Arteriotomy Closure Devices Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies

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Published: June 13, 2024 Report Code: GDME1760EPD-ST

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Arteriotomy Closure Devices Pipeline Market Report Overview

Arteriotomy closure devices are used to achieve the hemostasis of an arterial puncture site after an angiography procedure, percutaneous coronary intervention, or a peripheral intervention. Such devices are used to decrease vascular complications and reduce the time to hemostasis and ambulation compared to traditional methods such as manual or mechanical compression.

The arteriotomy closure devices pipeline market research report provides a comprehensive understanding of the pipeline products along with their comparative analysis at various stages of development. The report also includes information about the territories wherein the clinical trials are in progress, the regulatory paths followed by the trials, and the companies associated with the trials.

Key Segments ·       Active Closure Devices

·       Passive Closure Devices
Key Territories ·       The US

·       Europe

·       China

·       Japan

·       Australia
Key Regulatory Paths ·       PMA

·       CE

·       NMPA

·       510(k)

·       MDL

·       Ninsho

·       TGA
Leading Companies ·       Aporo Biomedical, Inc.

·       Arterica Inc

·       CardioDex Ltd (Inactive)

·       CaveoMed GmbH

·       CloSys Corp
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Arteriotomy Closure Devices Pipeline Market Segmentation by Segments

The key segments for the arteriotomy closure devices pipeline market are active closure devices and passive closure devices. As of June 2024, the active closure devices segment accounts for the highest share of pipeline products.

Arteriotomy Closure Devices Pipeline Market Analysis by Segments, 2024 (%)

Arteriotomy Closure Devices Pipeline Market Analysis by Segments, 2024 (%)

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Arteriotomy Closure Devices Pipeline Market Segmentation by Territories

A few of the key territories with the arteriotomy closure devices pipeline market are the US, Europe, China, Japan, and Australia. As of June 2024, the US accounts for the highest number of pipeline products.

Arteriotomy Closure Devices Pipeline Market Analysis by Territories, 2024 (%)

Arteriotomy Closure Devices Pipeline Market Analysis by Territories, 2024 (%)

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Arteriotomy Closure Devices Pipeline Market Segmentation by Regulatory Paths

A few of the key regulatory paths in the arteriotomy closure devices pipeline products market are PMA, CE, NMPA, 510(k), MDL, Ninsho, and TGA. As of June 2024, PMA Is the most followed pathway for pipeline products in the arteriotomy closure devices market.

Arteriotomy Closure Devices Pipeline Market Analysis by Regulatory Paths, 2024 (%)

Arteriotomy Closure Devices Pipeline Market Analysis by Regulatory Paths, 2024 (%)

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Arteriotomy Closure Devices Pipeline Market – Competitive Landscape

A few of the key companies associated with the arteriotomy closure devices pipeline market are Aporo Biomedical, Inc., Arterica Inc, CardioDex Ltd, CaveoMed GmbH, and CloSys Corp, among others.

Aporo Biomedical, Inc: ABI is headquartered in California, the US. It is a privately held medical device company engaged in the development of transformative closure technologies for cardiovascular and vascular therapies. The company seeks to leverage unique materials for devices to facilitate healing minimally invasively, and then biodegrade to leave no trace behind.

CardioDex Ltd.: CardioDex is headquartered at Cesarea, in Haifa, Israel. It is a medical product manufacturing company that manufactures and markets devices and disposable solutions for the closure of arterial access. The company’s products do not use any glue, collagen, suturing, or other foreign materials that can create a clinical reaction and do not deposit any residual material.

Arteriotomy Closure Devices Pipeline Market Analysis by Companies, 2024

Arteriotomy Closure Devices Pipeline Market Analysis by Companies, 2024

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Segments Covered in the Report

Arteriotomy Closure Devices Pipeline Market Segments Outlook (2024)

  • Active Closure Devices
  • Passive Closure Devices

Arteriotomy Closure Devices Pipeline Market Territories Outlook (2024)

  • The US
  • Europe
  • China
  • Japan
  • Australia

Arteriotomy Closure Devices Pipeline Market Regulatory Paths Outlook (2024)

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

Scope

This report provides:

  • Extensive coverage of the arteriotomy closure devices under development.

  • Exhaustive list of major pipeline products and their details, including product description, licensing and collaboration details, and other developmental activities.

  • Reviews of major players involved in the development of arteriotomy closure devices and lists all their pipeline projects.

  • Coverage of pipeline products based on various stages of development ranging from early development to approved/issued stage.

