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1 Table of Contents ........................................................................................................................................................................ 2
1.1 List of Tables..................................................................................................................................................................... 6
1.2 List of Figures ................................................................................................................................................................. 16
3 Products under Development .................................................................................................................................................... 18
3.1 Prosthetic Heart Valves - Pipeline Products by Stage of Development .......................................................................... 18
5.2 AorTech International plc Company Overview ................................................................................................................ 32
5.4 Boston Children's Hospital Company Overview .............................................................................................................. 35
5.5 Boston Scientific Corporation Company Overview .......................................................................................................... 37
5.8 Cardiac Dimensions, Inc. Company Overview ................................................................................................................ 49
5.9 CardiAQ Valve Technologies, Inc. Company Overview .................................................................................................. 53
5.10 Cardio3 BioSciences SA Company Overview ................................................................................................................. 59
5.11 Cephea Valve Technologies, Inc. Company Overview ................................................................................................... 60
5.12 Clemson University Company Overview ......................................................................................................................... 61
5.14 CorMatrix Cardiovascular, Inc. Company Overview ........................................................................................................ 70
5.15 CryoLife, Inc. Company Overview ................................................................................................................................... 75
5.16 Cytograft Tissue Engineering, Inc. Company Overview .................................................................................................. 77
5.17 Direct Flow Medical, Inc. Company Overview ................................................................................................................. 78
5.17.1 Direct Flow Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview ........................................................ 78
5.18 Dura Biotech Company Overview ................................................................................................................................... 83
5.20 Emory University Company Overview ........................................................................................................................... 106
5.21 HighLife SAS Company Overview ................................................................................................................................ 108
5.22 HLT, Inc. Company Overview ....................................................................................................................................... 109
5.26 Mayo Clinic Company Overview ................................................................................................................................... 121
5.29 Meril Life Sciences Pvt. Ltd. Company Overview .......................................................................................................... 135
5.30 Micro Interventional Devices, Inc. Company Overview ................................................................................................. 136
5.35 NaviGate Cardiac Structures, Inc. Company Overview ................................................................................................ 145
5.36 Neovasc Inc. Company Overview ................................................................................................................................. 146
5.37 Peca Labs, Inc. Company Overview ............................................................................................................................. 150
5.40 Revivicor, Inc. Company Overview ............................................................................................................................... 153
5.41 SAS Cormove Company Overview ............................................................................................................................... 154
5.44 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview ................................................. 160
5.44.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview ................................................................................................................................................................................. 160
5.45 St. Jude Medical, Inc. Company Overview ................................................................................................................... 162
5.45.1 St. Jude Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview........................................................... 162
5.46 Stellenbosch University Company Overview................................................................................................................. 175
5.48 Symetis AG Company Overview ................................................................................................................................... 178
5.49 Tendyne Medical, Inc. Company Overview ................................................................................................................... 184
5.50 The Tel Aviv Sourasky Medical Center Company Overview ......................................................................................... 187
5.50.1 The Tel Aviv Sourasky Medical Center Pipeline Products & Ongoing Clinical Trials Overview ................................ 187
5.51 Thubrikar Aortic Valve, Inc. Company Overview ........................................................................................................... 188
5.56 University College London Company Overview ............................................................................................................ 198
5.56.1 University College London Pipeline Products & Ongoing Clinical Trials Overview ................................................... 198
5.57 University of California, Irvine Company Overview ....................................................................................................... 199
5.57.1 University of California, Irvine Pipeline Products & Ongoing Clinical Trials Overview .............................................. 199
