Transcatheter Aortic Valve Replacement (TAVR) Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies

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TAVR Pipeline Market Report Overview

Transcatheter Aortic Valve Replacement (TAVR) is also known as Transcatheter Aortic Valve Implantation (TAVI). It is a minimally invasive procedure used to treat severe aortic valve stenosis by implanting a Transcatheter Heart Valve in a patient’s diseased aortic valve. The procedure is largely performed transfemorally (through the groin).

The TAVR pipeline market research report provides a comprehensive understanding of the pipeline products along with their comparative analysis at various stages of development. The report also includes information about the territories wherein the clinical trials are in progress, the regulatory paths followed by the trials, and the companies associated with the trials.

Key Territories ·       China

·       Europe

·       Japan

·       India

·       Israel

Key Regulatory Paths ·       510(k)

·       CE

·       PMA

·       TGA

·       NMPA

Leading Companies ·       Aegis Surgical Limited

·       Anteris Technologies Ltd

·       AorTx, Inc.

·       Arbor Surgical Technologies, Inc.

·       Atlas Medical

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TAVR Pipeline Market Segmentation by Territories

A few of the key territories with the TAVR pipeline market are Europe, China, India, Japan, and Israel among others. As of August 2024, China had the highest number of TAVR pipeline products.

TAVR Pipeline Market Analysis by Territories, 2024 (%)

TAVR Pipeline Market Analysis by Territories, 2024 (%)

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TAVR Pipeline Market Segmentation by Regulatory Paths

A few of the key regulatory paths in the TAVR pipeline products market are 510(k), CE, PMA, TGA, and NMPA. As of August 2024, NMPA was the most followed pathway for pipeline products in the TAVR market.

TAVR Pipeline Market Analysis by Regulatory Paths, 2024 (%)

TAVR Pipeline Market Analysis by Regulatory Paths, 2024 (%)

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TAVR Pipeline Market – Competitive Landscape

A few of the key companies associated with the TAVR pipeline market are Aegis Surgical Limited, Anteris Technologies Ltd, AorTx, Inc., Arbor Surgical Technologies, Inc., and Atlas Medical among others.

Anteris Technologies Ltd: Anteris Technologies, formerly Admedus Ltd develops, manufactures, and distributes medical devices and technologies with a focus on tissue engineering and immunotherapies. The company’s product portfolio includes ADAPT technology, a next-generation bioscaffold that reengineers xenograft tissue into a pure collagen scaffold, and the DurAVR heart valve, a 3D single-piece aortic valve that creates a wider valve opening and better blood flow. Anteris Technologies is headquartered in Brisbane, Queensland, Australia.

TAVR Pipeline Market Analysis by Companies, 2024
TAVR Pipeline Market Analysis by Companies, 2024Buy the Full Report for More Company Insights into the TAVR Pipeline Market
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Segments Covered in the Report

TAVR Pipeline Market Territories Outlook (2024)

  • China
  • Europe
  • India
  • Japan
  • Israel

TAVR Pipeline Market Regulatory Paths Outlook (2024)

  • 510(k)
  • CE
  • PMA
  • TGA
  • NMPA

Scope

This report provides:

  • Extensive coverage of the TAVR devices under development.
  • Exhaustive list of major pipeline products and their details, including product description, licensing and collaboration details, and other developmental activities.
  • Reviews of major players involved in the development of TAVR and lists all their pipeline projects.
  • Coverage of pipeline products based on various stages of development ranging from early development to approved/issued stage.
  • Key clinical trial data of ongoing clinical trials specific to pipeline products.
  • Recent developments in the segment/industry.

Reasons to Buy

  • 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 TAVR under development.
  • Develop market-entry and market-expansion strategies.
  • Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline.
  • Carry out an in-depth analysis of the product’s current stage of development, territory, and estimated launch date.

Aegis Surgical Limited
Anteris Technologies Ltd
AorTx, Inc.
Arbor Surgical Technologies, Inc.
Atlas Medical
Beijing Balance Medical Technology Co Ltd
Biotronik AG
Boston Scientific Corp
Carena Healthcare Ltd
Chengdu Silara Meditech Inc
Colibri Heart Valve LLC
ContiTech (Beijing) Medical Technology Co Ltd
Daidalos Solutions BV
Direct Flow Medical Inc (Inactive)
Dongguan Tiantianxiang Medical Technology Co Ltd
DSM Dyneema BV
Dura LLC
Edwards Lifesciences Corp
Endoluminal Technology Research LLC
Florida International University
Folda LLC
Foldax Inc
HLT, Inc.
JC Medical, Inc.
JenaValve Technology GmbH
Jenscare Scientific Co Ltd
Jinshi Biotechnology (Changshu) Co Ltd
KOKA Lifesciences Co Ltd
Laguna Tech USA Inc
Lepu Medical Technology (Beijing) Co Ltd
Mayo Clinic
Medtronic Plc
Meril Life Sciences Pvt Ltd
MicroPort CardioFlow Medtech Corp
Nanjing Saint Medical Technology Co Ltd
NewMed Medical Co Ltd
Novogate Medical Ltd.
NVT GmbH
P+F Products + Features GmbH
Peca Labs Inc
Peijia Medical Ltd
PolyNova Cardiovascular Inc
RegenaGraft
ReValve Med Inc
SAS Cormove
Shanghai Healing Medical Instruments Co Ltd
St. Jude Medical LLC
Stony Brook University
Strait Access Technologies (Pty) Ltd
Suzhou Jiecheng Medical Technology Co Ltd
Symetis SA
The University of British Columbia
Thubrikar Aortic Valve, Inc.
University College London
University of California San Francisco
University of Cambridge
University of Iowa
University of Pennsylvania
Valve Medical Ltd.
Vascular Concepts Ltd
Venus Medtech Hangzhou Inc
Xeltis AG
Youngheartvalve LLC

