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

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Cardiac Valve Repair Pipeline Product Market

Cardiac valve repair devices are used in Open-Heart surgery to repair malfunctioning valves. Only mitral valve repair has been covered in this report. 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 model can be used to repair both the mitral and tricuspid valves.

The cardiac valve repair devices pipeline market research report provides comprehensive information about the Cardiac valve repair devices pipeline products with a comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

Cardiac Valve Repair Devices Pipeline Products Market Segmentation by Territories

Some of the key territories with products in the pipeline are the US, Europe, China, Canada, Israel, Japan, South Africa, the United Kingdom, Australia, and India. The US led the cardiac valve repair devices pipeline products market as of February 2023.

Cardiac valve repair devices Pipeline Products Market Analysis by Territories, 2023 (%)

Cardiac valve repair devices Pipeline Products Market Analysis by Territories, 2023 (%)

For more territory insights into the cardiac valve repair devices pipeline products market, download a free report sample

Cardiac Valve Repair Devices Pipeline Products Market Segmentation by Regulatory Paths

The key regulatory paths in the cardiac valve repair devices pipeline report are PMA, CE, NMPA, 510(k), MDL, Shonin, TGA, UKCA, Ninsho, and ICAC. Most of the products follow the PMA regulatory pathway to enter the market.

Cardiac valve repair devices Pipeline Products Market Analysis by Regulatory Paths, 2023 (%)

Cardiac valve repair devices Pipeline Products Market Analysis by Regulatory Paths, 2023 (%)

For more regulatory path insights into the cardiac valve repair devices pipeline products market, download a free report sample

Cardiac Valve Repair Devices Pipeline Products Market - Competitive Landscape

Some of the leading companies in the cardiac valve repair devices pipeline products market are Affluent Medical SASU, Ample Medical Inc, Boston Scientific Corp, CUBE SRL, Kardium Inc, Mayo Clinic, Syntach AB, Valtech Cardio Ltd, Vesalius Cardiovascular Inc, and Viacor Inc among others.

Ample Medical Inc: Headquartered in Florida, USA, Ample Medical treats vascular heart disease and congestive heart failure.

Boston Scientific Corp: Boston Scientific is a medical technology company that is involved in the development, manufacturing, and commercialization of devices for a range of interventional medical specialties. The company offers products in the areas of electrophysiology, gastroenterology, gastrointestinal surgery, female pelvic medicine, gynecology, interventional cardiology, interventional radiology, neurological surgery, orthopedic surgery, pain medicine, pulmonology, urology and vascular surgery. Boston Scientific serves hospitals, clinics, outpatient facilities and medical offices across the world.

For more insights on the key companies of cardiac valve repair devices pipeline products market, download a free sample report

Cardiac Valve Repair Devices Pipeline Products Market Report Overview

Key Territories The US, Europe, China, Canada, Israel, Japan, South Africa, the United Kingdom, Australia, India, and others
Key Regulatory Paths PMA, CE, NMPA, 510(k), MDL, Shonin, TGA, UKCA, Ninsho, and ICAC.
Leading Companies Affluent Medical SASU, Ample Medical Inc, Boston Scientific Corp, CUBE SRL, Kardium Inc, Mayo Clinic, Syntach AB, Valtech Cardio Ltd, Vesalius Cardiovascular Inc, and Viacor Inc

Segments Covered in the Report 

Cardiac Valve Repair Devices Pipeline Products Territorial Outlook (Number of Products, 2023)

  • United States
  • Europe
  • China
  • Global
  • Canada
  • Israel
  • Japan
  • South Africa
  • United Kingdom
  • Australia
  • India 

Cardiac Valve Repair Devices Pipeline Products Regulatory Paths Outlook (Number of Products, 2023) 

  • PMA
  • CE
  • NMPA
  • 510(k)
  • MDL
  • Shonin
  • TGA
  • UKCA
  • Ninsho
  • ICAC

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 is based on various stages of development ranging from early development to the approved/issued stage
  • The report provides key clinical trial data of ongoing trials specific to pipeline products
  • Recent developments in the segment/industry

Reasons to Buy

The report enables you to:

