Cardiac Valve Repair Devices Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies

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Cardiac Valve Repair Devices Pipeline Market Report Overview

Cardiac valve repair devices are used in Open-Heart surgery to repair the malfunctioning of valves. Only mitral valve repair has been covered under this segment. Annuloplasty is a technique used to repair an enlarged annulus. This annuloplasty device makes the opening of the valve smaller and provides support to the valve so it can close more tightly. One unit refers to One cardiac valve repair device.

The Cardiac Valve Repair Devices pipeline market research report provides extensive coverage of the Cardiac Valve Repair Devices under development. It reviews details of major pipeline products which include product description, licensing and collaboration details, and other developmental activities including pipeline territories, regulatory paths, and estimated approval dates. Additionally, it reviews major players involved in the pipeline product development. The report also provides key clinical trial data related to ongoing clinical trials such as trial phase, trial status, trial start and end dates, and the number of trials of the major Cardiac Valve Repair Devices pipeline products.

Key Territories ·        The United States

·        Europe

·        China

·        Canada

·        Israel

·        Japan

Key Categories ·        Mitral Valve Annuloplasty Devices
Key Regulatory Paths ·        CE

·        PMA

·        NMPA

·        510(k)

·        MDL

·        TGA

Leading Companies ·        4Tech Cardio Ireland Ltd

·        Affluent Medical SASU

·        Ample Medical Inc

·        Anchorvalve

·        Ancora Heart Inc

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Cardiac Valve Repair Devices Pipeline Market Segmentation by Category

Mitral Valve Annuloplasty Devices is the only category in the Cardiac Valve Repair Devices pipeline market. Mitral Valve Annuloplasty Devices consist of the annuloplasty rings and bands that are used in the repair of mitral valves. Some of the mitral valve annuloplasty devices covered in this market can be used to repair both the mitral and tricuspid valves. One unit refers to either one annuloplasty mitral valve repair ring or one annuloplasty mitral valve repair band.

Cardiac Valve Repair Devices Pipeline Market Segmentation by Territories

A few of the key territories with the Cardiac Valve Repair Devices pipeline market are the United States, Europe, China, Canada, and Israel among others. As of May 2024, the US accounts for the highest number of Cardiac Valve Repair Devices products.

 Cardiac Valve Repair Devices Pipeline Market Analysis by Territories, 2024 (%)

Cardiac Valve Repair Devices Pipeline Market Analysis by Territories, 2024 (%)

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Cardiac Valve Repair Devices Pipeline Market Segmentation by Regulatory Paths

A few of the key regulatory paths in the Cardiac Valve Repair Devices pipeline market are CE, PMA, NMPA, 510(k), MDL, and TGA among others. As of May 2024, CE is the most followed pathway for pipeline products in the Cardiac Valve Repair Devices pipeline market.

 Cardiac Valve Repair Devices Pipeline Market Analysis by Regulatory Paths, 2024 (%)

 Cardiac Valve Repair Devices Pipeline Market Analysis by Regulatory Paths, 2024 (%)

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Cardiac Valve Repair Devices Pipeline Market – Competitive Landscape

A few of the key companies associated with the Cardiac Valve Repair Devices pipeline market are 4Tech Cardio Ireland Ltd, Affluent Medical SASU, Ample Medical Inc., Anchorvalve, and Ancora Heart Inc. among others.

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

 Cardiac Valve Repair Devices Pipeline Market Analysis by Companies, 2024

Cardiac Valve Repair Devices Pipeline Market Analysis by Companies, 2024

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Segments Covered in the Report

Cardiac Valve Repair Devices Pipeline Market Territories Outlook (As of May 2024)

  • The United States
  • Europe
  • China
  • Canada
  • Israel
  • Japan
  • Others

 Cardiac Valve Repair Devices Pipeline Market Regulatory Paths Outlook (As of May 2024)

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

 Cardiac Valve Repair Devices Pipeline Market Category Outlook (As of May 2024)

  • Mitral Valve Annuloplasty Devices

Scope

  • Extensive coverage of the Cardiac Valve Repair Devices under development
  • The report reviews details of major pipeline products which includes, product description, licensing and collaboration details, and other developmental activities
  • The report reviews the major players involved in the development of Cardiac Valve Repair Devices and lists all their pipeline projects
  • The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage
  • The report provides key clinical trial data of ongoing trials specific to pipeline products
  • Recent developments in the segment/industry

Reasons to Buy

The report enables you to:

  • Formulate significant competitor information, analysis, and insights to improve R&D strategies
  • Identify emerging players with potentially strong product portfolios and create effective counter strategies to gain competitive advantage
  • Identify and understand important and diverse types of Cardiac Valve Repair Devices under development
  • Develop market-entry and market-expansion strategies
  • Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline
  • In-depth analysis of the product’s current stage of development, territory, and estimated launch date