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 7

|1.2 List of Figures 14

2 Introduction 15

2.1 Transcatheter Aortic Valve Replacement (TAVR) Overview 15

3 Products under Development 16

3.1 Transcatheter Aortic Valve Replacement (TAVR) – Pipeline Products by Stage of Development 16

3.2 Transcatheter Aortic Valve Replacement (TAVR) – Pipeline Products by Territory 17

3.3 Transcatheter Aortic Valve Replacement (TAVR) – Pipeline Products by Regulatory Path 18

3.4 Transcatheter Aortic Valve Replacement (TAVR) – Pipeline Products by Estimated Approval Date 19

3.5 Transcatheter Aortic Valve Replacement (TAVR) – Ongoing Clinical Trials 20

4 Transcatheter Aortic Valve Replacement (TAVR) – Pipeline Products under Development by Companies 21

4.1 Transcatheter Aortic Valve Replacement (TAVR) Companies – Pipeline Products by Stage of Development 21

4.2 Transcatheter Aortic Valve Replacement (TAVR) – Pipeline Products by Stage of Development 24

5 Transcatheter Aortic Valve Replacement (TAVR) Companies and Product Overview 27

5.1 Aegis Surgical Limited Company Overview 27

5.1.1 Aegis Surgical Limited Pipeline Products & Ongoing Clinical Trials Overview 27

5.2 Anteris Technologies Ltd Company Overview 28

5.2.1 Anteris Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 28

5.3 AorTx, Inc. Company Overview 32

5.3.1 AorTx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 32

5.4 Arbor Surgical Technologies, Inc. Company Overview 33

5.4.1 Arbor Surgical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 33

5.5 Atlas Medical Company Overview 34

5.5.1 Atlas Medical Pipeline Products & Ongoing Clinical Trials Overview 34

5.6 Beijing Balance Medical Technology Co Ltd Company Overview 35

5.6.1 Beijing Balance Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 35

5.7 Biotronik AG Company Overview 36

5.7.1 Biotronik AG Pipeline Products & Ongoing Clinical Trials Overview 36

5.8 Boston Scientific Corp Company Overview 37

5.8.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 37

5.9 Carena Healthcare Ltd Company Overview 47

5.9.1 Carena Healthcare Ltd Pipeline Products & Ongoing Clinical Trials Overview 47

5.10 Chengdu Silara Meditech Inc Company Overview 48

5.10.1 Chengdu Silara Meditech Inc Pipeline Products & Ongoing Clinical Trials Overview 48

5.11 Colibri Heart Valve LLC Company Overview 51

5.11.1 Colibri Heart Valve LLC Pipeline Products & Ongoing Clinical Trials Overview 51

5.12 ContiTech (Beijing) Medical Technology Co Ltd Company Overview 56

5.12.1 ContiTech (Beijing) Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 56

5.13 Daidalos Solutions BV Company Overview 57

5.13.1 Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview 57

5.14 Direct Flow Medical Inc (Inactive) Company Overview 58

5.14.1 Direct Flow Medical Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 58

5.15 Dongguan Tiantianxiang Medical Technology Co Ltd Company Overview 60

5.15.1 Dongguan Tiantianxiang Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 60

5.16 DSM Dyneema BV Company Overview 61

5.16.1 DSM Dyneema BV Pipeline Products & Ongoing Clinical Trials Overview 61

5.17 Dura LLC Company Overview 62

5.17.1 Dura LLC Pipeline Products & Ongoing Clinical Trials Overview 62

5.18 Edwards Lifesciences Corp Company Overview 63

5.18.1 Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 63

5.19 Endoluminal Technology Research LLC Company Overview 70

5.19.1 Endoluminal Technology Research LLC Pipeline Products & Ongoing Clinical Trials Overview 70

5.20 Florida International University Company Overview 71

5.20.1 Florida International University Pipeline Products & Ongoing Clinical Trials Overview 71

5.21 Folda LLC Company Overview 72

5.21.1 Folda LLC Pipeline Products & Ongoing Clinical Trials Overview 72

5.22 Foldax Inc Company Overview 73

5.22.1 Foldax Inc Pipeline Products & Ongoing Clinical Trials Overview 73

5.23 HLT, Inc. Company Overview 74

5.23.1 HLT, Inc. Pipeline Products & Ongoing Clinical Trials Overview 74

5.24 JC Medical, Inc. Company Overview 77

5.24.1 JC Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 77

5.25 JenaValve Technology GmbH Company Overview 81

5.25.1 JenaValve Technology GmbH Pipeline Products & Ongoing Clinical Trials Overview 81

5.26 Jenscare Scientific Co Ltd Company Overview 86

5.26.1 Jenscare Scientific Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 86

5.27 Jinshi Biotechnology (Changshu) Co Ltd Company Overview 88

5.27.1 Jinshi Biotechnology (Changshu) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 88

5.28 KOKA Lifesciences Co Ltd Company Overview 89

5.28.1 KOKA Lifesciences Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 89

5.29 Laguna Tech USA Inc Company Overview 92

5.29.1 Laguna Tech USA Inc Pipeline Products & Ongoing Clinical Trials Overview 92

5.30 Lepu Medical Technology (Beijing) Co Ltd Company Overview 97

5.30.1 Lepu Medical Technology (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 97

5.31 Mayo Clinic Company Overview 99

5.31.1 Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 99

5.32 Medtronic Plc Company Overview 100

5.32.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 100

5.33 Meril Life Sciences Pvt Ltd Company Overview 101

5.33.1 Meril Life Sciences Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 101

5.34 MicroPort CardioFlow Medtech Corp Company Overview 102

5.34.1 MicroPort CardioFlow Medtech Corp Pipeline Products & Ongoing Clinical Trials Overview 102

5.35 Nanjing Saint Medical Technology Co Ltd Company Overview 105

5.35.1 Nanjing Saint Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 105

5.36 NewMed Medical Co Ltd Company Overview 109

5.36.1 NewMed Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 109

5.37 Novogate Medical Ltd. Company Overview 115

