Peripheral Embolic Protection Devices - Medical Devices Pipeline Assessment, 2018

Scope

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 5

1.2 List of Figures 6

2 Introduction 7

2.1 Peripheral Embolic Protection Devices Overview 7

3 Products under Development 8

3.1 Peripheral Embolic Protection Devices-Pipeline Products by Stage of Development 8

3.2 Peripheral Embolic Protection Devices-Pipeline Products by Segment 9

3.3 Peripheral Embolic Protection Devices-Pipeline Products by Territory 10

3.4 Peripheral Embolic Protection Devices-Pipeline Products by Regulatory Path 11

3.5 Peripheral Embolic Protection Devices-Pipeline Products by Estimated Approval Date 12

3.6 Peripheral Embolic Protection Devices-Ongoing Clinical Trials 13

4 Peripheral Embolic Protection Devices-Pipeline Products under Development by Companies 14

4.1 Peripheral Embolic Protection Devices Companies-Pipeline Products by Stage of Development 14

4.2 Peripheral Embolic Protection Devices-Pipeline Products by Stage of Development 15

5 Peripheral Embolic Protection Devices Companies and Product Overview 16

5.1 Abbott Vascular Inc Company Overview 16

5.1.1 Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 16

5.2 Allium Medical Solutions Ltd Company Overview 17

5.2.1 Allium Medical Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 17

5.3 Avantec Vascular Corp Company Overview 18

5.3.1 Avantec Vascular Corp Pipeline Products & Ongoing Clinical Trials Overview 18

5.4 BTG Plc Company Overview 19

5.4.1 BTG Plc Pipeline Products & Ongoing Clinical Trials Overview 19

5.5 Cardio-Flow Ltd. Company Overview 23

5.5.1 Cardio-Flow Ltd. Pipeline Products & Ongoing Clinical Trials Overview 23

5.6 CardioGard Ltd. Company Overview 24

5.6.1 CardioGard Ltd. Pipeline Products & Ongoing Clinical Trials Overview 24

5.7 Emboline, Inc. Company Overview 27

5.7.1 Emboline, Inc. Pipeline Products & Ongoing Clinical Trials Overview 27

5.8 Filterlex Medical Ltd Company Overview 28

5.8.1 Filterlex Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 28

5.9 Innovative Cardiovascular Solutions, LLC Company Overview 29

5.9.1 Innovative Cardiovascular Solutions, LLC Pipeline Products & Ongoing Clinical Trials Overview 29

5.10 Innovia LLC Company Overview 32

5.10.1 Innovia LLC Pipeline Products & Ongoing Clinical Trials Overview 32

5.11 Keystone Heart Ltd Company Overview 33

5.11.1 Keystone Heart Ltd Pipeline Products & Ongoing Clinical Trials Overview 33

5.12 Medtronic plc Company Overview 37

5.12.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 37

5.13 Metactive Medical LLC Company Overview 38

5.13.1 Metactive Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 38

5.14 MIV Therapeutics Inc Company Overview 39

5.14.1 MIV Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 39

5.15 Neurosonix Ltd. Company Overview 40

5.15.1 Neurosonix Ltd. Pipeline Products & Ongoing Clinical Trials Overview 40

5.16 Protembis GmbH Company Overview 41

5.16.1 Protembis GmbH Pipeline Products & Ongoing Clinical Trials Overview 41

5.17 Shape Memory Therapeutics, Inc. Company Overview 44

5.17.1 Shape Memory Therapeutics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 44

5.18 Trinity College Dublin Company Overview 45

5.18.1 Trinity College Dublin Pipeline Products & Ongoing Clinical Trials Overview 45

5.19 University of Minnesota Company Overview 46

5.19.1 University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 46

5.20 University of Toledo Company Overview 47

5.20.1 University of Toledo Pipeline Products & Ongoing Clinical Trials Overview 47

6 Peripheral Embolic Protection Devices- Recent Developments 48

6.1 May 31, 2018: Keystone Heart Announces First Enrollment in REFLECT Phase II incorporating TriGUARD 3 Cerebral Embolic Protection device 48

6.2 May 24, 2018: Medtronic Reports Fourth Quarter And Fiscal Year 2018 Financial Results 48

6.3 May 21, 2018: FlowTriever System from Inari Medical Receives FDA 510(k) Clearance for Treatment of Pulmonary Embolism 51

6.4 May 17, 2018: Mr. Jonathan Chen Promoted to Chief International Business Officer of MPSC 51

6.5 May 08, 2018: Penumbra Reports First Quarter 2018 Financial Results 52

6.6 May 07, 2018: Medtronic Appoints Mike Weinstein As Senior Vice President Of Strategy 52

6.7 Apr 27, 2018: Prospective Clinical Data on the FlowTriever System Confirms Excellent Results in the Treatment of Pulmonary Embolism 53

