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

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Transcatheter Aortic Valve Replacement Pipeline Products Market Report Overview

Transcatheter Aortic Valve Replacement (TAVR), also known as, Transcatheter Aortic Valve Implantation (TAVI), 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 Transcatheter Aortic Valve Replacement (TAVR) pipeline market research report provides comprehensive information about the TAVR pipeline products with a comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

TAVR Pipeline Products Market Segmentation by Territories

Some of the key territories with products in the pipeline are the US, China, Europe, Canada, Japan, Australia, India, Taiwan, Hong Kong, and Brazil among others. As of February 2023, the US has the highest number of products in the pipeline out of them all.

TAVR Pipeline Products Market Analysis, by Territories, 2023 (%)

TAVR Pipeline Products Market Analysis, by Territories, 2023 (%)

For more territory insights into the TAVR pipeline products market, download a free report sample

TAVR Pipeline Products Market Segmentation by Regulatory Paths

Some of the key regulatory paths followed by the TAVR pipeline products market are NMPA, PMA, CE, MDL, Shonin, TGA, BOPA, ICAC, HSA, and ANVISA. Most of the products follow the NMPA pathway to enter the market.

TAVR Pipeline Products Market Analysis, by Regulatory Paths, 2023 (%)

TAVR Pipeline Products Market Analysis, by Regulatory Paths, 2023 (%)

For more TAVR pipeline products regulatory path insights, download a free report sample

TAVR Pipeline Products Market - Competitive Landscape

Some of the leading companies in the TAVR pipeline products market are Aegis Surgical Limited, Anteris Technologies Ltd, AorTx, Inc., Arbor Surgical Technologies, Inc., Atlas Medical, Biotronik AG, Boston Scientific Corp, Carena Healthcare Ltd, Chengdu Silara Meditech Inc, and Colibri Heart Valve LLC.

Aegis Surgical Limited: Headquartered in Dublin, Ireland, Aegis Surgical is a medical device company engaged in developing healthcare equipment for the treatment of symptomatic aortic stenosis.

Anteris Technologies Ltd: Headquartered in Queensland, Australia, Anteris Technologies develops, manufactures, and distributes medical devices and technologies with a focus on tissue engineering and immunotherapies.

AorTx, Inc.: Headquartered in California, the US, AorTx is engaged in developing device solutions that convert aortic valve replacement to a minimally invasive, percutaneous, approach. The company is developing devices that cover the entire procedural solution for percutaneous heart valve therapy from the implant itself to the delivery and deployment of the valve.

TAVR Pipeline Products Market Report Overview

Key Territories The US, China, Europe, Canada, Japan, Australia, India, Taiwan, Hong Kong, and Brazil
Key Regulatory Paths NMPA, PMA, CE, MDL, Shonin, TGA, BOPA, ICAC, HSA, and ANVISA
Leading Companies Aegis Surgical Limited, Anteris Technologies Ltd, AorTx, Inc., Arbor Surgical Technologies, Inc., Atlas Medical, Biotronik AG, Boston Scientific Corp, Carena Healthcare Ltd, Chengdu Silara Meditech Inc, and Colibri Heart Valve LLC

Scope

This report provides:

  • Extensive coverage of the Transcatheter Aortic Valve Replacement (TAVR) under development.
  • Reviews of details of major pipeline products which includes product description, licensing and collaboration details, and other developmental activities.
  • Reviews of the major players involved in the development of Transcatheter Aortic Valve Replacement (TAVR) and lists all their pipeline projects.
  • The coverage of pipeline products is based on various stages of development ranging from early development to the approved/issued stage.
  • 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 Transcatheter Aortic Valve Replacement (TAVR) 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

Aegis Surgical Limited
Anteris Technologies Ltd
AorTx, Inc.
Arbor Surgical Technologies, Inc.
Atlas Medical
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)
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
Lepu Medical Technology (Beijing) Co Ltd
Mayo Clinic
Medtronic Plc
Meril Life Sciences Pvt Ltd
MicroPort CardioFlow Medtech Corp
MicroPort MedBot (Shanghai) Co Ltd
NewMed Medical Co Ltd
Novogate Medical Ltd.
NVT AG
Opsens Inc
P+F Products + Features GmbH
Peca Labs Inc
Peijia Medical Ltd
Pi-Cardia 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
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
Vascular Concepts Ltd
Vascular Innovations Co 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 19