5.37.1 Novogate Medical Ltd. Pipeline Products & Ongoing Clinical Trials Overview 115

5.38 NVT GmbH Company Overview 116

5.38.1 NVT GmbH Pipeline Products & Ongoing Clinical Trials Overview 116

5.39 P+F Products + Features GmbH Company Overview 119

5.39.1 P+F Products + Features GmbH Pipeline Products & Ongoing Clinical Trials Overview 119

5.40 Peca Labs Inc Company Overview 122

5.40.1 Peca Labs Inc Pipeline Products & Ongoing Clinical Trials Overview 122

5.41 Peijia Medical Ltd Company Overview 123

5.41.1 Peijia Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 123

5.42 PolyNova Cardiovascular Inc Company Overview 128

5.42.1 PolyNova Cardiovascular Inc Pipeline Products & Ongoing Clinical Trials Overview 128

5.43 RegenaGraft Company Overview 129

5.43.1 RegenaGraft Pipeline Products & Ongoing Clinical Trials Overview 129

5.44 ReValve Med Inc Company Overview 130

5.44.1 ReValve Med Inc Pipeline Products & Ongoing Clinical Trials Overview 130

5.45 SAS Cormove Company Overview 131

5.45.1 SAS Cormove Pipeline Products & Ongoing Clinical Trials Overview 131

5.46 Shanghai Healing Medical Instruments Co Ltd Company Overview 132

5.46.1 Shanghai Healing Medical Instruments Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 132

5.47 St. Jude Medical LLC Company Overview 136

5.47.1 St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 136

5.48 Stony Brook University Company Overview 139

5.48.1 Stony Brook University Pipeline Products & Ongoing Clinical Trials Overview 139

5.49 Strait Access Technologies (Pty) Ltd Company Overview 140

5.49.1 Strait Access Technologies (Pty) Ltd Pipeline Products & Ongoing Clinical Trials Overview 140

5.50 Suzhou Jiecheng Medical Technology Co Ltd Company Overview 141

5.50.1 Suzhou Jiecheng Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 141

5.51 Symetis SA Company Overview 142

5.51.1 Symetis SA Pipeline Products & Ongoing Clinical Trials Overview 142

5.52 The University of British Columbia Company Overview 145

5.52.1 The University of British Columbia Pipeline Products & Ongoing Clinical Trials Overview 145

5.53 Thubrikar Aortic Valve, Inc. Company Overview 146

5.53.1 Thubrikar Aortic Valve, Inc. Pipeline Products & Ongoing Clinical Trials Overview 146

5.54 University College London Company Overview 149

5.54.1 University College London Pipeline Products & Ongoing Clinical Trials Overview 149

5.55 University of California San Francisco Company Overview 150

5.55.1 University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview 150

5.56 University of Cambridge Company Overview 151

5.56.1 University of Cambridge Pipeline Products & Ongoing Clinical Trials Overview 151

5.57 University of Iowa Company Overview 152

5.57.1 University of Iowa Pipeline Products & Ongoing Clinical Trials Overview 152

5.58 University of Pennsylvania Company Overview 153

5.58.1 University of Pennsylvania Pipeline Products & Ongoing Clinical Trials Overview 153

5.59 Valve Medical Ltd. Company Overview 154

5.59.1 Valve Medical Ltd. Pipeline Products & Ongoing Clinical Trials Overview 154

5.60 Vascular Concepts Ltd Company Overview 157

5.60.1 Vascular Concepts Ltd Pipeline Products & Ongoing Clinical Trials Overview 157

5.61 Venus Medtech Hangzhou Inc Company Overview 158

5.61.1 Venus Medtech Hangzhou Inc Pipeline Products & Ongoing Clinical Trials Overview 158

5.62 Xeltis AG Company Overview 164

5.62.1 Xeltis AG Pipeline Products & Ongoing Clinical Trials Overview 164

5.63 Youngheartvalve LLC Company Overview 165

5.63.1 Youngheartvalve LLC Pipeline Products & Ongoing Clinical Trials Overview 165

6 Transcatheter Aortic Valve Replacement (TAVR)- Recent Developments 166

6.1 Aug 09, 2024: No Evidence to Support the Variation in Price the NHS Is Paying for Valves Used in Keyhole Heart Procedures 166

6.2 Jul 01, 2024: Anteris Technologies and v2vmedtech Announce Concept Lock of Next Generation Mitral and Tricuspid Repair System as VClip Passes Animal Study 167

6.3 Jun 24, 2024: The Landmark RCT marks a milestone for Meril’s Myval THV series 168

6.4 Jun 18, 2024: Anteris Provides Update on Pivotal Trial Submission US FDA has provided positive feedback on key elements of the study design 168

6.5 Jun 17, 2024: CardioFlow’s VitaFlow Liberty Granted EU CE-MDR Mark, Advancing Global Expansion Roadmap 169

6.6 Jun 13, 2024: Anteris Provides Update on DurAVR THV Valve-In-Valve Experience Presented at New York Valves 2024 170

6.7 Jun 13, 2024: Medtronic Confirms Global Layoffs 171

6.8 Jun 11, 2024: Anteris Provides Data Update on First in Human Study of DurAVR THV Presented at New York Valves 2024 171

6.9 Jun 07, 2024: New Data for Medtronic CoreValve/Evolut TAVR Systems Reinforces Excellent Valve Performance 172

6.10 Jun 06, 2024: MiRus Siegel TAVR: First in Human Results Presented at New York Valves 173

6.11 Jun 05, 2024: Five-Year Data Show Excellent Outcomes for Female and Small Annulus Patients With Edwards TAVR 173

6.12 May 22, 2024: MicroPort Donates Medical Devices for El Salvador’s First TAVI in a Public Hospital 174

6.13 May 08, 2024: Edwards Launches the SAPIEN 3 Ultra RESILIA Valve in Europe with Technology to Enhance Durability 175

6.14 May 06, 2024: Thubrikar Aortic Valve Announces Clinical Success of the New Precision 2 Delivery Catheter 175

6.15 Apr 18, 2024: Siriraj Hospital Shines Spotlight on TAVI Procedure as Alternative for High-Risk Patients Requiring Aortic Valve Replacement 176

6.16 Apr 17, 2024: International Study Compares Self-Expanding and Balloon-Expandable Transcatheter Aortic-Valve Replacement in Patients with Small Aortic Annulus 177

6.17 Apr 07, 2024: SMART Trial One-Year Data Demonstrates Medtronic Evolut TAVR Platform as Optimal Treatment for Severe Aortic Stenosis in Patients with Small Annulus, which Is Primarily Women 178

