Structural Heart Occluders Pipeline by Stages of Development, Segments, Region, Regulatory Path and Key Companies

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Structural Heart Occluders Pipeline Market Report Overview

Structural heart occluders are used for the treatment of congenital heart defects by closing openings in the heart. Structural heart occluders cover left atrial appendage closure devices, atrial septal defect occluders, ventricular septal defect occluders, patent foramen ovale closure devices, and patent ductus arteriosus closure devices. The structural heart occluders pipeline market research report provides comprehensive information about the structural heart occluders pipeline products with a comparative analysis of the products at various stages of development and information about the clinical trials that are in progress.

Key Segments ·        Left Atrial Appendage Closure Devices

·        Patent Foramen Ovale Closure Devices

·        Atrial Septal Defect Occluders

·        Ventricular Septal Defect Occluders

Key Territories ·        The US

·        China

·        Canada

·        Japan

·        Europe

Key Regulatory Paths ·        PMA

·        NMPA

·        Shonin

·        MDL

·        CE

Leading Companies ·        Abbott Japan Co Ltd

·        Append Medical

·        Boston Scientific Corp

·        CARAG AG

·        Dextera Surgical Inc

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Structural Heart Occluders Pipeline Market by Segments

Some of the key segments in the structural heart occluders pipeline market are Left Atrial Appendage Closure Devices, Patent Foramen Ovale Closure Devices, Atrial Septal Defect Occluders, and Ventricular Septal Defect Occluders. As of November 2023, left atrial appendage closure devices have the highest number of pipeline products.

Structural Heart Occluders Pipeline Market Analysis by Segments, 2023 (%)

Structural Heart Occluders Pipeline Market Analysis by Segments, 2023 (%)

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Structural Heart Occluders Pipeline Market Segmentation by Territories

Some of the key territories in the structural heart occluders market are the US, China, Canada, Japan, and Europe among others. As of November 2023, the US has the highest number of pipeline products.

Structural Heart Occluders Pipeline Market Analysis by Territories, 2023 (%)

Structural Heart Occluders Pipeline Market Analysis by Territories, 2023 (%)

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Structural Heart Occluders Pipeline Market Segmentation by Regulatory Paths

Some of the key regulatory paths in the structural heart occluders pipeline market are PMA, NMPA, Shonin, MDL, and CE, among others. As of November 2023, PMA is the most followed pathway for pipeline products in the market.

Structural Heart Occluders Pipeline Market Analysis by Regulatory Paths, 2023 (%)

Structural Heart Occluders Pipeline Market Analysis by Regulatory Paths, 2023 (%)

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Structural Heart Occluders Pipeline Market – Competitive Landscape

Some of the key companies in the structural heart occluders pipeline market are Abbott Japan Co Ltd, Append Medical, Boston Scientific Corp, CARAG AG, and Dextera Surgical Inc. among others.

Abbott Japan Co Ltd: Abbott Japan Co Ltd (Abbott Japan), a subsidiary of Abbott Laboratories is a healthcare company that develops, manufactures, and markets prescription drugs, diagnostic reagents, nutritional supplements, oral nutritional supplements, medical equipment, and diagnostic equipment. The company’s products include ethical drugs, blood sugar measurement-related products, gene-related products, immunoassay testing-related products, hematology testing-related products, and nutritious food products.

Structural Heart Occluders Pipeline Market Analysis by Companies, 2023

Structural Heart Occluders Pipeline Market Analysis by Companies, 2023

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Segments Covered in the Report

Structural Heart Occluders Pipeline Market Segments Outlook

  • Left Atrial Appendage Closure Devices
  • Patent Foramen Ovale Closure Devices
  • Atrial Septal Defect Occluders
  • Ventricular Septal Defect Occluders

Structural Heart Occluders Pipeline Market Territories Outlook

  • The US
  • China
  • Canada
  • Japan
  • Europe

Structural Heart Occluders Pipeline Market Regulatory Paths Outlook

  • PMA
  • NMPA
  • Shonin
  • MDL
  • CE

Scope

This report provides:

  • Extensive coverage of the structural heart occluders under development.
  • Details of major pipeline products which include product description, licensing and collaboration details, and other developmental activities.
  • Reviews of major players involved in the development of structural heart occluders and lists all their pipeline projects.
  • Coverage of pipeline products based on various stages of development ranging from early development to approved/issued stage.
  • Provides key clinical trial data of ongoing clinical 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 structural heart occluders 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.