3.4 Transcatheter Aortic Valve Replacement (TAVR) – Pipeline Products by Estimated Approval Date 20

3.5 Transcatheter Aortic Valve Replacement (TAVR) – Ongoing Clinical Trials 21

4 Transcatheter Aortic Valve Replacement (TAVR) – Pipeline Products under Development by Companies 22

4.1 Transcatheter Aortic Valve Replacement (TAVR) Companies – Pipeline Products by Stage of Development 22

4.2 Transcatheter Aortic Valve Replacement (TAVR) – Pipeline Products by Stage of Development 25

5 Transcatheter Aortic Valve Replacement (TAVR) Companies and Product Overview 28

5.1 Aegis Surgical Limited Company Overview 28

5.1.1 Aegis Surgical Limited Pipeline Products & Ongoing Clinical Trials Overview 28

5.2 Anteris Technologies Ltd Company Overview 29

5.2.1 Anteris Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 29

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 Biotronik AG Company Overview 35

5.6.1 Biotronik AG Pipeline Products & Ongoing Clinical Trials Overview 35

5.7 Boston Scientific Corp Company Overview 38

5.7.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 38

5.8 Carena Healthcare Ltd Company Overview 46

5.8.1 Carena Healthcare Ltd Pipeline Products & Ongoing Clinical Trials Overview 46

5.9 Chengdu Silara Meditech Inc Company Overview 47

5.9.1 Chengdu Silara Meditech Inc Pipeline Products & Ongoing Clinical Trials Overview 47

5.10 Colibri Heart Valve LLC Company Overview 50

5.10.1 Colibri Heart Valve LLC Pipeline Products & Ongoing Clinical Trials Overview 50

5.11 ContiTech (Beijing) Medical Technology Co Ltd Company Overview 55

5.11.1 ContiTech (Beijing) Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 55

5.12 Daidalos Solutions BV Company Overview 56

5.12.1 Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview 56

5.13 Direct Flow Medical Inc (Inactive) Company Overview 57

5.13.1 Direct Flow Medical Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 57

5.14 DSM Dyneema BV Company Overview 61

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

5.15 Dura LLC Company Overview 62

5.15.1 Dura LLC Pipeline Products & Ongoing Clinical Trials Overview 62

5.16 Edwards Lifesciences Corp Company Overview 64

5.16.1 Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 64

5.17 Endoluminal Technology Research LLC Company Overview 69

5.17.1 Endoluminal Technology Research LLC Pipeline Products & Ongoing Clinical Trials Overview 69

5.18 Florida International University Company Overview 70

5.18.1 Florida International University Pipeline Products & Ongoing Clinical Trials Overview 70

5.19 Folda LLC Company Overview 71

5.19.1 Folda LLC Pipeline Products & Ongoing Clinical Trials Overview 71

5.20 Foldax Inc Company Overview 72

5.20.1 Foldax Inc Pipeline Products & Ongoing Clinical Trials Overview 72

5.21 HLT, Inc. Company Overview 73

5.21.1 HLT, Inc. Pipeline Products & Ongoing Clinical Trials Overview 73

5.22 JC Medical, Inc. Company Overview 77

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

5.23 JenaValve Technology GmbH Company Overview 82

5.23.1 JenaValve Technology GmbH Pipeline Products & Ongoing Clinical Trials Overview 82

5.24 Jenscare Scientific Co Ltd Company Overview 87

5.24.1 Jenscare Scientific Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 87

5.25 Jinshi Biotechnology (Changshu) Co Ltd Company Overview 89

5.25.1 Jinshi Biotechnology (Changshu) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 89

5.26 KOKA Lifesciences Co Ltd Company Overview 90

5.26.1 KOKA Lifesciences Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 90

5.27 Lepu Medical Technology (Beijing) Co Ltd Company Overview 93

5.27.1 Lepu Medical Technology (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 93

5.28 Mayo Clinic Company Overview 97

5.28.1 Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 97

5.29 Medtronic Plc Company Overview 98

5.29.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 98

5.30 Meril Life Sciences Pvt Ltd Company Overview 99

5.30.1 Meril Life Sciences Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 99

5.31 MicroPort CardioFlow Medtech Corp Company Overview 100

5.31.1 MicroPort CardioFlow Medtech Corp Pipeline Products & Ongoing Clinical Trials Overview 100

5.32 MicroPort MedBot (Shanghai) Co Ltd Company Overview 105

5.32.1 MicroPort MedBot (Shanghai) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 105

5.33 NewMed Medical Co Ltd Company Overview 106

5.33.1 NewMed Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 106

5.34 Novogate Medical Ltd. Company Overview 111

5.34.1 Novogate Medical Ltd. Pipeline Products & Ongoing Clinical Trials Overview 111

5.35 NVT AG Company Overview 112

5.35.1 NVT AG Pipeline Products & Ongoing Clinical Trials Overview 112