6.18 Apr 07, 2024: Study of NFL Alumni Cohort Finds Majority Suffer From Heart Disease Without Knowing It 179

6.19 Apr 06, 2024: egnite and JenaValve Announce Novel Research on Outcomes with Untreated Aortic Regurgitation at the 2024 American College of Cardiology Conference 180

6.20 Mar 28, 2024: JenaValve Announces Publication of ALIGN-AR Pivotal Trial Results in The Lancet 180

6.21 Mar 27, 2024: Medtronic Announces FDA Approval of Newest-Generation Evolut TAVR System for Treatment of Symptomatic Severe Aortic Stenosis 181

6.22 Mar 19, 2024: Jenavalve’s Trilogy THV System Highlighted at CRT 2024 182

6.23 Mar 13, 2024: Edwards presents positive data from two valve studies at CRT 2024 182

6.24 Mar 12, 2024: Medtronic To Present At Barclays Global Healthcare Conference 183

6.25 Mar 11, 2024: New late-breaking data from Medtronic Evolut Low Risk Trial Demonstrate Strong Clinical and Cost-Effectiveness Benefits of TAVR Platform 183

6.26 Feb 28, 2024: Boston Scientific Raises $2.2B to Support Purchase of California Medical Device Company 184

6.27 Feb 23, 2024: Edwards Lifesciences to Present at the 44th Annual TD Cowen Healthcare Conference 184

6.28 Feb 23, 2024: Medical Tech Leader, Boston Scientific (BSX), Announces Notes Offering 185

6.29 Feb 13, 2024: Interventional Cardiology at Adventist Health Glendale Reaches Milestone with 500th TAVR Procedure 185

6.30 Feb 06, 2024: Genesis MedTech concludes US J-Valve study enrollment 185

6.31 Jan 29, 2024: Peijia Medical Announces Successful Completion of Patient Enrollment for Pivotal TaurusTrio Transcatheter Aortic Regurgitation Clinical Trial 186

6.32 Jan 05, 2024: Boston Scientific Announces Conference Call Discussing Fourth Quarter 2023 Results 187

6.33 Jan 04, 2024: EISENHOWER HEALTH BECOMES FIRST EDWARDS BENCHMARK PROGRAM OBSERVATION SITE FOR TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR), BEGINS HOSTING TAVR TEAMS FROM ACROSS THE NATION 187

6.34 Jan 03, 2024: Laguna Tech USA Announces Site Record Number of Transcatheter Heart Valves Implanted at Single Center on Same Day in First-in-Human Clinical Trial 187

6.35 Dec 15, 2023: Thubrikar Aortic Valve Announces Authorization to Expand the TAVI-1 CE Mark Trial with the Precision 2 Delivery Catheter 188

6.36 Dec 04, 2023: Colibri’s valve shows superior haemodynamics in pilot study 189

6.37 Nov 20, 2023: MicroPort CardioFlow Completes Five Pre-Market Implantations of VitaFlow Liberty in Denmark 190

6.38 Oct 27, 2023: Japan Lifeline Enters into Exclusive Distribution Agreement with Meril Life Sciences for Myval Octacor Transcatheter Heart Valve in Japan 191

6.39 Oct 24, 2023: JenaValve Announces Late-Breaking Data from the ALIGN-AR Pivotal Trial Meeting Safety and Efficacy Endpoints 191

6.40 Oct 24, 2023: Medtronic Evolut TAVRPlatform Outperforms Surgery With Sustained Valve Performance for Low-Risk Patients at Four Years 192

6.41 Oct 24, 2023: Five-Year Data From Partner 3 Trial Demonstrate Excellent Survival for Patients Receiving Edwards Sapien 3 Valve 193

6.42 Oct 18, 2023: Edwards Lifesciences to Host Earnings Conference Call on October 25, 2023 193

6.43 Oct 12, 2023: Medtronic Receives CE Mark for Evolut FX TAVI System for Treatment of Severe Aortic Stenosis 193

6.44 Sep 19, 2023: JenaValve Announces ALIGN-AR Pivotal Data to be Presented During the Late-Breaking Clinical Trial Sessions at TCT 2023 194

6.45 Sep 11, 2023: Multiple MicroPort Business Groups Make an Appearance at SOLACI-SBHCI 2023 195

6.46 Aug 28, 2023: Edwards Lifesciences to Present at the 2023 Wells Fargo Healthcare Conference 196

7 Appendix 197

7.1 Methodology 197

7.2 About GlobalData 200

7.3 Contact Us 200

7.4 Disclaimer 200

Table

Transcatheter Aortic Valve Replacement (TAVR) – Pipeline Products by Stage of Development 16

Transcatheter Aortic Valve Replacement (TAVR) – Pipeline Products by Territory 17

Transcatheter Aortic Valve Replacement (TAVR) – Pipeline Products by Regulatory Path 18

Transcatheter Aortic Valve Replacement (TAVR) – Pipeline Products by Estimated Approval Date 19

Transcatheter Aortic Valve Replacement (TAVR) – Ongoing Clinical Trials 20

Transcatheter Aortic Valve Replacement (TAVR) Companies – Pipeline Products by Stage of Development 21

Transcatheter Aortic Valve Replacement (TAVR) – Pipeline Products by Stage of Development 24

Aegis Surgical Limited Pipeline Products & Ongoing Clinical Trials Overview 27

pTAo-TAVR – Product Status 27

pTAo-TAVR – Product Description 27

Anteris Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 28

DurAVR THV System – Product Status 28

DurAVR THV System – Product Description 28

Anteris Technologies Ltd – Ongoing Clinical Trials Overview 29

DurAVR THV System – A Pivotal Study to Evaluate the Efficacy of DurAVR THV System for the Treatment Aortic Stenosis 30

DurAVR THV System – DurAVR THV System in a Valve-in-Valve Procedure: A First Successful Implantation in Humans 30

DurAVR THV System – DurAVR THV System: European Early Feasibility Study 30

DurAVR THV System – Use of DurAVR THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study 30

DurAVR THV System – Use of DurAVR THV System in Subjects with Severe Aortic Stenosis: First In Human Study 31