  • Key clinical trial data of ongoing clinical trials specific to pipeline products.

  • Recent developments in the segment/industry.

Reasons to Buy

  • 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 arteriotomy closure devices under development.

  • Develop market-entry and market-expansion strategies.

  • Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline.

  • Carry out an in-depth analysis of the product’s current stage of development, territory, and estimated launch date.

Aporo Biomedical, Inc. (Inactive)
Arterica Inc
CardioDex Ltd (Inactive)
CaveoMed GmbH
CloSys Corp
CPC of America Inc
CyndRX LLC
Dextera Surgical Inc
Genesis MedTech International Pvt Ltd
Harvard University
Lepu Medical Technology (Beijing) Co Ltd
Nanjing SealMed Medical Technology Corp Ltd
NewMed Medical Co Ltd
ProMed Inc
Rex Medical LP
Shanghai HeartCare Medical Technology Co Ltd
Spiorad Medical Ltd
Terumo Interventional Systems
University of Rochester
Vascular Closure Systems Inc
Vivasure Medical Ltd.
Zylox-Tonbridge Medical Technology Co Ltd

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 5

|1.2 List of Figures 8

2 Introduction 9

2.1 Arteriotomy Closure Devices Overview 9

3 Products under Development 10

3.1 Arteriotomy Closure Devices – Pipeline Products by Stage of Development 10

3.2 Arteriotomy Closure Devices – Pipeline Products by Segment 11

3.3 Arteriotomy Closure Devices – Pipeline Products by Territory 12

3.4 Arteriotomy Closure Devices – Pipeline Products by Regulatory Path 13

3.5 Arteriotomy Closure Devices – Pipeline Products by Estimated Approval Date 14

3.6 Arteriotomy Closure Devices – Ongoing Clinical Trials 15

4 Arteriotomy Closure Devices – Pipeline Products under Development by Companies 16

4.1 Arteriotomy Closure Devices Companies – Pipeline Products by Stage of Development 16

4.2 Arteriotomy Closure Devices – Pipeline Products by Stage of Development 17

5 Arteriotomy Closure Devices Companies and Product Overview 18

5.1 Aporo Biomedical, Inc. (Inactive) Company Overview 18

5.1.1 Aporo Biomedical, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 18

5.2 Arterica Inc Company Overview 19

5.2.1 Arterica Inc Pipeline Products & Ongoing Clinical Trials Overview 19

5.3 CardioDex Ltd (Inactive) Company Overview 20

5.3.1 CardioDex Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 20

5.4 CaveoMed GmbH Company Overview 21

5.4.1 CaveoMed GmbH Pipeline Products & Ongoing Clinical Trials Overview 21

5.5 CloSys Corp Company Overview 23

5.5.1 CloSys Corp Pipeline Products & Ongoing Clinical Trials Overview 23

5.6 CPC of America Inc Company Overview 24

5.6.1 CPC of America Inc Pipeline Products & Ongoing Clinical Trials Overview 24

5.7 CyndRX LLC Company Overview 25

5.7.1 CyndRX LLC Pipeline Products & Ongoing Clinical Trials Overview 25

5.8 Dextera Surgical Inc Company Overview 26

5.8.1 Dextera Surgical Inc Pipeline Products & Ongoing Clinical Trials Overview 26

5.9 Genesis MedTech International Pvt Ltd Company Overview 27

5.9.1 Genesis MedTech International Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 27

5.10 Harvard University Company Overview 30

5.10.1 Harvard University Pipeline Products & Ongoing Clinical Trials Overview 30

5.11 Lepu Medical Technology (Beijing) Co Ltd Company Overview 31

5.11.1 Lepu Medical Technology (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 31

5.12 Nanjing SealMed Medical Technology Corp Ltd Company Overview 32

5.12.1 Nanjing SealMed Medical Technology Corp Ltd Pipeline Products & Ongoing Clinical Trials Overview 32

5.13 NewMed Medical Co Ltd Company Overview 33

5.13.1 NewMed Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 33

5.14 ProMed Inc Company Overview 34

5.14.1 ProMed Inc Pipeline Products & Ongoing Clinical Trials Overview 34

5.15 Rex Medical LP Company Overview 35

5.15.1 Rex Medical LP Pipeline Products & Ongoing Clinical Trials Overview 35

5.16 Shanghai HeartCare Medical Technology Co Ltd Company Overview 37

5.16.1 Shanghai HeartCare Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 37

5.17 Spiorad Medical Ltd Company Overview 38

5.17.1 Spiorad Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 38

5.18 Terumo Interventional Systems Company Overview 39

