Arteriotomy Closure Devices-Medical Devices Pipeline Assessment, 2017

Table of Contents

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. 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

List of Figure

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

List of Table

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