Surgical Heart Valves Pipeline by Stages of Development, Segments, Region, Regulatory Path and Key Companies

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Surgical Heart Valves Pipeline Market Report Overview

Surgical heart valves are used in cardiac surgeries to treat heart valves diseases where the affected heart valves are either replaced or repaired. Cardiac valve repair devices and prosthetic heart valves are covered under this category.

The surgical heart valves pipeline market research report provides comprehensive information about the surgical heart valves pipeline products with a comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

Key Segment ·       Cardiac Valve Repair Devices

·       Prosthetic Heart Valves

·       Tissue Heart Valves

·       Transcatheter Valve Delivery Devices

·       Mitral Valve Annuloplasty Devices

Key Territories ·       The US

·       Europe

·       China

·       India

·       Japan

Key Regulatory Paths ·       PMA

·       CE

·       NMPA

·       TGA

·       Ninsho

Leading Companies ·       4Tech Cardio Ireland Ltd

·       Affluent Medical SASU

·       AGEless Biomedical Inc

·       Ample Medical Inc

·       Anchorvalve

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Surgical Heart Valves Pipeline Market Segments

Some of the key segments in the surgical heart valves market are cardiac valve repair devices, prosthetic heart valves, tissue heart valves, transcatheter valve delivery devices and mitral valve annuloplasty devices among others. The cardiac valve repair devices segment is leading in the market in 2023.

Surgical Heart Valves Pipeline Market Analysis, by Segments, 2023 (%)

Surgical Heart Valves Pipeline Market Analysis, by Segments, 2023 (%)

For more segments insights into the surgical heart valves pipeline market, download a free report sample

Surgical Heart Valves Pipeline Market Segmentation by Territories

Some of the key territories in the surgical heart valves market are the US, Europe, China, India, and Japan among others. As of June 2023, the US had the highest number of pipeline products.

Surgical Heart Valves Pipeline Market Analysis, by Territories, 2023 (%)

Surgical Heart Valves Pipeline Market Analysis, by Territories, 2023 (%)

or more territory insights into the surgical heart valves pipeline market, download a free report sample

Surgical Heart Valves Pipeline Market Segmentation by Regulatory Paths

Some of the regulatory paths in the surgical heart valves pipeline market are PMA, NMPA, TGA, CE, and Ninsho among others. As of June 2023, PMA was the most followed pathway for pipeline products.

Surgical Heart Valves Pipeline Market Analysis, by Regulatory Paths, 2023 (%)

Surgical Heart Valves Pipeline Market Analysis, by Regulatory Paths, 2023 (%)

For more regulatory path insights into the surgical heart valves pipeline market, download a free report sample

Surgical Heart Valves Pipeline Market – Competitive Landscape

Some of the key companies in the surgical heart valves pipeline market are 4Tech Cardio Ireland Ltd, Affluent Medical SASU, AGEless Biomedical Inc, Ample Medical Inc, and Anchorvalve among others.

4Tech Cardio Ireland Ltd: 4Tech Cardio Ireland Ltd (4Tech) is an independent clinical-stage medical device company that develops minimally invasive transcatheter solutions for the treatment of functional tricuspid regurgitation. The company’s lead product TriCinch coil system is a percutaneous catheter-based investigational medical device intended for tricuspid valve repair. It is dedicated to improving patients’ quality of life through pioneering a clinically advanced technology that offers an alternative solution for physicians and their patients with tricuspid regurgitation. The company has a presence in Ireland and the US. 4Tech is headquartered in Galway, Ireland.

Segments Covered in the Report

Surgical Heart Valves Pipeline Market Segments Outlook

  • Cardiac Valve Repair Devices
  • Prosthetic Heart Valves
  • Tissue Heart Valves
  • Transcatheter valve delivery devices

Surgical Heart Valves Pipeline Market Territories Outlook

  • The US
  • Europe
  • China
  • India
  • Japan

Surgical Heart Valves Pipeline Market Regulatory Paths Outlook

  • PMA
  • CE
  • NMPA
  • TGA
  • Ninsho

Scope

  • Extensive coverage of the surgical heart valves under development
  • Reviews details of major pipeline products which include, product description, licensing and collaboration details, and other developmental activities
  • Reviews the major players involved in the development of surgical 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 portfolios and create effective counter strategies to gain a competitive advantage
  • Identify and understand important and diverse types of surgical 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

4Tech Cardio Ireland Ltd
Affluent Medical SASU
AGEless Biomedical Inc
Ample Medical Inc
Anchorvalve
Ancora Heart Inc
Anteris Technologies Ltd
Approxima Srl
Aptus LLC
Artivion Inc
Autus Valve Technologies Inc
BioLife4D Corp
Biostage Inc
BioVentrix Inc
Boston Children's Hospital
Boston Scientific Corp
Boston Scientific Scimed Inc
Cambris Cardiac Ltd
Cardiac Implants LLC
Cardiosolutions Inc
Cedars-Sinai Medical Center
Celyad Oncology SA
Colibri Heart Valve LLC
Collagen Solutions Ltd
Collplant Biotechnologies Ltd
Colorado State University
Columbia University
ConKay Medical Systems Inc
CoreMedic AG
CorMatrix Cardiovascular Inc
CroiValve Ltd
CUBE SRL
Cytograft Tissue Engineering Inc (Inactive)
Daidalos Solutions BV
Department of Biomedical Engineering Columbia University
Edwards Lifesciences Corp
Emory University
Enlight Medical Technologies (Shanghai) Co Ltd
enVVeno Medical Corp
Florida International University
FluidForm Inc
Foldax Inc
Georgia Institute of Technology
Griffith University
Hangzhou DeJin Medtech Co Ltd
Hanxin Medical Technology (Shenzhen) Co Ltd
Harpoon Medical, Inc.
Hocor Cardiovascular Technologies, LLC
Innovator Lab Consultants India Pvt Ltd
Innovia LLC
InspireMD Inc
JC Medical, Inc.
Jiangsu Zhenyi Medical Technology Co Ltd
Jinshi Biotechnology (Changshu) Co Ltd
Kardium Inc
Kekai Life Sciences
Leman Cardiovascular SA
Lepu Medical Technology (Beijing) Co Ltd
Lifelet Medical Ltd
LuSeed Vascular
Mardil Medical, Inc.
Mayo Clinic
Meacor Inc
Medi-Line S.A.
Medtentia International Ltd Oy
Medtronic Plc
Meril Life Sciences Pvt Ltd
MiCardia Corp
Michigan Critical Care Consultants Inc
Micro Interventional Devices, Inc.
MicroPort Scientific Corp
Millipede LLC
Mitralign Inc
Mitre Medical Corp
MVRx, Inc.
Nanjing Shengde Medical Technology Co Ltd
National University of Singapore
NaviGate Cardiac Structures, Inc.
NewMed Medical Co Ltd
Occlufit AG
On-X Life Technologies Inc
OrbusNeich P&F
P+F Products + Features GmbH
Peca Labs Inc
Rambam Health Care Campus
Revivicor Inc
SCR, Inc.
Shanghai Aoliu Medical Technology Co Ltd
Shanghai Hanyu Medical Technology Co Ltd
Shanghai Healing Medical Instruments Co Ltd
Shanghai Shenqi Medical Technology Co Ltd
Sree Chitra Tirunal Institute for Medical Sciences & Technology
St. Jude Medical LLC
Stellenbosch University
Strait Access Technologies (Pty) Ltd
Suzhou Xinling Med Medical Technology Co Ltd
Suzhou Yinluo Medical Devices Co Ltd
Symetis SA
Syntach AB
Tel Aviv Sourasky Medical Center
Tgen Tech LLC
The Charles Stark Draper Laboratory Inc
Thoratec LLC
Thubrikar Aortic Valve, Inc.
TransCardiac Therapeutics, LLC
Transmural systems LLC
TRiCares SAS
TTK Healthcare Ltd
University College London
University of Arizona
University of California
University of California Irvine
University of Cambridge
University of Colorado
University of Florida
University of Manitoba
University of Missouri
University of Nebraska
University of Pennsylvania
University of Pittsburgh Medical Center
University of South Carolina
University of South Florida
University of Zurich
Valcare Medical
valsculp
Valtech Cardio Ltd
ValveXchange, Inc. (Inactive)
Vdyne LLC
Venus Haoyue Medtech Ltd
Venus Medtech Hangzhou Inc
Vesalius Cardiovascular Inc
Viacor Inc
VueKlar Cardiovascular Ltd (Inactive)
W. L. Gore & Associates Inc
Xeltis AG