5.36 Opsens Inc Company Overview 116

5.36.1 Opsens Inc Pipeline Products & Ongoing Clinical Trials Overview 116

5.37 P+F Products + Features GmbH Company Overview 119

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

5.38 Peca Labs Inc Company Overview 122

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

5.39 Peijia Medical Ltd Company Overview 123

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

5.40 Pi-Cardia Ltd Company Overview 128

5.40.1 Pi-Cardia Ltd Pipeline Products & Ongoing Clinical Trials Overview 128

5.41 PolyNova Cardiovascular Inc Company Overview 131

5.41.1 PolyNova Cardiovascular Inc Pipeline Products & Ongoing Clinical Trials Overview 131

5.42 RegenaGraft Company Overview 132

5.42.1 RegenaGraft Pipeline Products & Ongoing Clinical Trials Overview 132

5.43 ReValve Med Inc Company Overview 133

5.43.1 ReValve Med Inc Pipeline Products & Ongoing Clinical Trials Overview 133

5.44 SAS Cormove Company Overview 134

5.44.1 SAS Cormove Pipeline Products & Ongoing Clinical Trials Overview 134

5.45 Shanghai Healing Medical Instruments Co Ltd Company Overview 135

5.45.1 Shanghai Healing Medical Instruments Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 135

5.46 St. Jude Medical LLC Company Overview 139

5.46.1 St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 139

5.47 Stony Brook University Company Overview 142

5.47.1 Stony Brook University Pipeline Products & Ongoing Clinical Trials Overview 142

5.48 Strait Access Technologies (Pty) Ltd Company Overview 143

5.48.1 Strait Access Technologies (Pty) Ltd Pipeline Products & Ongoing Clinical Trials Overview 143

5.49 Symetis SA Company Overview 144

5.49.1 Symetis SA Pipeline Products & Ongoing Clinical Trials Overview 144

5.50 The University of British Columbia Company Overview 152

5.50.1 The University of British Columbia Pipeline Products & Ongoing Clinical Trials Overview 152

5.51 Thubrikar Aortic Valve, Inc. Company Overview 153

5.51.1 Thubrikar Aortic Valve, Inc. Pipeline Products & Ongoing Clinical Trials Overview 153

5.52 University College London Company Overview 156

5.52.1 University College London Pipeline Products & Ongoing Clinical Trials Overview 156

5.53 University of California San Francisco Company Overview 157

5.53.1 University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview 157

5.54 University of Cambridge Company Overview 158

5.54.1 University of Cambridge Pipeline Products & Ongoing Clinical Trials Overview 158

5.55 University of Iowa Company Overview 159

5.55.1 University of Iowa Pipeline Products & Ongoing Clinical Trials Overview 159

5.56 University of Pennsylvania Company Overview 160

5.56.1 University of Pennsylvania Pipeline Products & Ongoing Clinical Trials Overview 160

5.57 Vascular Concepts Ltd Company Overview 161

5.57.1 Vascular Concepts Ltd Pipeline Products & Ongoing Clinical Trials Overview 161

5.58 Vascular Innovations Co Ltd Company Overview 162

5.58.1 Vascular Innovations Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 162

5.59 Venus Medtech Hangzhou Inc Company Overview 163

5.59.1 Venus Medtech Hangzhou Inc Pipeline Products & Ongoing Clinical Trials Overview 163

5.60 Xeltis AG Company Overview 172

5.60.1 Xeltis AG Pipeline Products & Ongoing Clinical Trials Overview 172

5.61 Youngheartvalve LLC Company Overview 173

5.61.1 Youngheartvalve LLC Pipeline Products & Ongoing Clinical Trials Overview 173

6 Transcatheter Aortic Valve Replacement (TAVR)- Recent Developments 174

6.1 Jan 06, 2023: JenaValve Appoints Dan Dearen to Board of Directors 174

6.2 Dec 08, 2022: Edwards Lifesciences Announces CEO Succession Plan 174

6.3 Nov 23, 2022: Medtronic Reports Quarterly Earnings 175

6.4 Nov 22, 2022: Medtronic reports second quarter fiscal 2023 financial results 175

6.5 Nov 15, 2022: Medtronic Set to Announce Earnings on Tuesday 181

6.6 Oct 20, 2022: Edwards Lifesciences to Host Earnings Conference Call on October 27, 2022 181

6.7 Sep 07, 2022: Medtronic to appear at September investor conferences 181

6.8 Aug 23, 2022: Medtronic reports first quarter fiscal 2023 financial results 181

6.9 Aug 23, 2022: Medtronic Announces Quarterly Earnings Results 184

6.10 Aug 16, 2022: Boston Scientific Announces Upcoming Conference Schedule 186

6.11 Jul 21, 2022: Edwards Lifesciences to Host Earnings Conference Call on July 28, 2022 187

6.12 Jun 27, 2022: Medtronic Board appoints Lidia Fonseca as a new director 187

6.13 May 27, 2022: Medtronic reports full year and fourth quarter fiscal year 2022 financial results 188

6.14 May 26, 2022: Medtronic reports full year and fourth quarter fiscal year 2022 financial results announces 8% dividend increase 188

