Structural Heart Occluders Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2022 Update

Pages: 94 Published: November 29, 2022 Report Code: GDME1476EPD

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 which are in progress.

Structural Heart Occluders Pipeline Products Market Segments

The key segments in the structural heart occluders pipeline products market are left atrial appendage closure devices, patent foramen ovale closure devices, atrial septal defect occluders, and ventricular septal defect occluders. Left atrial appendage closure devices have the highest number of products in the structural heart occluders pipeline products market.

Structural Heart Occluders Pipeline Products Market Analysis by Segments, 2022 (%)

Structural Heart Occluders Pipeline Products Market Analysis by SegmentsFor more insights into the structural heart occluders pipeline products market segments, download a free report sample

Structural Heart Occluders Pipeline Products Market Segmentation, by Territories

Some of the key territories with structural heart occluders products in the pipeline are the United States, Europe, Global, China, Canada, Japan, South Korea, El Salvador, Costa Rica, and others. As of November 2022, the US has the highest number of products in the pipeline out of them all.

Structural Heart Occluders Pipeline Products Market Analysis, by Territories, 2022 (%)

Structural Heart Occluders Pipeline Products Market Analysis, by Territories

For more territory insights into the structural heart occluders pipeline products market, download a free report sample

Structural Heart Occluders Pipeline Products Market Segmentation by Regulatory Paths

Some of the key regulatory paths followed by the structural heart occluders pipeline products market are PMA, NMPA, CE, Shonin, MDL, NIFDS, HAS, ICAC, and MDA. Most of the products follow the PMA pathway to enter the market.

Structural Heart Occluders Pipeline Products Market Analysis, by Regulatory Paths, 2022 (%)

Structural Heart Occluders Pipeline Products Market Analysis, by Regulatory PathsFor more structural heart occluders pipeline products regulatory path insights, download a free report sample

Structural Heart Occluders Pipeline Products Market - Competitive Landscape

Some of the leading companies in the structural heart occluders pipeline products market are 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, and Cor Habere Corp.

Structural Heart Occluders Pipeline Products Market Report Overview

Key Segments Left Atrial Appendage Closure Devices, Patent Foramen Ovale Closure Devices, Atrial Septal Defect Occluders, and Ventricular Septal Defect Occluders
Analysis Year 2022
Key Territories The United States, Europe, Global, China, Canada, Japan, South Korea, El Salvador, Costa Rica, and Others
Key Regulatory Paths PMA, NMPA, CE, Shonin, MDL, NIFDS, HAS, ICAC, and MDA
Leading Companies 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, and Cor Habere Corp.

Structural Heart Occluders Pipeline Products Market Segments Outlook (2022)

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

Structural Heart Occluders Pipeline Products Market Territories Outlook (2022)

  • The United States
  • Europe
  • Global
  • China
  • Canada
  • Japan
  • South Korea
  • El Salvador
  • Costa Rica
  • Others

Structural Heart Occluders Pipeline Products Market Regulatory Paths Outlook (2022)

  • PMA
  • NMPA
  • CE
  • Shonin
  • MDL
  • NIFDS
  • HAS
  • ICAC
  • MDA

Scope

This report provides:

  • Extensive coverage of the structural heart occluders under development.
  • Details of major structural heart occluders pipeline products which include product description, licensing, collaboration details, and other developmental activities including pipeline territories, regulatory paths, and estimated approval dates.
  • Reviews of the major players involved in the development of structural heart occluders and list all their pipeline projects.
  • The coverage of structural heart occluders pipeline products based on various stages of development ranging from early development to the approved/issued stage.
  • Key clinical trial data of ongoing trials specific to structural heart occluders 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 a potentially strong product portfolio and create effective counterstrategies 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.