AorTx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 32

AorTx Valve – Product Status 32

AorTx Valve – Product Description 32

Arbor Surgical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 33

Trilogy Aortic Valve System – Product Status 33

Trilogy Aortic Valve System – Product Description 33

Atlas Medical Pipeline Products & Ongoing Clinical Trials Overview 34

Endurance Valve – Product Status 34

Endurance Valve – Product Description 34

Beijing Balance Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 35

Renatus – Product Status 35

Renatus – Product Description 35

Biotronik AG Pipeline Products & Ongoing Clinical Trials Overview 36

BIOVALVE Resheathable Transcatheter Aortic Valve – Product Status 36

BIOVALVE Resheathable Transcatheter Aortic Valve – Product Description 36

Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 37

ACURATE neo2 Transfemoral TAVR System – Product Status 37

ACURATE neo2 Transfemoral TAVR System – Product Description 38

Gen 4 Lotus Valve System – Product Status 38

Gen 4 Lotus Valve System – Product Description 38

Lotus Edge Sheath 15F – Product Status 39

Lotus Edge Sheath 15F – Product Description 39

Lotus Edge Valve System – 21mm – Product Status 39

Lotus Edge Valve System – 21mm – Product Description 40

Lotus Edge Valve System – 29mm – Product Status 40

Lotus Edge Valve System – 29mm – Product Description 41

LOTUS Mantra – Product Status 41

LOTUS Mantra – Product Description 41

NG ACURATE – Product Status 42

NG ACURATE – Product Description 42

Boston Scientific Corp – Ongoing Clinical Trials Overview 43

ACURATE neo2 Transfemoral TAVR System – ACURATE IDE: Transcatheter Replacement of Stenotic Aortic Valve Through Implantation of ACURATE in Subjects Indicated for TAVR 44

ACURATE neo2 Transfemoral TAVR System – ACURATE neo2 Post Market Clinical Follow up Study 44

ACURATE neo2 Transfemoral TAVR System – Project to Look for Early Discharge in Patients Undergoing TAVI With ACURATE – An International Multi-center Early Discharge TAVI Program 44

ACURATE neo2 Transfemoral TAVR System – Prospective Evaluation Complementing Investigation with Acurate Neo Device 45

ACURATE neo2 Transfemoral TAVR System – Prospective, Randomized, Cost-utility Analysis of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Brazil 45

ACURATE neo2 Transfemoral TAVR System – PROVE ACURATE neo2 – Post Market Safety and Performance Surveillance in Aortic Stenosis 45

ACURATE neo2 Transfemoral TAVR System – Randomized Study Comparing Both Latest Generation Self-expanding Valves and Local Anesthesia Vs. Conscious Sedation in Transcatheter Aortic Valve Implantation 46

ACURATE neo2 Transfemoral TAVR System – The Use of ACURATE Neo 2 Valve in Patients With Symptomatic Aortic Valve Stenosis 46

Carena Healthcare Ltd Pipeline Products & Ongoing Clinical Trials Overview 47

Pillar 3D Printed Replacement Heart Valve – Product Status 47

Pillar 3D Printed Replacement Heart Valve – Product Description 47

Chengdu Silara Meditech Inc Pipeline Products & Ongoing Clinical Trials Overview 48

Transcatheter Aortic Valve System – Product Status 48

Transcatheter Aortic Valve System – Product Description 48

Chengdu Silara Meditech Inc – Ongoing Clinical Trials Overview 49

Transcatheter Aortic Valve System – A Prospective, Multi-center, Single-arm Clinical Trial to Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System in Patients with Severe Aortic Stenosis with or without Moderate or Lower Degree Regurgitation 50

Transcatheter Aortic Valve System – A Prospective, Multicenter, Single-arm Target-value Clinical Trial To Evaluate the Transcatheter Aortic Valve System Safety and Efficacy for the Treatment of Patients With Severe Aortic Stenosis 50

Transcatheter Aortic Valve System – To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Symptomatic Aortic Insufficiency 50

Colibri Heart Valve LLC Pipeline Products & Ongoing Clinical Trials Overview 51

Colibri TAVI System – Product Status 51

Colibri TAVI System – Product Description 51

Delta Aortic Heart Valve – Product Status 52

Delta Aortic Heart Valve – Product Description 52

Second-Generation TAVI System – Product Status 52

Second-Generation TAVI System – Product Description 53

Venibri Transcatheter Heart Valve System – Product Status 53

Venibri Transcatheter Heart Valve System – Product Description 53

Colibri Heart Valve LLC – Ongoing Clinical Trials Overview 54

Colibri TAVI System – A Prospective, Single Arm Clinical Investigation Evaluating Safety and Performance of the Colibri Transcatheter Aortic Heart Valve System for the Treatment of Symptomatic Severe Aortic Stenosis Via Transfemoral Access in High Surgical Risk Patients 55

ContiTech (Beijing) Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 56

Balloon-Expandable Transcatheter Aortic Valve Replacement Device – Product Status 56

Balloon-Expandable Transcatheter Aortic Valve Replacement Device – Product Description 56

Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview 57

Sutureless Trans-Catheter Aortic Valve Replacement (TAVR) – Product Status 57

Sutureless Trans-Catheter Aortic Valve Replacement (TAVR) – Product Description 57

Direct Flow Medical Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 58

18F Direct Flow Medical Transcatheter Aortic Valve System – Product Status 58

18F Direct Flow Medical Transcatheter Aortic Valve System – Product Description 58

22F Percutaneous Aortic Valve System – Product Status 59

22F Percutaneous Aortic Valve System – Product Description 59

Dongguan Tiantianxiang Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 60

TAVR – Cardiovascular – Product Status 60

TAVR – Cardiovascular – Product Description 60

DSM Dyneema BV Pipeline Products & Ongoing Clinical Trials Overview 61

Dyneema Purity – Transcatheter Heart Valve – Product Status 61

Dyneema Purity – Transcatheter Heart Valve – Product Description 61

Dura LLC Pipeline Products & Ongoing Clinical Trials Overview 62

LowPro Valve – Product Status 62

LowPro Valve – Product Description 62

Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 63

Next Gen CENTERA – Product Status 63

Next Gen CENTERA – Product Description 63

SAPIEN 3 THV – Asymptomatic Severe Aortic Stenosis – Product Status 64

SAPIEN 3 THV – Asymptomatic Severe Aortic Stenosis – Product Description 64

SAPIEN 3 THV – Moderate Aortic Stenosis – Product Status 64

SAPIEN 3 THV – Moderate Aortic Stenosis – Product Description 65

SAPIEN X4 – Product Status 65

SAPIEN X4 – Product Description 65

Edwards Lifesciences Corp – Ongoing Clinical Trials Overview 66

SAPIEN 3 THV – Moderate Aortic Stenosis – Transcatheter Aortic Valve Replacement to Unload the Left Ventricle in Patients with Advanced Heart Failure: A Randomized Trial (TAVR UNLOAD) 67

