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Transcatheter Heart Valves-Medical Devices Pipeline Assessment, 2016

Transcatheter Heart Valves-Medical Devices Pipeline Assessment, 2016


  • Products Id :- GDME0299EPD
  • |
  • Pages: 257
  • |
  • December 2016
  • |
  • |
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Executive Summary

Transcatheter Heart Valves-Medical Devices Pipeline Assessment, 2016

Summary

GlobalData's Medical Devices sector report, "Transcatheter Heart Valves-Medical Devices Pipeline Assessment, 2016" 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



Contact Us:
Ken Research
Ankur Gupta, Head Marketing & Communications
ankur [@] kenresearch.com
+91-9015378249
www.kenresearch.com

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 27

5 Transcatheter Heart Valves Companies and Product Overview 31

5.1 Abbott Vascular Inc. Company Overview 31

5.1.1 Abbott Vascular Inc. Pipeline Products & Ongoing Clinical Trials Overview 31

5.2 Admedus Ltd Company Overview 32

5.2.1 Admedus Ltd Pipeline Products & Ongoing Clinical Trials Overview 32

5.3 Advanced Bio Prosthetic Surfaces Ltd. Company Overview 34

5.3.1 Advanced Bio Prosthetic Surfaces Ltd. Pipeline Products & Ongoing Clinical Trials Overview 34

5.4 Aegis Surgical Limited Company Overview 35

5.4.1 Aegis Surgical Limited Pipeline Products & Ongoing Clinical Trials Overview 35

5.5 Annulon Company Overview 36

5.5.1 Annulon Pipeline Products & Ongoing Clinical Trials Overview 36

5.6 AorTech International Plc Company Overview 37

5.6.1 AorTech International Plc Pipeline Products & Ongoing Clinical Trials Overview 37

5.7 Arbor Surgical Technologies, Inc. Company Overview 39

5.7.1 Arbor Surgical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 39

5.8 Boston Scientific Corp Company Overview 40

5.8.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 40

5.9 Celyad SA Company Overview 55

5.9.1 Celyad SA Pipeline Products & Ongoing Clinical Trials Overview 55

5.10 Cephea Valve Technologies, Inc. Company Overview 57

5.10.1 Cephea Valve Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 57

5.11 Children's Hospital Boston Company Overview 58

5.11.1 Children's Hospital Boston Pipeline Products & Ongoing Clinical Trials Overview 58

5.12 Clemson University Company Overview 60

5.12.1 Clemson University Pipeline Products & Ongoing Clinical Trials Overview 60

5.13 Colibri Heart Valve, LLC Company Overview 61

5.13.1 Colibri Heart Valve, LLC Pipeline Products & Ongoing Clinical Trials Overview 61

5.14 Direct Flow Medical Inc Company Overview 67

5.14.1 Direct Flow Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 67

5.15 Dura LLC Company Overview 73

5.15.1 Dura LLC Pipeline Products & Ongoing Clinical Trials Overview 73

5.16 Edwards Lifesciences Corp Company Overview 75

5.16.1 Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 76

5.17 Emory University Company Overview 100

5.17.1 Emory University Pipeline Products & Ongoing Clinical Trials Overview 100

5.18 Endoluminal Technology Research, LLC Company Overview 101

5.18.1 Endoluminal Technology Research, LLC Pipeline Products & Ongoing Clinical Trials Overview 101

5.19 Hansen Medical Inc Company Overview 103

5.19.1 Hansen Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 103

