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Report Title

Arteriotomy Closure Devices - Medical Devices Pipeline Assessment, 2018

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Arteriotomy Closure Devices - Medical Devices Pipeline Assessment, 2018


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Arteriotomy Closure Devices - Medical Devices Pipeline Assessment, 2018

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Arteriotomy Closure Devices - Medical Devices Pipeline Assessment, 2018



Executive Summary

Arteriotomy Closure Devices-Medical Devices Pipeline Assessment, 2018

Summary

GlobalData's Medical Devices sector report, Arteriotomy Closure Devices-Medical Devices Pipeline Assessment, 2018" provides an overview of Arteriotomy Closure Devices currently in pipeline stage.

The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The report reviews major players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Arteriotomy Closure Devices pipeline products.

This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData's team of industry experts.

*Note: Certain sections in the report may be removed or altered based on the availability and relevance of data in relation to the equipment type.

Scope

- Extensive coverage of the Arteriotomy Closure 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 Arteriotomy Closure Devices and list all their pipeline projects

- The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage

- The report provides key clinical trial data of ongoing trials specific to pipeline products

- Recent developments in the segment / industry

Reasons to buy

The report enables you to-

- Formulate significant competitor information, analysis, and insights to improve R&D strategies

- Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain 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

- In-depth analysis of the product's current stage of development, territory and estimated launch date