  • Formulate significant competitor information, analysis, and insights to improve R&D strategies
  • Identify emerging players with potentially strong product portfolios and create effective counter strategies to gain a competitive advantage
  • Identify and understand important and diverse types of 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

Affluent Medical SASU
Ample Medical Inc
Anchorvalve
Ancora Heart Inc
Boston Children's Hospital
Boston Scientific Corp
Cardiac Implants LLC
Cardiosolutions Inc
Celyad Oncology SA
Collplant Biotechnologies Ltd
ConKay Medical Systems Inc
CoreMedic AG
CUBE SRL
Edwards Lifesciences Corp
Emory University
Georgia Institute of Technology
Hangzhou DeJin Medtech Co Ltd
Harpoon Medical, Inc.
Kardium Inc
Kekai Life Sciences
Lepu Medical Technology (Beijing) Co Ltd
LuSeed Vascular
Mardil Medical, Inc.
Mayo Clinic
Meril Life Sciences Pvt Ltd
MiCardia Corp
Michigan Critical Care Consultants Inc
Micro Interventional Devices, Inc.
Millipede LLC
Mitralign Inc
Mitre Medical Corp
MVRx, Inc.
P+F Products + Features GmbH
Rambam Health Care Campus
Shanghai Shenqi Medical Technology Co Ltd
Strait Access Technologies (Pty) Ltd
Syntach AB
Tel Aviv Sourasky Medical Center
Tgen Tech LLC
TransCardiac Therapeutics, LLC
Transmural systems LLC
TTK Healthcare Ltd
University of Manitoba
Valcare Medical
valsculp
Valtech Cardio Ltd
Vesalius Cardiovascular Inc
Viacor Inc