Abbott Japan Co Ltd
Aegis Medical Innovations Inc.
Aporo Biomedical, Inc. (Inactive)
Append Medical
atHeart Medical
AuriGen Medical Ltd
Boston Scientific Corp
CARAG AG
Cierra, Inc. (Inactive)
Conformal Medical Inc
Cor Habere Corp
Dextera Surgical Inc
Endomimetics LLC
Ension, Inc.
Guangdong Pulse Medical Technology Co Ltd
Hangzhou Dinova EP Technology Co Ltd
Hansen Medical Inc (Inactive)
Jenscare Scientific Co Ltd
Laminar Inc
Lepu Scientech Medical Technology (Shanghai) Co Ltd
Lifetech Scientific (Shenzhen) Co Ltd
LuSeed Vascular
Mayo Clinic
Medtronic Plc
Micro Interventional Devices, Inc.
Northwestern University
Occlutech International AB
SentreHEART Inc
SeptRx, Inc. (Inactive)
Shanghai Shenqi Medical Technology Co Ltd
Swissimplant AG
The Chaim Sheba Medical Center
University of Minnesota
Vascular Closure Systems Inc
Vascular Concepts Ltd
W. L. Gore & Associates Inc
Worry Free Beating

Table of Contents

1 Table of Contents 3

1.1 List of Tables 6

1.2 List of Figures 10

2 Introduction 11

2.1 Structural Heart Occluders Overview 11

3 Products under Development 12

3.1 Structural Heart Occluders – Pipeline Products by Stage of Development 12

3.2 Structural Heart Occluders – Pipeline Products by Segment 13

3.3 Structural Heart Occluders – Pipeline Products by Territory 14

3.4 Structural Heart Occluders – Pipeline Products by Regulatory Path 15

3.5 Structural Heart Occluders – Pipeline Products by Estimated Approval Date 16

3.6 Structural Heart Occluders – Ongoing Clinical Trials 17

4 Structural Heart Occluders – Pipeline Products under Development by Companies 18

4.1 Structural Heart Occluders Companies – Pipeline Products by Stage of Development 18

4.2 Structural Heart Occluders – Pipeline Products by Stage of Development 20

5 Structural Heart Occluders Companies and Product Overview 22

5.1 Abbott Japan Co Ltd Company Overview 22

5.1.1 Abbott Japan Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 22

5.2 Aegis Medical Innovations Inc. Company Overview 23

5.2.1 Aegis Medical Innovations Inc. Pipeline Products & Ongoing Clinical Trials Overview 23

5.3 Aporo Biomedical, Inc. (Inactive) Company Overview 26

5.3.1 Aporo Biomedical, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 26

5.4 Append Medical Company Overview 27

5.4.1 Append Medical Pipeline Products & Ongoing Clinical Trials Overview 27

5.5 atHeart Medical Company Overview 28

5.5.1 atHeart Medical Pipeline Products & Ongoing Clinical Trials Overview 28

5.6 AuriGen Medical Ltd Company Overview 31

5.6.1 AuriGen Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 31

5.7 Boston Scientific Corp Company Overview 32

5.7.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 32

5.8 CARAG AG Company Overview 34

5.8.1 CARAG AG Pipeline Products & Ongoing Clinical Trials Overview 34

5.9 Cierra, Inc. (Inactive) Company Overview 37

5.9.1 Cierra, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 37

5.10 Conformal Medical Inc Company Overview 38

5.10.1 Conformal Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 38

5.11 Cor Habere Corp Company Overview 42

5.11.1 Cor Habere Corp Pipeline Products & Ongoing Clinical Trials Overview 42

5.12 Dextera Surgical Inc Company Overview 43

5.12.1 Dextera Surgical Inc Pipeline Products & Ongoing Clinical Trials Overview 43

5.13 Endomimetics LLC Company Overview 46