5.58 University of Pennsylvania Company Overview ............................................................................................................ 202
5.58.1 University of Pennsylvania Pipeline Products & Ongoing Clinical Trials Overview ................................................... 202
5.59 Valtech Cardio Ltd. Company Overview ....................................................................................................................... 204
5.60 ValveXchange, Inc. Company Overview ....................................................................................................................... 205
5.62 Xeltis AG Company Overview ....................................................................................................................................... 210
7.2 About GlobalData .......................................................................................................................................................... 308
Table 1: Prosthetic Heart Valves - Pipeline Products by Stage of Development ............................................................................ 18
Table 7: Prosthetic Heart Valves Companies - Pipeline Products by Stage of Development ......................................................... 24
Table 8: Prosthetic Heart Valves - Pipeline Products by Stage of Development ............................................................................ 27
Table 16: Next Generation Device For TAVI - Product Status ........................................................................................................ 34
Table 17: Next Generation Device For TAVI - Product Description ................................................................................................ 34
Table 22: 21 mm Lotus Valve System - Product Status ................................................................................................................. 37
Table 23: 21 mm Lotus Valve System - Product Description .......................................................................................................... 38
Table 24: 23 mm Lotus Valve System - Product Status ................................................................................................................. 38
Table 25: 23 mm Lotus Valve System - Product Description .......................................................................................................... 38
Table 26: 25 mm Lotus Valve System - Product Status ................................................................................................................. 39
Table 27: 25 mm Lotus Valve System - Product Description .......................................................................................................... 39
Table 28: 27 mm Lotus Valve System - Product Status ................................................................................................................. 40
Table 29: 27 mm Lotus Valve System - Product Description .......................................................................................................... 40
Table 30: 29 mm Lotus Valve System - Product Status ................................................................................................................. 41
Table 31: 29 mm Lotus Valve System - Product Description .......................................................................................................... 41
Table 33: 23 mm Lotus Valve System - Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation
of Lotus Valve System (REPRISE I) ................................................................................................................................................. 43
Table 34: 23 mm Lotus Valve System - REPRISE II: Repositionable Percutaneous Replacement Of Stenotic Aortic Valve
Through Implantation Of Lotus Valve System: Evaluation Of Safety And Performance ................................................................... 43
Table 35: 23 mm Lotus Valve System - RESPOND: Repositionable Lotus Valve System - Post Market Evaluation of Real World
Table 36: 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 .................................................................................. 44
Table 81: Custom Delivery System - Product Status ...................................................................................................................... 65
Table 82: Custom Delivery System - Product Description .............................................................................................................. 65
Table 115: 18F Direct Flow Medical Transcatheter Aortic Valve System - Direct Flow Medical Transcatheter Aortic Valve System
Demonstrates Trial Outcomes in SALUS Trial ................................................................................................................................. 81
Table 116: 18F Direct Flow Medical Transcatheter Aortic Valve System - The Direct Flow Medical Transcatheter Aortic Valve
Replacement System a US Pivotal Trial ........................................................................................................................................... 81
Table 117: 18F Direct Flow Medical Transcatheter Aortic Valve System - The Direct Flow Medical TranScatheter Aortic Valve
RepLacement System US Feasibility Trial ....................................................................................................................................... 82
Table 138: INTUITY Valve System - Product Status ...................................................................................................................... 90
Table 139: INTUITY Valve System - Product Description .............................................................................................................. 91
Table 140: Magna EASE Surgical Valve With GLX - Product Status ............................................................................................. 91
Table 141: Magna EASE Surgical Valve With GLX - Product Description ..................................................................................... 91
Table 142: Next Gen CENTERA - Product Status .......................................................................................................................... 92
Table 143: Next Gen CENTERA - Product Description .................................................................................................................. 92
Table 144: Next Gen SAPIEN - Product Status .............................................................................................................................. 92
Table 145: Next Gen SAPIEN - Product Description ...................................................................................................................... 93
Table 153: Edwards SAPIEN Pulmonic Transcatheter Heart Valve - Implantation of the SAPIEN Transcatheter Heart Valve (THV)
in the Pulmonic Position ................................................................................................................................................................... 98
Table 158: Edwards SAPIEN 3 Valve - The PARTNER II Trial "Placement of Aortic Transcatheter" Valves Trial" (US) [Edwards