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 9

|1.2 List of Figures 23

2 Introduction 24

2.1 Surgical Heart Valves Overview 24

3 Products under Development 25

3.1 Surgical Heart Valves – Pipeline Products by Stage of Development 25

3.2 Surgical Heart Valves – Pipeline Products by Segment 26

3.3 Surgical Heart Valves – Pipeline Products by Territory 27

3.4 Surgical Heart Valves – Pipeline Products by Regulatory Path 28

3.5 Surgical Heart Valves – Pipeline Products by Estimated Approval Date 29

3.6 Surgical Heart Valves – Ongoing Clinical Trials 30

4 Surgical Heart Valves – Pipeline Products under Development by Companies 31

4.1 Surgical Heart Valves Companies – Pipeline Products by Stage of Development 31

4.2 Surgical Heart Valves – Pipeline Products by Stage of Development 36

5 Surgical Heart Valves Companies and Product Overview 42

5.1 4Tech Cardio Ireland Ltd Company Overview 42

5.1.1 4Tech Cardio Ireland Ltd Pipeline Products & Ongoing Clinical Trials Overview 42

5.2 Affluent Medical SASU Company Overview 45

5.2.1 Affluent Medical SASU Pipeline Products & Ongoing Clinical Trials Overview 45

5.3 AGEless Biomedical Inc Company Overview 48

5.3.1 AGEless Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 48

5.4 Ample Medical Inc Company Overview 49

5.4.1 Ample Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 49

5.5 Anchorvalve Company Overview 50

5.5.1 Anchorvalve Pipeline Products & Ongoing Clinical Trials Overview 50

5.6 Ancora Heart Inc Company Overview 53

5.6.1 Ancora Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 53

5.7 Anteris Technologies Ltd Company Overview 57

5.7.1 Anteris Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 57

5.8 Approxima Srl Company Overview 62

5.8.1 Approxima Srl Pipeline Products & Ongoing Clinical Trials Overview 62

5.9 Aptus LLC Company Overview 63

5.9.1 Aptus LLC Pipeline Products & Ongoing Clinical Trials Overview 63

5.10 Artivion Inc Company Overview 64

5.10.1 Artivion Inc Pipeline Products & Ongoing Clinical Trials Overview 64

5.11 Autus Valve Technologies Inc Company Overview 69

5.11.1 Autus Valve Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 69

5.12 BioLife4D Corp Company Overview 72

5.12.1 BioLife4D Corp Pipeline Products & Ongoing Clinical Trials Overview 72

5.13 Biostage Inc Company Overview 73

5.13.1 Biostage Inc Pipeline Products & Ongoing Clinical Trials Overview 73

5.14 BioVentrix Inc Company Overview 74

5.14.1 BioVentrix Inc Pipeline Products & Ongoing Clinical Trials Overview 74

5.15 Boston Children’s Hospital Company Overview 77

5.15.1 Boston Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 77

5.16 Boston Scientific Corp Company Overview 81

5.16.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 81

5.17 Boston Scientific Scimed Inc Company Overview 83

5.17.1 Boston Scientific Scimed Inc Pipeline Products & Ongoing Clinical Trials Overview 83

5.18 Cambris Cardiac Ltd Company Overview 84

5.18.1 Cambris Cardiac Ltd Pipeline Products & Ongoing Clinical Trials Overview 84

5.19 Cardiac Implants LLC Company Overview 85

5.19.1 Cardiac Implants LLC Pipeline Products & Ongoing Clinical Trials Overview 85

5.20 Cardiosolutions Inc Company Overview 87

5.20.1 Cardiosolutions Inc Pipeline Products & Ongoing Clinical Trials Overview 87

5.21 Cedars-Sinai Medical Center Company Overview 88

5.21.1 Cedars-Sinai Medical Center Pipeline Products & Ongoing Clinical Trials Overview 88

5.22 Celyad Oncology SA Company Overview 89

5.22.1 Celyad Oncology SA Pipeline Products & Ongoing Clinical Trials Overview 89

5.23 Colibri Heart Valve LLC Company Overview 91

5.23.1 Colibri Heart Valve LLC Pipeline Products & Ongoing Clinical Trials Overview 91

5.24 Collagen Solutions Ltd Company Overview 94

5.24.1 Collagen Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 94

5.25 Collplant Biotechnologies Ltd Company Overview 95

5.25.1 Collplant Biotechnologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 95

5.26 Colorado State University Company Overview 97

5.26.1 Colorado State University Pipeline Products & Ongoing Clinical Trials Overview 97

5.27 Columbia University Company Overview 98

5.27.1 Columbia University Pipeline Products & Ongoing Clinical Trials Overview 98

5.28 ConKay Medical Systems Inc Company Overview 100

5.28.1 ConKay Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 100

5.29 CoreMedic AG Company Overview 101

5.29.1 CoreMedic AG Pipeline Products & Ongoing Clinical Trials Overview 101

5.30 CorMatrix Cardiovascular Inc Company Overview 105

5.30.1 CorMatrix Cardiovascular Inc Pipeline Products & Ongoing Clinical Trials Overview 105

5.31 CroiValve Ltd Company Overview 112

5.31.1 CroiValve Ltd Pipeline Products & Ongoing Clinical Trials Overview 112

5.32 CUBE SRL Company Overview 115

5.32.1 CUBE SRL Pipeline Products & Ongoing Clinical Trials Overview 115

5.33 Cytograft Tissue Engineering Inc (Inactive) Company Overview 116

5.33.1 Cytograft Tissue Engineering Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 116

5.34 Daidalos Solutions BV Company Overview 117

5.34.1 Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview 117

5.35 Department of Biomedical Engineering Columbia University Company Overview 120

5.35.1 Department of Biomedical Engineering Columbia University Pipeline Products & Ongoing Clinical Trials Overview 120

5.36 Edwards Lifesciences Corp Company Overview 121

5.36.1 Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 121

5.37 Emory University Company Overview 130

5.37.1 Emory University Pipeline Products & Ongoing Clinical Trials Overview 130

5.38 Enlight Medical Technologies (Shanghai) Co Ltd Company Overview 131

5.38.1 Enlight Medical Technologies (Shanghai) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 131

5.39 enVVeno Medical Corp Company Overview 132

5.39.1 enVVeno Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 132

5.40 Florida International University Company Overview 134

5.40.1 Florida International University Pipeline Products & Ongoing Clinical Trials Overview 134

5.41 FluidForm Inc Company Overview 135

5.41.1 FluidForm Inc Pipeline Products & Ongoing Clinical Trials Overview 135

5.42 Foldax Inc Company Overview 136

5.42.1 Foldax Inc Pipeline Products & Ongoing Clinical Trials Overview 136

5.43 Georgia Institute of Technology Company Overview 141

5.43.1 Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 141

5.44 Griffith University Company Overview 143

5.44.1 Griffith University Pipeline Products & Ongoing Clinical Trials Overview 143

5.45 Hangzhou DeJin Medtech Co Ltd Company Overview 144

5.45.1 Hangzhou DeJin Medtech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 144

5.46 Hanxin Medical Technology (Shenzhen) Co Ltd Company Overview 146

5.46.1 Hanxin Medical Technology (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 146

5.47 Harpoon Medical, Inc. Company Overview 149

5.47.1 Harpoon Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 149

5.48 Hocor Cardiovascular Technologies, LLC Company Overview 152

5.48.1 Hocor Cardiovascular Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 152

5.49 Innovator Lab Consultants India Pvt Ltd Company Overview 153

5.49.1 Innovator Lab Consultants India Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 153