5.13.1 Endomimetics LLC Pipeline Products & Ongoing Clinical Trials Overview 46

5.14 Ension, Inc. Company Overview 48

5.14.1 Ension, Inc. Pipeline Products & Ongoing Clinical Trials Overview 48

5.15 Guangdong Pulse Medical Technology Co Ltd Company Overview 49

5.15.1 Guangdong Pulse Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 49

5.16 Hangzhou Dinova EP Technology Co Ltd Company Overview 52

5.16.1 Hangzhou Dinova EP Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 52

5.17 Hansen Medical Inc (Inactive) Company Overview 55

5.17.1 Hansen Medical Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 55

5.18 Jenscare Scientific Co Ltd Company Overview 57

5.18.1 Jenscare Scientific Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 57

5.19 Laminar Inc Company Overview 59

5.19.1 Laminar Inc Pipeline Products & Ongoing Clinical Trials Overview 59

5.20 Lepu Scientech Medical Technology (Shanghai) Co Ltd Company Overview 62

5.20.1 Lepu Scientech Medical Technology (Shanghai) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 62

5.21 Lifetech Scientific (Shenzhen) Co Ltd Company Overview 65

5.21.1 Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 65

5.22 LuSeed Vascular Company Overview 69

5.22.1 LuSeed Vascular Pipeline Products & Ongoing Clinical Trials Overview 69

5.23 Mayo Clinic Company Overview 70

5.23.1 Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 70

5.24 Medtronic Plc Company Overview 71

5.24.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 71

5.25 Micro Interventional Devices, Inc. Company Overview 72

5.25.1 Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 72

5.26 Northwestern University Company Overview 73

5.26.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 73

5.27 Occlutech International AB Company Overview 74

5.27.1 Occlutech International AB Pipeline Products & Ongoing Clinical Trials Overview 74

5.28 SentreHEART Inc Company Overview 80

5.28.1 SentreHEART Inc Pipeline Products & Ongoing Clinical Trials Overview 80

5.29 SeptRx, Inc. (Inactive) Company Overview 84

5.29.1 SeptRx, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 84

5.30 Shanghai Shenqi Medical Technology Co Ltd Company Overview 85

5.30.1 Shanghai Shenqi Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 85

5.31 Swissimplant AG Company Overview 86

5.31.1 Swissimplant AG Pipeline Products & Ongoing Clinical Trials Overview 86

5.32 The Chaim Sheba Medical Center Company Overview 87

5.32.1 The Chaim Sheba Medical Center Pipeline Products & Ongoing Clinical Trials Overview 87

5.33 University of Minnesota Company Overview 88

5.33.1 University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 88

5.34 Vascular Closure Systems Inc Company Overview 89

5.34.1 Vascular Closure Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 89

5.35 Vascular Concepts Ltd Company Overview 90

5.35.1 Vascular Concepts Ltd Pipeline Products & Ongoing Clinical Trials Overview 90

5.36 W. L. Gore & Associates Inc Company Overview 91

5.36.1 W. L. Gore & Associates Inc Pipeline Products & Ongoing Clinical Trials Overview 91

5.37 Worry Free Beating Company Overview 92

5.37.1 Worry Free Beating Pipeline Products & Ongoing Clinical Trials Overview 92

6 Structural Heart Occluders- Recent Developments 93

6.1 Nov 13, 2023: Jenscare : Simulock Successfully Completes Implantation Surgery for the First Confirmatory Clinical Trial 93