5.18.1 Terumo Interventional Systems Pipeline Products & Ongoing Clinical Trials Overview 39

5.19 University of Rochester Company Overview 40

5.19.1 University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 40

5.20 Vascular Closure Systems Inc Company Overview 41

5.20.1 Vascular Closure Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 41

5.21 Vivasure Medical Ltd. Company Overview 44

5.21.1 Vivasure Medical Ltd. Pipeline Products & Ongoing Clinical Trials Overview 44

5.22 Zylox-Tonbridge Medical Technology Co Ltd Company Overview 51

5.22.1 Zylox-Tonbridge Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 51

6 Arteriotomy Closure Devices- Recent Developments 54

6.1 Apr 15, 2024: Vivasure Medical Announces First Large Hole Venous Patient Treated with PerQseal Elite Vascular Closure System 54

6.2 Dec 12, 2023: Vivasure Medical Announces First Patients Treated with PerQseal Elite Closure Device System 54

6.3 Nov 17, 2023: Teleflex enrols first patient in MANTA device trial 55

6.4 Nov 14, 2023: Vivasure Medical Announces 100th Patient Enrolled in U.S. Pivotal Study 56

6.5 Aug 29, 2023: Haemonetics Announces European Expansion for VASCADE Vascular Closure System 56

7 Appendix 58

7.1 Methodology 58

7.2 About GlobalData 61

7.3 Contact Us 61

7.4 Disclaimer 61

Table

Arteriotomy Closure Devices – Pipeline Products by Stage of Development 10

Arteriotomy Closure Devices – Pipeline Products by Segment 11

Arteriotomy Closure Devices – Pipeline Products by Territory 12

Arteriotomy Closure Devices – Pipeline Products by Regulatory Path 13

Arteriotomy Closure Devices – Pipeline Products by Estimated Approval Date 14

Arteriotomy Closure Devices – Ongoing Clinical Trials 15

Arteriotomy Closure Devices Companies – Pipeline Products by Stage of Development 16

Arteriotomy Closure Devices – Pipeline Products by Stage of Development 17

Aporo Biomedical, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 18

Femoral Artery Closure Device – Product Status 18

Femoral Artery Closure Device – Product Description 18

Arterica Inc Pipeline Products & Ongoing Clinical Trials Overview 19

Arterica System – Product Status 19

Arterica System – Product Description 19

CardioDex Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 20

EpiClose Plus – Product Status 20

EpiClose Plus – Product Description 20

CaveoMed GmbH Pipeline Products & Ongoing Clinical Trials Overview 21

CaveoVasc XL – Product Status 21

CaveoVasc XL – Product Description 21

CaveoVenous – Product Status 22

CaveoVenous – Product Description 22

CloSys Corp Pipeline Products & Ongoing Clinical Trials Overview 23

CloSys HD – Product Status 23

CloSys HD – Product Description 23

CPC of America Inc Pipeline Products & Ongoing Clinical Trials Overview 24

MedClose – Product Status 24

MedClose – Product Description 24

CyndRX LLC Pipeline Products & Ongoing Clinical Trials Overview 25

Absorbaseal Vascular Closure Device – Product Status 25

Absorbaseal Vascular Closure Device – Product Description 25

Dextera Surgical Inc Pipeline Products & Ongoing Clinical Trials Overview 26

X-Port Vascular Access Closure Device – Product Status 26

X-Port Vascular Access Closure Device – Product Description 26

Genesis MedTech International Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 27

SureClose Vascular Closure Device – Product Status 27

SureClose Vascular Closure Device – Product Description 27

Genesis MedTech International Pvt Ltd – Ongoing Clinical Trials Overview 28

SureClose Vascular Closure Device – Clinical First in Man Study of the Safety and Performance of the Genesis Medtech Innovation Private Limited Sureclose Vascular Closure Device (VCD) for use In Closing Femoral Access Sites 29

Harvard University Pipeline Products & Ongoing Clinical Trials Overview 30

Access-Closure Device – Product Status 30

Access-Closure Device – Product Description 30

Lepu Medical Technology (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 31

Vascular Closure Device System – Product Status 31

Vascular Closure Device System – Product Description 31

Nanjing SealMed Medical Technology Corp Ltd Pipeline Products & Ongoing Clinical Trials Overview 32