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 4

1.2 List of Figures 6

2 Introduction 7

2.1 Arteriotomy Closure Devices Overview 7

3 Products under Development 8

3.1 Arteriotomy Closure Devices-Pipeline Products by Stage of Development 8

3.2 Arteriotomy Closure Devices-Pipeline Products by Segment 9

3.3 Arteriotomy Closure Devices-Pipeline Products by Territory 10

3.4 Arteriotomy Closure Devices-Pipeline Products by Regulatory Path 11

3.5 Arteriotomy Closure Devices-Pipeline Products by Estimated Approval Date 12

3.6 Arteriotomy Closure Devices-Ongoing Clinical Trials 13

4 Arteriotomy Closure Devices-Pipeline Products under Development by Companies 14

4.1 Arteriotomy Closure Devices Companies-Pipeline Products by Stage of Development 14

4.2 Arteriotomy Closure Devices-Pipeline Products by Stage of Development 15

5 Arteriotomy Closure Devices Companies and Product Overview 16

5.1 Aporo Biomedical, Inc. (Inactive) Company Overview 16

5.1.1 Aporo Biomedical, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 16

5.2 Boston Scientific Corp Company Overview 17

5.2.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 17

5.3 CardioDex Ltd (Inactive) Company Overview 30

5.3.1 CardioDex Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 30

5.4 CloSys Corp Company Overview 31

5.4.1 CloSys Corp Pipeline Products & Ongoing Clinical Trials Overview 31

5.5 Cook Medical Inc Company Overview 32

5.5.1 Cook Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 32

5.6 CPC of America Inc Company Overview 33

5.6.1 CPC of America Inc Pipeline Products & Ongoing Clinical Trials Overview 33

5.7 Essential Medical Inc Company Overview 34

5.7.1 Essential Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 34

5.8 Harvard University Company Overview 39

5.8.1 Harvard University Pipeline Products & Ongoing Clinical Trials Overview 39

5.9 Mayo Clinic Company Overview 40

5.9.1 Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 40

5.10 ProMed, Inc. Company Overview 41

5.10.1 ProMed, Inc. Pipeline Products & Ongoing Clinical Trials Overview 41

5.11 Rex Medical LP Company Overview 42

5.11.1 Rex Medical LP Pipeline Products & Ongoing Clinical Trials Overview 42

5.12 Sheba Medical Center Company Overview 43

5.12.1 Sheba Medical Center Pipeline Products & Ongoing Clinical Trials Overview 43

5.13 Terumo Interventional Systems Company Overview 44

5.13.1 Terumo Interventional Systems Pipeline Products & Ongoing Clinical Trials Overview 44

5.14 University of Rochester Company Overview 45

5.14.1 University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 45

5.15 Vascular Closure Systems Inc Company Overview 46

5.15.1 Vascular Closure Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 46

5.16 Vivasure Medical Ltd. Company Overview 49

5.16.1 Vivasure Medical Ltd. Pipeline Products & Ongoing Clinical Trials Overview 49

6 Arteriotomy Closure Devices- Recent Developments 52

6.1 May 16, 2018: Boston Scientific Announces Schedule of Presentations at EuroPCR 2018 52

6.2 May 14, 2018: Vivasure Medical to exhibit at EuroPCR 2018 53

6.3 May 07, 2018: Cardiva Medical Announces Completion of the AMBULATE Pivotal Trial 53

6.4 May 04, 2018: Ross Harvey named new director of global Customer Support & Delivery at Cook Medical 54

6.5 May 03, 2018: Cardinal Health Announces Third-quarter Results for Fiscal Year 2018 55

6.6 Apr 20, 2018: Cook Medical Appoints Christina Anne Vice President of Distribution Channel Management 56

6.7 Apr 09, 2018: Houston Methodist The Woodlands Hospital is first hospital in The Woodlands to offer an alternative to long-term warfarin medication to reduce the risk of stroke 56

6.8 Apr 05, 2018: Cardiva Medical Announces FDA Approval of VASCADE Vascular Closure System for Use in Femoral Vein Closure 57

6.9 Mar 23, 2018: JenaValve Technology Appoints Keith D Dawkins MD as Board Member 58

6.10 Mar 15, 2018: Concord Hospital Offers WATCHMAN Device for Patients with Atrial fibrillation 58

6.11 Feb 08, 2018: Cardinal Health Reports Second-quarter Results for Fiscal Year 2018 59

6.12 Feb 07, 2018: Cardinal Health Adds Akhil Johri to its Board of Directors 61

6.13 Feb 02, 2018: JenaValve Technology Appoints Laura A Brenton as Vice President of Clinical and International Market Development 61

6.14 Jan 08, 2018: MANTA Large Bore Vascular Closure Device IDE Study Completes 60-day Patient Follow up, Clearing the Way to FDA Submission 61

6.15 Nov 06, 2017: Cardinal Health Reports First-quarter Results for Fiscal Year 2018 62

6.16 Nov 06, 2017: Cardinal Health Outlines Leadership Succession Plan 63

6.17 Nov 02, 2017: Five-year Follow-up Data Demonstrate the WATCHMAN Left Atrial Appendage Closure Device Provides Stroke Risk Reduction Comparable to Warfarin Therapy 67

6.18 Oct 23, 2017: Boston Scientific Presents Clinical Trial Data of WATCHMAN Device at Transcatheter Cardiovascular Therapeutics 2017 67

6.19 Oct 13, 2017: Vivasure Enrolls First Patient in Frontier IV Clinical Trial 68

6.20 Oct 09, 2017: The MANTA Large Bore Vascular Closure Device to be Evaluated in a 500-patient European Post Market Clinical Registry 69

6.21 Oct 02, 2017: Essential Medical Completes Enrollment in US IDE Trial for the MANTA Large Bore Vascular Closure Device Used Primarily in Percutaneous Heart Valve Replacement Procedures 70

6.22 Sep 19, 2017: Vivasure Medical to present their PerQseal technology at PCR London Valves 2017 70

6.23 Sep 12, 2017: Vasorum Launches Celt ACD Second Generation Vascular Closure Device in the USA 71

6.24 Aug 08, 2017: Essential Medical Marks First 1,000 MANTA Cases and Expands Production Capacity 71

6.25 Aug 02, 2017: Cardinal Health Reports Q4 and Fiscal 2017 Results, Provides 2018 Guidance 72

7 Appendix 74

7.1 Methodology 74

7.2 About GlobalData 77

7.3 Contact Us 77

7.4 Disclaimer 77

To know more information on Purchase by Section, please send a mail to sales@kenresearch.com

1.2 List of Figures

Figure 1: Arteriotomy Closure Devices-Pipeline Products by Stage of Development 8