6.2 Oct 24, 2023: Conformal Medical Announces Compelling One-Year Data from its Left Atrial Appendage Occlusion (LAAO) Early Feasibility Study 93

6.3 Oct 17, 2023: The Gore Relief Clinical Study Begins Randomizing Patients to Evaluate PFO Closure for Migraine Headache Relief 94

6.4 Sep 07, 2023: Boston Scientific’s LAAC device gets FDA approval 95

6.5 Sep 06, 2023: Boston Scientific Announces FDA Approval for the Latest-Generation WATCHMAN FLX Pro Left Atrial Appendage Closure Device 95

6.6 May 17, 2023: MicroPort’s LAA closure AnchorMan device achieves primary endpoint from SAFE PROTECT clinical trial, showing very promising results 96

6.7 Feb 27, 2023: Study demonstrates successful device size selection when assessing left atrial appendage by angiography compared to TEE 97

6.8 Jan 31, 2023: Conformal Medical announces positive one-year data from its left atrial appendage closure performed under conscious sedation study 98

6.9 Jan 05, 2023: JSCAI publishes peer-reviewed article highlighting effective performance of conformal medical’s Left Atrial Appendage (CLAAS) Device 98

6.10 Dec 06, 2022: Henry Ford Health to lead first-of-its-kind national trial for innovative heart device 99

7 Appendix 101

7.1 Methodology 101

7.2 About GlobalData 104

7.3 Contact Us 104

7.4 Disclaimer 104

Table

Structural Heart Occluders – Pipeline Products by Stage of Development 12

Structural Heart Occluders – Pipeline Products by Segment 13

Structural Heart Occluders – Pipeline Products by Territory 14

Structural Heart Occluders – Pipeline Products by Regulatory Path 15

Structural Heart Occluders – Pipeline Products by Estimated Approval Date 16

Structural Heart Occluders – Ongoing Clinical Trials 17

Structural Heart Occluders Companies – Pipeline Products by Stage of Development 18

Structural Heart Occluders – Pipeline Products by Stage of Development 20

Abbott Japan Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 22

AMJ-505 Left Atrial Appendage Occlusion System – Product Status 22

AMJ-505 Left Atrial Appendage Occlusion System – Product Description 22

Aegis Medical Innovations Inc. Pipeline Products & Ongoing Clinical Trials Overview 23

Aegis Sierra Ligation System – Product Status 23

Aegis Sierra Ligation System – Product Description 23

Aegis Medical Innovations Inc. – Ongoing Clinical Trials Overview 24

Aegis Sierra Ligation System – A Single-arm, Open Label, Multi-center Feasibility Study of the Aegis Sierra Ligation System in Left Atrial Appendage Closure in Patients with Atrial Fibrillation 25

Aporo Biomedical, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 26

Patent Foramen Ovale Closure Device – Product Status 26

Patent Foramen Ovale Closure Device – Product Description 26

Append Medical Pipeline Products & Ongoing Clinical Trials Overview 27

Appligator – Product Status 27

Appligator – Product Description 27

atHeart Medical Pipeline Products & Ongoing Clinical Trials Overview 28

reSept ASD Occluder – Product Status 28

reSept ASD Occluder – Product Description 28

atHeart Medical – Ongoing Clinical Trials Overview 29

reSept ASD Occluder – Evaluation of the Safety and Efficacy of the reSept ASD Occluder to Treat Patients with Clinically Significant Secundum Atrial Septal Defect 30