Key Players

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
Ension, Inc.
Guangdong Pulse Medical Technology Co Ltd
Hangzhou Dinova EP Technology Co Ltd
Hansen Medical Inc (Inactive)
Laminar Inc
Lepu Scientech Medical Technology (Shanghai) Co Ltd
Lifetech Scientific (Shenzhen) Co Ltd
LuSeed Vascular
Mayo Clinic
Medtronic Plc
Meril Life Sciences Pvt Ltd
Micro Interventional Devices, Inc.
MicroPort Scientific Corp
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

Table of Contents

  • 1 Table of Contents

    • 1.1 List of Tables

  • 1.2 List of Figures
  • 2 Introduction

    • 2.1 Structural Heart Occluders Overview

  • 3 Products under Development

    • 3.1 Structural Heart Occluders – Pipeline Products by Stage of Development
    • 3.2 Structural Heart Occluders – Pipeline Products by Segment
    • 3.3 Structural Heart Occluders – Pipeline Products by Territory
    • 3.4 Structural Heart Occluders – Pipeline Products by Regulatory Path
    • 3.5 Structural Heart Occluders – Pipeline Products by Estimated Approval Date
    • 3.6 Structural Heart Occluders – Ongoing Clinical Trials

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

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

  • 5 Structural Heart Occluders Companies and Product Overview

    • 5.1 Aegis Medical Innovations Inc. Company Overview

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

    • 5.2 Aporo Biomedical, Inc. (Inactive) Company Overview

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

    • 5.3 Append Medical Company Overview

      • 5.3.1 Append Medical Pipeline Products & Ongoing Clinical Trials Overview

    • 5.4 atHeart Medical Company Overview

      • 5.4.1 atHeart Medical Pipeline Products & Ongoing Clinical Trials Overview

    • 5.5 AuriGen Medical Ltd Company Overview

      • 5.5.1 AuriGen Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview

    • 5.6 Boston Scientific Corp Company Overview

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

    • 5.7 CARAG AG Company Overview

      • 5.7.1 CARAG AG Pipeline Products & Ongoing Clinical Trials Overview

    • 5.8 Cierra, Inc. (Inactive) Company Overview

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

    • 5.9 Conformal Medical Inc Company Overview

      • 5.9.1 Conformal Medical Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.10 Cor Habere Corp Company Overview

      • 5.10.1 Cor Habere Corp Pipeline Products & Ongoing Clinical Trials Overview

    • 5.11 Dextera Surgical Inc Company Overview

      • 5.11.1 Dextera Surgical Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.12 Ension, Inc. Company Overview

      • 5.12.1 Ension, Inc. Pipeline Products & Ongoing Clinical Trials Overview

    • 5.13 Guangdong Pulse Medical Technology Co Ltd Company Overview

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

    • 5.14 Hangzhou Dinova EP Technology Co Ltd Company Overview

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

    • 5.15 Hansen Medical Inc (Inactive) Company Overview

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

    • 5.16 Laminar Inc Company Overview

      • 5.16.1 Laminar Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.17 Lepu Scientech Medical Technology (Shanghai) Co Ltd Company Overview

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

    • 5.18 Lifetech Scientific (Shenzhen) Co Ltd Company Overview

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

    • 5.19 LuSeed Vascular Company Overview

      • 5.19.1 LuSeed Vascular Pipeline Products & Ongoing Clinical Trials Overview

    • 5.20 Mayo Clinic Company Overview

      • 5.20.1 Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview

    • 5.21 Medtronic Plc Company Overview

      • 5.21.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.22 Meril Life Sciences Pvt Ltd Company Overview

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

    • 5.23 Micro Interventional Devices, Inc. Company Overview

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

    • 5.24 MicroPort Scientific Corp Company Overview

      • 5.24.1 MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview

    • 5.25 Northwestern University Company Overview

      • 5.25.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview

    • 5.26 Occlutech International AB Company Overview

      • 5.26.1 Occlutech International AB Pipeline Products & Ongoing Clinical Trials Overview

    • 5.27 SentreHEART Inc Company Overview

      • 5.27.1 SentreHEART Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.28 SeptRx, Inc. (Inactive) Company Overview

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

    • 5.29 Shanghai Shenqi Medical Technology Co Ltd Company Overview

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

    • 5.30 Swissimplant AG Company Overview

      • 5.30.1 Swissimplant AG Pipeline Products & Ongoing Clinical Trials Overview

    • 5.31 The Chaim Sheba Medical Center Company Overview

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

    • 5.32 University of Minnesota Company Overview

      • 5.32.1 University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview

    • 5.33 Vascular Closure Systems Inc Company Overview

      • 5.33.1 Vascular Closure Systems Inc Pipeline Products & Ongoing Clinical Trials Overview