Vascular Closure Device – Product Status 32

Vascular Closure Device – Product Description 32

NewMed Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 33

Suture-Mediated Closure System – Product Status 33

Suture-Mediated Closure System – Product Description 33

ProMed Inc Pipeline Products & Ongoing Clinical Trials Overview 34

Large Hole Closure Device – Product Status 34

Large Hole Closure Device – Product Description 34

Rex Medical LP Pipeline Products & Ongoing Clinical Trials Overview 35

Auto-Close Vascular Sealing System – Product Status 35

Auto-Close Vascular Sealing System – Product Description 35

Large Bore Closer Vascular Sealing System – Product Status 36

Large Bore Closer Vascular Sealing System – Product Description 36

Shanghai HeartCare Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 37

Vascular Stapler Device – Product Status 37

Vascular Stapler Device – Product Description 37

Spiorad Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 38

Femoral Artery Access Site Closure Device – Product Status 38

Femoral Artery Access Site Closure Device – Product Description 38

Terumo Interventional Systems Pipeline Products & Ongoing Clinical Trials Overview 39

Radial Access Closure Device – Product Status 39

Radial Access Closure Device – Product Description 39

University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 40

Vascular Closure Device – Product Status 40

Vascular Closure Device – Product Description 40

Vascular Closure Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 41

FastSeal Bioabsorbable Vascular Access Closure System – Product Status 41

FastSeal Bioabsorbable Vascular Access Closure System – Product Description 41

FastSeal Bioabsorbable Vascular Access Closure System – 18 Fr – Product Status 42

FastSeal Bioabsorbable Vascular Access Closure System – 18 Fr – Product Description 42

FastSeal Self – Closing Nitinol Clip System – Product Status 42

FastSeal Self – Closing Nitinol Clip System – Product Description 43

FastSeal Swellable And Bioabsorbable Tubular Plug System – Product Status 43

FastSeal Swellable And Bioabsorbable Tubular Plug System – Product Description 43

Vivasure Medical Ltd. Pipeline Products & Ongoing Clinical Trials Overview 44

PerQseal – Product Status 44

PerQseal – Product Description 44

PerQseal Blue – Product Status 45

PerQseal Blue – Product Description 45

PerQseal ELITE – Product Status 45

PerQseal ELITE – Product Description 46

PerQseal+ – Product Status 46

PerQseal+ – Product Description 46

Vivasure Medical Ltd. – Ongoing Clinical Trials Overview 47

PerQseal – A Multicentre, Single-Arm, Pivotal Study to Evaluate the Safety and Efficacy of the Vivasure PerQseal Closure Device System When Used to Achieve Haemostasis of Common Femoral Arteriotomies Created by 12 to 22 F Sheaths in Patients Undergoing Percutaneous Catheter-Based Interventional Procedures 48

PerQseal+ – An Early Feasibility Study Evaluating the Safety and Efficacy of PerQseal+ in Patients Undergoing Percutaneous Transcatheter Aortic Valve Replacement Procedures 49

PerQseal+ – Clinical Investigation Plan (CIP) for Safety and Performance Study of Large Hole Vascular Closure Device – FRONTIER V Study 49

PerQseal ELITE – Clinical Investigation Plan (CIP) for: Safety and Performance Study for Arterial Large Hole Vascular Closure Device – ELITE Study 50

PerQseal ELITE – Safety and Performance Study for Venous Large Hole Vascular Closure Device – ELITE Study 50

Zylox-Tonbridge Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 51

Suture-Mediated Closure System – Product Status 51

Suture-Mediated Closure System – Product Description 51

Zylox-Tonbridge Medical Technology Co Ltd – Ongoing Clinical Trials Overview 52

Suture-Mediated Closure System – A Prospective, Multi-center, Randomized Controlled, Non-inferiority Clinical Trial of the Safety and Efficacy of the Suture-Mediated Closure System for Percutaneous Closure of the Common Femoral Artery Puncture Site 53

Suture-Mediated Closure System – Multi-center, Randomized and Non-inferiority Clinical Trial to Assess Efficacy and Safety of Suture-mediated Closure system 53

Glossary 60

Figures

Arteriotomy Closure Devices – Pipeline Products by Stage of Development 10

Arteriotomy Closure Devices – Pipeline Products by Segment 11

Arteriotomy Closure Devices – Pipeline Products by Territory 12

Arteriotomy Closure Devices – Pipeline Products by Regulatory Path 13

Arteriotomy Closure Devices – Pipeline Products by Estimated Approval Date 14

Arteriotomy Closure Devices – Ongoing Clinical Trials 15

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