4Tech Cardio Ireland Ltd
Affluent Medical SASU
Ample Medical Inc
Anchorvalve
Ancora Heart Inc
Approxima Srl
Asan Medical Center
BioVentrix Inc
Boston Children's Hospital
Boston Scientific Corp
Cardiac Implants LLC
Cardiosolutions Inc
Cedars-Sinai Medical Center
Celyad Oncology SA
Collplant Biotechnologies Ltd
Columbia University
ConKay Medical Systems Inc
CoreMedic AG
CUBE SRL
Edwards Lifesciences Corp
Emory University
Georgia Institute of Technology
Hangzhou DeJin Medtech Co Ltd
Hanxin Medical Technology (Shenzhen) Co Ltd
Harpoon Medical Inc
HVR Cardio Oy
Kardium Inc
Kekai Life Sciences
Lepu Medical Technology (Beijing) Co Ltd
LuSeed Vascular
Mardil Medical, Inc.
Mayo Clinic
Meacor Inc
Medical University of Vienna
Meril Life Sciences Pvt Ltd
MiCardia Corp
Michigan Critical Care Consultants Inc
Micro Interventional Devices, Inc.
MicroPort CardioFlow Medtech Corp
Millipede LLC
Mitral Print Inc
Mitralflex Sarl
Mitralign Inc
Mitre Medical Corp
MVRx, Inc.
Occlufit AG
P+F Products + Features GmbH
Pi-Cardia Ltd
Rambam Health Care Campus
SCR, Inc.
Shanghai Shenqi Medical Technology Co Ltd
Strait Access Technologies (Pty) Ltd
Syntach AB
Tau Pnu Medical Co., Ltd.
Tel Aviv Sourasky Medical Center
Tgen Tech LLC
TransCardiac Therapeutics, LLC (Inactive)
Transmural systems LLC
TTK Healthcare Ltd
University of Manitoba
University of South Carolina
Valcare Medical
valsculp
Valtech Cardio Ltd
Vesalius Cardiovascular Inc
Viacor Inc

Table of Contents

1 Table of Contents 3

1.1 List of Tables 7

1.2 List of Figures 13

2 Introduction 14

2.1 Cardiac Valve Repair Devices Overview 14

3 Products under Development 15

3.1 Cardiac Valve Repair Devices – Pipeline Products by Stage of Development 15

3.2 Cardiac Valve Repair Devices – Pipeline Products by Segment 16

3.3 Cardiac Valve Repair Devices – Pipeline Products by Territory 17

3.4 Cardiac Valve Repair Devices – Pipeline Products by Regulatory Path 18

3.5 Cardiac Valve Repair Devices – Pipeline Products by Estimated Approval Date 19

3.6 Cardiac Valve Repair Devices – Ongoing Clinical Trials 20

4 Cardiac Valve Repair Devices – Pipeline Products under Development by Companies 21

4.1 Cardiac Valve Repair Devices Companies – Pipeline Products by Stage of Development 21

4.2 Cardiac Valve Repair Devices – Pipeline Products by Stage of Development 24

5 Cardiac Valve Repair Devices Companies and Product Overview 27

5.1 4Tech Cardio Ireland Ltd Company Overview 27

5.1.1 4Tech Cardio Ireland Ltd Pipeline Products & Ongoing Clinical Trials Overview 27

