Published : Aug-2017
No. of Pages : 79
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. Company Overview 27
5.3.1 CardioDex Ltd. Pipeline Products & Ongoing Clinical Trials Overview 27
5.4 CloSys Corp Company Overview 28
5.4.1 CloSys Corp Pipeline Products & Ongoing Clinical Trials Overview 28
5.5 Cook Medical Inc Company Overview 29
5.5.1 Cook Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 29
5.6 CPC of America Inc Company Overview 30
5.6.1 CPC of America Inc Pipeline Products & Ongoing Clinical Trials Overview 30
5.7 Essential Medical Inc Company Overview 31
5.7.1 Essential Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 31
5.8 Harvard University Company Overview 36
5.8.1 Harvard University Pipeline Products & Ongoing Clinical Trials Overview 36
5.9 Mayo Clinic US Company Overview 37
5.9.1 Mayo Clinic US Pipeline Products & Ongoing Clinical Trials Overview 37
5.10 ProMed, Inc. Company Overview 38
5.10.1 ProMed, Inc. Pipeline Products & Ongoing Clinical Trials Overview 38
5.11 Rex Medical LP Company Overview 39
5.11.1 Rex Medical LP Pipeline Products & Ongoing Clinical Trials Overview 39
5.12 Sheba Medical Center Company Overview 40
5.12.1 Sheba Medical Center Pipeline Products & Ongoing Clinical Trials Overview 40
5.13 Terumo Corp Company Overview 41
5.13.1 Terumo Corp Pipeline Products & Ongoing Clinical Trials Overview 41
5.14 Transluminal Technologies LLC Company Overview 42
5.14.1 Transluminal Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 42
5.15 University of Rochester Company Overview 43
5.15.1 University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 43
5.16 Vascular Closure Systems, Inc. Company Overview 44
5.16.1 Vascular Closure Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 44
5.17 Vascular Solutions Inc Company Overview 47
5.17.1 Vascular Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 47
5.18 Vivasure Medical Ltd. Company Overview 48
5.18.1 Vivasure Medical Ltd. Pipeline Products & Ongoing Clinical Trials Overview 48
6 Arteriotomy Closure Devices- Recent Developments 51
6.1 May 12, 2017: Boston Scientific Announces Positive European Registry Results For WATCHMAN Left Atrial Appendage Closure Device 51
6.2 May 10, 2017: Boston Scientific to Present Data On WATCHMAN Left Atrial Appendage System at EuroPCR 2017 51
6.3 May 01, 2017: Cardinal Health Reports Third-quarter Results for Fiscal Year 2017 52
6.4 Apr 18, 2017: Cardinal Health updates fiscal 2017 guidance; Provides early outlook for future fiscal years 53
6.5 Mar 13, 2017: Cook Medical Announces Umesh Patel as President of Cook Biotech 54
6.6 Mar 07, 2017: Anteo Technologies Announces Verification Study With Cook Medical Australia 54
6.7 Feb 07, 2017: Cardinal Health Reports Second-quarter Results for Fiscal Year 2017 55
6.8 Jan 30, 2017: Memorial City Cardiology Associates Among First to Offer Breakthrough Atrial Fibrillation Treatment 56
6.9 Jan 09, 2017: Cardinal Health Reaches Settlement With West Virginia 57
6.10 Dec 23, 2016: Cardinal Health Announces Civil Settlement with DOJ 57
6.11 Dec 12, 2016: Essential Medical Announces the Successful Initiation of the U.S. MANTA Vascular Closure Device Trial With the First Patients Enrolled in TAVR and EVAR Cases 58
6.12 Nov 07, 2016: Essential Medical Announces Successful Live Case at TCT 59
6.13 Nov 02, 2016: Boston Scientific Announces Initial U.S. Commercial Performance Of The WATCHMAN Left Atrial Appendage Closure Device 59
6.14 Oct 31, 2016: Cardinal Health Reports First-quarter Results for Fiscal Year 2017 60
6.15 Oct 26, 2016: Vivasure Medical Appoints Robert Hance to Companys Board of Directors 61
6.16 Oct 24, 2016: Boston Scientific announced key Presentations on WATCHMAN Left Atrial Appendage System at Transcatheter Cardiovascular Therapeutics 2016 62
