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