6.15 May 23, 2022: Edwards Lifesciences to Present at the Bernstein 38th Annual Strategic Decisions Conference 188

6.16 Apr 28, 2022: Boston Scientific reports net sales of $3.03bn in Q1 2022 188

6.17 Apr 27, 2022: Boston Scientific Announces Results for First Quarter 2022 189

6.18 Apr 19, 2022: Edwards Lifesciences to Host Earnings Conference Call on April 26, 2022 191

6.19 Mar 31, 2022: Vizient Medical Device tech watch provides trends in transcatheter valve replacement and a model for assessing new technology in musculoskeletal care 191

6.20 Mar 18, 2022: Venus Medtech appoints Shakeel Osman as Senior VP of Sales Europe to drive commercialization of TPVR system 192

7 Appendix 194

7.1 Methodology 194

7.2 About GlobalData 197

7.3 Contact Us 197

7.4 Disclaimer 197

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 19

Transcatheter Aortic Valve Replacement (TAVR) – Pipeline Products by Estimated Approval Date 20

Transcatheter Aortic Valve Replacement (TAVR) – Ongoing Clinical Trials 21

Transcatheter Aortic Valve Replacement (TAVR) Companies – Pipeline Products by Stage of Development 22

Transcatheter Aortic Valve Replacement (TAVR) – Pipeline Products by Stage of Development 25

Aegis Surgical Limited Pipeline Products & Ongoing Clinical Trials Overview 28

pTAo-TAVR – Product Status 28

pTAo-TAVR – Product Description 28

Anteris Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 29

DurAVR THV System – Product Status 29

DurAVR THV System – Product Description 29

Anteris Technologies Ltd – Ongoing Clinical Trials Overview 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

Biotronik AG Pipeline Products & Ongoing Clinical Trials Overview 35

BIOVALVE Resheathable Transcatheter Aortic Valve – Product Status 35

BIOVALVE Resheathable Transcatheter Aortic Valve – Product Description 35

Biotronik AG – Ongoing Clinical Trials Overview 36

BIOVALVE Resheathable Transcatheter Aortic Valve – Safety and Clinical Performance of the Self-expanding Transcatheter BIOVALVE Prosthesis in Subjects with Severe Symptomatic Aortic Stenosis Suitable for Transfemoral Transcatheter Aortic Valve Implantation 37

Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 38

ACURATE neo2 Transfemoral TAVR System – Product Status 38

ACURATE neo2 Transfemoral TAVR System – Product Description 39

Gen 4 Lotus Valve System – Product Status 39

Gen 4 Lotus Valve System – Product Description 39

Lotus Edge Sheath 15F – Product Status 40

Lotus Edge Sheath 15F – Product Description 40

Lotus Edge Valve System – 21mm – Product Status 40

Lotus Edge Valve System – 21mm – Product Description 41

Lotus Edge Valve System – 29mm – Product Status 41

Lotus Edge Valve System – 29mm – Product Description 42

LOTUS Mantra – Product Status 42

LOTUS Mantra – 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 Neo AS Aortic Bioprosthesis for Implantation Using the ACURATE neo AS TF Transfemoral Delivery System in Patients with Severe Aortic Stenosis 44

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

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 45

Carena Healthcare Ltd Pipeline Products & Ongoing Clinical Trials Overview 46

Pillar 3D Printed Replacement Heart Valve – Product Status 46

Pillar 3D Printed Replacement Heart Valve – Product Description 46

Chengdu Silara Meditech Inc Pipeline Products & Ongoing Clinical Trials Overview 47

Transcatheter Aortic Valve System – Product Status 47

Transcatheter Aortic Valve System – Product Description 47

Chengdu Silara Meditech Inc – Ongoing Clinical Trials Overview 48

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 49

Transcatheter Aortic Valve System – To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Symptomatic Aortic Insufficiency 49