5.20 HighLife SAS Company Overview 105

5.20.1 HighLife SAS Pipeline Products & Ongoing Clinical Trials Overview 105

5.21 HLT, Inc. Company Overview 106

5.21.1 HLT, Inc. Pipeline Products & Ongoing Clinical Trials Overview 106

5.22 InterVene Inc. Company Overview 108

5.22.1 InterVene Inc. Pipeline Products & Ongoing Clinical Trials Overview 108

5.23 JC Medical, Inc. Company Overview 109

5.23.1 JC Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 109

5.24 JenaValve Technology GmbH Company Overview 111

5.24.1 JenaValve Technology GmbH Pipeline Products & Ongoing Clinical Trials Overview 111

5.25 Mayo Clinic US Company Overview 114

5.25.1 Mayo Clinic US Pipeline Products & Ongoing Clinical Trials Overview 114

5.26 Medtronic plc Company Overview 115

5.26.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 115

5.27 Meril Life Sciences Pvt Ltd Company Overview 130

5.27.1 Meril Life Sciences Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 130

5.28 Micro Interventional Devices, Inc. Company Overview 131

5.28.1 Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 131

5.29 MicroPort Scientific Corp Company Overview 133

5.29.1 MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 133

5.30 Mitralix Ltd. Company Overview 135

5.30.1 Mitralix Ltd. Pipeline Products & Ongoing Clinical Trials Overview 135

5.31 MitrAssist Ltd. Company Overview 136

5.31.1 MitrAssist Ltd. Pipeline Products & Ongoing Clinical Trials Overview 136

5.32 MValve Technologies Ltd. Company Overview 137

5.32.1 MValve Technologies Ltd. Pipeline Products & Ongoing Clinical Trials Overview 137

5.33 NaviGate Cardiac Structures, Inc. Company Overview 139

5.33.1 NaviGate Cardiac Structures, Inc. Pipeline Products & Ongoing Clinical Trials Overview 139

5.34 Neovasc Inc Company Overview 140

5.34.1 Neovasc Inc Pipeline Products & Ongoing Clinical Trials Overview 140

5.35 PolyNova Cardiovascular LLC Company Overview 143

5.35.1 PolyNova Cardiovascular LLC Pipeline Products & Ongoing Clinical Trials Overview 143

5.36 RegenaGraft Company Overview 144

5.36.1 RegenaGraft Pipeline Products & Ongoing Clinical Trials Overview 144

5.37 SAS Cormove Company Overview 145

5.37.1 SAS Cormove Pipeline Products & Ongoing Clinical Trials Overview 145

5.38 Sino Medical Sciences Technology Inc. Company Overview 146

5.38.1 Sino Medical Sciences Technology Inc. Pipeline Products & Ongoing Clinical Trials Overview 146

5.39 St. Jude Medical Inc Company Overview 147

5.39.1 St. Jude Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 147

5.40 Symetis AG Company Overview 160

5.40.1 Symetis AG Pipeline Products & Ongoing Clinical Trials Overview 160

5.41 Thubrikar Aortic Valve, Inc. Company Overview 166

5.41.1 Thubrikar Aortic Valve, Inc. Pipeline Products & Ongoing Clinical Trials Overview 166

5.42 Universiteit Utrecht Company Overview 167

5.42.1 Universiteit Utrecht Pipeline Products & Ongoing Clinical Trials Overview 167

5.43 University College London Company Overview 168

5.43.1 University College London Pipeline Products & Ongoing Clinical Trials Overview 168

5.44 University of California San Francisco Company Overview 170

5.44.1 University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview 170