Figure 2: Arteriotomy Closure Devices-Pipeline Products by Segment 9

Figure 3: Arteriotomy Closure Devices-Pipeline Products by Territory 10

Figure 4: Arteriotomy Closure Devices-Pipeline Products by Regulatory Path 11

Figure 5: Arteriotomy Closure Devices-Pipeline Products by Estimated Approval Date 12

Figure 6: Arteriotomy Closure Devices-Ongoing Clinical Trials 13

1.1 List of Tables

Table 1: Arteriotomy Closure Devices-Pipeline Products by Stage of Development 8

Table 2: Arteriotomy Closure Devices-Pipeline Products by Segment 9

Table 3: Arteriotomy Closure Devices-Pipeline Products by Territory 10

Table 4: Arteriotomy Closure Devices-Pipeline Products by Regulatory Path 11

Table 5: Arteriotomy Closure Devices-Pipeline Products by Estimated Approval Date 12

Table 6: Arteriotomy Closure Devices-Ongoing Clinical Trials 13

Table 7: Arteriotomy Closure Devices Companies-Pipeline Products by Stage of Development 14

Table 8: Arteriotomy Closure Devices-Pipeline Products by Stage of Development 15

Table 9: Aporo Biomedical, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 16

Table 10: Femoral Artery Closure Device-Product Status 16

Table 11: Femoral Artery Closure Device-Product Description 16

Table 12: Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 17

Table 13: WATCHMAN Device-Oral Anticoagulation-Product Status 17

Table 14: WATCHMAN Device-Oral Anticoagulation-Product Description 17

Table 15: WATCHMAN FLX-Product Status 18

Table 16: WATCHMAN FLX-Product Description 18

Table 17: WATCHMAN Left Atrial Appendage System-Product Status 18

Table 18: WATCHMAN Left Atrial Appendage System-Product Description 19

Table 19: Boston Scientific Corp-Ongoing Clinical Trials Overview 20

Table 20: WATCHMAN Left Atrial Appendage System-A Prospective, Multi-center, Pilot Study to Compare the Safety and Effectiveness of WATCHMAN Left Atrial Appendage Occlusion Device with Rivaroxaban for Stroke Prevention in Patients with Atrial Fibrillation 22

Table 21: WATCHMAN Left Atrial Appendage System-AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled Trial 22

Table 22: WATCHMAN Left Atrial Appendage System-China Registry of WATCHMAN Left Atrial Appendage Closure for Non-valvular Atrial Fibrillation 22

Table 23: WATCHMAN Left Atrial Appendage System-Comparison of Amplatzer Amulet vs. Watchman Device in Patients Undergoing Left Atrial Appendage Closure: the SWISS-APERO Randomized Clinical Trial 23

Table 24: WATCHMAN Left Atrial Appendage System-Comparison of Safety and Efficacy of Left Atrial Appendage Occlusion Devices 23

Table 25: WATCHMAN Left Atrial Appendage System-Continued Access To PREVAIL (CAP2)- Watchman Left Atrial Appendage (LAA) Closure Technology 23

Table 26: WATCHMAN Left Atrial Appendage System-Interventional Left Atrial Appendage Closure Vs. Novel Anticoagulation Agents in High-risk Patients with Atrial Fibrillation (PRAGUE-17 Study) 24

Table 27: WATCHMAN Left Atrial Appendage System-Left Atrial Appendage Closure Compared to Standard Antiplatelet Therapy in Patients with AF Who Underwent Percutaneous Coronary Intervention 24

Table 28: WATCHMAN Left Atrial Appendage System-Long Term Clinical Outcomes of Left Atrial Appendage Occlusion Versus New Oral Anticoagulants for Stroke Prevention in Patients with Non-valvular Atrial Fibrillation: From Korean Multicenter Registry 24

Table 29: WATCHMAN Left Atrial Appendage System-Protection Against Embolism for Non-valvular AF Subjects: Investigational Device Evaluation of the Watchman FLX LAA Closure Technology 25