Colibri Heart Valve LLC Pipeline Products & Ongoing Clinical Trials Overview 50

Colibri TAVI System – Product Status 50

Colibri TAVI System – Product Description 50

Delta Aortic Heart Valve – Product Status 51

Delta Aortic Heart Valve – Product Description 51

Second-Generation TAVI System – Product Status 51

Second-Generation TAVI System – Product Description 52

Venibri Transcatheter Heart Valve System – Product Status 52

Venibri Transcatheter Heart Valve System – Product Description 52

Colibri Heart Valve LLC – Ongoing Clinical Trials Overview 53

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 54

ContiTech (Beijing) Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 55

Balloon-Expandable Transcatheter Aortic Valve Replacement Device – Product Status 55

Balloon-Expandable Transcatheter Aortic Valve Replacement Device – Product Description 55

Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview 56

Sutureless Trans-Catheter Aortic Valve Replacement (TAVR) – Product Status 56

Sutureless Trans-Catheter Aortic Valve Replacement (TAVR) – Product Description 56

Direct Flow Medical Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 57

18F Direct Flow Medical Transcatheter Aortic Valve System – Product Status 57

18F Direct Flow Medical Transcatheter Aortic Valve System – Product Description 57

22F Percutaneous Aortic Valve System – Product Status 58

22F Percutaneous Aortic Valve System – Product Description 58

Direct Flow Medical Inc (Inactive) – Ongoing Clinical Trials Overview 59

18F Direct Flow Medical Transcatheter Aortic Valve System – SALUS Trial Transcatheter Aortic Valve Replacement System Pivotal Trial the Safety and Effectiveness of the Direct Flow Medical Tanscatheter Aortic Valve System 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

VirtuTAVR System – Product Status 63

VirtuTAVR System – Product Description 63

Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 64

Next Gen CENTERA – Product Status 64

Next Gen CENTERA – Product Description 64

SAPIEN 3 THV – Asymptomatic Severe Aortic Stenosis – Product Status 65

SAPIEN 3 THV – Asymptomatic Severe Aortic Stenosis – Product Description 65

SAPIEN 3 THV – Moderate Aortic Stenosis – Product Status 65

SAPIEN 3 THV – Moderate Aortic Stenosis – Product Description 66

SAPIEN X4 – Product Status 66

SAPIEN X4 – Product Description 66

Edwards Lifesciences Corp – Ongoing Clinical Trials Overview 67

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) 68

Endoluminal Technology Research LLC Pipeline Products & Ongoing Clinical Trials Overview 69

Balloon Expandable Paniagua Heart Valve – Product Status 69

Balloon Expandable Paniagua Heart Valve – Product Description 69

Florida International University Pipeline Products & Ongoing Clinical Trials Overview 70

Percutaneous Aortic Heart Valve – Product Status 70

Percutaneous Aortic Heart Valve – Product Description 70

Folda LLC Pipeline Products & Ongoing Clinical Trials Overview 71

Foldavalve – Product Status 71

Foldavalve – Product Description 71

Foldax Inc Pipeline Products & Ongoing Clinical Trials Overview 72

Tria Transcatheter Aortic Valve Replacement Device – Product Status 72

Tria Transcatheter Aortic Valve Replacement Device – Product Description 72

HLT, Inc. Pipeline Products & Ongoing Clinical Trials Overview 73

Meridian II Transcatheter Aortic Valve Replacement System – Product Status 73

Meridian II Transcatheter Aortic Valve Replacement System – Product Description 73

HLT, Inc. – Ongoing Clinical Trials Overview 74

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 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 Stenosis 75

Meridian II Transcatheter Aortic Valve Replacement System – Transfemoral Replacement of Aortic Valve with HLT Meridian Valve Early Feasibility Trial 75

Meridian II Transcatheter Aortic Valve Replacement System – Transfemoral Replacement of Aortic Valve with HLT Meridian Valve Feasibility Trial Canada 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 TAVI System – Transfemoral – Product Status 78

J-Valve TAVI System – Transfemoral – Product Description 78

JC Medical, Inc. – Ongoing Clinical Trials Overview 79

J-Valve TAVI System – Transapical – Efficacy and Safety Evaluation for the Interventional Aortic Valve Bioprosthesis and Delivery System in Patients with Severe Aortic Stenosis and/or Aortic Regurgitation with Elevated Surgical Risk 80

J-Valve TAVI System – Transfemoral – J-Valve Compassionate Use Cases 81

JenaValve Technology GmbH Pipeline Products & Ongoing Clinical Trials Overview 82

JenaValve Pericardial TAVR System – Product Status 82

JenaValve Pericardial TAVR System – Product Description 82

Trilogy Heart Valve System – Product Status 83

Trilogy Heart Valve System – Product Description 83

JenaValve Technology GmbH – Ongoing Clinical Trials Overview 84

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) 85

JenaValve Pericardial TAVR System – JENAVALVE ALIGN-AS TRIAL: Safety and Effectiveness/Performance of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Stenosis (AS) 85