5.2 Affluent Medical SASU Company Overview 30

5.2.1 Affluent Medical SASU Pipeline Products & Ongoing Clinical Trials Overview 30

5.3 Ample Medical Inc Company Overview 31

5.3.1 Ample Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 31

5.4 Anchorvalve Company Overview 32

5.4.1 Anchorvalve Pipeline Products & Ongoing Clinical Trials Overview 32

5.5 Ancora Heart Inc Company Overview 34

5.5.1 Ancora Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 34

5.6 Approxima Srl Company Overview 37

5.6.1 Approxima Srl Pipeline Products & Ongoing Clinical Trials Overview 37

5.7 Asan Medical Center Company Overview 38

5.7.1 Asan Medical Center Pipeline Products & Ongoing Clinical Trials Overview 38

5.8 BioVentrix Inc Company Overview 39

5.8.1 BioVentrix Inc Pipeline Products & Ongoing Clinical Trials Overview 39

5.9 Boston Children’s Hospital Company Overview 42

5.9.1 Boston Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 42

5.10 Boston Scientific Corp Company Overview 44

5.10.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 44

5.11 Cardiac Implants LLC Company Overview 46

5.11.1 Cardiac Implants LLC Pipeline Products & Ongoing Clinical Trials Overview 46

5.12 Cardiosolutions Inc Company Overview 51

5.12.1 Cardiosolutions Inc Pipeline Products & Ongoing Clinical Trials Overview 51

5.13 Cedars-Sinai Medical Center Company Overview 52

5.13.1 Cedars-Sinai Medical Center Pipeline Products & Ongoing Clinical Trials Overview 52

5.14 Celyad Oncology SA Company Overview 53

5.14.1 Celyad Oncology SA Pipeline Products & Ongoing Clinical Trials Overview 53

5.15 Collplant Biotechnologies Ltd Company Overview 55

5.15.1 Collplant Biotechnologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 55

5.16 Columbia University Company Overview 56

5.16.1 Columbia University Pipeline Products & Ongoing Clinical Trials Overview 56

5.17 ConKay Medical Systems Inc Company Overview 57

5.17.1 ConKay Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 57

5.18 CoreMedic AG Company Overview 58

5.18.1 CoreMedic AG Pipeline Products & Ongoing Clinical Trials Overview 58

5.19 CUBE SRL Company Overview 61

5.19.1 CUBE SRL Pipeline Products & Ongoing Clinical Trials Overview 61

5.20 Edwards Lifesciences Corp Company Overview 62

5.20.1 Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 62

5.21 Emory University Company Overview 68

5.21.1 Emory University Pipeline Products & Ongoing Clinical Trials Overview 68

5.22 Georgia Institute of Technology Company Overview 69

5.22.1 Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 69

5.23 Hangzhou DeJin Medtech Co Ltd Company Overview 70

5.23.1 Hangzhou DeJin Medtech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 70

5.24 Hanxin Medical Technology (Shenzhen) Co Ltd Company Overview 72

5.24.1 Hanxin Medical Technology (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 72

5.25 Harpoon Medical Inc Company Overview 75

5.25.1 Harpoon Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 75

5.26 HVR Cardio Oy Company Overview 78

5.26.1 HVR Cardio Oy Pipeline Products & Ongoing Clinical Trials Overview 78

5.27 Kardium Inc Company Overview 80

5.27.1 Kardium Inc Pipeline Products & Ongoing Clinical Trials Overview 80

5.28 Kekai Life Sciences Company Overview 81

5.28.1 Kekai Life Sciences Pipeline Products & Ongoing Clinical Trials Overview 81

5.29 Lepu Medical Technology (Beijing) Co Ltd Company Overview 83

5.29.1 Lepu Medical Technology (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 83

5.30 LuSeed Vascular Company Overview 87

5.30.1 LuSeed Vascular Pipeline Products & Ongoing Clinical Trials Overview 87

5.31 Mardil Medical, Inc. Company Overview 88

5.31.1 Mardil Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 88

5.32 Mayo Clinic Company Overview 89

5.32.1 Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 89

5.33 Meacor Inc Company Overview 90

5.33.1 Meacor Inc Pipeline Products & Ongoing Clinical Trials Overview 90

5.34 Medical University of Vienna Company Overview 91

5.34.1 Medical University of Vienna Pipeline Products & Ongoing Clinical Trials Overview 91

5.35 Meril Life Sciences Pvt Ltd Company Overview 92

5.35.1 Meril Life Sciences Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 92

5.36 MiCardia Corp Company Overview 93

5.36.1 MiCardia Corp Pipeline Products & Ongoing Clinical Trials Overview 93

5.37 Michigan Critical Care Consultants Inc Company Overview 94

5.37.1 Michigan Critical Care Consultants Inc Pipeline Products & Ongoing Clinical Trials Overview 94

5.38 Micro Interventional Devices, Inc. Company Overview 95

5.38.1 Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 95

5.39 MicroPort CardioFlow Medtech Corp Company Overview 97

5.39.1 MicroPort CardioFlow Medtech Corp Pipeline Products & Ongoing Clinical Trials Overview 97

5.40 Millipede LLC Company Overview 98

5.40.1 Millipede LLC Pipeline Products & Ongoing Clinical Trials Overview 98

5.41 Mitral Print Inc Company Overview 99

5.41.1 Mitral Print Inc Pipeline Products & Ongoing Clinical Trials Overview 99

5.42 Mitralflex Sarl Company Overview 100

5.42.1 Mitralflex Sarl Pipeline Products & Ongoing Clinical Trials Overview 100

5.43 Mitralign Inc Company Overview 101

5.43.1 Mitralign Inc Pipeline Products & Ongoing Clinical Trials Overview 101

5.44 Mitre Medical Corp Company Overview 104

5.44.1 Mitre Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 104

5.45 MVRx, Inc. Company Overview 108