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 6

|1.2 List of Figures 11

2 Introduction 12

2.1 Cardiac Valve Repair Devices Overview 12

3 Products under Development 13

3.1 Cardiac Valve Repair Devices – Pipeline Products by Stage of Development 13

3.2 Cardiac Valve Repair Devices – Pipeline Products by Segment 14

3.3 Cardiac Valve Repair Devices – Pipeline Products by Territory 15

3.4 Cardiac Valve Repair Devices – Pipeline Products by Regulatory Path 16

3.5 Cardiac Valve Repair Devices – Pipeline Products by Estimated Approval Date 17

3.6 Cardiac Valve Repair Devices – Ongoing Clinical Trials 18

4 Cardiac Valve Repair Devices – Pipeline Products under Development by Companies 19

4.1 Cardiac Valve Repair Devices Companies – Pipeline Products by Stage of Development 19

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

5 Cardiac Valve Repair Devices Companies and Product Overview 23

5.1 Affluent Medical SASU Company Overview 23

5.1.1 Affluent Medical SASU Pipeline Products & Ongoing Clinical Trials Overview 23

5.2 Ample Medical Inc Company Overview 26

5.2.1 Ample Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 26

5.3 Anchorvalve Company Overview 27

5.3.1 Anchorvalve Pipeline Products & Ongoing Clinical Trials Overview 27

5.4 Ancora Heart Inc Company Overview 29

5.4.1 Ancora Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 29

5.5 Boston Children’s Hospital Company Overview 33

5.5.1 Boston Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 33

5.6 Boston Scientific Corp Company Overview 36

5.6.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 36

5.7 Cardiac Implants LLC Company Overview 37

5.7.1 Cardiac Implants LLC Pipeline Products & Ongoing Clinical Trials Overview 37

5.8 Cardiosolutions Inc Company Overview 39

5.8.1 Cardiosolutions Inc Pipeline Products & Ongoing Clinical Trials Overview 39

5.9 Celyad Oncology SA Company Overview 40

5.9.1 Celyad Oncology SA Pipeline Products & Ongoing Clinical Trials Overview 40

5.10 Collplant Biotechnologies Ltd Company Overview 42

5.10.1 Collplant Biotechnologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 42

5.11 ConKay Medical Systems Inc Company Overview 43

5.11.1 ConKay Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 43

5.12 CoreMedic AG Company Overview 44

5.12.1 CoreMedic AG Pipeline Products & Ongoing Clinical Trials Overview 44

5.13 CUBE SRL Company Overview 47

5.13.1 CUBE SRL Pipeline Products & Ongoing Clinical Trials Overview 47

5.14 Edwards Lifesciences Corp Company Overview 48

5.14.1 Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 48

5.15 Emory University Company Overview 54

5.15.1 Emory University Pipeline Products & Ongoing Clinical Trials Overview 54

5.16 Georgia Institute of Technology Company Overview 55

5.16.1 Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 55

5.17 Hangzhou DeJin Medtech Co Ltd Company Overview 56

5.17.1 Hangzhou DeJin Medtech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 56

5.18 Harpoon Medical, Inc. Company Overview 58

5.18.1 Harpoon Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 58

5.19 Kardium Inc Company Overview 61

5.19.1 Kardium Inc Pipeline Products & Ongoing Clinical Trials Overview 61

5.20 Kekai Life Sciences Company Overview 62

5.20.1 Kekai Life Sciences Pipeline Products & Ongoing Clinical Trials Overview 62

5.21 Lepu Medical Technology (Beijing) Co Ltd Company Overview 64

5.21.1 Lepu Medical Technology (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 64

5.22 LuSeed Vascular Company Overview 68

5.22.1 LuSeed Vascular Pipeline Products & Ongoing Clinical Trials Overview 68

5.23 Mardil Medical, Inc. Company Overview 69

5.23.1 Mardil Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 69

5.24 Mayo Clinic Company Overview 72

5.24.1 Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 72

5.25 Meril Life Sciences Pvt Ltd Company Overview 73

5.25.1 Meril Life Sciences Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 73

5.26 MiCardia Corp Company Overview 74

5.26.1 MiCardia Corp Pipeline Products & Ongoing Clinical Trials Overview 74

5.27 Michigan Critical Care Consultants Inc Company Overview 75

5.27.1 Michigan Critical Care Consultants Inc Pipeline Products & Ongoing Clinical Trials Overview 75

5.28 Micro Interventional Devices, Inc. Company Overview 76

5.28.1 Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 76

5.29 Millipede LLC Company Overview 80

5.29.1 Millipede LLC Pipeline Products & Ongoing Clinical Trials Overview 80

5.30 Mitralign Inc Company Overview 83

5.30.1 Mitralign Inc Pipeline Products & Ongoing Clinical Trials Overview 83

5.31 Mitre Medical Corp Company Overview 86

5.31.1 Mitre Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 86

5.32 MVRx, Inc. Company Overview 90