SAPIEN 3 THV – Asymptomatic Severe Aortic Stenosis – Risk of Coronary Obstruction Due to Sinus Sequestration by Redo Transcatheter Aortic Valve Implantation in Japanese Patients with SAPIEN 3 68

SAPIEN X4 – Prospective, Single Arm, Multicentre, Feasibility Study to Demonstrate the Safety and Functionality of the Edwards 12f Sheath Introducer Set In Conjunction with the Sapien X4 Transcatheter Heart Valve (THV) In Subjects with Symptomatic, Severe, Calcific Aortic Stenosis (AS) (Protocol Number: 2023-06) 69

SAPIEN X4 – Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve 69

SAPIEN X4 – Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve – Mitral 69

Endoluminal Technology Research LLC Pipeline Products & Ongoing Clinical Trials Overview 70

Balloon Expandable Paniagua Heart Valve – Product Status 70

Balloon Expandable Paniagua Heart Valve – Product Description 70

Florida International University Pipeline Products & Ongoing Clinical Trials Overview 71

Percutaneous Aortic Heart Valve – Product Status 71

Percutaneous Aortic Heart Valve – Product Description 71

Folda LLC Pipeline Products & Ongoing Clinical Trials Overview 72

Foldavalve – Product Status 72

Foldavalve – Product Description 72

Foldax Inc Pipeline Products & Ongoing Clinical Trials Overview 73

Tria Transcatheter Aortic Valve Replacement Device – Product Status 73

Tria Transcatheter Aortic Valve Replacement Device – Product Description 73

HLT, Inc. Pipeline Products & Ongoing Clinical Trials Overview 74

Meridian II Transcatheter Aortic Valve Replacement System – Product Status 74

Meridian II Transcatheter Aortic Valve Replacement System – Product Description 74

HLT, Inc. – Ongoing Clinical Trials Overview 75

Meridian II Transcatheter Aortic Valve Replacement System – Study to Evaluate the Safety and Performance of HLT Meridian TAVR Valve System in the Treatment of Aortic Regurgitation 76

Meridian II Transcatheter Aortic Valve Replacement System – Study to Evaluate the Safety and Performance of HLT Meridian TAVR Valve System in the Treatment of Aortic Stenosis 76

JC Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 77

J-Valve TAVI System – Transapical – Product Status 77

J-Valve TAVI System – Transapical – Product Description 77

J-Valve TF System – Product Status 78

J-Valve TF System – Product Description 78

JC Medical, Inc. – Ongoing Clinical Trials Overview 79

J-Valve TF System – J-Valve Compassionate Use Cases 80

J-Valve TF System – J-Valve TF Early Feasibility Study 80

J-Valve TF System – J-Valve to Treat Aortic Regurgitation Via Transcatheter Therapy 80

JenaValve Technology GmbH Pipeline Products & Ongoing Clinical Trials Overview 81

JenaValve Pericardial TAVR System – Product Status 81

JenaValve Pericardial TAVR System – Product Description 81

Trilogy Heart Valve System – Product Status 82

Trilogy Heart Valve System – Product Description 82

JenaValve Technology GmbH – Ongoing Clinical Trials Overview 83

JenaValve Pericardial TAVR System – A Study to Assess Safety and Effectiveness of the JenaValve Trilogy Heart Valve System in the Treatment of High Surgical Risk Patients with Symptomatic, Severe Aortic Regurgitation (AR) 84

JenaValve Pericardial TAVR System – THE ALIGN-AR TRIAL: Safety and Effectiveness/Performance of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients with Symptomatic Severe Aortic Regurgitation (AR) 84

Trilogy Heart Valve System – A Prospective, Multicenter, Single-group Clinical Study to Evaluate the Safety and Efficacy of Peijia Medical Transcatheter Aortic Valve System in the Treatment of Severe Aortic Valve Regurgitation 85

Trilogy Heart Valve System – Trilogy Heart Valve System for Management of Patients with Aortic Valve Disease: Patient Registry and Post-market Clinical Follow-up Study 85

Jenscare Scientific Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 86

Ken-Valve – Product Status 86

Ken-Valve – Product Description 86

KenFlex – Product Status 87

KenFlex – Product Description 87

Jinshi Biotechnology (Changshu) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 88

Transcatheter Aortic Valve Replacement Device – Product Status 88

Transcatheter Aortic Valve Replacement Device – Product Description 88

KOKA Lifesciences Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 89

Koka Valve – Product Status 89

Koka Valve – Product Description 89

KOKA Lifesciences Co Ltd – Ongoing Clinical Trials Overview 90

Koka Valve – A Clinical Trial of the Transcatheter Aortic Valve Implantation System With a Prospective, Multi-Center, One-Arm Approach to Evaluate the Efficacy and Safety in the Treatment of Patients With Severe Aortic Stenosis 91

Laguna Tech USA Inc Pipeline Products & Ongoing Clinical Trials Overview 92

Alpha Self-Expanding Aortic Valve system – Product Status 92

Alpha Self-Expanding Aortic Valve system – Product Description 92

Zeta Balloon Expandable Aortic Valve System – Product Status 93

Zeta Balloon Expandable Aortic Valve System – Product Description 93

Laguna Tech USA Inc – Ongoing Clinical Trials Overview 94

Zeta Balloon Expandable Aortic Valve System – First-in-Human Clinical Study of Zeta Balloon Expandable Aortic Valve System in Patients at High Surgical Risk With Severe Aortic Regurgitation 95