5.45.1 MVRx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 108

5.46 Occlufit AG Company Overview 109

5.46.1 Occlufit AG Pipeline Products & Ongoing Clinical Trials Overview 109

5.47 P+F Products + Features GmbH Company Overview 110

5.47.1 P+F Products + Features GmbH Pipeline Products & Ongoing Clinical Trials Overview 110

5.48 Pi-Cardia Ltd Company Overview 111

5.48.1 Pi-Cardia Ltd Pipeline Products & Ongoing Clinical Trials Overview 111

5.49 Rambam Health Care Campus Company Overview 112

5.49.1 Rambam Health Care Campus Pipeline Products & Ongoing Clinical Trials Overview 112

5.50 SCR, Inc. Company Overview 113

5.50.1 SCR, Inc. Pipeline Products & Ongoing Clinical Trials Overview 113

5.51 Shanghai Shenqi Medical Technology Co Ltd Company Overview 114

5.51.1 Shanghai Shenqi Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 114

5.52 Strait Access Technologies (Pty) Ltd Company Overview 115

5.52.1 Strait Access Technologies (Pty) Ltd Pipeline Products & Ongoing Clinical Trials Overview 115

5.53 Syntach AB Company Overview 116

5.53.1 Syntach AB Pipeline Products & Ongoing Clinical Trials Overview 116

5.54 Tau Pnu Medical Co., Ltd. Company Overview 117

5.54.1 Tau Pnu Medical Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 117

5.55 Tel Aviv Sourasky Medical Center Company Overview 118

5.55.1 Tel Aviv Sourasky Medical Center Pipeline Products & Ongoing Clinical Trials Overview 118

5.56 Tgen Tech LLC Company Overview 119

5.56.1 Tgen Tech LLC Pipeline Products & Ongoing Clinical Trials Overview 119

5.57 TransCardiac Therapeutics, LLC (Inactive) Company Overview 120

5.57.1 TransCardiac Therapeutics, LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 120

5.58 Transmural systems LLC Company Overview 121

5.58.1 Transmural systems LLC Pipeline Products & Ongoing Clinical Trials Overview 121

5.59 TTK Healthcare Ltd Company Overview 124

5.59.1 TTK Healthcare Ltd Pipeline Products & Ongoing Clinical Trials Overview 124

5.60 University of Manitoba Company Overview 125

5.60.1 University of Manitoba Pipeline Products & Ongoing Clinical Trials Overview 125

5.61 University of South Carolina Company Overview 126

5.61.1 University of South Carolina Pipeline Products & Ongoing Clinical Trials Overview 126

5.62 Valcare Medical Company Overview 127

5.62.1 Valcare Medical Pipeline Products & Ongoing Clinical Trials Overview 127

5.63 valsculp Company Overview 129

5.63.1 valsculp Pipeline Products & Ongoing Clinical Trials Overview 129

5.64 Valtech Cardio Ltd Company Overview 130

5.64.1 Valtech Cardio Ltd Pipeline Products & Ongoing Clinical Trials Overview 130

5.65 Vesalius Cardiovascular Inc Company Overview 135

5.65.1 Vesalius Cardiovascular Inc Pipeline Products & Ongoing Clinical Trials Overview 135

5.66 Viacor Inc Company Overview 136

5.66.1 Viacor Inc Pipeline Products & Ongoing Clinical Trials Overview 136

6 Cardiac Valve Repair Devices- Recent Developments 137

6.1 Apr 25, 2024: Edwards Lifesciences Reports First Quarter Results 137

6.2 Apr 24, 2024: Medtronic Names Yarmela Pavlovic as Chief Regulatory Officer 138

6.3 Apr 22, 2024: Genesee BioMedical Receives FDA 510(k) Clearance for TransForm McCarthy Mitral Annuloplasty Ring (TF) 138

6.4 Apr 17, 2024: Annoviant wins $2.9m NIH grant for paediatric heart conduits 139

6.5 Apr 15, 2024: Edwards Lifesciences Appoints New China Head 139

6.6 Apr 08, 2024: Cardiology Team Performs Novel Heart Valve Repair with Newly Approved Device 139

6.7 Mar 29, 2024: MicroPort CardioFlow Medtech Full Year 2023 Earnings 140

6.8 Mar 12, 2024: Medtronic To Present At Barclays Global Healthcare Conference 141

6.9 Feb 23, 2024: Edwards Lifesciences to Present at the 44th Annual TD Cowen Healthcare Conference 141

6.10 Feb 22, 2024: NeoChord Appoints New Chief Executive Officer to Lead Commercialization Efforts and Study Novel First-Line Therapy for Mitral Valve Regurgitation 141

6.11 Feb 16, 2024: Jim Robo, Former Chairman and CEO of NextEra Energy, to Join Mayo Clinic Board of Trustees 141

6.12 Feb 14, 2024: AMC Professor Joon Bum Kim invited to lecture at Stanford Medicine, USA 142

6.13 Jan 15, 2024: Affluent Medical : Pre-submission Dossier for the 510(K) of Medical Device Kaliostm Filed With FDA for Review 142

6.14 Oct 18, 2023: Edwards Lifesciences to Host Earnings Conference Call on October 25, 2023 143

6.15 Oct 04, 2023: Medtronic Names Paolo Di Vincenzo President of the Neuromodulation Business 143

6.16 Sep 13, 2023: Affluent Medical announces positive clinical results and further insights to enhance its strategy on Structural Heart activities 144

6.17 Aug 29, 2023: MicroPort CardioFlow Medtech Corp. Announces Change of Directors and Chairman 146

6.18 Aug 29, 2023: Microport Cardioflow Medtech Announces Change of Directors and Chairman 148

6.19 Aug 28, 2023: Edwards Lifesciences to Present at the 2023 Wells Fargo Healthcare Conference 148

6.20 Aug 26, 2023: Medtronic Q2 2024 Earnings Estimates Increased by William Blair 148

6.21 Aug 24, 2023: CollPlant Biotechnologies Announces Second Quarter Financial Results For 2023 with Revenues of $10.2 Million 149

6.22 Aug 17, 2023: Mayo Clinic Reports Strong Finances for 2023 So Far with Q2 Revenue of $4.47 billion 152

6.23 Aug 11, 2023: Kristin Peck, CEO of Zoetis, to join Mayo Clinic Board of Trustees 152

6.24 Aug 09, 2023: Collplant Biotechnologies Announces Date for 2023 Second Quarter Financial Results and Conference Call Information 153