5.50 Innovia LLC Company Overview 154

5.50.1 Innovia LLC Pipeline Products & Ongoing Clinical Trials Overview 154

5.51 InspireMD Inc Company Overview 156

5.51.1 InspireMD Inc Pipeline Products & Ongoing Clinical Trials Overview 156

5.52 JC Medical, Inc. Company Overview 158

5.52.1 JC Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 158

5.53 Jiangsu Zhenyi Medical Technology Co Ltd Company Overview 161

5.53.1 Jiangsu Zhenyi Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 161

5.54 Jinshi Biotechnology (Changshu) Co Ltd Company Overview 162

5.54.1 Jinshi Biotechnology (Changshu) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 162

5.55 Kardium Inc Company Overview 163

5.55.1 Kardium Inc Pipeline Products & Ongoing Clinical Trials Overview 163

5.56 Kekai Life Sciences Company Overview 164

5.56.1 Kekai Life Sciences Pipeline Products & Ongoing Clinical Trials Overview 164

5.57 Leman Cardiovascular SA Company Overview 166

5.57.1 Leman Cardiovascular SA Pipeline Products & Ongoing Clinical Trials Overview 166

5.58 Lepu Medical Technology (Beijing) Co Ltd Company Overview 167

5.58.1 Lepu Medical Technology (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 167

5.59 Lifelet Medical Ltd Company Overview 171

5.59.1 Lifelet Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 171

5.60 LuSeed Vascular Company Overview 172

5.60.1 LuSeed Vascular Pipeline Products & Ongoing Clinical Trials Overview 172

5.61 Mardil Medical, Inc. Company Overview 173

5.61.1 Mardil Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 173

5.62 Mayo Clinic Company Overview 176

5.62.1 Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 176

5.63 Meacor Inc Company Overview 177

5.63.1 Meacor Inc Pipeline Products & Ongoing Clinical Trials Overview 177

5.64 Medi-Line S.A. Company Overview 178

5.64.1 Medi-Line S.A. Pipeline Products & Ongoing Clinical Trials Overview 178

5.65 Medtentia International Ltd Oy Company Overview 179

5.65.1 Medtentia International Ltd Oy Pipeline Products & Ongoing Clinical Trials Overview 179

5.66 Medtronic Plc Company Overview 180

5.66.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 180

5.67 Meril Life Sciences Pvt Ltd Company Overview 182

5.67.1 Meril Life Sciences Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 182

5.68 MiCardia Corp Company Overview 190

5.68.1 MiCardia Corp Pipeline Products & Ongoing Clinical Trials Overview 190

5.69 Michigan Critical Care Consultants Inc Company Overview 191

5.69.1 Michigan Critical Care Consultants Inc Pipeline Products & Ongoing Clinical Trials Overview 191

5.70 Micro Interventional Devices, Inc. Company Overview 192

5.70.1 Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 192

5.71 MicroPort Scientific Corp Company Overview 196

5.71.1 MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 196

5.72 Millipede LLC Company Overview 198

5.72.1 Millipede LLC Pipeline Products & Ongoing Clinical Trials Overview 198

5.73 Mitralign Inc Company Overview 201

5.73.1 Mitralign Inc Pipeline Products & Ongoing Clinical Trials Overview 201

5.74 Mitre Medical Corp Company Overview 204

5.74.1 Mitre Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 204

5.75 MVRx, Inc. Company Overview 208

5.75.1 MVRx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 208

5.76 Nanjing Shengde Medical Technology Co Ltd Company Overview 211

5.76.1 Nanjing Shengde Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 211

5.77 National University of Singapore Company Overview 213

5.77.1 National University of Singapore Pipeline Products & Ongoing Clinical Trials Overview 213

5.78 NaviGate Cardiac Structures, Inc. Company Overview 214

5.78.1 NaviGate Cardiac Structures, Inc. Pipeline Products & Ongoing Clinical Trials Overview 214

5.79 NewMed Medical Co Ltd Company Overview 215

5.79.1 NewMed Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 215

5.80 Occlufit AG Company Overview 219

5.80.1 Occlufit AG Pipeline Products & Ongoing Clinical Trials Overview 219

5.81 On-X Life Technologies Inc Company Overview 220

5.81.1 On-X Life Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 220

5.82 OrbusNeich P&F Company Overview 222

5.82.1 OrbusNeich P&F Pipeline Products & Ongoing Clinical Trials Overview 222

5.83 P+F Products + Features GmbH Company Overview 224

5.83.1 P+F Products + Features GmbH Pipeline Products & Ongoing Clinical Trials Overview 224

5.84 Peca Labs Inc Company Overview 225

5.84.1 Peca Labs Inc Pipeline Products & Ongoing Clinical Trials Overview 225

5.85 Rambam Health Care Campus Company Overview 228

5.85.1 Rambam Health Care Campus Pipeline Products & Ongoing Clinical Trials Overview 228

5.86 Revivicor Inc Company Overview 230

5.86.1 Revivicor Inc Pipeline Products & Ongoing Clinical Trials Overview 230

5.87 SCR, Inc. Company Overview 231

5.87.1 SCR, Inc. Pipeline Products & Ongoing Clinical Trials Overview 231

5.88 Shanghai Aoliu Medical Technology Co Ltd Company Overview 232

5.88.1 Shanghai Aoliu Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 232

5.89 Shanghai Hanyu Medical Technology Co Ltd Company Overview 233

5.89.1 Shanghai Hanyu Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 233

5.90 Shanghai Healing Medical Instruments Co Ltd Company Overview 234

5.90.1 Shanghai Healing Medical Instruments Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 234

5.91 Shanghai Shenqi Medical Technology Co Ltd Company Overview 235

5.91.1 Shanghai Shenqi Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 235

5.92 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 236

5.92.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 236

5.93 St. Jude Medical LLC Company Overview 238

5.93.1 St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 238

5.94 Stellenbosch University Company Overview 241

5.94.1 Stellenbosch University Pipeline Products & Ongoing Clinical Trials Overview 241

5.95 Strait Access Technologies (Pty) Ltd Company Overview 242

5.95.1 Strait Access Technologies (Pty) Ltd Pipeline Products & Ongoing Clinical Trials Overview 242

5.96 Suzhou Xinling Med Medical Technology Co Ltd Company Overview 243

5.96.1 Suzhou Xinling Med Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 243

5.97 Suzhou Yinluo Medical Devices Co Ltd Company Overview 244

5.97.1 Suzhou Yinluo Medical Devices Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 244

5.98 Symetis SA Company Overview 245

5.98.1 Symetis SA Pipeline Products & Ongoing Clinical Trials Overview 245

5.99 Syntach AB Company Overview 246

5.99.1 Syntach AB Pipeline Products & Ongoing Clinical Trials Overview 246

5.100 Tel Aviv Sourasky Medical Center Company Overview 247

5.100.1 Tel Aviv Sourasky Medical Center Pipeline Products & Ongoing Clinical Trials Overview 247

5.101 Tgen Tech LLC Company Overview 248

5.101.1 Tgen Tech LLC Pipeline Products & Ongoing Clinical Trials Overview 248

5.102 The Charles Stark Draper Laboratory Inc Company Overview 249

5.102.1 The Charles Stark Draper Laboratory Inc Pipeline Products & Ongoing Clinical Trials Overview 249

5.103 Thoratec LLC Company Overview 252

5.103.1 Thoratec LLC Pipeline Products & Ongoing Clinical Trials Overview 252

5.104 Thubrikar Aortic Valve, Inc. Company Overview 253

5.104.1 Thubrikar Aortic Valve, Inc. Pipeline Products & Ongoing Clinical Trials Overview 253