Alpha Self-Expanding Aortic Valve system – First-in-Human Clinical Trial of Alpha Transcatheter Aortic Valve Replacement (TAVR) System for the Treatment of Aortic Regurgitation 96

Lepu Medical Technology (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 97

Sinocrown Transcatheter Aortic Valve Replacement System – Product Status 97

Sinocrown Transcatheter Aortic Valve Replacement System – Product Description 97

Transcatheter Aortic Valve Replacement System – Product Status 98

Transcatheter Aortic Valve Replacement System – Product Description 98

Transcatheter Aortic Valve System (Balloon Dilation) – Product Status 98

Transcatheter Aortic Valve System (Balloon Dilation) – Product Description 98

Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 99

Percutaneous Aortic Valve – Product Status 99

Percutaneous Aortic Valve – Product Description 99

Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 100

Evolut Next Gen – Product Status 100

Evolut Next Gen – Product Description 100

Meril Life Sciences Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 101

MyVal S/Ex – Product Status 101

MyVal S/Ex – Product Description 101

MicroPort CardioFlow Medtech Corp Pipeline Products & Ongoing Clinical Trials Overview 102

VitaFlow Balloon Expandable – Product Status 102

VitaFlow Balloon Expandable – Product Description 102

VitaFlow III – Product Status 103

VitaFlow III – Product Description 103

VitaFlow Novo Generation – Product Status 103

VitaFlow Novo Generation – Product Description 104

Nanjing Saint Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 105

Transcatheter Aortic Valve System – Product Status 105

Transcatheter Aortic Valve System – Product Description 105

Xcor – Product Status 106

Xcor – Product Description 106

Nanjing Saint Medical Technology Co Ltd – Ongoing Clinical Trials Overview 107

Transcatheter Aortic Valve System – To Evaluate the Efficacy and Safety of Transcatheter Aortic Valve System in the Treatment of Severe Aortic Valve Stenosis 108

NewMed Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 109

Prizvalve II TAVR Valve – Product Status 109

Prizvalve II TAVR Valve – Product Description 109

Prizvalve Pro TAVR Valve – Product Status 110

Prizvalve Pro TAVR Valve – Product Description 110

Prizvalve System – Product Status 110

Prizvalve System – Product Description 111

Starr-A TAVR Valve – Product Status 111

Starr-A TAVR Valve – Product Description 111

NewMed Medical Co Ltd – Ongoing Clinical Trials Overview 112

Prizvalve System – An Exploratory Study to Evaluate the Prizvalve System in Patients With Failing Bioprosthetic Valve 113

Prizvalve System – An Exploratory Study to Evaluate the Prizvalve System in Patients with Severe Atrioventricular Annular Calcification or Failed Prosthetic Atrioventricular Valve/ Annulus Repair 113

Prizvalve System – Evaluation of the Efficacy and Safety of the Transcatheter Aortic Valve Replacement System in Patients with Severe Aortic Valve Stenosis Disease at High Surgical Risk 113

Prizvalve Pro TAVR Valve – Evaluation of the Safety and Efficacy of the Prizvalve Pro Transcatheter Aortic Valve System in the Treatment of Patients With Severe Aortic Valve Stenosis Disease at High Surgical Risk 114

Novogate Medical Ltd. Pipeline Products & Ongoing Clinical Trials Overview 115

Wisefix System – Transcatheter Aortic Valve Implantation – Product Status 115

Wisefix System – Transcatheter Aortic Valve Implantation – Product Description 115

NVT GmbH Pipeline Products & Ongoing Clinical Trials Overview 116

ALLEGRA Plus Transcatheter Heart Valve (THV) System – Product Status 116

ALLEGRA Plus Transcatheter Heart Valve (THV) System – Product Description 116

NVT GmbH – Ongoing Clinical Trials Overview 117

ALLEGRA Plus Transcatheter Heart Valve (THV) System – Investigation of the Safety and Performance of the NVT ALLEGRA Plus THV System in Patients With Severe aortic Stenosis or Failed surgical Aortic bioprosthesis 118

P+F Products + Features GmbH Pipeline Products & Ongoing Clinical Trials Overview 119

Vienna Aortic Self-Expandable Transcatheter Valve – Product Status 119

Vienna Aortic Self-Expandable Transcatheter Valve – Product Description 119

P+F Products + Features GmbH – Ongoing Clinical Trials Overview 120

Vienna Aortic Self-Expandable Transcatheter Valve – A Two -Stage First in Human (FIH) Feasibility / Pivotal Study of the Vienna Aortic Valve SE System 121

Peca Labs Inc Pipeline Products & Ongoing Clinical Trials Overview 122

Fully Synthetic Transcatheter Valve – Product Status 122

Fully Synthetic Transcatheter Valve – Product Description 122

Peijia Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 123

Peijia Balloon Expandable Valve – Product Status 123

Peijia Balloon Expandable Valve – Product Description 123

TaurusApex Polymer Leaflets TAVR System – Product Status 124

TaurusApex Polymer Leaflets TAVR System – Product Description 124

TaurusNXT – Product Status 124

TaurusNXT – Product Description 125

Peijia Medical Ltd – Ongoing Clinical Trials Overview 126

TaurusNXT – A Multi-center, Prospective Study to Evaluate the Safety and Efficacy of TaurusNXT TAVR System for Treating Calcific Severe Aortic Stenosis 127

PolyNova Cardiovascular Inc Pipeline Products & Ongoing Clinical Trials Overview 128

Trileaflet Polymeric Prosthetic Heart Valve – Product Status 128

Trileaflet Polymeric Prosthetic Heart Valve – Product Description 128

RegenaGraft Pipeline Products & Ongoing Clinical Trials Overview 129

Synthetic Heart Valve – Product Status 129

Synthetic Heart Valve – Product Description 129

ReValve Med Inc Pipeline Products & Ongoing Clinical Trials Overview 130

Removable Transcatheter Aortic Valve – Product Status 130

Removable Transcatheter Aortic Valve – Product Description 130

SAS Cormove Pipeline Products & Ongoing Clinical Trials Overview 131

Cormove Percutaneous Aortic Valve – Product Status 131

Cormove Percutaneous Aortic Valve – Product Description 131

Shanghai Healing Medical Instruments Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 132