AuriGen Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 31

12F Aurigen Delivery System – Product Status 31

12F Aurigen Delivery System – Product Description 31

Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 32

AnchorMan Left Atrial Appendage Closure – Product Status 32

AnchorMan Left Atrial Appendage Closure – Product Description 33

WATCHMAN FLX Pro – Product Status 33

WATCHMAN FLX Pro – Product Description 33

CARAG AG Pipeline Products & Ongoing Clinical Trials Overview 34

Carag BioResorbable Septal Occluder – Product Status 34

Carag BioResorbable Septal Occluder – Product Description 34

CARAG AG – Ongoing Clinical Trials Overview 35

Carag BioResorbable Septal Occluder – Multi Centre, International, Post Market Registry to Monitor the Clinical Performance and Safety of an Atrial Septal Closure Device with Bioresorbable Framework in Patients with Clinically Significant Atrial Septum Defect (ASD) or Patent Foramen Ovale (PFO) in Routine Clinical Use 36

Cierra, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 37

PFx Closure System – Product Status 37

PFx Closure System – Product Description 37

Conformal Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 38

CLAAS Device – Product Status 38

CLAAS Device – Product Description 38

Conformal Medical Inc – Ongoing Clinical Trials Overview 39

CLAAS Device – An Evaluation of the Safety and Effectiveness of the Conformal CLAAS System for Left Atrial Appendage Occlusion 40

CLAAS Device – The CONFORMAL Early Feasibility Study an Evaluation of the Safety and Performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion 40

CLAAS Device – The Conformal Prague Study: An Evaluation of the Safety and Performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion 40

CLAAS Device – The Conscious Sedation Single Arm Sub-Study 41

Cor Habere Corp Pipeline Products & Ongoing Clinical Trials Overview 42

StrokeShield System – Product Status 42

StrokeShield System – Product Description 42

Dextera Surgical Inc Pipeline Products & Ongoing Clinical Trials Overview 43

PFO Closure Device – Product Status 43

PFO Closure Device – Product Description 43

Dextera Surgical Inc – Ongoing Clinical Trials Overview 44

PFO Closure Device – Effectivity and Safety of PFO Closure Vs Medicine in Alleviating Migraine (SPRING): A Multicenter, Random, Case Control Study 45

Endomimetics LLC Pipeline Products & Ongoing Clinical Trials Overview 46

Atrial Septal Defect Device – Product Status 46

Atrial Septal Defect Device – Product Description 46

Vascular Septal Defect (VSD) Occluder – Product Status 47

Vascular Septal Defect (VSD) Occluder – Product Description 47

Ension, Inc. Pipeline Products & Ongoing Clinical Trials Overview 48

Atrial Septal Defect Correction Device – Product Status 48

Atrial Septal Defect Correction Device – Product Description 48

Guangdong Pulse Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 49

Patent Foramen Ovale (PFO) Occluder – Product Status 49

Patent Foramen Ovale (PFO) Occluder – Product Description 49

Guangdong Pulse Medical Technology Co Ltd – Ongoing Clinical Trials Overview 50

Patent Foramen Ovale (PFO) Occluder – Prospective, Multicenter, Single-Group Target Value Method To Evaluate the Safety and Effectiveness of Patent Foramen Ovale Occluder System 51

Hangzhou Dinova EP Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 52

Snowy PFO Closure System – Product Status 52

Snowy PFO Closure System – Product Description 52

Hangzhou Dinova EP Technology Co Ltd – Ongoing Clinical Trials Overview 53

Snowy PFO Closure System – A Prospective, Multicenter, Randomized Controlled Clinical Study on the Safety and Effectiveness of the Snowy PFO Closure System in Plugging Patent Foramen Ovale 54

Hansen Medical Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 55

Sensei Robotic Catheter System – LAA – Product Status 55

Sensei Robotic Catheter System – LAA – Product Description 55

Sensei Robotic Catheter System – PFO Closure – Product Status 56

Sensei Robotic Catheter System – PFO Closure – Product Description 56

Jenscare Scientific Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 57

OmniSeal – Product Status 57

OmniSeal – Product Description 57

SimuLock – Product Status 58

SimuLock – Product Description 58

Laminar Inc Pipeline Products & Ongoing Clinical Trials Overview 59

Laminar Left Atrial Appendage Closure System – Product Status 59

Laminar Left Atrial Appendage Closure System – Product Description 59

Laminar Inc – Ongoing Clinical Trials Overview 60

Laminar Left Atrial Appendage Closure System – A European Trial Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System in Subjects with Non-Valvular Atrial Fibrillation 61