5.32.1 MVRx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 90

5.33 P+F Products + Features GmbH Company Overview 93

5.33.1 P+F Products + Features GmbH Pipeline Products & Ongoing Clinical Trials Overview 93

5.34 Rambam Health Care Campus Company Overview 94

5.34.1 Rambam Health Care Campus Pipeline Products & Ongoing Clinical Trials Overview 94

5.35 Shanghai Shenqi Medical Technology Co Ltd Company Overview 95

5.35.1 Shanghai Shenqi Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 95

5.36 Strait Access Technologies (Pty) Ltd Company Overview 96

5.36.1 Strait Access Technologies (Pty) Ltd Pipeline Products & Ongoing Clinical Trials Overview 96

5.37 Syntach AB Company Overview 97

5.37.1 Syntach AB Pipeline Products & Ongoing Clinical Trials Overview 97

5.38 Tel Aviv Sourasky Medical Center Company Overview 98

5.38.1 Tel Aviv Sourasky Medical Center Pipeline Products & Ongoing Clinical Trials Overview 98

5.39 Tgen Tech LLC Company Overview 99

5.39.1 Tgen Tech LLC Pipeline Products & Ongoing Clinical Trials Overview 99

5.40 TransCardiac Therapeutics, LLC Company Overview 100

5.40.1 TransCardiac Therapeutics, LLC Pipeline Products & Ongoing Clinical Trials Overview 100

5.41 Transmural systems LLC Company Overview 101

5.41.1 Transmural systems LLC Pipeline Products & Ongoing Clinical Trials Overview 101

5.42 TTK Healthcare Ltd Company Overview 106

5.42.1 TTK Healthcare Ltd Pipeline Products & Ongoing Clinical Trials Overview 106

5.43 University of Manitoba Company Overview 107

5.43.1 University of Manitoba Pipeline Products & Ongoing Clinical Trials Overview 107

5.44 Valcare Medical Company Overview 108

5.44.1 Valcare Medical Pipeline Products & Ongoing Clinical Trials Overview 108

5.45 valsculp Company Overview 112

5.45.1 valsculp Pipeline Products & Ongoing Clinical Trials Overview 112

5.46 Valtech Cardio Ltd Company Overview 113

5.46.1 Valtech Cardio Ltd Pipeline Products & Ongoing Clinical Trials Overview 113

5.47 Vesalius Cardiovascular Inc Company Overview 118

5.47.1 Vesalius Cardiovascular Inc Pipeline Products & Ongoing Clinical Trials Overview 118

5.48 Viacor Inc Company Overview 119

5.48.1 Viacor Inc Pipeline Products & Ongoing Clinical Trials Overview 119

6 Cardiac Valve Repair Devices- Recent Developments 120

6.1 Jan 30, 2023: Medtronic appoints Michael Blackwell as India vice-president 120

6.2 Jan 30, 2023: Medtronic India appoints Michael Blackwell as Vice President 120

6.3 Dec 08, 2022: Edwards Lifesciences Announces CEO Succession Plan 120

6.4 Dec 01, 2022: CollPlant Biotechnologies Provides Business Updates and Third Quarter 2022 Financial Results 121

6.5 Nov 23, 2022: Medtronic Reports Quarterly Earnings 123

6.6 Nov 22, 2022: Medtronic reports second quarter fiscal 2023 financial results 123

6.7 Nov 22, 2022: Mayo Clinic surgeon takes the wheel as Kwik Trip’s new CEO 128

6.8 Nov 15, 2022: Medtronic Set to Announce Earnings on Tuesday 129

6.9 Oct 20, 2022: Edwards Lifesciences to Host Earnings Conference Call on October 27, 2022 129

6.10 Sep 30, 2022: Natalie Caine named chief administrative officer at Mayo Clinic in Rochester 129

6.11 Sep 07, 2022: Medtronic to appear at September investor conferences 129

6.12 Sep 06, 2022: Occlutech Appoints Chief Commercial Officer and Vice President Global Business Development & Marketing 129

6.13 Aug 25, 2022: Collplant Biotechnologies Provides Business Updates and Second Quarter 2022 Financial Results 130

6.14 Aug 25, 2022: Atrion Announces CFO Succession Plan 132

6.15 Aug 23, 2022: Medtronic reports first quarter fiscal 2023 financial results 133

6.16 Aug 23, 2022: Medtronic Announces Quarterly Earnings Results 135

6.17 Jul 21, 2022: Edwards Lifesciences to Host Earnings Conference Call on July 28, 2022 138

6.18 Jun 27, 2022: Medtronic Board appoints Lidia Fonseca as a new director 138

6.19 May 27, 2022: Medtronic reports full year and fourth quarter fiscal year 2022 financial results 139

6.20 May 26, 2022: CollPlant Biotechnologies Provides Business Updates and First Quarter 2022 Financial Results 139

6.21 May 26, 2022: Medtronic reports full year and fourth quarter fiscal year 2022 financial results announces 8% dividend increase 141

6.22 May 23, 2022: Edwards Lifesciences to Present at the Bernstein 38th Annual Strategic Decisions Conference 141

6.23 Apr 19, 2022: Edwards Lifesciences to Host Earnings Conference Call on April 26, 2022 141

6.24 Apr 13, 2022: CollPlant To Present at the Aesthetics Innovation Summit 2022 141

6.25 Mar 24, 2022: CollPlant Biotechnologies Provides Business Updates and Fiscal Year 2021 Financial Results 142

6.26 Mar 14, 2022: NeoChord Appoints Martin B. Leon, M.D. as Executive Chair of the U.S. Early Feasibility Study of the NeoChord Transcatheter NeXuS System 143