5.45 University of Cambridge Company Overview 171

5.45.1 University of Cambridge Pipeline Products & Ongoing Clinical Trials Overview 171

5.46 University of Iowa Company Overview 172

5.46.1 University of Iowa Pipeline Products & Ongoing Clinical Trials Overview 172

5.47 Valtech Cardio Ltd Company Overview 174

5.47.1 Valtech Cardio Ltd Pipeline Products & Ongoing Clinical Trials Overview 174

5.48 Venus MedTech Company Overview 175

5.48.1 Venus MedTech Pipeline Products & Ongoing Clinical Trials Overview 175

5.49 Xeltis AG Company Overview 181

5.49.1 Xeltis AG Pipeline Products & Ongoing Clinical Trials Overview 181

6 Transcatheter Heart Valves- Recent Developments 182

6.1 Dec 01, 2016: Medtronic Announces Reimbursement Approval and Launch of CoreValve Evolut R System in Japan 182

6.2 Nov 28, 2016: Neovasc Receives Regulatory Approval To Initiate TIARA II CE Mark Study 183

6.3 Nov 26, 2016: Edwards Lifesciences to Acquire Valtech Cardio 183

6.4 Nov 22, 2016: Medtronic Reports Second Quarter Financial Results 183

6.5 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 186

6.6 Nov 15, 2016: CEVA to work with Medtronic for distribution facility construction 187

6.7 Nov 14, 2016: Neovasc Reports Third Quarter Results for 2016 187

6.8 Nov 03, 2016: Study Deems Transcaval Valve Replacement Pioneered at Henry Ford Hospital Successful 190

6.9 Nov 01, 2016: Medtronic Harmony Transcatheter Pulmonary Valve Demonstrates Positive Early Clinical Outcomes At One Year 190

6.10 Nov 01, 2016: Neovasc Announces Update in Litigation with CardiAQ 191

6.11 Nov 01, 2016: Xeltis Announces Multidisciplinary Scientific Advisory Board of Global Leading Experts 192

6.12 Nov 01, 2016: Early And Sustained Quality Of Life Improvements Seen For Intermediate Risk Patients Treated With Edwards Transcatheter Valves 192

6.13 Oct 31, 2016: New Data on Medtronic Evolut R TAVR System Show Excellent 'Real-World' Outcomes in Global Patient Population 193

6.14 Oct 31, 2016: New method for performing aortic valve replacement proves successful in high risk patients 194

6.15 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 195

6.16 Oct 26, 2016: Neovasc to Present Tiara Data at TCT in Washington DC 196

6.17 Oct 26, 2016: Medtronic Announces FDA Approval of New Recaptureable TAVR System Available for Severe Aortic Stenosis Patients with Large Anatomies 196

6.18 Oct 26, 2016: Boston Scientific Announces Results For Third Quarter 2016 197

6.19 Oct 25, 2016: Edwards Lifesciences Reports Third Quarter Results 198

6.20 Oct 24, 2016: Boston Scientific announced key Presentations on Lotus Valve System at Transcatheter Cardiovascular Therapeutics 2016 200

6.21 Oct 19, 2016: St. Jude Medical Reports Third Quarter 2016 Results 201

6.22 Oct 14, 2016: AorTech International Announces Board Changes 202

6.23 Oct 10, 2016: Professor Ian Meredith To Join Boston Scientific As Executive Vice President And Global Chief Medical Officer 203

6.24 Sep 19, 2016: Boston Scientific Receives CE Mark For LOTUS Edge Valve System 203

6.25 Sep 19, 2016: Edwards Sapien 3 Transcatheter Heart Valve Receives Expanded Indication In Europe 204

6.26 Sep 19, 2016: Venus Medtech's Transcatheter Pulmonary Valve Debuts in Europe, Marking the Start of Global Clinical Trial 204

