pennsylvania, Sutureless Mitral Valve Replacement Device; University of Pennsylvania, Thoracotomy Mitral Valve Delivery System; University of Pennsylvania, Transatrial Mitral Valve Delivery System; University of South Florida, Ascending Aortic Prosthesis; University of Zurich, Prostheses Heart Valve; Valtech Cardio Ltd, Valtech Cardiovalve; ValveXchange, Inc. (Inactive), Pulmonic Pediatric Valve; ValveXchange, Inc. (Inactive), Vanguard System; ValveXchange, Inc. (Inactive), Vitality Exchangeable Valve System; ValveXchange, Inc. (Inactive), VXi Vanguard II; Vascular Concepts Ltd, TAVI (Transcatheter Aortic Valve Replacement); Venus MedTech, Transapical Trinity Aortic Valve Implantation System; Venus MedTech, Transfemoral Trinity Aortic Valve Implantation System; Venus MedTech, Tresillo System; Venus MedTech, Venus A-Valve; Venus MedTech, Venus P-Valve; VueKlar Cardiovascular Ltd (Inactive), MR-Enhancing Percutaneous Heart Valve; Xeltis AG, Transcatheter Aortic Heart Valve; Xeltis AG, Xeltis Pulmonary Valve


Companies

4C Medical Technologies Inc

Abbott Vascular Inc

Admedus Ltd

Aegis Surgical Limited

Annulon

AorTech International Plc

AorTx, Inc.

Arbor Surgical Technologies, Inc.

Boston Children's Hospital

Boston Scientific Corp

Carena Healthcare Ltd

Cephea Valve Technologies, Inc.

Children's Hospital Boston

Clemson University

Colibri Heart Valve, LLC

Collagen Solutions Plc

Colorado State University

CorMatrix Cardiovascular Inc

CryoLife Inc

Cytograft Tissue Engineering Inc

Daidalos Solutions BV

Direct Flow Medical Inc

DSM Dyneema BV

Dura LLC

Edwards Lifesciences Corp

Emory University

Endoluminal Technology Research, LLC

Florida International University

Georgia Institute of Technology

Hancock Jaffe Laboratories Inc

HighLife SAS

HLT, Inc.

Hocor Cardiovascular Technologies, LLC

Innovia LLC

JC Medical, Inc.

JenaValve Technology GmbH

Leman Cardiovascular SA

LivaNova PLC

Mayo Clinic

Medi-Line S.A.

Medtronic plc

Meril Life Sciences Pvt Ltd

Micro Interventional Devices, Inc.

MicroPort Scientific Corp

Mitralix Ltd.

MitrAssist Ltd.

Mitricares

MValve Technologies Ltd.

NaviGate Cardiac Structures, Inc.

Neovasc Inc

Peca Labs, Inc.

PolyNova Cardiovascular LLC

Polyvascular Corp

Rambam Health Care Campus

RegenaGraft

ReValve Med Inc

Revivicor Inc

SAS Cormove

Sino Medical Sciences Technology Inc

Sree Chitra Tirunal Institute for Medical Sciences & Technology

St. Jude Medical LLC

Stellenbosch University

Strait Access Technologies (Pty) Ltd

Symetis SA

Thoratec Corp

Thubrikar Aortic Valve, Inc.

Tissue Regenix Ltd

Trinity College Dublin

TTK Healthcare Ltd

University College London

University of Arizona

University of California

University of California Irvine

University of California San Francisco

University of Cambridge

University of Colorado

University of Florida

University of Iowa

University of Minnesota

University of Pennsylvania

University of South Florida

University of Zurich

Valtech Cardio Ltd

ValveXchange, Inc.

Vascular Concepts Ltd

Venus MedTech

VueKlar Cardiovascular Ltd

Xeltis AG