5.105 TransCardiac Therapeutics, LLC Company Overview 255

5.105.1 TransCardiac Therapeutics, LLC Pipeline Products & Ongoing Clinical Trials Overview 255

5.106 Transmural systems LLC Company Overview 256

5.106.1 Transmural systems LLC Pipeline Products & Ongoing Clinical Trials Overview 256

5.107 TRiCares SAS Company Overview 261

5.107.1 TRiCares SAS Pipeline Products & Ongoing Clinical Trials Overview 261

5.108 TTK Healthcare Ltd Company Overview 264

5.108.1 TTK Healthcare Ltd Pipeline Products & Ongoing Clinical Trials Overview 264

5.109 University College London Company Overview 266

5.109.1 University College London Pipeline Products & Ongoing Clinical Trials Overview 266

5.110 University of Arizona Company Overview 267

5.110.1 University of Arizona Pipeline Products & Ongoing Clinical Trials Overview 267

5.111 University of California Company Overview 268

5.111.1 University of California Pipeline Products & Ongoing Clinical Trials Overview 268

5.112 University of California Irvine Company Overview 269

5.112.1 University of California Irvine Pipeline Products & Ongoing Clinical Trials Overview 269

5.113 University of Cambridge Company Overview 272

5.113.1 University of Cambridge Pipeline Products & Ongoing Clinical Trials Overview 272

5.114 University of Colorado Company Overview 273

5.114.1 University of Colorado Pipeline Products & Ongoing Clinical Trials Overview 273

5.115 University of Florida Company Overview 274

5.115.1 University of Florida Pipeline Products & Ongoing Clinical Trials Overview 274

5.116 University of Manitoba Company Overview 275

5.116.1 University of Manitoba Pipeline Products & Ongoing Clinical Trials Overview 275

5.117 University of Missouri Company Overview 276

5.117.1 University of Missouri Pipeline Products & Ongoing Clinical Trials Overview 276

5.118 University of Nebraska Company Overview 277

5.118.1 University of Nebraska Pipeline Products & Ongoing Clinical Trials Overview 277

5.119 University of Pennsylvania Company Overview 278

5.119.1 University of Pennsylvania Pipeline Products & Ongoing Clinical Trials Overview 278

5.120 University of Pittsburgh Medical Center Company Overview 281

5.120.1 University of Pittsburgh Medical Center Pipeline Products & Ongoing Clinical Trials Overview 281

5.121 University of South Carolina Company Overview 282

5.121.1 University of South Carolina Pipeline Products & Ongoing Clinical Trials Overview 282

5.122 University of South Florida Company Overview 283

5.122.1 University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 283

5.123 University of Zurich Company Overview 284

5.123.1 University of Zurich Pipeline Products & Ongoing Clinical Trials Overview 284

5.124 Valcare Medical Company Overview 285

5.124.1 Valcare Medical Pipeline Products & Ongoing Clinical Trials Overview 285

5.125 valsculp Company Overview 289

5.125.1 valsculp Pipeline Products & Ongoing Clinical Trials Overview 289

5.126 Valtech Cardio Ltd Company Overview 290

5.126.1 Valtech Cardio Ltd Pipeline Products & Ongoing Clinical Trials Overview 290

5.127 ValveXchange, Inc. (Inactive) Company Overview 295

5.127.1 ValveXchange, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 295

5.128 Vdyne LLC Company Overview 298

5.128.1 Vdyne LLC Pipeline Products & Ongoing Clinical Trials Overview 298

5.129 Venus Haoyue Medtech Ltd Company Overview 301

5.129.1 Venus Haoyue Medtech Ltd Pipeline Products & Ongoing Clinical Trials Overview 301

5.130 Venus Medtech Hangzhou Inc Company Overview 302

5.130.1 Venus Medtech Hangzhou Inc Pipeline Products & Ongoing Clinical Trials Overview 302

5.131 Vesalius Cardiovascular Inc Company Overview 304

5.131.1 Vesalius Cardiovascular Inc Pipeline Products & Ongoing Clinical Trials Overview 304

5.132 Viacor Inc Company Overview 305

5.132.1 Viacor Inc Pipeline Products & Ongoing Clinical Trials Overview 305

5.133 VueKlar Cardiovascular Ltd (Inactive) Company Overview 306

5.133.1 VueKlar Cardiovascular Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 306

5.134 W. L. Gore & Associates Inc Company Overview 307

5.134.1 W. L. Gore & Associates Inc Pipeline Products & Ongoing Clinical Trials Overview 307

5.135 Xeltis AG Company Overview 308

5.135.1 Xeltis AG Pipeline Products & Ongoing Clinical Trials Overview 308

6 Surgical Heart Valves- Recent Developments 311

6.1 Jun 08, 2023: Venus Medtech Hangzhou Notice of 2022 Annual General Meeting 311

6.2 Jun 02, 2023: Venus Medtech Hangzhou proposes a change of auditors, adoption of the share option scheme and resignation of joint company secretary and chief financial officer 311

6.3 May 24, 2023: CollPlant Biotechnologies announces first quarter financial results for 2023 and provides corporate update 313

6.4 May 23, 2023: TTK Healthcare Announces Audited Financial Results for the Fourth Quarter and Year Ended 31st March, 2023 315

6.5 May 11, 2023: Medtronic to announce financial results for its fourth quarter and full fiscal year 2023 315

6.6 Apr 26, 2023: MicroPort announces annual results for 2022 316

6.7 Apr 12, 2023: Medtronic has a layoff in California 316

6.8 Apr 05, 2023: JenaValve Appoints Ken MacLeod, Ph.D. to Board of Directors 316

6.9 Mar 21, 2023: Tissue Regenix Group Announces Final results for the year ended 31 December 2022 317

6.10 Mar 16, 2023: Medtronic joins in $25M funding round for home monitoring company 318

6.11 Feb 07, 2023: TTK Healthcare Announces Statement of Unaudited Financial Results for the Quarter and Period Ended 31st December, 2022 319

6.12 Feb 01, 2023: It might be the end ofoOpen-heart surgeries: Israeli Biomed company TruLeaf medical will implant a mitral heart valve via two needle sticks only in a two-stage catheterization without surgery 319

6.13 Feb 01, 2023: Japan Lifeline Announces Consolidated Financial Results for the Nine months Ended December 31, 2022 321

6.14 Jan 17, 2023: New electromagnetic device could catapult advances in mechanobiology research into the clinical arena 322

6.15 Jan 06, 2023: JenaValve Appoints Dan Dearen to Board of Directors 323

6.16 Dec 12, 2022: RUA Life Sciences confirms half-year loss and revenue 323

6.17 Dec 08, 2022: Edwards Lifesciences Announces CEO Succession Plan 323

6.18 Dec 07, 2022: SIH announces that 76 leadership positions will be eliminated, reorganized 324

6.19 Dec 01, 2022: CollPlant Biotechnologies Provides Business Updates and Third Quarter 2022 Financial Results 324

6.20 Nov 23, 2022: Medtronic Reports Quarterly Earnings 326

6.21 Nov 22, 2022: Medtronic reports second quarter fiscal 2023 financial results 326

6.22 Nov 22, 2022: Mayo Clinic surgeon takes the wheel as Kwik Trip’s new CEO 332

6.23 Nov 15, 2022: Medtronic Set to Announce Earnings on Tuesday 332

6.24 Oct 20, 2022: Edwards Lifesciences to Host Earnings Conference Call on October 27, 2022 332

6.25 Sep 30, 2022: Natalie Caine named chief administrative officer at Mayo Clinic in Rochester 332

6.26 Sep 29, 2022: Artivion AORT Appoints Elizabeth Hoff to its Board 333

6.27 Sep 07, 2022: Medtronic to appear at September investor conferences 333

6.28 Sep 07, 2022: Tissue Regenix Group Announces Half-year Report 333

6.29 Sep 06, 2022: Occlutech Appoints Chief Commercial Officer and Vice President Global Business Development & Marketing 334