6.27 Sep 16, 2016: FEops Elects Rob Michiels as Chairman 205

6.28 Sep 15, 2016: Medtronic Names Mark Ploof Senior Vice President of Global Operations and Business Services 205

6.29 Sep 13, 2016: Colibri Heart Valve and Venus Medtech to Form Joint Venture 206

6.30 Sep 13, 2016: Colibri Heart Valve Raises Additional Funds through Series C Financing 206

6.31 Aug 30, 2016: MPSC Announces 2016 Interim Results 207

6.32 Aug 26, 2016: VitaFlow Granted CFDA Green-Path 208

6.33 Aug 25, 2016: Medtronic Reports First Quarter Financial Results 208

6.34 Aug 25, 2016: Celyad Reports First Half 2016 Financial Results and Operational Progress 211

6.35 Aug 19, 2016: Northwestern Medicine First in Illinois to Perform TAVR Procedure on Low-Risk Patient 212

6.36 Aug 18, 2016: FDA approves expanded indication for Edwards Sapien XT Transcatheter Heart Valve 214

6.37 Aug 18, 2016: FDA approves expanded indication for Edwards SAPIEN 3 Transcatheter Heart Valve 214

6.38 Aug 15, 2016: AorTech International: Audited results for the year ended 31 March 2016 215

6.39 Aug 09, 2016: Neovasc Reports Second Quarter Results for 2016 217

6.40 Aug 08, 2016: Thubrikar Aortic Valve Enters into Licensing Agreement with Wide Line 220

6.41 Aug 01, 2016: Medtronic CoreValve Evolut R System First TAVI to Receive CE Mark for Intermediate Risk Aortic Stenosis Patients 221

6.42 Jul 28, 2016: Boston Scientific Announces Results For Second Quarter 2016 221

6.43 Jul 27, 2016: Edwards Receives Approval For SAPIEN 3 Heart Valve In Canada 223

6.44 Jul 26, 2016: Edwards Lifesciences Reports Second Quarter Results 223

6.45 Jul 20, 2016: St. Jude Medical Reports Second Quarter 2016 Results 225

6.46 Jul 13, 2016: Boston Scientific Elects Yoshiaki Fujimori to Board of Directors 226

6.47 Jul 08, 2016: UTHealth Structural Heart Program team launches latest TAVR trial 227

6.48 Jul 08, 2016: New Clinical Trial Investigates Minimally Invasive Treatment Option for Aortic Stenosis Patients With a Larger Valve Size 227

6.49 Jul 05, 2016: Neovasc Receives NASDAQ Notification Regarding Minimum Bid Requirements 228

7 Appendix 254

7.1 Methodology 254

7.2 About GlobalData 257

7.3 Contact Us 257

7.4 Disclaimer 257

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

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 27

Table 9: Abbott Vascular Inc. Pipeline Products & Ongoing Clinical Trials Overview 31

Table 10: Next Generation Mitral Regurgitation System-Product Status 31

Table 11: Next Generation Mitral Regurgitation System-Product Description 31

Table 12: Admedus Ltd Pipeline Products & Ongoing Clinical Trials Overview 32

Table 13: Cardiocel-Aortic Valve Replacement-Product Status 32

Table 14: Cardiocel-Aortic Valve Replacement-Product Description 33

Table 15: Advanced Bio Prosthetic Surfaces Ltd. Pipeline Products & Ongoing Clinical Trials Overview 34

Table 16: PercValve-Product Status 34

Table 17: PercValve-Product Description 34

Table 18: Aegis Surgical Limited Pipeline Products & Ongoing Clinical Trials Overview 35

Table 19: pTAo-TAVR-Product Status 35

Table 20: pTAo-TAVR-Product Description 35

Table 21: Annulon Pipeline Products & Ongoing Clinical Trials Overview 36

Table 22: Mitral Valve Replacement-Product Status 36

Table 23: Mitral Valve Replacement-Product Description 36

Table 24: AorTech International Plc Pipeline Products & Ongoing Clinical Trials Overview 37