6.25 Aug 08, 2023: Medtronic to Announce Financial Results for its First Quarter of Fiscal Year 2024 153

6.26 Jun 15, 2023: Genesee BioMedical Receives 510(k) Clearance for WellsForm Tricuspid Annuloplasty Band (WF) 154

6.27 May 24, 2023: CollPlant Biotechnologies announces first quarter financial results for 2023 and provides corporate update 154

6.28 May 23, 2023: Study: Transcatheter Mitral Valve Repair Safe, Successful 156

7 Appendix 158

7.1 Methodology 158

7.2 About GlobalData 161

7.3 Contact Us 161

7.4 Disclaimer 161

Table

Cardiac Valve Repair Devices – Pipeline Products by Stage of Development 15

Cardiac Valve Repair Devices – Pipeline Products by Segment 16

Cardiac Valve Repair Devices – Pipeline Products by Territory 17

Cardiac Valve Repair Devices – Pipeline Products by Regulatory Path 18

Cardiac Valve Repair Devices – Pipeline Products by Estimated Approval Date 19

Cardiac Valve Repair Devices – Ongoing Clinical Trials 20

Cardiac Valve Repair Devices Companies – Pipeline Products by Stage of Development 21

Cardiac Valve Repair Devices – Pipeline Products by Stage of Development 24

4Tech Cardio Ireland Ltd Pipeline Products & Ongoing Clinical Trials Overview 27

TriCinch Coil Tricuspid Valve Repair System – Product Status 27

TriCinch Coil Tricuspid Valve Repair System – Product Description 27

4Tech Cardio Ireland Ltd – Ongoing Clinical Trials Overview 28

TriCinch Coil Tricuspid Valve Repair System – Early Feasibility Study of TriCinch Coil Tricuspid Valve Repair System 29

TriCinch Coil Tricuspid Valve Repair System – International Multisite Transcatheter Tricuspid Valve Therapies Registry 29

Affluent Medical SASU Pipeline Products & Ongoing Clinical Trials Overview 30

Kalios – Product Status 30

Kalios – Product Description 30

Ample Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 31

PS3 System – Product Status 31

PS3 System – Product Description 31

Anchorvalve Pipeline Products & Ongoing Clinical Trials Overview 32

Sutureless Mitral Valve Repair Ring – Product Status 32

Sutureless Mitral Valve Repair Ring – Product Description 32

Sutureless Tricuspid Valve Repair Ring – Product Status 33

Sutureless Tricuspid Valve Repair Ring – Product Description 33

Ancora Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 34

AccuCinch Ventricular Restoration System – Product Status 34

AccuCinch Ventricular Restoration System – Product Description 34

Ancora Heart Inc – Ongoing Clinical Trials Overview 35

AccuCinch Ventricular Restoration System – Randomized Clinical Evaluation of the AccuCinch Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study 36

AccuCinch Ventricular Restoration System – Safety and Performance Evaluation of the AccuCinch Ventricular Repair System for Functional Mitral Regurgitation Due to Dilated Ischemic or Non-Ischemic Cardiomyopathy – The CorCinch-EU Study 36

Approxima Srl Pipeline Products & Ongoing Clinical Trials Overview 37

Tricuspid Valve Repair System – Product Status 37

Tricuspid Valve Repair System – Product Description 37

Asan Medical Center Pipeline Products & Ongoing Clinical Trials Overview 38

3D Ring – Product Status 38

3D Ring – Product Description 38

BioVentrix Inc Pipeline Products & Ongoing Clinical Trials Overview 39

Revivent-TC System – Product Status 39

Revivent-TC System – Product Description 39

BioVentrix Inc – Ongoing Clinical Trials Overview 40

Revivent-TC System – Clinical Study of the BioVentrix Revivent TC System for Treatment of Left Ventricular Aneurysms ALIVE-EA (American Less Invasive Ventricular Enhancement-Expanded Access) 41

Revivent-TC System – Clinical Study of the BioVentrix Revivent TC System for Treatment of Left Ventricular Aneurysms: ALIVE 41

Revivent-TC System – Randomized Evaluation and Verification of Ventricular Enhancement: The REVIVE-HF Study 41

Boston Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 42

Endovascular Prosthesis – Product Status 42

Endovascular Prosthesis – Product Description 42

Mitral Valve Repair Clip – Product Status 43

Mitral Valve Repair Clip – Product Description 43

Tricuspid Valve Repair Device – Product Status 43

Tricuspid Valve Repair Device – Product Description 43

Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 44

Millipede Percutaneous Annuloplasty Ring – Product Status 44

Millipede Percutaneous Annuloplasty Ring – Product Description 45

Cardiac Implants LLC Pipeline Products & Ongoing Clinical Trials Overview 46

DaVingiTR System – Product Status 46

DaVingiTR System – Product Description 46

Ring Annuloplasty Device – Product Status 47

Ring Annuloplasty Device – Product Description 47

Tri-Ring Device – Product Status 47

Tri-Ring Device – Product Description 48

Cardiac Implants LLC – Ongoing Clinical Trials Overview 49

DaVingiTR System – Early Feasibility Study (EFS) of the Cardiac Implants Percutaneous Ring Annuloplasty System for the Treatment of Functional Tricuspid Regurgitation 50