    • 5.34 Vascular Concepts Ltd Company Overview

      • 5.34.1 Vascular Concepts Ltd Pipeline Products & Ongoing Clinical Trials Overview

    • 5.35 W. L. Gore & Associates Inc Company Overview

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

  • 6 Appendix

    • 6.1 Methodology
    • 6.2 About GlobalData
    • 6.3 Contact Us
    • 6.4 Disclaimer

List of Tables

Structural Heart Occluders – Pipeline Products by Stage of Development 11

Structural Heart Occluders – Pipeline Products by Segment 12

Structural Heart Occluders – Pipeline Products by Territory 13

Structural Heart Occluders – Pipeline Products by Regulatory Path 14

Structural Heart Occluders – Pipeline Products by Estimated Approval Date 15

Structural Heart Occluders – Ongoing Clinical Trials 16

Structural Heart Occluders Companies – Pipeline Products by Stage of Development 17

Structural Heart Occluders – Pipeline Products by Stage of Development 19

Aegis Medical Innovations Inc. Pipeline Products & Ongoing Clinical Trials Overview 21

Aegis Sierra Ligation System – Product Status 21

Aegis Sierra Ligation System – Product Description 21

Aegis Medical Innovations Inc. – Ongoing Clinical Trials Overview 22

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 23

Aporo Biomedical, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 24

Patent Foramen Ovale Closure Device – Product Status 24

Patent Foramen Ovale Closure Device – Product Description 24

Append Medical Pipeline Products & Ongoing Clinical Trials Overview 25

Appligator – Product Status 25

Appligator – Product Description 25

atHeart Medical Pipeline Products & Ongoing Clinical Trials Overview 26

reSept ASD Occluder – Product Status 26

reSept ASD Occluder – Product Description 26

atHeart Medical – Ongoing Clinical Trials Overview 27

reSept ASD Occluder – Evaluation of the Safety and Efficacy of the reSept ASD Occluder to Treat Patients with Clinically Significant Secundum Atrial Septal Defect 28

AuriGen Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 29

12F Aurigen Delivery System – Product Status 29

12F Aurigen Delivery System – Product Description 29

Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 30

WATCHMAN FLX – Product Status 30

WATCHMAN FLX – Product Description 31

Boston Scientific Corp – Ongoing Clinical Trials Overview 32

WATCHMAN FLX – A Pilot Study to Assess WATCHMAN FLX Implants by Cardiac Computed Tomography, Magnetic Resonance Imaging and Transesophageal Echocardiography: WATCHMAN FLX CT 33

WATCHMAN FLX – Comparison of Anticoagulation with Left Atrial Appendage Closure After AF Ablation 33

WATCHMAN FLX – Observe the Safety and Effectiveness of the WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device for Subjects with Non-valvular Atrial Fibrillation to Reduce the Risk of Stroke in Hong Kong Area 33

WATCHMAN FLX – Randomized Comparison of Interventional Closure of the Left Atrial Appendage Using a LAA Closure Device Versus Oral Anticoagulation Therapy in Patients with Non-valvular Atrial Fibrillation and Status Post Intracranial Bleeding 34

WATCHMAN FLX – Safety and Feasibility of Intra-cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion with the Watchman Device: The ICE WATCHMAN Study 34

WATCHMAN FLX – WATCHMAN FLX Versus NOAC for Embolic Protection in in the Management of Patients with Non-Valvular Atrial Fibrillation 34

CARAG AG Pipeline Products & Ongoing Clinical Trials Overview 35

Carag BioResorbable Septal Occluder – Product Status 35

Carag BioResorbable Septal Occluder – Product Description 35

CARAG AG – Ongoing Clinical Trials Overview 36

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 37

Cierra, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 38

PFx Closure System – Product Status 38

PFx Closure System – Product Description 38

Conformal Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 39

CLAAS Device – Product Status 39

CLAAS Device – Product Description 39

Conformal Medical Inc – Ongoing Clinical Trials Overview 40

CLAAS Device – An Evaluation of the Safety and Effectiveness of the Conformal CLAAS System for Left Atrial Appendage Occlusion 41