Table 25: AorTech Polymer Valve-Product Status 37

Table 26: AorTech Polymer Valve-Product Description 38

Table 27: Arbor Surgical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 39

Table 28: Trilogy Aortic Valve System-Product Status 39

Table 29: Trilogy Aortic Valve System-Product Description 39

Table 30: Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 40

Table 31: 21 mm Lotus Valve System-Product Status 41

Table 32: 21 mm Lotus Valve System-Product Description 41

Table 33: 23 mm Lotus Valve System-Product Status 42

Table 34: 23 mm Lotus Valve System-Product Description 42

Table 35: 25 mm Lotus Valve System-Product Status 43

Table 36: 25 mm Lotus Valve System-Product Description 43

Table 37: 27 mm Lotus Valve System-Product Status 44

Table 38: 27 mm Lotus Valve System-Product Description 44

Table 39: 29 mm Lotus Valve System-Product Status 44

Table 40: 29 mm Lotus Valve System-Product Description 45

Table 41: Gen 4 Lotus Valve System-Product Status 45

Table 42: Gen 4 Lotus Valve System-Product Description 46

Table 43: Lotus Edge Valve System-Product Status 46

Table 44: Lotus Edge Valve System-Product Description 47

Table 45: Transaortic Sheath-Product Status 47

Table 46: Transaortic Sheath-Product Description 47

Table 47: Boston Scientific Corp-Ongoing Clinical Trials Overview 48

Table 48: 23 mm Lotus Valve System-Experience with Percutaneous Transcatheter Aortic Valve Implantation in Patients with Symptomatic Aortic Valve Disease in Two German Centers 50

Table 49: 23 mm Lotus Valve System-Repositionable Lotus Valve System-Post Market Evaluation of Real World Clinical Outcomes (RESPOND) 50

Table 50: 23 mm Lotus Valve System-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in Japan: REPRISE Japan 50

Table 51: 27 mm Lotus Valve System-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in Japan: REPRISE Japan 51

Table 52: 27 mm Lotus Valve System-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve with the Next Generation Delivery System: REPRISE NGDS 51

Table 53: 25 mm Lotus Valve System-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Clinical Evaluation in Japan: REPRISE Japan 52

Table 54: 25 mm Lotus Valve System-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Randomized Clinical Evaluation: REPRISE III 52

Table 55: Lotus Edge Valve System-Randomized Comparison of Repositionable and Balloon-Expandable Prostheses in Patients Undergoing Trans-catheter Aortic Valve Implantation 53

Table 56: Lotus Edge Valve System-Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve with the Next Generation Delivery System: REPRISE NGDS 53

Table 57: Lotus Edge Valve System-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 54

Table 58: Lotus Edge Valve System-REPRISE EDGE: REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System-Evaluation of Performance and Safety 54

Table 59: Celyad SA Pipeline Products & Ongoing Clinical Trials Overview 55

Table 60: Mitral Valve Neo-chordae-Product Status 55

Table 61: Mitral Valve Neo-chordae-Product Description 56

Table 62: Cephea Valve Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 57

Table 63: Mitral Valve Replacement Device-Product Status 57

Table 64: Mitral Valve Replacement Device-Product Description 57

Table 65: Children's Hospital Boston Pipeline Products & Ongoing Clinical Trials Overview 58

Table 66: Two Piece Replacement Heart Valve-Product Status 58

Table 67: Two Piece Replacement Heart Valve-Product Description 59

Table 68: Clemson University Pipeline Products & Ongoing Clinical Trials Overview 60

Table 69: Transcatheter Bioprosthetic Heart Valve-Product Status 60

Table 70: Transcatheter Bioprosthetic Heart Valve-Product Description 60

Table 71: Colibri Heart Valve, LLC Pipeline Products & Ongoing Clinical Trials Overview 61

Table 72: Colibri Aortic Heart Valve-24mm-Product Status 61

Table 73: Colibri Aortic Heart Valve-24mm-Product Description 62

Table 74: Colibri Aortic Heart Valve-21mm-Product Status 62

Table 75: Colibri Aortic Heart Valve-21mm-Product Description 62

Table 76: Colibri Aortic Heart Valve-27mm-Product Status 63

Table 77: Colibri Aortic Heart Valve-27mm-Product Description 63

Table 78: Colibri TAVI Device-Product Status 63

Table 79: Colibri TAVI Device-Product Description 64

Table 80: Delta Aortic Heart Valve-Product Status 64

Table 81: Delta Aortic Heart Valve-Product Description 64

Table 82: Venibri Valve-Product Status 65

Table 83: Venibri Valve-Product Description 65

Table 84: Colibri Heart Valve, LLC-Ongoing Clinical Trials Overview 66

Table 85: Colibri TAVI Device-Feasibility Study of the First Ready-to-Use Transcatheter Heart Valve System 66