Cardiosolutions Inc Pipeline Products & Ongoing Clinical Trials Overview 51

Mitra-Spacer – Product Status 51

Mitra-Spacer – Product Description 51

Cedars-Sinai Medical Center Pipeline Products & Ongoing Clinical Trials Overview 52

Percutaneous Tricuspid Valve Repair Device – Product Status 52

Percutaneous Tricuspid Valve Repair Device – Product Description 52

Celyad Oncology SA Pipeline Products & Ongoing Clinical Trials Overview 53

Heart Access Sheath – Mitral Valve Repair – Product Status 53

Heart Access Sheath – Mitral Valve Repair – Product Description 53

Mitral Valve Neo-chordae – Product Status 54

Mitral Valve Neo-chordae – Product Description 54

Collplant Biotechnologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 55

Vergenix HVR – Product Status 55

Vergenix HVR – Product Description 55

Columbia University Pipeline Products & Ongoing Clinical Trials Overview 56

Hybrid Regenerative Prosthetic Heart Valve – Product Status 56

Hybrid Regenerative Prosthetic Heart Valve – Product Description 56

ConKay Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 57

Valvular Regurgitation Treatment Device – Product Status 57

Valvular Regurgitation Treatment Device – Product Description 57

CoreMedic AG Pipeline Products & Ongoing Clinical Trials Overview 58

ChordArt – Product Status 58

ChordArt – Product Description 58

CoreMedic AG – Ongoing Clinical Trials Overview 59

ChordArt – Chordart System Study for the Treatment of Mitral Regurgitation Due to Leaflet Prolapse or Flail 60

CUBE SRL Pipeline Products & Ongoing Clinical Trials Overview 61

Mitral-FERCube Ring – Product Status 61

Mitral-FERCube Ring – Product Description 61

Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 62

Coapsys – Product Status 62

Coapsys – Product Description 62

MOBIUS Leaflet Repair System – Product Status 63

MOBIUS Leaflet Repair System – Product Description 63

PASCAL Transcatheter Tricuspid Valve Repair System – Product Status 63

PASCAL Transcatheter Tricuspid Valve Repair System – Product Description 64

Edwards Lifesciences Corp – Ongoing Clinical Trials Overview 65

PASCAL Transcatheter Tricuspid Valve Repair System – A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair with the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients with Tricuspid Regurgitation 66

PASCAL Transcatheter Tricuspid Valve Repair System – Edwards PASCAL Transcatheter Valve Repair System Registry: A Multicenter Observational Registry with the Edwards PASCAL Transcatheter Valve Repair System 66

PASCAL Transcatheter Tricuspid Valve Repair System – Evaluation of the Safety, Efficacy and Cost-effectiveness of Transcatheter Tricuspid Valve Repair in Patients With Severe Tricuspid Regurgitation in the Netherlands. 66

PASCAL Transcatheter Tricuspid Valve Repair System – PASTE: PASCAL for Tricuspid Regurgitation – A European Registry 67

PASCAL Transcatheter Tricuspid Valve Repair System – Transcatheter Repair of Tricuspid Regurgitation with Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post-market Clinical Follow up 67

Emory University Pipeline Products & Ongoing Clinical Trials Overview 68

MitraSurg – Product Status 68

MitraSurg – Product Description 68

Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 69

Tricuspid Annuloplasty Ring – Product Status 69

Tricuspid Annuloplasty Ring – Product Description 69

Hangzhou DeJin Medtech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 70

Second Generation Mitral Valve Repair Device – Product Status 70

Second Generation Mitral Valve Repair Device – Product Description 70

Tricuspid Repair Device – Product Status 71

Tricuspid Repair Device – Product Description 71

Hanxin Medical Technology (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 72

Mitral Valve Tendon Repair System – Product Status 72

Mitral Valve Tendon Repair System – Product Description 72

Hanxin Medical Technology (Shenzhen) Co Ltd – Ongoing Clinical Trials Overview 73

Mitral Valve Tendon Repair System – A Prospective, Multicentre, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of an Interventional Mitral Chordae Tendineae Repair System for the Treatment of Mitral Regurgitation 74

Mitral Valve Tendon Repair System – Clinical Trial to Evaluate the Safety and Efficacy of an Interventional Mitral Valve Tendon Repair System for the Treatment of Mitral Regurgitation 74

Mitral Valve Tendon Repair System – Clinical Trial to Evaluate the Safety and Efficacy of an Interventional Mitral Valve Tendon Repair System for the Treatment of Mitral Regurgitation 74

Harpoon Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 75

HARPOON Beating Heart Mitral Valve Repair System – Product Status 75

HARPOON Beating Heart Mitral Valve Repair System – Product Description 75

Harpoon Medical Inc – Ongoing Clinical Trials Overview 76

HARPOON Beating Heart Mitral Valve Repair System – A Prospective, Multi-center Trial to Evaluate the Safety and Effectiveness of Beating Heart Mitral Valve Repair with the HARPOON System (RESTORE) 77