7 Appendix 145

7.1 Methodology 145

7.2 About GlobalData 148

7.3 Contact Us 148

7.4 Disclaimer 148

Table

Cardiac Valve Repair Devices – Pipeline Products by Stage of Development 13

Cardiac Valve Repair Devices – Pipeline Products by Segment 14

Cardiac Valve Repair Devices – Pipeline Products by Territory 15

Cardiac Valve Repair Devices – Pipeline Products by Regulatory Path 16

Cardiac Valve Repair Devices – Pipeline Products by Estimated Approval Date 17

Cardiac Valve Repair Devices – Ongoing Clinical Trials 18

Cardiac Valve Repair Devices Companies – Pipeline Products by Stage of Development 19

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

Affluent Medical SASU Pipeline Products & Ongoing Clinical Trials Overview 23

Kalios – Product Status 23

Kalios – Product Description 23

Affluent Medical SASU – Ongoing Clinical Trials Overview 24

Kalios – Optimization of Surgical Repair for Treating Insufficiency of the Mitral Valve – Safety and Effectiveness Evaluation: OPTIMISE II 25

Ample Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 26

PS3 System – Product Status 26

PS3 System – Product Description 26

Anchorvalve Pipeline Products & Ongoing Clinical Trials Overview 27

Sutureless Mitral Valve Repair Ring – Product Status 27

Sutureless Mitral Valve Repair Ring – Product Description 27

Sutureless Tricuspid Valve Repair Ring – Product Status 28

Sutureless Tricuspid Valve Repair Ring – Product Description 28

Ancora Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 29

AccuCinch Ventriculoplasty System – Product Status 29

AccuCinch Ventriculoplasty System – Product Description 29

Ancora Heart Inc – Ongoing Clinical Trials Overview 30

AccuCinch Ventriculoplasty System – An Early Feasibility Evaluation of the AccuCinch Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF) – The CorCinch-HFrEF Study 31

AccuCinch Ventriculoplasty System – An Early Feasibility Study of the AccuCinch Ventricular Repair System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation – The CorCinch-PMVI Study 31

AccuCinch Ventriculoplasty System – Early Feasibility Study of the AccuCinch Ventricular Restoration System 31

AccuCinch Ventriculoplasty 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 32

AccuCinch Ventriculoplasty 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 32

Boston Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 33

Endovascular Prosthesis – Product Status 33

Endovascular Prosthesis – Product Description 33

Mitral Valve Repair Clip – Product Status 34

Mitral Valve Repair Clip – Product Description 34

Tricuspid Valve Repair Device – Product Status 34

Tricuspid Valve Repair Device – Product Description 35

Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 36

Millipede Percutaneous Annuloplasty Ring – Product Status 36

Millipede Percutaneous Annuloplasty Ring – Product Description 36

Cardiac Implants LLC Pipeline Products & Ongoing Clinical Trials Overview 37

Ring Annuloplasty Device – Product Status 37

Ring Annuloplasty Device – Product Description 37

Tri-Ring Device – Product Status 38

Tri-Ring Device – Product Description 38

Cardiosolutions Inc Pipeline Products & Ongoing Clinical Trials Overview 39

Mitra-Spacer – Product Status 39

Mitra-Spacer – Product Description 39

Celyad Oncology SA Pipeline Products & Ongoing Clinical Trials Overview 40

Heart Access Sheath – Mitral Valve Repair – Product Status 40

Heart Access Sheath – Mitral Valve Repair – Product Description 40

Mitral Valve Neo-chordae – Product Status 41

Mitral Valve Neo-chordae – Product Description 41

Collplant Biotechnologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 42

Vergenix HVR – Product Status 42

Vergenix HVR – Product Description 42

ConKay Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 43

Valvular Regurgitation Treatment Device – Product Status 43

Valvular Regurgitation Treatment Device – Product Description 43

CoreMedic AG Pipeline Products & Ongoing Clinical Trials Overview 44

ChordArt – Product Status 44

ChordArt – Product Description 44

CoreMedic AG – Ongoing Clinical Trials Overview 45

ChordArt – Chordart System Study for the Treatment of Mitral Regurgitation Due to Leaflet Prolapse or Flail 46