Table 86: Direct Flow Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 67

Table 87: 18F Direct Flow Medical Transcatheter Aortic Valve System-Product Status 67

Table 88: 18F Direct Flow Medical Transcatheter Aortic Valve System-Product Description 68

Table 89: 22F Percutaneous Aortic Valve System-Product Status 68

Table 90: 22F Percutaneous Aortic Valve System-Product Description 69

Table 91: 23mm Direct Flow Medical Transcatheter Aortic Valve System-Product Status 69

Table 92: 23mm Direct Flow Medical Transcatheter Aortic Valve System-Product Description 70

Table 93: Direct Flow Medical Transcatheter Mitral Valve-Product Status 70

Table 94: Direct Flow Medical Transcatheter Mitral Valve-Product Description 71

Table 95: Direct Flow Medical Inc-Ongoing Clinical Trials Overview 71

Table 96: 18F Direct Flow Medical Transcatheter Aortic Valve System-A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System for the Treatment of Patients with Severe Aortic Stenosis 72

Table 97: 18F Direct Flow Medical Transcatheter Aortic Valve System-SALUS Trial Transcatheter Aortic Valve Replacement System Pivotal Trial the Safety and Effectiveness of the Direct Flow Medical Tanscatheter Aortic Valve System 72

Table 98: Dura LLC Pipeline Products & Ongoing Clinical Trials Overview 73

Table 99: Dura Heart Valve-Product Status 73

Table 100: Dura Heart Valve-Product Description 73

Table 101: LowPro Valve-Product Status 74

Table 102: LowPro Valve-Product Description 74

Table 103: Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 76

Table 104: CardiAQ Valve System-Transseptal-Product Status 77

Table 105: CardiAQ Valve System-Transseptal-Product Description 77

Table 106: Centera Heart Valve-Heart Failure-Product Status 78

Table 107: Centera Heart Valve-Heart Failure-Product Description 78

Table 108: Centera Heart Valve-Inferior Vena Cava (Tricuspid)-Product Status 78

Table 109: Centera Heart Valve-Inferior Vena Cava (Tricuspid)-Product Description 79

Table 110: Centera Heart Valve-Mitral Annular Calcification-Product Status 79

Table 111: Centera Heart Valve-Mitral Annular Calcification-Product Description 79

Table 112: Centera Heart Valve-Pulmonary Disease-Product Status 80

Table 113: Centera Heart Valve-Pulmonary Disease-Product Description 80

Table 114: Edwards CENTERA Valve-Product Status 80

Table 115: Edwards CENTERA Valve-Product Description 81

Table 116: Edwards SAPIEN 3 Transcatheter Heart Valve-Low Risk-Product Status 81

Table 117: Edwards SAPIEN 3 Transcatheter Heart Valve-Low Risk-Product Description 81

Table 118: FORTIS Mitral Transcatheter Heart Valve-Product Status 82

Table 119: FORTIS Mitral Transcatheter Heart Valve-Product Description 82

Table 120: INTUITY Valve System-Product Status 82

Table 121: INTUITY Valve System-Product Description 83

Table 122: Next Gen CENTERA-Product Status 83

Table 123: Next Gen CENTERA-Product Description 83

Table 124: Next Gen SAPIEN-Product Status 84

Table 125: Next Gen SAPIEN-Product Description 84

Table 126: Sapien 3 Heart Valve-Heart Failure-Product Status 84

Table 127: Sapien 3 Heart Valve-Heart Failure-Product Description 85

Table 128: Sapien 3 Heart Valve-Inferior Vena Cava (Tricuspid)-Product Status 85

Table 129: Sapien 3 Heart Valve-Inferior Vena Cava (Tricuspid)-Product Description 85

Table 130: Sapien 3 Heart Valve-Mitral Annular Calcification-Product Status 86

Table 131: Sapien 3 Heart Valve-Mitral Annular Calcification-Product Description 86