HVR Cardio Oy Pipeline Products & Ongoing Clinical Trials Overview 78

CathHELIX – Product Status 78

CathHELIX – Product Description 78

Medtentia Annuloplasty Ring (MAR) – Product Status 79

Medtentia Annuloplasty Ring (MAR) – Product Description 79

Kardium Inc Pipeline Products & Ongoing Clinical Trials Overview 80

Percutaneous Mitral Valve Regurgitation Device – Product Status 80

Percutaneous Mitral Valve Regurgitation Device – Product Description 80

Kekai Life Sciences Pipeline Products & Ongoing Clinical Trials Overview 81

FlexClamp – Product Status 81

FlexClamp – Product Description 81

FlexClip – Product Status 82

FlexClip – Product Description 82

SuperClip – Product Status 82

SuperClip – Product Description 82

Lepu Medical Technology (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 83

MemoChord Transapical Mitral Valve Repair System (Chordal) – Product Status 83

MemoChord Transapical Mitral Valve Repair System (Chordal) – Product Description 84

MemoClamp Transcatheter Tricuspid Valve Repair System – Product Status 84

MemoClamp Transcatheter Tricuspid Valve Repair System – Product Description 84

Transapical Mitral Valve Clip Repair System – Product Status 85

Transapical Mitral Valve Clip Repair System – Product Description 85

Transcatheter Papillary Muscle Repair System – Product Status 85

Transcatheter Papillary Muscle Repair System – Product Description 86

Transfemoral Mitral Valve Clip Repair System – Product Status 86

Transfemoral Mitral Valve Clip Repair System – Product Description 86

LuSeed Vascular Pipeline Products & Ongoing Clinical Trials Overview 87

LuSeed Intrasaccular Device – Heart Valve Insufficiency – Product Status 87

LuSeed Intrasaccular Device – Heart Valve Insufficiency – Product Description 87

Mardil Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 88

VenTouch Triad Targeted Ventricular Reshaping System – Product Status 88

VenTouch Triad Targeted Ventricular Reshaping System – Product Description 88

Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 89

Catheter-Based Mitral Valve Repair Device – Product Status 89

Catheter-Based Mitral Valve Repair Device – Product Description 89

Meacor Inc Pipeline Products & Ongoing Clinical Trials Overview 90

CryoCinch – Product Status 90

CryoCinch – Product Description 90

Medical University of Vienna Pipeline Products & Ongoing Clinical Trials Overview 91

Degradable Annuloplasty Ring – Product Status 91

Degradable Annuloplasty Ring – Product Description 91

Meril Life Sciences Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 92

CALIX-R – Product Status 92

CALIX-R – Product Description 92

MiCardia Corp Pipeline Products & Ongoing Clinical Trials Overview 93

enCorTC – Product Status 93

enCorTC – Product Description 93

Michigan Critical Care Consultants Inc Pipeline Products & Ongoing Clinical Trials Overview 94

Percutaneous Mitral Annuloplasty Ring – Product Status 94

Percutaneous Mitral Annuloplasty Ring – Product Description 94

Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 95

MIA System – Mitral Valve Repair – Product Status 95

MIA System – Mitral Valve Repair – Product Description 95

MIA-T Percutaneous Tricuspid Annuloplasty System – Product Status 96

MIA-T Percutaneous Tricuspid Annuloplasty System – Product Description 96

MicroPort CardioFlow Medtech Corp Pipeline Products & Ongoing Clinical Trials Overview 97

Edge To Edge Tricuspid Valve Repair Device – Product Status 97

Edge To Edge Tricuspid Valve Repair Device – Product Description 97

Millipede LLC Pipeline Products & Ongoing Clinical Trials Overview 98

IRIS Transcatheter Annuloplasty Ring – Product Status 98

IRIS Transcatheter Annuloplasty Ring – Product Description 98

Mitral Print Inc Pipeline Products & Ongoing Clinical Trials Overview 99

MitralPrint – Product Status 99

MitralPrint – Product Description 99

Mitralflex Sarl Pipeline Products & Ongoing Clinical Trials Overview 100

Heart Valve Repair Device – Product Status 100

Heart Valve Repair Device – Product Description 100

Mitralign Inc Pipeline Products & Ongoing Clinical Trials Overview 101

Trialign Percutaneous Tricuspid Valve Annuloplasty System – Product Status 101

Trialign Percutaneous Tricuspid Valve Annuloplasty System – Product Description 101

Mitralign Inc – Ongoing Clinical Trials Overview 102

Trialign Percutaneous Tricuspid Valve Annuloplasty System – International Multisite Transcatheter Tricuspid Valve Therapies Registry 103

Mitre Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 104

Mitral Touch – Product Status 104

Mitral Touch – Product Description 104

Next Generation Mitral Touch – Product Status 105

Next Generation Mitral Touch – Product Description 105

Mitre Medical Corp – Ongoing Clinical Trials Overview 106

Mitral Touch – ENRAPT-MR Trial: Epicardial Mitral Repair 107

Mitral Touch – ENRAPTUS Epicardial Mitral Touch System for Mitral Insufficiency 107

MVRx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 108

ARTO System – Product Status 108

ARTO System – Product Description 108

Occlufit AG Pipeline Products & Ongoing Clinical Trials Overview 109

Cardiovascular Occluder Device – Product Status 109

Cardiovascular Occluder Device – Product Description 109

P+F Products + Features GmbH Pipeline Products & Ongoing Clinical Trials Overview 110