6.30 Aug 25, 2022: Collplant Biotechnologies Provides Business Updates and Second Quarter 2022 Financial Results 335

6.31 Aug 25, 2022: Atrion Announces CFO Succession Plan 337

6.32 Aug 24, 2022: Artivion to Present at the Gilmartin Group Emerging Growth Company Showcase 337

6.33 Aug 23, 2022: Medtronic reports first quarter fiscal 2023 financial results 338

6.34 Aug 23, 2022: Medtronic Announces Quarterly Earnings Results 340

6.35 Jul 21, 2022: Edwards Lifesciences to Host Earnings Conference Call on July 28, 2022 343

7 Appendix 344

7.1 Methodology 344

7.2 About GlobalData 347

7.3 Contact Us 347

7.4 Disclaimer 347

Table

Surgical Heart Valves – Pipeline Products by Stage of Development 25

Surgical Heart Valves – Pipeline Products by Segment 26

Surgical Heart Valves – Pipeline Products by Territory 27

Surgical Heart Valves – Pipeline Products by Regulatory Path 28

Surgical Heart Valves – Pipeline Products by Estimated Approval Date 29

Surgical Heart Valves – Ongoing Clinical Trials 30

Surgical Heart Valves Companies – Pipeline Products by Stage of Development 31

Surgical Heart Valves – Pipeline Products by Stage of Development 36

4Tech Cardio Ireland Ltd Pipeline Products & Ongoing Clinical Trials Overview 42

TriCinch Coil Tricuspid Valve Repair System – Product Status 42

TriCinch Coil Tricuspid Valve Repair System – Product Description 42

4Tech Cardio Ireland Ltd – Ongoing Clinical Trials Overview 43

TriCinch Coil Tricuspid Valve Repair System – Assessment of the All Cause Mortality at 30 days for Patients suffering from Tricuspid Regurgitation implanted with the Percutaneous 4Tech TriCinch Coil System 44

TriCinch Coil Tricuspid Valve Repair System – Early Feasibility Study of TriCinch Coil Tricuspid Valve Repair System 44

TriCinch Coil Tricuspid Valve Repair System – International Multisite Transcatheter Tricuspid Valve Therapies Registry 44

Affluent Medical SASU Pipeline Products & Ongoing Clinical Trials Overview 45

Kalios – Product Status 45

Kalios – Product Description 45

Affluent Medical SASU – Ongoing Clinical Trials Overview 46

Kalios – Optimization of Surgical Repair for Treating Insufficiency of the Mitral Valve – Safety and Effectiveness Evaluation: OPTIMISE II 47

AGEless Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 48

AGEless Valve – Product Status 48

AGEless Valve – Product Description 48

Ample Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 49

PS3 System – Product Status 49

PS3 System – Product Description 49

Anchorvalve Pipeline Products & Ongoing Clinical Trials Overview 50

Sutureless Mitral Valve Prostheses – Product Status 50

Sutureless Mitral Valve Prostheses – Product Description 50

Sutureless Mitral Valve Repair Ring – Product Status 51

Sutureless Mitral Valve Repair Ring – Product Description 51

Sutureless Tricuspid Valve Prostheses – Product Status 51

Sutureless Tricuspid Valve Prostheses – Product Description 52

Sutureless Tricuspid Valve Repair Ring – Product Status 52

Sutureless Tricuspid Valve Repair Ring – Product Description 52

Ancora Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 53

AccuCinch Ventricular Restoration System – Product Status 53

AccuCinch Ventricular Restoration System – Product Description 53

Ancora Heart Inc – Ongoing Clinical Trials Overview 54

AccuCinch Ventricular Restoration System – An Early Feasibility Evaluation of the AccuCinch Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF) – The CorCinch-HFrEF Study 55

AccuCinch Ventricular Restoration System – An Early Feasibility Study of the AccuCinch Ventricular Repair System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation – The CorCinch-PMVI Study 55

AccuCinch Ventricular Restoration System – Early Feasibility Study of the AccuCinch Ventricular Restoration System 55

AccuCinch Ventricular Restoration System – Randomized Clinical Evaluation of the AccuCinch Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study 56

AccuCinch Ventricular Restoration System – Safety and Performance Evaluation of the AccuCinch Ventricular Repair System for Functional Mitral Regurgitation Due to Dilated Ischemic or Non-Ischemic Cardiomyopathy – The CorCinch-EU Study 56

Anteris Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 57

ComASUR Transfemoral Delivery System – Product Status 57

ComASUR Transfemoral Delivery System – Product Description 57

DurAVR Heart Valve – Product Status 58

DurAVR Heart Valve – Product Description 58

DurAVR Leaflet Repair (RP) – Product Status 58

DurAVR Leaflet Repair (RP) – Product Description 59

Anteris Technologies Ltd – Ongoing Clinical Trials Overview 60

DurAVR Heart Valve – First in Human Surgical Implantation of Single Piece ADAPT Treated 3D ALR (Aortic Leaflet Repair), Feasibility and Clinical Safety Study 61

Approxima Srl Pipeline Products & Ongoing Clinical Trials Overview 62

Tricuspid Valve Repair System – Product Status 62

Tricuspid Valve Repair System – Product Description 62

Aptus LLC Pipeline Products & Ongoing Clinical Trials Overview 63

Pediatric Heart Valve – Product Status 63

Pediatric Heart Valve – Product Description 63

Artivion Inc Pipeline Products & Ongoing Clinical Trials Overview 64

Antyllus – Product Status 64

Antyllus – Product Description 65

Aortiger – Product Status 65

Aortiger – Product Description 65

Artivion – Product Status 65

Artivion – Product Description 66

CryoValve SGAV – Product Status 66

CryoValve SGAV – Product Description 66

On-X Mechanical Aortic Valve – ELIQUIS – Product Status 67

On-X Mechanical Aortic Valve – ELIQUIS – Product Description 67

Sanevo – Product Status 67

Sanevo – Product Description 67

Semtis – Product Status 68

Semtis – Product Description 68

Synergraft Xenograft Heart Valve – Product Status 68

Synergraft Xenograft Heart Valve – Product Description 68

Autus Valve Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 69

Autus Size-Adaptable Valve – Product Status 69

Autus Size-Adaptable Valve – Product Description 69

Autus Valve Technologies Inc – Ongoing Clinical Trials Overview 70

Autus Size-Adaptable Valve – Autus Size-Adjustable Valve for Surgical Pulmonary Valve Replacement Early Feasibility Study 71

BioLife4D Corp Pipeline Products & Ongoing Clinical Trials Overview 72

Cardiac Valve – Product Status 72

Cardiac Valve – Product Description 72

Biostage Inc Pipeline Products & Ongoing Clinical Trials Overview 73

3D Printed Heart Valve – Product Status 73

3D Printed Heart Valve – Product Description 73

BioVentrix Inc Pipeline Products & Ongoing Clinical Trials Overview 74

Revivent-TC System – Product Status 74

Revivent-TC System – Product Description 74

BioVentrix Inc – Ongoing Clinical Trials Overview 75

Revivent-TC System – Clinical Study of the BioVentrix Revivent TC System for Treatment of Left Ventricular Aneurysms ALIVE-EA (American Less Invasive Ventricular Enhancement-Expanded Access) 76

Revivent-TC System – Clinical Study of the BioVentrix Revivent TC System for Treatment of Left Ventricular Aneurysms: ALIVE 76

Revivent-TC System – Randomized Evaluation and Verification of Ventricular Enhancement: The REVIVE-HF Study 76

Boston Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 77

Endovascular Prosthesis – Product Status 77

Endovascular Prosthesis – Product Description 77

Heart Valve Leaflet – Product Status 78

Heart Valve Leaflet – Product Description 78

Mitral Valve Repair Clip – Product Status 78

Mitral Valve Repair Clip – Product Description 79

Prosthetic Heart Valve – Product Status 79

Prosthetic Heart Valve – Product Description 79

Tricuspid Valve Repair Device – Product Status 80

Tricuspid Valve Repair Device – Product Description 80

Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 81

Millipede Percutaneous Annuloplasty Ring – Product Status 81

Millipede Percutaneous Annuloplasty Ring – Product Description 82

Boston Scientific Scimed Inc Pipeline Products & Ongoing Clinical Trials Overview 83

LOTUS eMantra – Product Status 83

LOTUS eMantra – Product Description 83

Cambris Cardiac Ltd Pipeline Products & Ongoing Clinical Trials Overview 84

Polymeric Heart Valve – Product Status 84

Polymeric Heart Valve – Product Description 84

Cardiac Implants LLC Pipeline Products & Ongoing Clinical Trials Overview 85

Ring Annuloplasty Device – Product Status 85

Ring Annuloplasty Device – Product Description 85

Tri-Ring Device – Product Status 86

Tri-Ring Device – Product Description 86

Cardiosolutions Inc Pipeline Products & Ongoing Clinical Trials Overview 87

Mitra-Spacer – Product Status 87

Mitra-Spacer – Product Description 87

Cedars-Sinai Medical Center Pipeline Products & Ongoing Clinical Trials Overview 88