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) 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 86

Jenscare Scientific Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 87

Ken-Valve – Product Status 87

Ken-Valve – Product Description 87

KenFlex – Product Status 88

KenFlex – Product Description 88

Jinshi Biotechnology (Changshu) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 89

Transcatheter Aortic Valve Replacement Device – Product Status 89

Transcatheter Aortic Valve Replacement Device – Product Description 89

KOKA Lifesciences Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 90

Koka Valve – Product Status 90

Koka Valve – Product Description 90

KOKA Lifesciences Co Ltd – Ongoing Clinical Trials Overview 91

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 92

Lepu Medical Technology (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 93

Sinocrown Transcatheter Aortic Valve Replacement System – Product Status 93

Sinocrown Transcatheter Aortic Valve Replacement System – Product Description 93

Transcatheter Aortic Valve Replacement System – Product Status 94

Transcatheter Aortic Valve Replacement System – Product Description 94

Transcatheter Aortic Valve System (Balloon Dilation) – Product Status 94

Transcatheter Aortic Valve System (Balloon Dilation) – Product Description 94

Lepu Medical Technology (Beijing) Co Ltd – Ongoing Clinical Trials Overview 95

Sinocrown Transcatheter Aortic Valve Replacement System – A Prospective, Multicenter, Single-arm Clinical Trial to Evaluate Safety and Efficacy of Sinocrown Transcatheter Aortic Valve Replacement System with Accessories in Patients with Symptomatic, Calcified and Severe Aortic Stenosis 96

Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 97

Percutaneous Aortic Valve – Product Status 97

Percutaneous Aortic Valve – Product Description 97

Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 98

Evolut Next Gen – Product Status 98

Evolut Next Gen – Product Description 98

Meril Life Sciences Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 99

MyVal S/Ex – Product Status 99

MyVal S/Ex – Product Description 99

MicroPort CardioFlow Medtech Corp Pipeline Products & Ongoing Clinical Trials Overview 100

VitaFlow Balloon Expandable – Product Status 100

VitaFlow Balloon Expandable – Product Description 100

VitaFlow III – Product Status 101

VitaFlow III – Product Description 101

VitaFlow Liberty – Product Status 101

VitaFlow Liberty – Product Description 102

VitaFlow Novo Generation – Product Status 102

VitaFlow Novo Generation – Product Description 102

MicroPort CardioFlow Medtech Corp – Ongoing Clinical Trials Overview 103

VitaFlow Liberty – A Prospective, Multicenter, Single-arm, Objective Performance Clinical Investigation For Evaluation of the Safety and Effectiveness of MicroPort CardioFlow VitaFlow II Transcatheter Aortic Valve System in the Treatment of Severe Aortic Valve Stenosis 104

VitaFlow Liberty – Clinical Evaluation of Safety and Efficacy of Retrievable Transcatheter Aortic Valve Implantation Device for the Treatment of Severe Aortic Regurgitation: A Prospective, Multicenter Study 104

VitaFlow Liberty – Evaluating Safety and Effectiveness/Performance of the Microport CardioFlow VitaFlow II – Transcatheter Aortic Valve System: The VITALE Study 104

MicroPort MedBot (Shanghai) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 105

TAVR Surgical Robot – Product Status 105

TAVR Surgical Robot – Product Description 105

NewMed Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 106

Prizvalve II TAVR Valve – Product Status 106

Prizvalve II TAVR Valve – Product Description 106

Prizvalve Pro TAVR Valve – Product Status 107

Prizvalve Pro TAVR Valve – Product Description 107

Prizvalve System – Product Status 107

Prizvalve System – Product Description 107

Starr-A TAVR Valve – Product Status 108

Starr-A TAVR Valve – Product Description 108

NewMed Medical Co Ltd – Ongoing Clinical Trials Overview 109

Prizvalve System – An Exploratory Study to Evaluate the Prizvalve System in Patients With Failing Bioprosthetic Valve 110

Prizvalve System – An Exploratory Study to Evaluate the Prizvalve System in Patients with Severe Atrioventricular Annular Calcification or Failed Prosthetic Atrioventricular Valve/ Annulus Repair 110

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 110

Novogate Medical Ltd. Pipeline Products & Ongoing Clinical Trials Overview 111

Wisefix System – Transcatheter Aortic Valve Implantation – Product Status 111

Wisefix System – Transcatheter Aortic Valve Implantation – Product Description 111