Study 2010-12] ............................................................................................................................................................................... 100
Table 159: Edwards CENTERA Valve - Safety and Performance Study of the Edwards Centera Self-expanding Transcatheter
Table 161: SAPIEN XT – Valve-In-Valve Indication - A Randomized Comparison of Transcatheter Heart Valves in High Risk
Patients With Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT (The CHOICE Trial) ........................... 103
Table 162: SAPIEN XT – Valve-In-Valve Indication - Cerebral Protection in Transcatheter Aortic Valve Replacement - The
SENTINEL Study ............................................................................................................................................................................ 103
Table 163: SAPIEN XT – Valve-In-Valve Indication - Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve
Implantation and Surgical Aortic Valve Replacement ..................................................................................................................... 104
Table 164: Edwards SAPIEN XT Valve - 20mm - A Clinical Trial of a 20mm Transcatheter Bioprosthetic Valve for Patients With
Table 181: Sutured In Synthetic Tri - Leaflet Heart Valve - Product Status .................................................................................. 114
Table 182: Sutured In Synthetic Tri - Leaflet Heart Valve - Product Description .......................................................................... 114
Table 191: JenaValve Transapical TAVI System - "The JenaValve" Evaluation of Long Term Performance and Safety in Patients
with Severe Aortic Stenosis ............................................................................................................................................................ 119
Table 192: JenaValve Transapical TAVI System - Efficacy Study Of Jenavalve Transapical TAVI System For The Treatment Of
Severe Stenotic Aortic Valve Disease In Elderly High-Risk Patients .............................................................................................. 119
Table 203: 23 mm CoreValve Evolut R Transcatheter Valve - Product Status ............................................................................. 124
Table 204: 23 mm CoreValve Evolut R Transcatheter Valve - Product Description ..................................................................... 124
Table 205: 26 mm CoreValve Evolut R Transcatheter Valve - Product Status ............................................................................. 124
Table 206: 26 mm CoreValve Evolut R Transcatheter Valve - Product Description ..................................................................... 125
Table 207: 29 mm CoreValve Evolut R Transcatheter Valve - Product Status ............................................................................. 125
Table 208: 29 mm CoreValve Evolut R Transcatheter Valve - Product Description ..................................................................... 125
Table 209: CoreValve EnVeo R Delivery Catheter System - Product Status ............................................................................... 126
Table 210: CoreValve EnVeo R Delivery Catheter System - Product Description ........................................................................ 126
Table 211: CoreValve Evolut R Recapturable System - Product Status ...................................................................................... 127
Table 212: CoreValve Evolut R Recapturable System - Product Description ............................................................................... 127
Table 213: Engager Transcatheter Aortic Valve Implantation System - Product Status ............................................................... 127
Table 217: Next Generation TCV - Product Status ....................................................................................................................... 129
Table 218: Next Generation TCV - Product Description ............................................................................................................... 129
Table 220: Engager Transcatheter Aortic Valve Implantation System - Catheter-Based Transapical Implantation of the Ventor
Embracer Heart Valve Prosthesis in Patients With Severe Aortic Valve Disease .......................................................................... 131
Table 221: Engager Transcatheter Aortic Valve Implantation System - Engager Direct Aortic Clinical Study: Medtronic Engager
Transcatheter Aortic Valve Implantation System Via Direct Aortic Approach ................................................................................. 131
Table 222: Engager Transcatheter Aortic Valve Implantation System - Pivotal Trial for Engager Transcatheter Aortic Valve
Implantation System In Patients Suffering From Severe Aortic Stenosis ....................................................................................... 131
Table 223: Engager Transcatheter Aortic Valve Implantation System - The Engager ALIGN Study: To Characterize the Safety
and Clinical Benefit of the Engager Transcatheter Aortic Valve Implantation System in a Real World Environment ..................... 132
Table 224: Engager Transcatheter Aortic Valve Implantation System - Transapical Implantation of the Medtronic Engager
Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial ................................................................ 132
Clinical Study .................................................................................................................................................................................. 133
Table 226: CoreValve Evolut R Recapturable System - Medtronic CoreValve Evolut R United States IDE Clinical Study .......... 134
Table 239: Transcatheter Aortic Valve Implantation System - Clinical Evaluation of the Safety and Performance of the MicroPort's
Transcatheter Aortic Valve and Delivery System for Treatment of Severe Aortic Stenosis ............................................................ 141
Table 256: Tiara Transcatheter Mitral Valve - Early Feasibility Study of the Neovasc Tiara Mitral Transcatheter Heart Valve with
the Tiara Transapical Delivery System ........................................................................................................................................... 149
Table 258: Masa Valve - Product Status ...................................................................................................................................... 150
Table 288: St. Jude Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview ............................................................ 162
Table 289: Masters HP Series 15mm Mechanical Heart Valve - Product Status ......................................................................... 162
Table 290: Masters HP Series 15mm Mechanical Heart Valve - Product Description .................................................................. 163
Table 291: Portico Transapical Aortic Heart Valve System - 23 mm - Product Status ................................................................. 163