CUBE SRL Pipeline Products & Ongoing Clinical Trials Overview 47

Mitral-FERCube Ring – Product Status 47

Mitral-FERCube Ring – Product Description 47

Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 48

Coapsys – Product Status 48

Coapsys – Product Description 49

MOBIUS Leaflet Repair System – Product Status 49

MOBIUS Leaflet Repair System – Product Description 49

PASCAL Transcatheter Tricuspid Valve Repair System – Product Status 50

PASCAL Transcatheter Tricuspid Valve Repair System – Product Description 50

Edwards Lifesciences Corp – Ongoing Clinical Trials Overview 51

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 52

PASCAL Transcatheter Tricuspid Valve Repair System – Edwards PASCAL Transcatheter Valve Repair System in Tricuspid Regurgitation (CLASP TR) Early Feasibility Study 52

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 52

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. 53

PASCAL Transcatheter Tricuspid Valve Repair System – PASTE: PASCAL for Tricuspid Regurgitation – A European Registry 53

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 53

Emory University Pipeline Products & Ongoing Clinical Trials Overview 54

MitraSurg – Product Status 54

MitraSurg – Product Description 54

Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 55

Tricuspid Annuloplasty Ring – Product Status 55

Tricuspid Annuloplasty Ring – Product Description 55

Hangzhou DeJin Medtech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 56

Second Generation Mitral Valve Repair Device – Product Status 56

Second Generation Mitral Valve Repair Device – Product Description 56

Tricuspid Repair Device – Product Status 57

Tricuspid Repair Device – Product Description 57

Harpoon Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 58

HARPOON Beating Heart Mitral Valve Repair System – Product Status 58

HARPOON Beating Heart Mitral Valve Repair System – Product Description 58

Harpoon Medical, Inc. – Ongoing Clinical Trials Overview 59

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) 60

HARPOON Beating Heart Mitral Valve Repair System – Beating Heart Mitral Valve Repair with the HARPOON System: Real World Outcomes from a Multicenter Observational European Registry 60

HARPOON Beating Heart Mitral Valve Repair System – Safety and Performance Study of the Harpoon Medical Transapical Suturing Device (TSD-5) in Subjects with Degenerative Mitral Regurgitation – CE Mark Study for the Harpoon Medical Device in Poland 60

Kardium Inc Pipeline Products & Ongoing Clinical Trials Overview 61

Percutaneous Mitral Valve Regurgitation Device – Product Status 61

Percutaneous Mitral Valve Regurgitation Device – Product Description 61

Kekai Life Sciences Pipeline Products & Ongoing Clinical Trials Overview 62

FlexClamp – Product Status 62

FlexClamp – Product Description 62

FlexClip – Product Status 63

FlexClip – Product Description 63

SuperClip – Product Status 63

SuperClip – Product Description 63

Lepu Medical Technology (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 64

Transapical Mitral Valve Clip Repair System – Product Status 64

Transapical Mitral Valve Clip Repair System – Product Description 65

Transapical Mitral Valve Repair System – Chordal – Product Status 65

Transapical Mitral Valve Repair System – Chordal – Product Description 65

Transcatheter Papillary Muscle Repair System – Product Status 66

Transcatheter Papillary Muscle Repair System – Product Description 66

Transcatheter Tricuspid Valve Repair System – Product Status 66

Transcatheter Tricuspid Valve Repair System – Product Description 67

Transfemoral Mitral Valve Clip Repair System – Product Status 67

Transfemoral Mitral Valve Clip Repair System – Product Description 67

LuSeed Vascular Pipeline Products & Ongoing Clinical Trials Overview 68

LuSeed Intrasaccular Device – Heart Valve Insufficiency – Product Status 68

LuSeed Intrasaccular Device – Heart Valve Insufficiency – Product Description 68

Mardil Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 69

VenTouch Triad Targeted Ventricular Reshaping System – Product Status 69

VenTouch Triad Targeted Ventricular Reshaping System – Product Description 69

Mardil Medical, Inc. – Ongoing Clinical Trials Overview 70

VenTouch Triad Targeted Ventricular Reshaping System – Evaluation of the Minimally Invasive VenTouch System in the Treatment of Functional Mitral Valve Regurgitation (FMR): First-in-man Continuation Study 71