Laminar Left Atrial Appendage Closure System – A Trial Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System in Subjects with Non- Valvular Atrial Fibrillation 61

Laminar Left Atrial Appendage Closure System – An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects with Non-Valvular Atrial Fibrillation 61

Lepu Scientech Medical Technology (Shanghai) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 62

LAA Closure Occluder II – Product Status 62

LAA Closure Occluder II – Product Description 62

MemoSorb ASD Occluder IV – Product Status 63

MemoSorb ASD Occluder IV – Product Description 63

MemoSorb PFO Occluder II – Product Status 63

MemoSorb PFO Occluder II – Product Description 64

Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 65

LAmbre LAA Closure System – Product Status 65

LAmbre LAA Closure System – Product Description 65

Lifetech Scientific (Shenzhen) Co Ltd – Ongoing Clinical Trials Overview 66

LAmbre LAA Closure System – Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF: The CORRAL-AF Study 67

LAmbre LAA Closure System – LAmbre Versus AMPLATZER Amulet Left Atrial Appendage Occluder for Stroke Prophylaxis: The Randomized AMPIRI Trial 67

LAmbre LAA Closure System – LifeTech LAmbre Keft Atrial Appendage (LAA) Closure System Post-market Clinical Follow-up 67

LAmbre LAA Closure System – Lifetech LAmbre Left Atrial Appendage Closure System Post-Market Clinical Follow-up Multi-center, Single-arm, Prospective, Post-market study 68

LAmbre LAA Closure System – Lifetech Lambre Left Atrial Appendage Closure System Post-market Registry Single-center, Single-arm, Prospective, Post-market Registry 68

LAmbre LAA Closure System – Safety and Efficacy Study of LAmbre Plus LAA occluder System in Non-valvular Atrial Fibrillation Patients 68

LuSeed Vascular Pipeline Products & Ongoing Clinical Trials Overview 69

LuSeed Intrasaccular Device – LAA Occlusion – Product Status 69

LuSeed Intrasaccular Device – LAA Occlusion – Product Description 69

Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 70

Left Atrial Appendage Closure Device – Product Status 70

Left Atrial Appendage Closure Device – Product Description 70

Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 71

Cardioblate Closure LAA Occlusion Device – Product Status 71

Cardioblate Closure LAA Occlusion Device – Product Description 71

Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 72

Patent Foramen Ovale Fixation Device – Product Status 72

Patent Foramen Ovale Fixation Device – Product Description 72

Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 73

Left Atrial Appendage Occluder – Product Status 73

Left Atrial Appendage Occluder – Product Description 73

Occlutech International AB Pipeline Products & Ongoing Clinical Trials Overview 74

Occlutech Figulla Flex II ASD Occluder – Product Status 74

Occlutech Figulla Flex II ASD Occluder – Product Description 74

Occlutech Figulla Flex UNI – Product Status 75

Occlutech Figulla Flex UNI – Product Description 75

Occlutech Pistol Pusher – Product Status 75

Occlutech Pistol Pusher – Product Description 76

Occlutech International AB – Ongoing Clinical Trials Overview 77

Occlutech Figulla Flex II ASD Occluder – Comparative Effectiveness of Three Devices for Transcatheter Closure of Atrial Septal Defects for Adults: A Pilot Study (Trio-ASD) 78

Occlutech Figulla Flex II ASD Occluder – MitraClip and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure – Evaluation of Morphologic and Functional Changes in a Randomized Setting 78

Occlutech Figulla Flex II ASD Occluder – Study to Evaluate the Efficacy of Occlutech ASD Occluder in the Treatment of Atrial Septal Defects 78