Table 132: Sapien 3 Heart Valve-Pulmonary Disease-Product Status 87

Table 133: Sapien 3 Heart Valve-Pulmonary Disease-Product Description 87

Table 134: Sapien XT Heart Valve-Heart Failure-Product Status 88

Table 135: Sapien XT Heart Valve-Heart Failure-Product Description 88

Table 136: Sapien XT Heart Valve-Inferior Vena Cava (Tricuspid)-Product Status 88

Table 137: Sapien XT Heart Valve-Inferior Vena Cava (Tricuspid)-Product Description 89

Table 138: Second Generation Transapical Transcatheter Mitral Valve-Product Status 89

Table 139: Second Generation Transapical Transcatheter Mitral Valve-Product Description 90

Table 140: Edwards Lifesciences Corp-Ongoing Clinical Trials Overview 91

Table 141: INTUITY Valve System-A Randomized Comparison of the EDWARDS INTUITY Valve System and Commercially Available Aortic Bioprostheses in Subjects Undergoing Surgical Aortic Valve Replacement 93

Table 142: INTUITY Valve System-Multi-center Experience with the Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement 93

Table 143: INTUITY Valve System-Surgical Treatment of Aortic Stenosis with a Next Generation Surgical Aortic Valve 94

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Abbott Vascular Inc., Admedus Ltd, Advanced Bio Prosthetic Surfaces 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, Direct Flow Medical Inc, Dura LLC, Edwards Lifesciences Corp, Emory University, Endoluminal Technology Research, LLC, Hansen Medical Inc, HighLife SAS, HLT, Inc., InterVene Inc., JC Medical, Inc., JenaValve Technology GmbH, 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 Inc, Symetis AG, Thubrikar Aortic Valve, Inc., Universiteit Utrecht, University College London, University of California San Francisco, University of Cambridge, University of Iowa, Valtech Cardio Ltd, Venus MedTech, Xeltis AG