VenTouch Triad Targeted Ventricular Reshaping System – Evaluation of The Minimally Invasive VenTouch System in The Treatment of Functional Mitral Valve Regurgitation (FMR): OUS Feasibility Study 71

Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 72

Catheter-Based Mitral Valve Repair Device – Product Status 72

Catheter-Based Mitral Valve Repair Device – Product Description 72

Meril Life Sciences Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 73

CALIX-R – Product Status 73

CALIX-R – Product Description 73

MiCardia Corp Pipeline Products & Ongoing Clinical Trials Overview 74

enCorTC – Product Status 74

enCorTC – Product Description 74

Michigan Critical Care Consultants Inc Pipeline Products & Ongoing Clinical Trials Overview 75

Percutaneous Mitral Annuloplasty Ring – Product Status 75

Percutaneous Mitral Annuloplasty Ring – Product Description 75

Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 76

MIA System – Mitral Valve Repair – Product Status 76

MIA System – Mitral Valve Repair – Product Description 76

MIA-T Percutaneous Tricuspid Annuloplasty System – Product Status 77

MIA-T Percutaneous Tricuspid Annuloplasty System – Product Description 77

Micro Interventional Devices, Inc. – Ongoing Clinical Trials Overview 78

MIA-T Percutaneous Tricuspid Annuloplasty System – Study of Transcatheter Tricuspid Annular Repair 79

Millipede LLC Pipeline Products & Ongoing Clinical Trials Overview 80

IRIS Transcatheter Annuloplasty Ring – Product Status 80

IRIS Transcatheter Annuloplasty Ring – Product Description 80

Millipede LLC – Ongoing Clinical Trials Overview 81

IRIS Transcatheter Annuloplasty Ring – A Study to Evaluate the Feasibility and Safety of the Millipede Transcatheter Annuloplasty Ring System in Patients with Functional Mitral Regurgitation: (Millipede Feasibility Study) 82

Mitralign Inc Pipeline Products & Ongoing Clinical Trials Overview 83

Trialign Percutaneous Tricuspid Valve Annuloplasty System – Product Status 83

Trialign Percutaneous Tricuspid Valve Annuloplasty System – Product Description 83

Mitralign Inc – Ongoing Clinical Trials Overview 84

Trialign Percutaneous Tricuspid Valve Annuloplasty System – International Multisite Transcatheter Tricuspid Valve Therapies Registry 85

Trialign Percutaneous Tricuspid Valve Annuloplasty System – Safety and Feasibility of the Transcatheter Tricuspid Valve Repair System (Trialign) for the Treatment or Reduction of Moderate to Severe Functional Tricuspid Regurgitation 85

Trialign Percutaneous Tricuspid Valve Annuloplasty System – Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation 85

Mitre Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 86

Mitral Touch – Product Status 86

Mitral Touch – Product Description 86

Next Generation Mitral Touch – Product Status 87

Next Generation Mitral Touch – Product Description 87

Mitre Medical Corp – Ongoing Clinical Trials Overview 88

Mitral Touch – ENRAPT-MR Trial: Epicardial Mitral Repair 89

Mitral Touch – ENRAPTUS Epicardial Mitral Touch System for Mitral Insufficiency 89

MVRx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 90

ARTO System – Product Status 90

ARTO System – Product Description 90

MVRx, Inc. – Ongoing Clinical Trials Overview 91

ARTO System – Mitral Valve Repair Clinical Trial: MAVERIC Trial 92

P+F Products + Features GmbH Pipeline Products & Ongoing Clinical Trials Overview 93

Endobental Device – Product Status 93

Endobental Device – Product Description 93

Rambam Health Care Campus Pipeline Products & Ongoing Clinical Trials Overview 94

Adjustable Annuloplasty Apparatus – Product Status 94

Adjustable Annuloplasty Apparatus – Product Description 94

Shanghai Shenqi Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 95

Qilin System – Product Status 95

Qilin System – Product Description 95

Strait Access Technologies (Pty) Ltd Pipeline Products & Ongoing Clinical Trials Overview 96