Table 292: Portico Transapical Aortic Heart Valve System - 23 mm - Product Description .......................................................... 163
Table 293: Portico Transcatheter Aortic Valve Implantation System - Product Status ................................................................. 164
Table 303: Subclavian Delivery System - Product Status............................................................................................................. 168
Table 304: Subclavian Delivery System - Product Description ..................................................................................................... 168
Table 305: St. Jude Medical, Inc. - Ongoing Clinical Trials Overview .......................................................................................... 169
Table 306: Portico Transapical Aortic Heart Valve System - 23 mm - Next-Generation Transcatheter Aortic Valve System
Designed To Offer Increased Functionality For Transfemoral And Transapical Implantation ......................................................... 170
Table 307: Portico Transfemoral Aortic Heart Valve System - 23 mm - Assessment of the St. Jude Medical Portico Transcatheter
Aortic Valve Implant (TAVI) and the SJM TAVI Transfemoral Delivery System (Portico TF EU) .................................................... 171
Table 308: Portico Transfemoral Aortic Heart Valve System - 23 mm - First In Human Experience and Assessment of the 23mm
SJM Transcatheter Aortic Valve Implant and the SJM TAVI Transfemoral Delivery System (SJM TAVI FIH) ............................... 171
Table 309: Portico Transfemoral Aortic Heart Valve System - 23 mm - International International Long-term Follow-up Study Of
Patients Implanted With A Portico Valve ........................................................................................................................................ 171
Table 310: Portico Transfemoral Aortic Heart Valve System - 23 mm - Long Term Follow-up of the 23mm Portico Aortic Valve
Implant and the SJM Transfemoral Delivery System ...................................................................................................................... 172
Table 311: Portico Transfemoral Aortic Heart Valve System - 25mm - Portico Valve System Offers A Minimally Invasive
Treatment For Patients With Severe Aortic Stenosis: A Narrowing Of The Aortic Valve That Obstructs Blood Flow From The Heart
Table 322: Acurate TA - Product Status ....................................................................................................................................... 178
Table 323: Acurate TA - Product Description ............................................................................................................................... 178
Table 324: ACURATE TAo - Product Status ................................................................................................................................ 179
Table 325: ACURATE TAo - Product Description ........................................................................................................................ 179
Table 326: Acurate TF - Product Status ....................................................................................................................................... 179
Table 344: Optimum TAVI System - Product Status .................................................................................................................... 189
Table 345: Optimum TAVI System - Product Description ............................................................................................................. 189
Table 358: Tresillo System - Product Status ................................................................................................................................ 195
Table 359: Tresillo System - Product Description ......................................................................................................................... 195
Table 383: Vanguard System - Product Status ............................................................................................................................ 205
Table 384: Vanguard System - Product Description ..................................................................................................................... 205
Table 385: Vitality Exchangeable Valve System - Product Status ................................................................................................ 206
Table 387: VXi Vanguard II - Product Status ................................................................................................................................ 207
Table 388: VXi Vanguard II - Product Description ........................................................................................................................ 207
Figure 1: Prosthetic Heart Valves - Pipeline Products by Stage of Development ........................................................................... 18
The data and analysis within this report is driven by GlobalData. GlobalData gives you key information to drive sales, investment and deal making activity in your business.
Our coverage includes 200,000 + reports on 185,000+ companies (including 150,000+ private) across 200+ countries and 29
industries. The key industries include Alternative Energy, Oil & Gas, Clean Technology, Technology and Telecommunication,
Pharmaceutical and Healthcare, Power, Financial Services, Chemical and Metal & Mining.
7.1 Methodology
GlobalData company reports are based on a core set of research techniques which ensure the best possible level of quality and
accuracy of data. The key sources used include:
• Company Websites
• Company Annual Reports
• SEC Filings
• Press Releases
• Proprietary Databases
Taxonomy:
GlobalData has developed an industry-leading four tier (market, category, segment, subsegment) medical devices taxonomy. The
taxonomy is both comprehensive and constantly updated ensuring data quality. The report published is a category based report
where the product taxonomy vary from category level to sub-segment level.
Origination:
GlobalData’s pipeline products and clinical trials data is built using information and data from a number of important sources based
on both internal and external sources to develop a comprehensive and robust view of the medical devices market.
Secondary Research:
Extensive secondary research is done to gather data specific to the pipeline products and clinical trials. We track medical devices
that are in development related to nearly 18 markets (ie, cardiovascular devices, dental devices etc) that we cover.
GlobalData conducts extensive research to gather data specific to pipeline products (product status, current stage of development,
product description, technology and estimation timelines of medical devices) and clinical trials. Hundreds of medical specific live
news sources are monitored on a daily basis.
Primary Research:
Primary research is conducted to validate the product status, stage of development and estimated timelines.
GlobalData’s pool of primary research candidates for the pipeline products enquiries includes marketing / product managers, R&D
director, sales director and key person involving with regulatory process.