NVT AG Pipeline Products & Ongoing Clinical Trials Overview 112

ALLEGRA Transfemoral TAVI System – Product Status 112

ALLEGRA Transfemoral TAVI System – Product Description 112

ALLEGRA Valve-In-Valve – Product Status 113

ALLEGRA Valve-In-Valve – Product Description 113

NVT AG – Ongoing Clinical Trials Overview 114

ALLEGRA Transfemoral TAVI System – Clinical Outcomes of the NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population with Elevated Surgical Risk 115

ALLEGRA Transfemoral TAVI System – Investigation of the Safety and Performance of the NVT ALLEGRA THV System with a New Delivery System in Patients with Severe Calcified Aortic Stenosis or Failed Surgical Aortic Bioprosthesis 115

Opsens Inc Pipeline Products & Ongoing Clinical Trials Overview 116

SavvyWire – Product Status 116

SavvyWire – Product Description 116

Opsens Inc – Ongoing Clinical Trials Overview 117

SavvyWire – SAvvyWire EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI) 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

Pi-Cardia Ltd Pipeline Products & Ongoing Clinical Trials Overview 128

ShortCut Aortic Device – Product Status 128

ShortCut Aortic Device – Product Description 128

Pi-Cardia Ltd – Ongoing Clinical Trials Overview 129

ShortCut Aortic Device – A Prospective, Multicenter, Non-randomized, Single-arm, Open-label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut Device (The ShortCut Study) 130

ShortCut Aortic Device – A Prospective, Multicenter, Non-randomized, Single-arm, Open-label Clinical Study to Demonstrate the Safety and Performance of the Leaflex Performer 130

PolyNova Cardiovascular Inc Pipeline Products & Ongoing Clinical Trials Overview 131

Trileaflet Polymeric Prosthetic Heart Valve – Product Status 131

Trileaflet Polymeric Prosthetic Heart Valve – Product Description 131

RegenaGraft Pipeline Products & Ongoing Clinical Trials Overview 132

Synthetic Heart Valve – Product Status 132

Synthetic Heart Valve – Product Description 132

ReValve Med Inc Pipeline Products & Ongoing Clinical Trials Overview 133

Removable Transcatheter Aortic Valve – Product Status 133

Removable Transcatheter Aortic Valve – Product Description 133

SAS Cormove Pipeline Products & Ongoing Clinical Trials Overview 134

CORMOVE Percutaneous Aortic Valve – Product Status 134

CORMOVE Percutaneous Aortic Valve – Product Description 134

Shanghai Healing Medical Instruments Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 135

HanchorValve – Product Status 135

HanchorValve – Product Description 135

Transcatheter Aortic Valve Replacement Device – Product Status 136

Transcatheter Aortic Valve Replacement Device – Product Description 136

Shanghai Healing Medical Instruments Co Ltd – Ongoing Clinical Trials Overview 137

HanchorValve – A Multi-center Clinical Study of HanchorValve to Treat Patients with Severe Aortic Regurgitation 138

St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 139

Portico Next Generation Transcatheter Aortic Heart Valve – Product Status 139

Portico Next Generation Transcatheter Aortic Heart Valve – Product Description 139

St. Jude Medical LLC – Ongoing Clinical Trials Overview 140

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 141

Stony Brook University Pipeline Products & Ongoing Clinical Trials Overview 142

Next Generation TAVR Valve – Product Status 142

Next Generation TAVR Valve – Product Description 142

Strait Access Technologies (Pty) Ltd Pipeline Products & Ongoing Clinical Trials Overview 143

SAT TAVI System – Product Status 143

SAT TAVI System – Product Description 143

Symetis SA Pipeline Products & Ongoing Clinical Trials Overview 144

ACURATE neo2 Aortic Valve System – Product Status 144

ACURATE neo2 Aortic Valve System – Product Description 144

ACURATE Prime – Product Status 145

ACURATE Prime – Product Description 145

ACURATE Prime XL Transfemoral Aortic Valve System – Product Status 145

ACURATE Prime XL Transfemoral Aortic Valve System – Product Description 146

ACURATE TAo – Product Status 146

ACURATE TAo – Product Description 146

NG ACURATE – Product Status 147

NG ACURATE – Product Description 147

Symetis SA – Ongoing Clinical Trials Overview 148

ACURATE neo2 Aortic Valve System – ACURATE Neo AS Aortic Bioprosthesis for Implantation Using the ACURATE neo AS TF Transfemoral Delivery System in Patients with Severe Aortic Stenosis 149