Percutaneous Tricuspid Valve Repair Device – Product Status 88

Percutaneous Tricuspid Valve Repair Device – Product Description 88

Celyad Oncology SA Pipeline Products & Ongoing Clinical Trials Overview 89

Heart Access Sheath – Mitral Valve Repair – Product Status 89

Heart Access Sheath – Mitral Valve Repair – Product Description 89

Mitral Valve Neo-chordae – Product Status 90

Mitral Valve Neo-chordae – Product Description 90

Colibri Heart Valve LLC Pipeline Products & Ongoing Clinical Trials Overview 91

Custom Delivery System – Product Status 91

Custom Delivery System – Product Description 91

Pulmonary Valve – Product Status 92

Pulmonary Valve – Product Description 92

Sutureless Surgical Aortic Valve – Product Status 92

Sutureless Surgical Aortic Valve – Product Description 93

Collagen Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 94

Heart Valve Device – Product Status 94

Heart Valve Device – Product Description 94

Collplant Biotechnologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 95

3D Printed Heart Valve Tissue – Product Status 95

3D Printed Heart Valve Tissue – Product Description 95

Vergenix HVR – Product Status 96

Vergenix HVR – Product Description 96

Colorado State University Pipeline Products & Ongoing Clinical Trials Overview 97

BioPoly Heart Valve – Product Status 97

BioPoly Heart Valve – Product Description 97

Columbia University Pipeline Products & Ongoing Clinical Trials Overview 98

Hybrid Regenerative Prosthetic Heart Valve – Product Status 98

Hybrid Regenerative Prosthetic Heart Valve – Product Description 98

Prosthetic Heart Valve – Product Status 99

Prosthetic Heart Valve – Product Description 99

ConKay Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 100

Valvular Regurgitation Treatment Device – Product Status 100

Valvular Regurgitation Treatment Device – Product Description 100

CoreMedic AG Pipeline Products & Ongoing Clinical Trials Overview 101

ChordArt – Product Status 101

ChordArt – Product Description 101

ChordArt S – Product Status 102

ChordArt S – Product Description 102

CoreMedic AG – Ongoing Clinical Trials Overview 103

ChordArt – Chordart System Study for the Treatment of Mitral Regurgitation Due to Leaflet Prolapse or Flail 104

CorMatrix Cardiovascular Inc Pipeline Products & Ongoing Clinical Trials Overview 105

Cor Tricupsid ECM Pediatric Valve Device – Product Status 105

Cor Tricupsid ECM Pediatric Valve Device – Product Description 105

Cor Tricupsid ECM Valve Device – Product Status 106

Cor Tricupsid ECM Valve Device – Product Description 106

CorMatrix ECM – Heart Valve Repair – Product Status 106

CorMatrix ECM – Heart Valve Repair – Product Description 107

CorMatrix ECM – Heart Valve Replacement – Product Status 107

CorMatrix ECM – Heart Valve Replacement – Product Description 107

Regenerating Tubular Mitral Valve – Product Status 108

Regenerating Tubular Mitral Valve – Product Description 108

CorMatrix Cardiovascular Inc – Ongoing Clinical Trials Overview 109

Cor Tricupsid ECM Pediatric Valve Device – CorMatrix Cor TRICUSPID ECM Valve Replacement Safety and Early Feasibility 110

Cor Tricupsid ECM Valve Device – CorMatrix Cor TRICUSPID ECM Valve Replacement Safety and Early Feasibility 111

Cor Tricupsid ECM Valve Device – CorMatrix Cor TRICUSPID ECM Valve Replacement Study 111

CroiValve Ltd Pipeline Products & Ongoing Clinical Trials Overview 112

Duo Tricuspid Coaptation Valve – Product Status 112

Duo Tricuspid Coaptation Valve – Product Description 112

CroiValve Ltd – Ongoing Clinical Trials Overview 113

Duo Tricuspid Coaptation Valve – A European Feasibility Study of the CroiValve DUO Transcatheter Tricuspid Coaptation Valve System in Patients with Tricuspid Regurgitation 114

CUBE SRL Pipeline Products & Ongoing Clinical Trials Overview 115

Mitral-FERCube Ring – Product Status 115

Mitral-FERCube Ring – Product Description 115

Cytograft Tissue Engineering Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 116

Cytograft Valve – Product Status 116

Cytograft Valve – Product Description 116

Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview 117

Heart Valve Prostheses Applicator – Product Status 117

Heart Valve Prostheses Applicator – Product Description 117

Loading Device – Sutureless Heart Valve Prostheses – Product Status 118

Loading Device – Sutureless Heart Valve Prostheses – Product Description 118

Sutureless Aortic Valve Prosthesis – Product Status 118

Sutureless Aortic Valve Prosthesis – Product Description 119

Department of Biomedical Engineering Columbia University Pipeline Products & Ongoing Clinical Trials Overview 120

GEVI – Product Status 120

GEVI – Product Description 120

Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 121

Carpentier-Edwards BioPhysio Aortic Valve – Product Status 121

Carpentier-Edwards BioPhysio Aortic Valve – Product Description 122

Coapsys – Product Status 122

Coapsys – Product Description 122

GLX Aortic Conduit – Product Status 123

GLX Aortic Conduit – Product Description 123

Magna Ease Surgical Valve With GLX – Product Status 123

Magna Ease Surgical Valve With GLX – Product Description 124

MOBIUS Leaflet Repair System – Product Status 124

MOBIUS Leaflet Repair System – Product Description 124

MultiShot – Product Status 124

MultiShot – Product Description 125

Next Generation Mitral Heart Valve – Product Status 125

Next Generation Mitral Heart Valve – Product Description 125

PASCAL Transcatheter Tricuspid Valve Repair System – Product Status 126

PASCAL Transcatheter Tricuspid Valve Repair System – Product Description 126

Edwards Lifesciences Corp – Ongoing Clinical Trials Overview 127

PASCAL Transcatheter Tricuspid Valve Repair System – A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair with the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients with Tricuspid Regurgitation 128

PASCAL Transcatheter Tricuspid Valve Repair System – Edwards PASCAL Transcatheter Valve Repair System in Tricuspid Regurgitation (CLASP TR) Early Feasibility Study 128

PASCAL Transcatheter Tricuspid Valve Repair System – Edwards PASCAL Transcatheter Valve Repair System Registry: A Multicenter Observational Registry with the Edwards PASCAL Transcatheter Valve Repair System 128

PASCAL Transcatheter Tricuspid Valve Repair System – Evaluation of the Safety, Efficacy and Cost-effectiveness of Transcatheter Tricuspid Valve Repair in Patients With Severe Tricuspid Regurgitation in the Netherlands. 129

PASCAL Transcatheter Tricuspid Valve Repair System – PASTE: PASCAL for Tricuspid Regurgitation – A European Registry 129

PASCAL Transcatheter Tricuspid Valve Repair System – Transcatheter Repair of Tricuspid Regurgitation with Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post-market Clinical Follow up 129

Emory University Pipeline Products & Ongoing Clinical Trials Overview 130

MitraSurg – Product Status 130

MitraSurg – Product Description 130

Enlight Medical Technologies (Shanghai) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 131

Mitral Valve Replacement System – Product Status 131

Mitral Valve Replacement System – Product Description 131

enVVeno Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 132

Bioprosthetic Aortic Heart Valve – Product Status 132

Bioprosthetic Aortic Heart Valve – Product Description 132

Bioprosthetic Mitral Heart Valve – Product Status 133

Bioprosthetic Mitral Heart Valve – Product Description 133

Florida International University Pipeline Products & Ongoing Clinical Trials Overview 134