Mitral Valve Repair System – Product Status 96

Mitral Valve Repair System – Product Description 96

Syntach AB Pipeline Products & Ongoing Clinical Trials Overview 97

Syntach MB – Product Status 97

Syntach MB – Product Description 97

Tel Aviv Sourasky Medical Center Pipeline Products & Ongoing Clinical Trials Overview 98

Mitral Valve Implantation Device – Product Status 98

Mitral Valve Implantation Device – Product Description 98

Tgen Tech LLC Pipeline Products & Ongoing Clinical Trials Overview 99

TxGuard-LP – Product Status 99

TxGuard-LP – Product Description 99

TransCardiac Therapeutics, LLC Pipeline Products & Ongoing Clinical Trials Overview 100

MitraFlex – Product Status 100

MitraFlex – Product Description 100

Transmural systems LLC Pipeline Products & Ongoing Clinical Trials Overview 101

MIRTH Device – Product Status 101

MIRTH Device – Product Description 101

SCIMITAR Device – Product Status 102

SCIMITAR Device – Product Description 102

Transmural Cerclage – Product Status 102

Transmural Cerclage – Product Description 103

Transmural systems LLC – Ongoing Clinical Trials Overview 104

Transmural Cerclage – NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study 105

TTK Healthcare Ltd Pipeline Products & Ongoing Clinical Trials Overview 106

Mitral Annuloplasty Ring – Product Status 106

Mitral Annuloplasty Ring – Product Description 106

University of Manitoba Pipeline Products & Ongoing Clinical Trials Overview 107

Aortic Annular System – Product Status 107

Aortic Annular System – Product Description 107

Valcare Medical Pipeline Products & Ongoing Clinical Trials Overview 108

Amend Mitral Valve Repair System – Product Status 108

Amend Mitral Valve Repair System – Product Description 108

Trivid – Product Status 109

Trivid – Product Description 109

Valcare Medical – Ongoing Clinical Trials Overview 110

Amend Mitral Valve Repair System – Pilot Study Evaluating the Efficacy of AMEND Mitral Valve Repair System 111

valsculp Pipeline Products & Ongoing Clinical Trials Overview 112

SATAR – Product Status 112

SATAR – Product Description 112

Valtech Cardio Ltd Pipeline Products & Ongoing Clinical Trials Overview 113

Cardinal Adjustable Annuloplasty Ring System – Tricuspid Repair – Product Status 113

Cardinal Adjustable Annuloplasty Ring System – Tricuspid Repair – Product Description 113

Cardioband Direct Access – Product Status 114

Cardioband Direct Access – Product Description 114

Edwards Cardioband Mitral Reconstruction System – Product Status 114

Edwards Cardioband Mitral Reconstruction System – Product Description 115

V-Chordal-Off Pump – Product Status 115

V-Chordal-Off Pump – Product Description 115

Valtech Cardio Ltd – Ongoing Clinical Trials Overview 116

Edwards Cardioband Mitral Reconstruction System – A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Assess Transcatheter Mitral Valve Repair with Edwards Cardioband System and GDMT Versus GDMT Alone in Patients with FMR and Heart Failure: Annular Reduction for Transcatheter Treatment of Insufficient Mitral Valve (ACTIVE) 117

Edwards Cardioband Mitral Reconstruction System – European Registry of Transcatheter Repair for Secondary Mitral Regurgitation 117

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 117

Vesalius Cardiovascular Inc Pipeline Products & Ongoing Clinical Trials Overview 118

Calla Mitral Valve Repair System – Product Status 118

Calla Mitral Valve Repair System – Product Description 118

Viacor Inc Pipeline Products & Ongoing Clinical Trials Overview 119

PTMA System – Product Status 119

PTMA System – Product Description 119

Glossary 147

Figures

Cardiac Valve Repair Devices – Pipeline Products by Stage of Development 13

Cardiac Valve Repair Devices – Pipeline Products by Segment 14

Cardiac Valve Repair Devices – Pipeline Products by Territory 15

Cardiac Valve Repair Devices – Pipeline Products by Regulatory Path 16

Cardiac Valve Repair Devices – Pipeline Products by Estimated Approval Date 17

Cardiac Valve Repair Devices – Ongoing Clinical Trials 18

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