ACURATE neo2 Aortic Valve System – Evaluation of Safety and Clinical Efficacy of Boston Scientific ACURATE NEO/TF Transcatheter Heart Valves and Comparison with Medtronic EVOLUT R/ PRO Systems in All Comers Undergoing TAVR 149

ACURATE neo2 Aortic Valve System – Project to Look for Early Discharge in Patients Undergoing TAVI With ACURATE – An International Multi-center Early Discharge TAVI Program 149

ACURATE neo2 Aortic Valve System – Prospective Evaluation Complementing Investigation with Acurate Neo Device 150

ACURATE neo2 Aortic Valve System – Prospective, Randomized, Cost-utility Analysis of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Brazil 150

ACURATE Prime XL Transfemoral Aortic Valve System – A Study to Evaluate the Feasibility and Safety of the ACURATE Prime XL Aortic Valve System in Patients Indicated for TAVI: ACURATE Prime XL Human Feasibility Study 151

The University of British Columbia Pipeline Products & Ongoing Clinical Trials Overview 152

Biomaterial Heart Valve – Product Status 152

Biomaterial Heart Valve – Product Description 152

Thubrikar Aortic Valve, Inc. Pipeline Products & Ongoing Clinical Trials Overview 153

Optimum TAVI System – Product Status 153

Optimum TAVI System – Product Description 153

Thubrikar Aortic Valve, Inc. – Ongoing Clinical Trials Overview 154

Optimum TAVI System – Efficacy and Safety of Optimum TAVI System in Subjects with Severe Aortic Stenosis: A First-in-Human Study 155

University College London Pipeline Products & Ongoing Clinical Trials Overview 156

TRISKELE Aortic Valve – Product Status 156

TRISKELE Aortic Valve – Product Description 156

University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview 157

Transcatheter Aortic Valve – Product Status 157

Transcatheter Aortic Valve – Product Description 157

University of Cambridge Pipeline Products & Ongoing Clinical Trials Overview 158

Removable Transcatheter Valve – Product Status 158

Removable Transcatheter Valve – Product Description 158

University of Iowa Pipeline Products & Ongoing Clinical Trials Overview 159

Cellulose Based Aortic Heart Valve – Product Status 159

Cellulose Based Aortic Heart Valve – Product Description 159

University of Pennsylvania Pipeline Products & Ongoing Clinical Trials Overview 160

Aortic Repair Device – Product Status 160

Aortic Repair Device – Product Description 160

Vascular Concepts Ltd Pipeline Products & Ongoing Clinical Trials Overview 161

TAVI (Transcatheter Aortic Valve Replacement) – Product Status 161

TAVI (Transcatheter Aortic Valve Replacement) – Product Description 161

Vascular Innovations Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 162

Hydra TAVI Bioprosthesis – Product Status 162

Hydra TAVI Bioprosthesis – Product Description 162

Venus Medtech Hangzhou Inc Pipeline Products & Ongoing Clinical Trials Overview 163

AR Valve – Product Status 163

AR Valve – Product Description 164

Transapical Trinity Aortic Valve Implantation System – Product Status 164

Transapical Trinity Aortic Valve Implantation System – Product Description 164

Transfemoral Trinity Aortic Valve Implantation System – Product Status 165

Transfemoral Trinity Aortic Valve Implantation System – Product Description 165

Venus PowerX Valve – Product Status 165

Venus PowerX Valve – Product Description 166

Venus Vitae Valve – Product Status 166

Venus Vitae Valve – Product Description 166

VenusA-Plus – Product Status 167

VenusA-Plus – Product Description 167

VenusA-Pro Valve – Product Status 167

VenusA-Pro Valve – Product Description 168

VenusA-Valve – Product Status 168

VenusA-Valve – Product Description 168

Venus Medtech Hangzhou Inc – Ongoing Clinical Trials Overview 169

VenusA-Valve – Venus Panorama II Post-marketing Registry Study 170

Venus Vitae Valve – A First-in-man Clinical Trial of Venus Vitae Valve in Patients with Heart Valvular 171

Disease 171

Xeltis AG Pipeline Products & Ongoing Clinical Trials Overview 172

Transcatheter Aortic Heart Valve – Product Status 172

Transcatheter Aortic Heart Valve – Product Description 172

Youngheartvalve LLC Pipeline Products & Ongoing Clinical Trials Overview 173

Polymeric Trans-Catheter Aortic Valve – Product Status 173

Polymeric Trans-Catheter Aortic Valve – Product Description 173

Glossary 196

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 19

Transcatheter Aortic Valve Replacement (TAVR) – Pipeline Products by Estimated Approval Date 20

Transcatheter Aortic Valve Replacement (TAVR) – Ongoing Clinical Trials 21

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