Percutaneous Heart Valve Delivery System – Product Status 134

Percutaneous Heart Valve Delivery System – Product Description 134

FluidForm Inc Pipeline Products & Ongoing Clinical Trials Overview 135

Bioprosthetic Collagen Heart Valve – Product Status 135

Bioprosthetic Collagen Heart Valve – Product Description 135

Foldax Inc Pipeline Products & Ongoing Clinical Trials Overview 136

Tria Biopolymer Mitral Surgical Heart Valve – Product Status 136

Tria Biopolymer Mitral Surgical Heart Valve – Product Description 136

TRIA Biopolymer Surgical Aortic Heart Valve – Product Status 136

TRIA Biopolymer Surgical Aortic Heart Valve – Product Description 137

Tria Surgical Tricuspid Heart Valve – Product Status 137

Tria Surgical Tricuspid Heart Valve – Product Description 137

Foldax Inc – Ongoing Clinical Trials Overview 138

TRIA Biopolymer Surgical Aortic Heart Valve – Early Feasibility Study for the Foldax Tria Aortic Heart Valve 139

TRIA Biopolymer Surgical Aortic Heart Valve – Study to Evaluate the Efficacy of TRIA Biopolymer Surgical Aortic Heart Valve in the Treatment of Patients with Aortic valve Disease 139

Tria Biopolymer Mitral Surgical Heart Valve – Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement Investigational Device Exemption 140

Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 141

Replaceable Heart Valve Prosthesis – Product Status 141

Replaceable Heart Valve Prosthesis – Product Description 141

Tricuspid Annuloplasty Ring – Product Status 142

Tricuspid Annuloplasty Ring – Product Description 142

Griffith University Pipeline Products & Ongoing Clinical Trials Overview 143

Next Generation Heart Valve – Product Status 143

Next Generation Heart Valve – Product Description 143

Hangzhou DeJin Medtech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 144

Second Generation Mitral Valve Repair Device – Product Status 144

Second Generation Mitral Valve Repair Device – Product Description 144

Tricuspid Repair Device – Product Status 145

Tricuspid Repair Device – Product Description 145

Hanxin Medical Technology (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 146

Mitral Valve Tendon Repair System – Product Status 146

Mitral Valve Tendon Repair System – Product Description 146

Hanxin Medical Technology (Shenzhen) Co Ltd – Ongoing Clinical Trials Overview 147

Mitral Valve Tendon Repair System – A Prospective, Multicentre, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of an Interventional Mitral Chordae Tendineae Repair System for the Treatment of Mitral Regurgitation 148

Mitral Valve Tendon Repair System – Clinical Trial to Evaluate the Safety and Efficacy of an Interventional Mitral Valve Tendon Repair System for the Treatment of Mitral Regurgitation 148

Mitral Valve Tendon Repair System – Clinical Trial to Evaluate the Safety and Efficacy of an Interventional Mitral Valve Tendon Repair System for the Treatment of Mitral Regurgitation 148

Harpoon Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 149

HARPOON Beating Heart Mitral Valve Repair System – Product Status 149

HARPOON Beating Heart Mitral Valve Repair System – Product Description 149

Harpoon Medical, Inc. – Ongoing Clinical Trials Overview 150

HARPOON Beating Heart Mitral Valve Repair System – A Prospective, Multi-center Trial to Evaluate the Safety and Effectiveness of Beating Heart Mitral Valve Repair with the HARPOON System (RESTORE) 151

Hocor Cardiovascular Technologies, LLC Pipeline Products & Ongoing Clinical Trials Overview 152

HOCOR System – Product Status 152

HOCOR System – Product Description 152

Innovator Lab Consultants India Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 153

Mechanical Heart Valve 2.0 – Product Status 153

Mechanical Heart Valve 2.0 – Product Description 153

Innovia LLC Pipeline Products & Ongoing Clinical Trials Overview 154

Minimally Invasive Synthetic Tri – Leaflet Heart Valve – Product Status 154

Minimally Invasive Synthetic Tri – Leaflet Heart Valve – Product Description 154

Percutaneous Synthetic Tri – Leaflet Heart Valve – Product Status 155

Percutaneous Synthetic Tri – Leaflet Heart Valve – Product Description 155

Sutured In Synthetic Tri – Leaflet Heart Valve – Product Status 155

Sutured In Synthetic Tri – Leaflet Heart Valve – Product Description 155

InspireMD Inc Pipeline Products & Ongoing Clinical Trials Overview 156

CGuard Prime – Product Status 156

CGuard Prime – Product Description 156

Delivery System – Product Status 157

Delivery System – Product Description 157

JC Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 158

J-Valve TF Delivery System – Product Status 158

J-Valve TF Delivery System – Product Description 158

JC Medical, Inc. – Ongoing Clinical Trials Overview 159

J-Valve TF Delivery System – Efficacy and Safety of the J-Valve Transcatheter Aortic Valve Replacement System in Patients With Aortic Stenosis Disease 160

Jiangsu Zhenyi Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 161

Aortic Valve Stem Valve – Product Status 161

Aortic Valve Stem Valve – Product Description 161

Jinshi Biotechnology (Changshu) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 162

Xinli Bioprosthetic Heart Valve – Product Status 162

Xinli Bioprosthetic Heart Valve – Product Description 162

Kardium Inc Pipeline Products & Ongoing Clinical Trials Overview 163

Percutaneous Mitral Valve Regurgitation Device – Product Status 163

Percutaneous Mitral Valve Regurgitation Device – Product Description 163

Kekai Life Sciences Pipeline Products & Ongoing Clinical Trials Overview 164

FlexClamp – Product Status 164

FlexClamp – Product Description 164

FlexClip – Product Status 165

FlexClip – Product Description 165

SuperClip – Product Status 165

SuperClip – Product Description 165

Leman Cardiovascular SA Pipeline Products & Ongoing Clinical Trials Overview 166

Kalangos Valve – Product Status 166

Kalangos Valve – Product Description 166

Lepu Medical Technology (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 167

Transapical Mitral Valve Clip Repair System – Product Status 167

Transapical Mitral Valve Clip Repair System – Product Description 168

Transapical Mitral Valve Repair System – Chordal – Product Status 168

Transapical Mitral Valve Repair System – Chordal – Product Description 168

Transcatheter Papillary Muscle Repair System – Product Status 169

Transcatheter Papillary Muscle Repair System – Product Description 169

Transcatheter Tricuspid Valve Repair System – Product Status 169

Transcatheter Tricuspid Valve Repair System – Product Description 170

Transfemoral Mitral Valve Clip Repair System – Product Status 170

Transfemoral Mitral Valve Clip Repair System – Product Description 170

Lifelet Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 171

Lifelet Polymer Valve – Product Status 171

Lifelet Polymer Valve – Product Description 171

LuSeed Vascular Pipeline Products & Ongoing Clinical Trials Overview 172

LuSeed Intrasaccular Device – Heart Valve Insufficiency – Product Status 172

LuSeed Intrasaccular Device – Heart Valve Insufficiency – Product Description 172

Mardil Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 173

VenTouch Triad Targeted Ventricular Reshaping System – Product Status 173

VenTouch Triad Targeted Ventricular Reshaping System – Product Description 173

Mardil Medical, Inc. – Ongoing Clinical Trials Overview 174

VenTouch Triad Targeted Ventricular Reshaping System – Evaluation of the Minimally Invasive VenTouch System in the Treatment of Functional Mitral Valve Regurgitation (FMR): First-in-man Continuation Study 175

VenTouch Triad Targeted Ventricular Reshaping System – Evaluation of The Minimally Invasive VenTouch System in The Treatment of Functional Mitral Valve Regurgitation (FMR): OUS Feasibility Study 175

Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 176

Catheter-Based Mitral Valve Repair Device – Product Status 176

Catheter-Based Mitral Valve Repair Device – Product Description 176

Meacor Inc Pipeline Products & Ongoing Clinical Trials Overview 177

CryoCinch – Product Status 177

CryoCinch – Product Description 177

Medi-Line S.A. Pipeline Products & Ongoing Clinical Trials Overview 178

AVATAR² Device – Product Status 178

AVATAR² Device – Product Description 178

Medtentia International Ltd Oy Pipeline Products & Ongoing Clinical Trials Overview 179