6.17 Oct 24, 2016: New study compares different approaches for stroke prevention in patients with non-valvular atrial fibrillation 63
6.18 Oct 24, 2016: Vascular Solutions Reports Third Quarter Results 64
6.19 Oct 19, 2016: St. Jude Medical Reports Third Quarter 2016 Results 67
6.20 Oct 11, 2016: SentreHEART Announces First Clinical Use of the Eclipse Surgical Left Atrial Appendage Closure Device 68
6.21 Sep 26, 2016: Jon Giacomin of Cardinal Health Elected Chairman of HDA Board of Directors 69
6.22 Aug 31, 2016: Rose Medical Center among First Hospitals in Colorado Offering Alternative to Long-Term Warfarin Medication with Newly Approved WATCHMAN LAAC Implant 69
6.23 Aug 31, 2016: Cook Medical Names Jean-Marc Creissel Vice President of Operations in Greater China 70
6.24 Aug 08, 2016: InSeal Medical Announces CE Mark Approval for the InClosure Large Bore Vascular Closure Device 70
6.25 Aug 02, 2016: Cardinal Health Reports Q4 And Fiscal 2016 Results, Provides Fiscal 2017 Outlook 71
6.26 Aug 01, 2016: Essential Medical Announces FDA Approval to Begin a U.S. Clinical Trial for the X-Seal 6F Vascular Closure Device 73
6.27 Jul 25, 2016: Vascular Solutions Reports Second Quarter Results 73
7 Appendix 76
7.1 Methodology 76
7.2 About GlobalData 79
7.3 Contact Us 79
7.4 Disclaimer 79
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 Left Atrial Appendage System - Product Status 17
Table 14: WATCHMAN Left Atrial Appendage System - Product Description 18
Table 15: Boston Scientific Corp - Ongoing Clinical Trials Overview 19
Table 16: 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 21
Table 17: WATCHMAN Left Atrial Appendage System - AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled Trial 21
Table 18: WATCHMAN Left Atrial Appendage System - Assessment of the Watchman Device in Patients Unsuitable for Oral Anticoagulation: ASAP-TOO 21
Table 19: WATCHMAN Left Atrial Appendage System - China Registry of WATCHMAN Left Atrial Appendage Closure for Non-valvular Atrial Fibrillation 22
Table 20: WATCHMAN Left Atrial Appendage System - Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage 22
Table 21: WATCHMAN Left Atrial Appendage System - Comparison of Safety and Efficacy of Left Atrial Appendage Occlusion Devices 22
Table 22: WATCHMAN Left Atrial Appendage System - Continued Access To PREVAIL (CAP2)- Watchman Left Atrial Appendage (LAA) Closure Technology 23
Table 23: WATCHMAN Left Atrial Appendage System - Interventional Left Atrial Appendage Closure Vs. Novel Anticoagulation Agents in High-risk Patients with Atrial Fibrillation (PRAGUE-17 Study) 23
Table 24: WATCHMAN Left Atrial Appendage System - Left Atrial Appendage Closure Compared to Standard Antiplatelet Therapy in Patients With AF Who Underwent Percutaneous Coronary Intervention 23
Table 25: 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 26: WATCHMAN Left Atrial Appendage System - Registry on WATCHMAN Outcomes in Real-life Utilization 24
Table 27: WATCHMAN Left Atrial Appendage System - Registry on WATCHMAN Outcomes in Real-Life Utilization WASP Registry 24
Table 28: WATCHMAN Left Atrial Appendage System - The Evaluation of Thrombogenicity in Patients Undergoing WATCHMAN Left Atrial Appendage Closure Trial 25
Table 29: WATCHMAN Left Atrial Appendage System - The Strategy to Prevent Hemorrhage Associated with Anticoagulation in Renal Disease Management (STOP HARM) Trial 25
Table 30: 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) 25
Table 31: WATCHMAN Left Atrial Appendage System - WATCHMAN for Patients with Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement 26
Table 32: CardioDex Ltd. Pipeline Products & Ongoing Clinical Trials Overview 27
Table 33: EpiClose Plus - Product Status 27
Table 34: EpiClose Plus - Product Description 27
Table 35: CloSys Corp Pipeline Products & Ongoing Clinical Trials Overview 28
Table 36: CloSys HD - Product Status 28