Occlutech Pistol Pusher – A Registry-based, Multicenter, International, Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices:Occlutech Delivery Set (ODS), Occlutech Pistol Pusher (OPP), Occlutech Occlusions-Pusher (OOP), Occlutech Sizing Balloon (OSB) Used During to Implantation Procedures of Cardiac Implant Devices 79

SentreHEART Inc Pipeline Products & Ongoing Clinical Trials Overview 80

Eclipse Surgical Left Atrial Appendage Closure Device – Product Status 80

Eclipse Surgical Left Atrial Appendage Closure Device – Product Description 80

LARIAT Suture Delivery Device – Adjunctive Therapy – Product Status 81

LARIAT Suture Delivery Device – Adjunctive Therapy – Product Description 81

SentreHEART Inc – Ongoing Clinical Trials Overview 82

LARIAT Suture Delivery Device – Adjunctive Therapy – Left Atrial Appendage Ligation with the LARIAT Suture Delivery System as Adjunctive Therapy to Pulmonary Vein Isolation for Persistent or Longstanding Persistent Atrial Fibrillation 83

LARIAT Suture Delivery Device – Adjunctive Therapy – Non-randomized, Multicenter Expanded Use Evaluation of the LARIAT Suture Delivery Device (Appendix 16 to Ongoing Investigation) 83

SeptRx, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 84

SeptRx IPO – Product Status 84

SeptRx IPO – Product Description 84

Shanghai Shenqi Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 85

Left Atrial Appendage Occluder System – Product Status 85

Left Atrial Appendage Occluder System – Product Description 85

Swissimplant AG Pipeline Products & Ongoing Clinical Trials Overview 86

Solysafe Septal Occluder – 10Fr Sheath – Product Status 86

Solysafe Septal Occluder – 10Fr Sheath – Product Description 86

The Chaim Sheba Medical Center Pipeline Products & Ongoing Clinical Trials Overview 87

Left Atrial Appendage Intraatrial Transcatheter Sutureless Closure – Product Status 87

Left Atrial Appendage Intraatrial Transcatheter Sutureless Closure – Product Description 87

University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 88

Bioresorbable Occlusion Device – Product Status 88

Bioresorbable Occlusion Device – Product Description 88

Vascular Closure Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 89

RF Thermal Closure System – Product Status 89

RF Thermal Closure System – Product Description 89

Vascular Concepts Ltd Pipeline Products & Ongoing Clinical Trials Overview 90

VSD (Ventricular Septal Device) – Product Status 90

VSD (Ventricular Septal Device) – Product Description 90

W. L. Gore & Associates Inc Pipeline Products & Ongoing Clinical Trials Overview 91

BioTREK – Product Status 91

BioTREK – Product Description 91

Worry Free Beating Pipeline Products & Ongoing Clinical Trials Overview 92

Degradable Occlusion System – Product Status 92

Degradable Occlusion System – Product Description 92

Glossary 103

Figures

Structural Heart Occluders – Pipeline Products by Stage of Development 12

Structural Heart Occluders – Pipeline Products by Segment 13

Structural Heart Occluders – Pipeline Products by Territory 14

Structural Heart Occluders – Pipeline Products by Regulatory Path 15

Structural Heart Occluders – Pipeline Products by Estimated Approval Date 16

Structural Heart Occluders – Ongoing Clinical Trials 17

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GlobalData is very customer orientated, with a high degree of personalised services, which benefits everyday use. The highly detailed project intelligence and forecast reports can be utilised across multiple departments and workflow scopes, from operational to strategic level, and often support strategic decisions. GlobalData Analytics and visualisation solutions has contributed positively when preparing management presentations and strategic papers.”

Business Intelligence & Marketing Manager, SAL Heavy Lift

“COVID-19 has caused significant interference to our business and the COVID-19 intelligence from GlobalData has helped us reach better decisions around strategy. These two highlights have helped enormously to understand the projections into the future concerning our business units, we also utilise the project database to source new projects for Liebherr-Werk to use as an additional source to pitch for new business.”