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 41

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 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

Ension, Inc. Pipeline Products & Ongoing Clinical Trials Overview 46

Atrial Septal Defect Correction Device – Product Status 46

Atrial Septal Defect Correction Device – Product Description 46

Guangdong Pulse Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 47

Leftear Left Atrial Appendage Occluder – Product Status 47

Leftear Left Atrial Appendage Occluder – Product Description 47

Patent Foramen Ovale (PFO) Occluder – Product Status 48

Patent Foramen Ovale (PFO) Occluder – Product Description 48

Hangzhou Dinova EP Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 49

Snowy PFO Closure System – Product Status 49

Snowy PFO Closure System – Product Description 49

Hangzhou Dinova EP Technology Co Ltd – Ongoing Clinical Trials Overview 50

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 51

Hansen Medical Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 52

Sensei Robotic Catheter System – LAA – Product Status 52

Sensei Robotic Catheter System – LAA – Product Description 52

Sensei Robotic Catheter System – PFO Closure – Product Status 53

Sensei Robotic Catheter System – PFO Closure – Product Description 53

Laminar Inc Pipeline Products & Ongoing Clinical Trials Overview 54

Laminar Left Atrial Appendage Closure System – Product Status 54

Laminar Left Atrial Appendage Closure System – Product Description 54

Laminar Inc – Ongoing Clinical Trials Overview 55

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 56

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 56

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 56

Lepu Scientech Medical Technology (Shanghai) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 57

LAA Closure Occluder II – Product Status 57

LAA Closure Occluder II – Product Description 57

MemoSorb ASD Occluder IV – Product Status 58

MemoSorb ASD Occluder IV – Product Description 58

MemoSorb PFO Occluder II – Product Status 58

MemoSorb PFO Occluder II – Product Description 59

Lifetech Scientific (Shenzhen) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 60

LAmbre LAA Closure System – Product Status 60

LAmbre LAA Closure System – Product Description 60

Lifetech Scientific (Shenzhen) Co Ltd – Ongoing Clinical Trials Overview 61

LAmbre LAA Closure System – Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF (CORRAL-AF) IDE Registry Trial 62

LAmbre LAA Closure System – Feasibility and Prognostic Role of Percutaneous Left Atrial Appendage Closure in Patients with Heart Failure and Atrial Fibrillation at High Risk for Cerebrovascular Events 62

LAmbre LAA Closure System – LAmbre Left Atrial Appendage Closure System Post-market 2-5 Years Follow-up Study 62

LAmbre LAA Closure System – LifeTech LAmbre Keft Atrial Appendage (LAA) Closure System Post-market Clinical Follow-up 63

LAmbre LAA Closure System – Lifetech LAmbre Left Atrial Appendage Closure System Post-Market Clinical Follow-up Multi-center, Single-arm, Prospective, Post-market study 63

LAmbre LAA Closure System – Lifetech Lambre Left Atrial Appendage Closure System Post-market Registry Single-center, Single-arm, Prospective, Post-market Registry 63

LAmbre LAA Closure System – Safety and Efficacy Study of LAmbre Plus LAA occluder System in Non-valvular Atrial Fibrillation Patients 64

LuSeed Vascular Pipeline Products & Ongoing Clinical Trials Overview 65

LuSeed Intrasaccular Device – LAA Occlusion – Product Status 65

LuSeed Intrasaccular Device – LAA Occlusion – Product Description 65

Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 66

Left Atrial Appendage Closure Device – Product Status 66

Left Atrial Appendage Closure Device – Product Description 66

Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 67

Cardioblate Closure LAA Occlusion Device – Product Status 67

Cardioblate Closure LAA Occlusion Device – Product Description 67

Meril Life Sciences Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 68

Floret BRO – Product Status 68

Floret BRO – Product Description 68

Micro Interventional Devices, Inc. Pipeline Products & Ongoing Clinical Trials Overview 69

Patent Foramen Ovale Fixation Device – Product Status 69

Patent Foramen Ovale Fixation Device – Product Description 69

MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 70

Next Generation WATCHMAN FLX – Product Status 70

Next Generation WATCHMAN FLX – Product Description 70

Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 71

Left Atrial Appendage Occluder – Product Status 71

Left Atrial Appendage Occluder – Product Description 71

Occlutech International AB Pipeline Products & Ongoing Clinical Trials Overview 72