Table 37: CloSys HD - Product Description 28
Table 38: Cook Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 29
Table 39: X-Port Vascular Access Closure Device - Product Status 29
Table 40: X-Port Vascular Access Closure Device - Product Description 29
Table 41: CPC of America Inc Pipeline Products & Ongoing Clinical Trials Overview 30
Table 42: MedClose - Product Status 30
Table 43: MedClose - Product Description 30
Table 44: Essential Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 31
Table 45: MANTA - Product Status 31
Table 46: MANTA - Product Description 31
Table 47: X-Seal - Product Status 32
Table 48: X-Seal - Product Description 32
Table 49: Essential Medical Inc - Ongoing Clinical Trials Overview 33
Table 50: X-Seal - US Clinical Trial for the X-Seal 6F Vascular Closure Device 34
Table 51: MANTA - Pivotal Clinical Study to Evaluate the Safety and Effectiveness of MANTA Vascular Closure Device 35
Table 52: Harvard University Pipeline Products & Ongoing Clinical Trials Overview 36
Table 53: Access-Closure Device - Product Status 36
Table 54: Access-Closure Device - Product Description 36
Table 55: Mayo Clinic US Pipeline Products & Ongoing Clinical Trials Overview 37
Table 56: Left Atrial Appendage Closure Device - Product Status 37
Table 57: Left Atrial Appendage Closure Device - Product Description 37
Table 58: ProMed, Inc. Pipeline Products & Ongoing Clinical Trials Overview 38
Table 59: Large Hole Closure Device - Product Status 38
Table 60: Large Hole Closure Device - Product Description 38
Table 61: Rex Medical LP Pipeline Products & Ongoing Clinical Trials Overview 39
Table 62: Auto-Close Vascular Sealing System - Product Status 39
Table 63: Auto-Close Vascular Sealing System - Product Description 39
Table 64: Sheba Medical Center Pipeline Products & Ongoing Clinical Trials Overview 40
Table 65: Left Atrial Appendage Intraatrial Transcatheter Sutureless Closure - Product Status 40
Table 66: Left Atrial Appendage Intraatrial Transcatheter Sutureless Closure - Product Description 40
Table 67: Terumo Corp Pipeline Products & Ongoing Clinical Trials Overview 41
Table 68: Vascular Closure Device - Product Status 41
Table 69: Vascular Closure Device - Product Description 41
Table 70: Transluminal Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 42
Table 71: Velox CD - Product Status 42
Table 72: Velox CD - Product Description 42
Table 73: University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 43
Table 74: Vascular Closure Device - Product Status 43
Table 75: Vascular Closure Device - Product Description 43
Table 76: Vascular Closure Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 44
Table 77: FastSeal Bioabsorbable Vascular Access Closure System - Product Status 44
Table 78: FastSeal Bioabsorbable Vascular Access Closure System - Product Description 44
Table 79: FastSeal Self - Closing Nitinol Clip System - Product Status 45
Table 80: FastSeal Self - Closing Nitinol Clip System - Product Description 45
Table 81: FastSeal Swellable And Bioabsorbable Tubular Plug System - Product Status 45
Table 82: FastSeal Swellable And Bioabsorbable Tubular Plug System - Product Description 46
Table 83: Vascular Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 47
Table 84: Magna Seal - Product Status 47
Table 85: Magna Seal - Product Description 47
Table 86: Vivasure Medical Ltd. Pipeline Products & Ongoing Clinical Trials Overview 48
Table 87: PerQseal - Product Status 48
Table 88: PerQseal - Product Description 48
Table 89: Vivasure Medical Ltd. - Ongoing Clinical Trials Overview 49
Table 90: PerQseal - Clinical Investigation Plan (CIP) for Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER III Study 50
Table 91: PerQseal - Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER II Study 50
Table 92: Glossary 78
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