Abbott Vascular Inc., Next Generation Mitral Regurgitation System; Admedus Ltd, Cardiocel-Aortic Valve Replacement; Advanced Bio Prosthetic Surfaces Ltd., PercValve; Aegis Surgical Limited, pTAo-TAVR; Annulon, Mitral Valve Replacement; AorTech International Plc, AorTech Polymer Valve; Arbor Surgical Technologies, Inc., Trilogy Aortic Valve System; Boston Scientific Corp, 21 mm Lotus Valve System; Boston Scientific Corp, 23 mm Lotus Valve System; Boston Scientific Corp, 25 mm Lotus Valve System; Boston Scientific Corp, 27 mm Lotus Valve System; Boston Scientific Corp, 29 mm Lotus Valve System; Boston Scientific Corp, Gen 4 Lotus Valve System; Boston Scientific Corp, Lotus Edge Valve System; Boston Scientific Corp, Transaortic Sheath; Celyad SA, Mitral Valve Neo-chordae; Cephea Valve Technologies, Inc., Mitral Valve Replacement Device; 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 Device; Colibri Heart Valve, LLC, Delta Aortic Heart Valve; Colibri Heart Valve, LLC, Venibri Valve; Direct Flow Medical Inc, 18F Direct Flow Medical Transcatheter Aortic Valve System; Direct Flow Medical Inc, 22F Percutaneous Aortic Valve System; Direct Flow Medical Inc, 23mm Direct Flow Medical Transcatheter Aortic Valve System; Direct Flow Medical Inc, Direct Flow Medical Transcatheter Mitral Valve; Dura LLC, Dura Heart Valve; Dura LLC, LowPro Valve; Edwards Lifesciences Corp, CardiAQ Valve System-Transseptal; Edwards Lifesciences Corp, Centera Heart Valve-Heart Failure; Edwards Lifesciences Corp, Centera Heart Valve-Inferior Vena Cava (Tricuspid); Edwards Lifesciences Corp, Centera Heart Valve-Mitral Annular Calcification; Edwards Lifesciences Corp, Centera Heart Valve-Pulmonary Disease; 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, INTUITY Valve System; Edwards Lifesciences Corp, Next Gen CENTERA; Edwards Lifesciences Corp, Next Gen SAPIEN; Edwards Lifesciences Corp, Sapien 3 Heart Valve-Heart Failure; Edwards Lifesciences Corp, Sapien 3 Heart Valve-Inferior Vena Cava (Tricuspid); Edwards Lifesciences Corp, Sapien 3 Heart Valve-Mitral Annular Calcification; Edwards Lifesciences Corp, Sapien 3 Heart Valve-Pulmonary Disease; Edwards Lifesciences Corp, Sapien XT Heart Valve-Heart Failure; Edwards Lifesciences Corp, Sapien XT Heart Valve-Inferior Vena Cava (Tricuspid); 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; Hansen Medical Inc, AorTx Valve; HighLife SAS, Transcatheter Mitral Valve Replacement System; HLT, Inc., HLT Transcatheter Aortic Valve System; InterVene Inc., BlueLeaf Endovenous Valve Formation System; JC Medical, Inc., J-Valve Ausper TAVI System; JenaValve Technology GmbH, JenaValve Pericardial TAVR System; Mayo Clinic US, Percutaneous Aortic Valve; Medtronic plc, CoreValve Evolut PRO TAVR System; Medtronic plc, CoreValve Evolut R Recapturable System-Low-Risk Aortic Stenosis; Medtronic plc, CoreValve Evolut R XL; 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, Vitaflow Transcatheter Aortic Valve; Mitralix Ltd., MAESTRO; MitrAssist Ltd., MitrAssist Valve; MValve Technologies Ltd., MValve Docking System; NaviGate Cardiac Structures, Inc., Transcatheter Mitral Valve; Neovasc Inc, Tiara Transcatheter Mitral Valve; PolyNova Cardiovascular LLC, Trileaflet Polymeric Prosthetic Heart Valve; RegenaGraft, Synthetic Heart Valve; SAS Cormove, CORMOVE Percutaneous Aortic Valve; Sino Medical Sciences Technology Inc., AccuFit Transapical Mitral Valve Replacement Device; St. Jude Medical Inc, Next Generation-Portico Valve; St. Jude Medical Inc, Portico Transapical Aortic Heart Valve System-23 mm; St. Jude Medical Inc, Portico Transapical Aortic Heart Valve System-25 mm; St. Jude Medical Inc, Portico Transapical Aortic Heart Valve System-27 mm; St. Jude Medical Inc, Portico Transapical Aortic Heart Valve System-29 mm; St. Jude Medical Inc, Portico Transcatheter Aortic Valve Implantation System; St. Jude Medical Inc, Portico Transfemoral Aortic Heart Valve System-23 mm; St. Jude Medical Inc, Portico Transfemoral Aortic Heart Valve System-25mm; St. Jude Medical Inc, Portico Transfemoral Aortic Heart Valve System-27 mm; St. Jude Medical Inc, Portico Transfemoral Aortic Heart Valve System-29mm; St. Jude Medical Inc, Repositionable Valved Stent; Symetis AG, Acurate TA; Symetis AG, ACURATE TAo; Symetis AG, Acurate TF; Symetis AG, StentValve; Thubrikar Aortic Valve, Inc., Optimum TAVI System; Universiteit Utrecht, Dyneema Purity-Transcatheter Heart Valve; University College London, Transcatheter Aortic Valve; University College London, TRISKELE Aortic Valve; University of California San Francisco, Transcatheter Aortic Valve; University of Cambridge, Removable Transcatheter Valve; University of Iowa, Cellulose Based Aortic Heart Valve; University of Iowa, Expandable Transcatheter Flutter Valve; Valtech Cardio Ltd, Valtech Cardiovalve; 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; Xeltis AG, Transcatheter Heart Valve


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