Occlutech Figulla Flex II ASD Occluder – Product Status 72

Occlutech Figulla Flex II ASD Occluder – Product Description 72

Occlutech Figulla Flex UNI – Product Status 73

Occlutech Figulla Flex UNI – Product Description 73

Occlutech Pistol Pusher – Product Status 73

Occlutech Pistol Pusher – Product Description 74

Occlutech International AB – Ongoing Clinical Trials Overview 75

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) 76

Occlutech Figulla Flex II ASD Occluder – International Registry for Secundum Atrial Septal Defects Closure by Using the Occlutech Flex II Device in More than 2000 Patients 76

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 76

Occlutech Figulla Flex II ASD Occluder – Study to Evaluate the Efficacy of Occlutech ASD Occluder in the Treatment of Atrial Septal Defects 77

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 78

SentreHEART Inc Pipeline Products & Ongoing Clinical Trials Overview 79

Eclipse Surgical Left Atrial Appendage Closure Device – Product Status 79

Eclipse Surgical Left Atrial Appendage Closure Device – Product Description 79

LARIAT Suture Delivery Device – Adjunctive Therapy – Product Status 80

LARIAT Suture Delivery Device – Adjunctive Therapy – Product Description 80

SentreHEART Inc – Ongoing Clinical Trials Overview 81

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 82

LARIAT Suture Delivery Device – Adjunctive Therapy – Non-randomized, Multicenter Expanded Use Evaluation of the LARIAT Suture Delivery Device (Appendix 16 to Ongoing Investigation) 82

SeptRx, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 83

SeptRx IPO – Product Status 83

SeptRx IPO – Product Description 83

Shanghai Shenqi Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 84

Left Atrial Appendage Occluder System – Product Status 84

Left Atrial Appendage Occluder System – Product Description 84

Swissimplant AG Pipeline Products & Ongoing Clinical Trials Overview 85

Solysafe Septal Occluder – 10Fr Sheath – Product Status 85

Solysafe Septal Occluder – 10Fr Sheath – Product Description 85

The Chaim Sheba Medical Center Pipeline Products & Ongoing Clinical Trials Overview 86

Left Atrial Appendage Intraatrial Transcatheter Sutureless Closure – Product Status 86

Left Atrial Appendage Intraatrial Transcatheter Sutureless Closure – Product Description 86

University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 87

Bioresorbable Occlusion Device – Product Status 87

Bioresorbable Occlusion Device – Product Description 87

Vascular Closure Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 88

RF Thermal Closure System – Product Status 88

RF Thermal Closure System – Product Description 88

Vascular Concepts Ltd Pipeline Products & Ongoing Clinical Trials Overview 89

VSD (Ventricular Septal Device) – Product Status 89

VSD (Ventricular Septal Device) – Product Description 89

W. L. Gore & Associates Inc Pipeline Products & Ongoing Clinical Trials Overview 90

BioTREK – Product Status 90

BioTREK – Product Description 90

Glossary 93

List of Figures

Structural Heart Occluders – Pipeline Products by Stage of Development 11

Structural Heart Occluders – Pipeline Products by Segment 12

Structural Heart Occluders – Pipeline Products by Territory 13

Structural Heart Occluders – Pipeline Products by Regulatory Path 14

Structural Heart Occluders – Pipeline Products by Estimated Approval Date 15

Structural Heart Occluders – Ongoing Clinical Trials 16

Frequently Asked Questions

The key segments in the structural heart occluders products pipeline market are left atrial appendage closure devices, patent foramen ovale closure devices, atrial septal defect occluders, and ventricular septal defect occluders.

The United States, Europe, Global, China, Canada, Japan, South Korea, El Salvador, Costa Rica, and others are some of the key territories with structural heart occluders in the pipeline.

The US leads the structural heart occluders pipeline market in terms of the number of products.

Some of the key regulatory paths followed by the structural heart occluders pipeline products market are PMA, NMPA, CE, Shonin, MDL, NIFDS, HAS, ICAC, and MDA.

Most of the products follow the PMA pathway to enter the structural heart occluders market.

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