Endobental Device – Product Status 110

Endobental Device – Product Description 110

Pi-Cardia Ltd Pipeline Products & Ongoing Clinical Trials Overview 111

ShortCut Mitral Device – Product Status 111

ShortCut Mitral Device – Product Description 111

Rambam Health Care Campus Pipeline Products & Ongoing Clinical Trials Overview 112

Adjustable Annuloplasty Apparatus – Product Status 112

Adjustable Annuloplasty Apparatus – Product Description 112

SCR, Inc. Pipeline Products & Ongoing Clinical Trials Overview 113

Chronic Implantable Counterpulsation Device – Product Status 113

Chronic Implantable Counterpulsation Device – Product Description 113

Shanghai Shenqi Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 114

Qilin System – Product Status 114

Qilin System – Product Description 114

Strait Access Technologies (Pty) Ltd Pipeline Products & Ongoing Clinical Trials Overview 115

Mitral Valve Repair System – Product Status 115

Mitral Valve Repair System – Product Description 115

Syntach AB Pipeline Products & Ongoing Clinical Trials Overview 116

Syntach Mitral Device (MD) – Product Status 116

Syntach Mitral Device (MD) – Product Description 116

Tau Pnu Medical Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 117

Mitral Loop Cerclage – Product Status 117

Mitral Loop Cerclage – Product Description 117

Tel Aviv Sourasky Medical Center Pipeline Products & Ongoing Clinical Trials Overview 118

Mitral Valve Implantation Device – Product Status 118

Mitral Valve Implantation Device – Product Description 118

Tgen Tech LLC Pipeline Products & Ongoing Clinical Trials Overview 119

TxGuard-LP – Product Status 119

TxGuard-LP – Product Description 119

TransCardiac Therapeutics, LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 120

MitraFlex – Product Status 120

MitraFlex – Product Description 120

Transmural systems LLC Pipeline Products & Ongoing Clinical Trials Overview 121

MIRTH Device – Product Status 121

MIRTH Device – Product Description 121

SCIMITAR Device – Product Status 122

SCIMITAR Device – Product Description 122

Transmural Cerclage – Product Status 122

Transmural Cerclage – Product Description 123

TTK Healthcare Ltd Pipeline Products & Ongoing Clinical Trials Overview 124

Mitral Annuloplasty Ring – Product Status 124

Mitral Annuloplasty Ring – Product Description 124

University of Manitoba Pipeline Products & Ongoing Clinical Trials Overview 125

Aortic Annular System – Product Status 125

Aortic Annular System – Product Description 125

University of South Carolina Pipeline Products & Ongoing Clinical Trials Overview 126

Artificial Myocardium – Product Status 126

Artificial Myocardium – Product Description 126

Valcare Medical Pipeline Products & Ongoing Clinical Trials Overview 127

Amend Mitral Valve Repair System – Product Status 127

Amend Mitral Valve Repair System – Product Description 127

Trivid – Product Status 128

Trivid – Product Description 128

valsculp Pipeline Products & Ongoing Clinical Trials Overview 129

SATAR – Product Status 129

SATAR – Product Description 129

Valtech Cardio Ltd Pipeline Products & Ongoing Clinical Trials Overview 130

Cardinal Adjustable Annuloplasty Ring System – Tricuspid Repair – Product Status 130

Cardinal Adjustable Annuloplasty Ring System – Tricuspid Repair – Product Description 130

Cardioband Direct Access – Product Status 131

Cardioband Direct Access – Product Description 131

Edwards Cardioband Mitral Reconstruction System – Product Status 131

Edwards Cardioband Mitral Reconstruction System – Product Description 132

V-Chordal-Off Pump – Product Status 132

V-Chordal-Off Pump – Product Description 132

Valtech Cardio Ltd – Ongoing Clinical Trials Overview 133

Edwards Cardioband Mitral Reconstruction System – European Registry of Transcatheter Repair for Secondary Mitral Regurgitation 134

Edwards Cardioband Mitral Reconstruction System – Transcatheter Repair of Mitral Regurgitation with Cardioband System Post Market Study: A European Prospective, Multicenter Study to Assess Transcatheter Mitral Valve Repair with Edwards Cardioband System in Patients with Symptomatic MR 134

Vesalius Cardiovascular Inc Pipeline Products & Ongoing Clinical Trials Overview 135

Calla Mitral Valve Repair System – Product Status 135

Calla Mitral Valve Repair System – Product Description 135

Viacor Inc Pipeline Products & Ongoing Clinical Trials Overview 136

PTMA System – Product Status 136

PTMA System – Product Description 136

Glossary 160

Figures

Cardiac Valve Repair Devices – Pipeline Products by Stage of Development 14

Cardiac Valve Repair Devices – Pipeline Products by Segment 15

Cardiac Valve Repair Devices – Pipeline Products by Territory 16

Cardiac Valve Repair Devices – Pipeline Products by Regulatory Path 17

Cardiac Valve Repair Devices – Pipeline Products by Estimated Approval Date 18

Cardiac Valve Repair Devices – Ongoing Clinical Trials 19

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