Table 30: WATCHMAN Left Atrial Appendage System-Registry of Left Atrial Appendage Occlusion with WATCHMAN Device in Patients with Non-valvular Atrial Fibrillation and End-stage Chronic Kidney Disease on Hemodialysis 25

Table 31: WATCHMAN Left Atrial Appendage System-Registry on WATCHMAN Outcomes in Real-life Utilization 25

Table 32: WATCHMAN Left Atrial Appendage System-Registry on WATCHMAN Outcomes in Real-Life Utilization WASP Registry 26

Table 33: WATCHMAN Left Atrial Appendage System-The Evaluation of Thrombogenicity in Patients Undergoing WATCHMAN Left Atrial Appendage Closure Trial 26

Table 34: WATCHMAN Left Atrial Appendage System-The WASPS Trails:WATCHMAN for Second Prevention of Stroke 26

Table 35: WATCHMAN Left Atrial Appendage System-Watch Bleeding Episodes after Left Atrial Appendage Occlusion Versus Usual Care in Patients with Atrial Fibrillation and Severe to end-stage Chronic Kidney Disease (WatchAFIB in CKD) 27

Table 36: WATCHMAN Left Atrial Appendage System-Watchman FLX Left Atrial Appendage Closure Device Post Approval Study 27

Table 37: WATCHMAN Left Atrial Appendage System-WATCHMAN for Patients with Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement 27

Table 38: WATCHMAN Left Atrial Appendage System-WaveCrest Versus Watchman Transseptal LAA Closure to Reduce AF-Mediated Stroke 2. A Prospective, Multicenter, Randomized, Active Controlled, Clinical Trial of the Coherex WaveCrest Left Atrial Appendage Occlusion System Compared to the Watchman LAA Closure Device for the Reduction in Risk of Ischemic Stroke or Systemic Embolism in Subjects with Non-valvular Atrial Fibrillation That Have an Appropriate Rationale to Seek a Non-pharmacologic Alternative to Chronic Oral Anticoagulation 28

Table 39: WATCHMAN Device-Oral Anticoagulation-Assessment of the Watchman Device in Patients Unsuitable for Oral Anticoagulation: ASAP-TOO 29

Table 40: CardioDex Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 30

Table 41: EpiClose Plus-Product Status 30

Table 42: EpiClose Plus-Product Description 30

Table 43: CloSys Corp Pipeline Products & Ongoing Clinical Trials Overview 31

Table 44: CloSys HD-Product Status 31

Table 45: CloSys HD-Product Description 31

Table 46: Cook Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 32

Table 47: X-Port Vascular Access Closure Device-Product Status 32

Table 48: X-Port Vascular Access Closure Device-Product Description 32

Table 49: CPC of America Inc Pipeline Products & Ongoing Clinical Trials Overview 33

Table 50: MedClose-Product Status 33

Table 51: MedClose-Product Description 33

Table 52: Essential Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 34

Table 53: MANTA-Product Status 34

Table 54: MANTA-Product Description 34

Table 55: X-Seal-Product Status 35

Table 56: X-Seal-Product Description 35

Table 57: Essential Medical Inc-Ongoing Clinical Trials Overview 36

Table 58: X-Seal-US Clinical Trial for the X-Seal 6F Vascular Closure Device 37

Table 59: MANTA-Post-market Clinical Registry to Evaluate the Safety and Performance of MANTA Vascular Closure Device (VCD) Under Real World Conditions in the European Union (EU) 38

Table 60: MANTA-Safety and Efficacy of Large Bore Vascular Closure Device: A prospective, Multi-center, European Post Market Clinical Study 38

Table 61: Harvard University Pipeline Products & Ongoing Clinical Trials Overview 39

Table 62: Access-Closure Device-Product Status 39

Table 63: Access-Closure Device-Product Description 39

Table 64: Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 40

Table 65: Left Atrial Appendage Closure Device-Product Status 40

Table 66: Left Atrial Appendage Closure Device-Product Description 40

Table 67: ProMed, Inc. Pipeline Products & Ongoing Clinical Trials Overview 41

Table 68: Large Hole Closure Device-Product Status 41

Table 69: Large Hole Closure Device-Product Description 41

Table 70: Rex Medical LP Pipeline Products & Ongoing Clinical Trials Overview 42

Table 71: Auto-Close Vascular Sealing System-Product Status 42

Table 72: Auto-Close Vascular Sealing System-Product Description 42

Table 73: Sheba Medical Center Pipeline Products & Ongoing Clinical Trials Overview 43