HanchorValve – Product Status 132

HanchorValve – Product Description 132

Transcatheter Aortic Valve Replacement Device – Product Status 133

Transcatheter Aortic Valve Replacement Device – Product Description 133

Shanghai Healing Medical Instruments Co Ltd – Ongoing Clinical Trials Overview 134

HanchorValve – A Multi-center Clinical Study of HanchorValve to Treat Patients with Severe Aortic Regurgitation 135

St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 136

Portico Next Generation Transcatheter Aortic Heart Valve – Product Status 136

Portico Next Generation Transcatheter Aortic Heart Valve – Product Description 136

St. Jude Medical LLC – Ongoing Clinical Trials Overview 137

Portico Next Generation Transcatheter Aortic Heart Valve – Evaluation of the Portico NG (Next Generation) Transcatheter Aortic Valve in High and Extreme Risk Patients with Symptomatic Severe Aortic Stenosis 138

Stony Brook University Pipeline Products & Ongoing Clinical Trials Overview 139

Next Generation TAVR Valve – Product Status 139

Next Generation TAVR Valve – Product Description 139

Strait Access Technologies (Pty) Ltd Pipeline Products & Ongoing Clinical Trials Overview 140

SAT TAVI System – Product Status 140

SAT TAVI System – Product Description 140

Suzhou Jiecheng Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 141

Jiecheng Transvascular Interventional Biological Aortic Valve – Product Status 141

Jiecheng Transvascular Interventional Biological Aortic Valve – Product Description 141

Symetis SA Pipeline Products & Ongoing Clinical Trials Overview 142

ACURATE Prime – Product Status 142

ACURATE Prime – Product Description 142

ACURATE Prime XL Transfemoral Aortic Valve System – Product Status 143

ACURATE Prime XL Transfemoral Aortic Valve System – Product Description 143

ACURATE TAo – Product Status 143

ACURATE TAo – Product Description 144

The University of British Columbia Pipeline Products & Ongoing Clinical Trials Overview 145

Biomaterial Heart Valve – Product Status 145

Biomaterial Heart Valve – Product Description 145

Thubrikar Aortic Valve, Inc. Pipeline Products & Ongoing Clinical Trials Overview 146

Optimum TAVI System – Product Status 146

Optimum TAVI System – Product Description 146

Thubrikar Aortic Valve, Inc. – Ongoing Clinical Trials Overview 147

Optimum TAVI System – A First-in-human Study to Access Feasibility and Safety of the Optimum Aortic Valve Implant 148

Optimum TAVI System – Efficacy and Safety of Optimum TAVI System in Subjects with Severe Aortic Stenosis: A First-in-Human Study 148

University College London Pipeline Products & Ongoing Clinical Trials Overview 149

TRISKELE Aortic Valve – Product Status 149

TRISKELE Aortic Valve – Product Description 149

University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview 150

Transcatheter Aortic Valve – Product Status 150

Transcatheter Aortic Valve – Product Description 150

University of Cambridge Pipeline Products & Ongoing Clinical Trials Overview 151

Removable Transcatheter Valve – Product Status 151

Removable Transcatheter Valve – Product Description 151

University of Iowa Pipeline Products & Ongoing Clinical Trials Overview 152

Cellulose Based Aortic Heart Valve – Product Status 152

Cellulose Based Aortic Heart Valve – Product Description 152

University of Pennsylvania Pipeline Products & Ongoing Clinical Trials Overview 153

Aortic Repair Device – Product Status 153

Aortic Repair Device – Product Description 153

Valve Medical Ltd. Pipeline Products & Ongoing Clinical Trials Overview 154

Xemed TAVR Device – Product Status 154

Xemed TAVR Device – Product Description 154

Valve Medical Ltd. – Ongoing Clinical Trials Overview 155

Xemed TAVR Device – First in Human Study of the GEMINUS Transcatheter Aortic Valve Implantation System in Patients with Severe Symptomatic Aortic Stenosis 156

Vascular Concepts Ltd Pipeline Products & Ongoing Clinical Trials Overview 157

TAVI (Transcatheter Aortic Valve Replacement) – Product Status 157

TAVI (Transcatheter Aortic Valve Replacement) – Product Description 157

Venus Medtech Hangzhou Inc Pipeline Products & Ongoing Clinical Trials Overview 158

AR Valve – Product Status 158

AR Valve – Product Description 158

Transapical Trinity Aortic Valve Implantation System – Product Status 159

Transapical Trinity Aortic Valve Implantation System – Product Description 159

Transfemoral Trinity Aortic Valve Implantation System – Product Status 159

Transfemoral Trinity Aortic Valve Implantation System – Product Description 160

Venus PowerX Valve – Product Status 160

Venus PowerX Valve – Product Description 160

Venus Vitae Valve – Product Status 161

Venus Vitae Valve – Product Description 161

Venus Medtech Hangzhou Inc – Ongoing Clinical Trials Overview 162

Venus Vitae Valve – A First-in-man Clinical Trial of Venus Vitae Valve in Patients with Heart Valvular 163

Disease 163

Venus Vitae Valve – Multicenter Pivotal Study to Evaluate the Treatment of Severe Aortic Valve Stenosis With Next-Generation Venus-Vitae Transcatheter Heart Valve (THV) System 163

Xeltis AG Pipeline Products & Ongoing Clinical Trials Overview 164

Transcatheter Aortic Heart Valve – Product Status 164

Transcatheter Aortic Heart Valve – Product Description 164

Youngheartvalve LLC Pipeline Products & Ongoing Clinical Trials Overview 165

Polymeric Trans-Catheter Aortic Valve – Product Status 165

Polymeric Trans-Catheter Aortic Valve – Product Description 165

Glossary 199

Figures

Transcatheter Aortic Valve Replacement (TAVR) – Pipeline Products by Stage of Development 16

Transcatheter Aortic Valve Replacement (TAVR) – Pipeline Products by Territory 17

Transcatheter Aortic Valve Replacement (TAVR) – Pipeline Products by Regulatory Path 18

Transcatheter Aortic Valve Replacement (TAVR) – Pipeline Products by Estimated Approval Date 19

Transcatheter Aortic Valve Replacement (TAVR) – Ongoing Clinical Trials 20

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