CathHELIX – Product Status 179

CathHELIX – Product Description 179

Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 180

Closed-Chest Aortic Tissue Valve – Product Status 180

Closed-Chest Aortic Tissue Valve – Product Description 180

Enable Valve – Beating Heart Procedure – Product Status 181

Enable Valve – Beating Heart Procedure – Product Description 181

Meril Life Sciences Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 182

CALIX-R – Product Status 182

CALIX-R – Product Description 183

Daffodil AV – Product Status 183

Daffodil AV – Product Description 183

Daffodil MV – Product Status 183

Daffodil MV – Product Description 184

Dafodil DRI – Product Status 184

Dafodil DRI – Product Description 184

Miltonia-UNO – Product Status 184

Miltonia-UNO – Product Description 185

Mitva – Product Status 185

Mitva – Product Description 185

MyVal 2 – Product Status 185

MyVal 2 – Product Description 186

MyVal Genesis – Product Status 186

MyVal Genesis – Product Description 186

MyVal Hexa – Product Status 186

MyVal Hexa – Product Description 187

MyVal Integra – Product Status 187

MyVal Integra – Product Description 187

Myval Rondevu – Product Status 187

Myval Rondevu – Product Description 188

Navigator 2 – Product Status 188

Navigator 2 – Product Description 188

Navigator Neo – Product Status 188

Navigator Neo – Product Description 189

Senarius – Product Status 189

Senarius – Product Description 189

MiCardia Corp Pipeline Products & Ongoing Clinical Trials Overview 190

enCorTC – Product Status 190

enCorTC – Product Description 190

Michigan Critical Care Consultants Inc Pipeline Products & Ongoing Clinical Trials Overview 191

Percutaneous Mitral Annuloplasty Ring – Product Status 191

Percutaneous Mitral Annuloplasty Ring – Product Description 191

Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 192

MIA System – Mitral Valve Repair – Product Status 192

MIA System – Mitral Valve Repair – Product Description 192

MIA-T Percutaneous Tricuspid Annuloplasty System – Product Status 193

MIA-T Percutaneous Tricuspid Annuloplasty System – Product Description 193

Micro Interventional Devices, Inc. – Ongoing Clinical Trials Overview 194

MIA-T Percutaneous Tricuspid Annuloplasty System – Study of Transcatheter Tricuspid Annular Repair 195

MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 196

Biomaterial Replacement Heart Valve – Product Status 196

Biomaterial Replacement Heart Valve – Product Description 196

Surgical Valve – Product Status 197

Surgical Valve – Product Description 197

Millipede LLC Pipeline Products & Ongoing Clinical Trials Overview 198

IRIS Transcatheter Annuloplasty Ring – Product Status 198

IRIS Transcatheter Annuloplasty Ring – Product Description 198

Millipede LLC – Ongoing Clinical Trials Overview 199

IRIS Transcatheter Annuloplasty Ring – A Study to Evaluate the Feasibility and Safety of the Millipede Transcatheter Annuloplasty Ring System in Patients with Functional Mitral Regurgitation: (Millipede Feasibility Study) 200

Mitralign Inc Pipeline Products & Ongoing Clinical Trials Overview 201

Trialign Percutaneous Tricuspid Valve Annuloplasty System – Product Status 201

Trialign Percutaneous Tricuspid Valve Annuloplasty System – Product Description 201

Mitralign Inc – Ongoing Clinical Trials Overview 202

Trialign Percutaneous Tricuspid Valve Annuloplasty System – International Multisite Transcatheter Tricuspid Valve Therapies Registry 203

Trialign Percutaneous Tricuspid Valve Annuloplasty System – Safety and Feasibility of the Transcatheter Tricuspid Valve Repair System (Trialign) for the Treatment or Reduction of Moderate to Severe Functional Tricuspid Regurgitation 203

Trialign Percutaneous Tricuspid Valve Annuloplasty System – Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation 203

Mitre Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 204

Mitral Touch – Product Status 204

Mitral Touch – Product Description 204

Next Generation Mitral Touch – Product Status 205

Next Generation Mitral Touch – Product Description 205

Mitre Medical Corp – Ongoing Clinical Trials Overview 206

Mitral Touch – ENRAPT-MR Trial: Epicardial Mitral Repair 207

Mitral Touch – ENRAPTUS Epicardial Mitral Touch System for Mitral Insufficiency 207

MVRx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 208

ARTO System – Product Status 208

ARTO System – Product Description 208

MVRx, Inc. – Ongoing Clinical Trials Overview 209

ARTO System – Mitral Valve Repair Clinical Trial: MAVERIC Trial 210

Nanjing Shengde Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 211

Alive – Product Status 211

Alive – Product Description 211

Infinicor – Product Status 212

Infinicor – Product Description 212

National University of Singapore Pipeline Products & Ongoing Clinical Trials Overview 213

SingValve – Product Status 213

SingValve – Product Description 213

NaviGate Cardiac Structures, Inc. Pipeline Products & Ongoing Clinical Trials Overview 214

Trans Femoral Delivery System – Product Status 214

Trans Femoral Delivery System – Product Description 214

NewMed Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 215

ValveClip-M – Product Status 215

ValveClip-M – Product Description 215

ValveClip-T – Product Status 216

ValveClip-T – Product Description 216

NewMed Medical Co Ltd – Ongoing Clinical Trials Overview 217

ValveClip-M – Evaluation of the Efficacy and Safety of the Transcatheter Mitral Valve Repair System in Patients with Moderate and Above Degenerative Mitral Regurgitation at High Surgical Risk 218

Occlufit AG Pipeline Products & Ongoing Clinical Trials Overview 219

Cardiovascular Occluder Device – Product Status 219

Cardiovascular Occluder Device – Product Description 219

On-X Life Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 220

On-X Mitral Heart Valve – Product Status 220

On-X Mitral Heart Valve – Product Description 220

On-X Mitral Valve-Low INR – Product Status 221

On-X Mitral Valve-Low INR – Product Description 221

OrbusNeich P&F Pipeline Products & Ongoing Clinical Trials Overview 222

Vienna Mitral Valve – Replacement – Product Status 222

Vienna Mitral Valve – Replacement – Product Description 222

Vienna Pulmonary Valve – Replacement – Product Status 223

Vienna Pulmonary Valve – Replacement – Product Description 223

P+F Products + Features GmbH Pipeline Products & Ongoing Clinical Trials Overview 224

Endobental Device – Product Status 224

Endobental Device – Product Description 224

Peca Labs Inc Pipeline Products & Ongoing Clinical Trials Overview 225

Masa Valve – Product Status 225

Masa Valve – Product Description 225

Peca Labs Inc – Ongoing Clinical Trials Overview 226

Masa Valve – MASA Valve Early Feasibility Study 227

Rambam Health Care Campus Pipeline Products & Ongoing Clinical Trials Overview 228

Adjustable Annuloplasty Apparatus – Product Status 228

Adjustable Annuloplasty Apparatus – Product Description 228

Prosthetic Heart Valve – Product Status 229

Prosthetic Heart Valve – Product Description 229

Revivicor Inc Pipeline Products & Ongoing Clinical Trials Overview 230

Heart Valve – Product Status 230

Heart Valve – Product Description 230

SCR, Inc. Pipeline Products & Ongoing Clinical Trials Overview 231

Chronic Implantable Counterpulsation Device – Product Status 231

Chronic Implantable Counterpulsation Device – Product Description 231

Shanghai Aoliu Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 232

Congenital Heart Valve Device – Product Status 232

Congenital Heart Valve Device – Product Description 232

Shanghai Hanyu Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 233

ValveNeo – Product Status 233

ValveNeo – Product Description 233

Shanghai Healing Medical Instruments Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 234

Aortic Intervention Valve – Product Status 234

Aortic Intervention Valve – Product Description 234

Shanghai Shenqi Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 235

Qilin System – Product Status 235

Qilin System – Product Description 235

Sree Chitra Tirunal Institute for Medical Sciences

Figures

Surgical Heart Valves – Pipeline Products by Stage of Development 25

Surgical Heart Valves – Pipeline Products by Segment 26

Surgical Heart Valves – Pipeline Products by Territory 27

Surgical Heart Valves – Pipeline Products by Regulatory Path 28

Surgical Heart Valves – Pipeline Products by Estimated Approval Date 29

Surgical Heart Valves – Ongoing Clinical Trials 30

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