Table 74: Left Atrial Appendage Intraatrial Transcatheter Sutureless Closure-Product Status 43

Table 75: Left Atrial Appendage Intraatrial Transcatheter Sutureless Closure-Product Description 43

Table 76: Terumo Interventional Systems Pipeline Products & Ongoing Clinical Trials Overview 44

Table 77: Vascular Closure Device-Product Status 44

Table 78: Vascular Closure Device-Product Description 44

Table 79: University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 45

Table 80: Vascular Closure Device-Product Status 45

Table 81: Vascular Closure Device-Product Description 45

Table 82: Vascular Closure Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 46

Table 83: FastSeal Bioabsorbable Vascular Access Closure System-Product Status 46

Table 84: FastSeal Bioabsorbable Vascular Access Closure System-Product Description 46

Table 85: FastSeal Bioabsorbable Vascular Access Closure System-18 Fr-Product Status 47

Table 86: FastSeal Bioabsorbable Vascular Access Closure System-18 Fr-Product Description 47

Table 87: FastSeal Self-Closing Nitinol Clip System-Product Status 47

Table 88: FastSeal Self-Closing Nitinol Clip System-Product Description 48

Table 89: FastSeal Swellable And Bioabsorbable Tubular Plug System-Product Status 48

Table 90: FastSeal Swellable And Bioabsorbable Tubular Plug System-Product Description 48

Table 91: Vivasure Medical Ltd. Pipeline Products & Ongoing Clinical Trials Overview 49

Table 92: PerQseal-Product Status 49

Table 93: PerQseal-Product Description 49

Table 94: Vivasure Medical Ltd.-Ongoing Clinical Trials Overview 50

Table 95: PerQseal-Expanded Indication Study of Proprietary PerQseal Large Arteriotomy Closure Technology: Frontier IV Clinical Study 51

Table 96: Glossary 76

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Aporo Biomedical, Inc.

Boston Scientific Corp

CardioDex Ltd

CloSys Corp

Cook Medical Inc

CPC of America Inc

Essential Medical Inc

Harvard University

Mayo Clinic

ProMed, Inc.

Rex Medical LP

Sheba Medical Center

Terumo Interventional Systems

University of Rochester

Vascular Closure Systems Inc

Vivasure Medical Ltd.

Aporo Biomedical, Inc. (Inactive), Femoral Artery Closure Device; Boston Scientific Corp, WATCHMAN Device - Oral Anticoagulation; Boston Scientific Corp, WATCHMAN FLX; Boston Scientific Corp, WATCHMAN Left Atrial Appendage System; CardioDex Ltd (Inactive), EpiClose Plus; CloSys Corp, CloSys HD; Cook Medical Inc, X-Port Vascular Access Closure Device; CPC of America Inc, MedClose; Essential Medical Inc, MANTA; Essential Medical Inc, X-Seal; Harvard University, Access-Closure Device; Mayo Clinic, Left Atrial Appendage Closure Device; ProMed, Inc., Large Hole Closure Device; Rex Medical LP, Auto-Close Vascular Sealing System; Sheba Medical Center, Left Atrial Appendage Intraatrial Transcatheter Sutureless Closure; Terumo Interventional Systems, Vascular Closure Device; University of Rochester, Vascular Closure Device; Vascular Closure Systems Inc, FastSeal Bioabsorbable Vascular Access Closure System; Vascular Closure Systems Inc, FastSeal Bioabsorbable Vascular Access Closure System - 18 Fr; Vascular Closure Systems Inc, FastSeal Self - Closing Nitinol Clip System; Vascular Closure Systems Inc, FastSeal Swellable And Bioabsorbable Tubular Plug System; Vivasure Medical Ltd., PerQseal


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