Market Analyst & Management, Liebherr-Werk

Your daily news has saved me a lot of time and keeps me up-to-date with what is happening in the market, I like that you almost always have a link to the source origin. We also use your market data in our Strategic Business Process to support our business decisions. By having everything in one place on the Intelligence Center it has saved me a lot of time versus looking on different sources, the alert function also helps with this.

Head of Key Accounts, Saab AB

Having used several other market research companies, I find that GlobalData manages to provide that ‘difficult-to-get’ market data that others can’t, as well as very diverse and complete consumer surveys.

Marketing Intelligence Manager, Portugal Foods

Our experience with GlobalData has been very good, from the platform itself to the people. I find that the analysts and the account team have a high level of customer focus and responsiveness and therefore I can always rely on. The platform is more holistic than other providers. It is convenient and almost like a one stop shop. The pricing suite is highly competitive and value for our organisation.

I like reports that inform new segments such as the analysis on generation Z, millennials, the impact of COVID 19 to our banking customers and their new channel habits. Secondly the specialist insight on affluent sector significantly increases our understanding about this group of customers. The combination of those give us depth and breadth of the evolving market.

I’m in the business of answering and helping people make decisions so with the intelligence center I can do that, effectively and efficiently. I can share quickly key insights that answer and satisfy our country stakeholders by giving them many quality studies and primary research about competitive landscape beyond the outlook of our bank. It helps me be seen as an advisory partner and that makes a big difference. A big benefit of our subscription is that no one holds the whole data and because it allows so many people, so many different parts of our organisation have access, it enables all teams to have the same level of knowledge and decision support.

Head of Customer Insight and Research, Standard Chartered

“I know that I can always rely on Globaldata’s work when I’m searching for the right consumer and market insights. I use Globaldata insights to understand the changing market & consumer landscape and help create better taste & wellbeing solutions for our customers in food, beverage and healthcare industries.

Globaldata has the right data and the reports are of very high quality compared to your competitors. Globaldata not only has overall market sizes & consumer insights on food & beverages but also provides insights at the ingredient & flavour level. That is key for B2B companies like Givaudan. This way we understand our customers’ business and also gain insight to our unique industry”

Head of Consumer Sensory Insights, Givaudan

GlobalData provides a great range of information and reports on various sectors that is highly relevant, timely, easy to access and utilise.  The reports and data dashboards help engagement with clients; they provide valuable industry and market insights that can enrich client conversations and can help in the shaping of value propositions. Moreover, using GlobalData products has helped increase my knowledge of the finance sector, the players within it, and the general threats and opportunities.

I find the consumer surveys that are carried out to be extremely beneficial and not something I have seen anywhere else. They provided an insightful view of why and which consumers take (or don’t) particular financial products. This can help shape conversations with clients to ensure they make the right strategic decisions for their business.

One of the challenges I have found is that data in the payments space is often piecemeal. With GD all of the data I need is in one place, but it also comes with additional market reports that provide useful extra context and information. Having the ability to set-up alerts on relevant movements in the industry, be it competitors or customers, and have them emailed directly to me, ensures I get early sight of industry activity and don’t have to search for news.

Senior Account Manager, TSYS
Go even deeper with GlobalData Intelligence Center

Every Company Report we produce is powered by the GlobalData Intelligence Center.

Subscribing to our intelligence platform means you can monitor developments at Structural Heart Occluders Pipeline by Stages of Development, Segments, Region, Regulatory Path and Key Companies in real time.

  • Access a live Structural Heart Occluders Pipeline by Stages of Development, Segments, Region, Regulatory Path and Key Companies dashboard for 12 months, with up-to-the-minute insights.
  • Fuel your decision making with real-time deal coverage and media activity.
  • Turn insights on financials, deals, products and pipelines into powerful agents of commercial advantage.