6.8 Apr 27, 2018: OPTALYSE PE Results Presented at Society for Cardiovascular Angiography and Interventions 54

6.9 Apr 25, 2018: Boston Scientific Reports Financial Results For First Quarter 2018 55

6.10 Apr 24, 2018: Edwards Lifesciences Announces First Quarter 2018 Financial Results 57

6.11 Apr 05, 2018: Dr. Laura Mauri to Join Medtronic as Vice President, Global Clinical Research & Analytics 58

6.12 Mar 29, 2018: AngioDynamics Reports Fiscal 2018 Third Quarter Financial Results 59

6.13 Mar 28, 2018: MicroPort Scientific Announces 2017 Annual Results 61

6.14 Mar 27, 2018: MicroPort Scientific Announces Year Ended 31 December 2017 Financial Results 62

6.15 Mar 21, 2018: New Biocompatible Particle Embolic Device to Therapeutically Slow or Stop Blood Flow Presented at the 2018 Society of Interventional Radiology (SIR) Conference 63

6.16 Mar 13, 2018: United States Patent and Trademark Office Issues Multiple Patents on New Arterial & Venous Embolic Device to Control Bleeding, Seal Leaks, and De-Vascularize Tumors 64

6.17 Mar 08, 2018: Metactive Medical Awarded USD1.5 Million Grant from the National Institutes of Health 64

6.18 Feb 27, 2018: Penumbra Reports Fourth Quarter and Full Year 2017 Financial Results 65

6.19 Feb 14, 2018: Claret Medical's Sentinel Cerebral Protection System Emerging as U.S. Standard of Care for Protecting the Brain from Risk of Stroke During Transcatheter Aortic Heart Valve Replacement 66

6.20 Feb 06, 2018: OPTALYSE PE Long Term Results Reinforce Safety and Efficacy of Shorter, Lower Dose EKOS Therapy For Pulmonary Embolism 67

6.21 Feb 01, 2018: Boston Scientific Announces Results for Fourth Quarter and Full Year 2017 68

6.22 Feb 01, 2018: Edwards Lifesciences Reports Fourth Quarter Results 70

6.23 Jan 30, 2018: Alex Gu Named Senior Vice President and President of Medtronic's Greater China Region 72

6.24 Jan 09, 2018: Boston Scientific Announces Preliminary Unaudited Sales For The Fourth Quarter And Full Year Ended December 31, 2017 72

6.25 Jan 04, 2018: AngioDynamics Reports Fiscal 2018 Second Quarter Financial Results 73

6.26 Dec 19, 2017: Bob White Named Executive Vice President and President of Medtronic's Minimally Invasive Therapies Group; Chris Lee to Assume Leadership of Medtronic's Asia Pacific Region 74

6.27 Dec 14, 2017: Centers Commence Enrollment in KNOCOUT PE Study to Measure the Impact of Shorter, Even Safer EKOS Therapy Protocols for Pulmonary Embolism 75

6.28 Dec 07, 2017: Edwards Lifesciences Outlines Growth Strategy At Annual Investor Conference 76

6.29 Nov 21, 2017: Medtronic Reports Second Quarter Financial Results 78

6.30 Nov 08, 2017: Medtronic Announces Preliminary Second Quarter Revenue 80

6.31 Nov 07, 2017: Penumbra Reports Third Quarter 2017 Financial Results 81

6.32 Nov 02, 2017: Medtronic Releases Fiscal Year 2017 Integrated Performance Report 82

6.33 Oct 26, 2017: Boston Scientific Announces Results For Third Quarter 2017 83

6.34 Oct 24, 2017: Edwards Lifesciences Announces Third Quarter Results 84

6.35 Oct 19, 2017: Inari Medical Announces Completion of Patient Enrollment in the FLARE Study for the Treatment of Pulmonary Embolism 86

6.36 Oct 18, 2017: Abrazo Arizona Heart and OhioHealth McConnell Heart Hospital To Use MegaVac System 87

6.37 Oct 06, 2017: Medtronic Provides Update on Impact from Hurricane Maria 87

6.38 Oct 05, 2017: Capture Continues with New Clinical Cases for its MegaVacTM Mechanical Thrombectomy System-ATK 88

6.39 Oct 04, 2017: Boston Scientific Appoints Desiree Ralls-Morrison General Counsel and Corporate Secretary 89

6.40 Sep 28, 2017: AngioDynamics Reports Fiscal 2018 First Quarter Results 89

6.41 Sep 24, 2017: Edwards Announces Key Events For PCR London Valves 2017 91

6.42 Sep 18, 2017: New Study Shows That Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality Associated with Transcatheter Aortic Valve Replacement (TAVR) 91

6.43 Sep 11, 2017: MPSC Achieves Substantial Growth in 1H 2017 Net Profit Increases 272.4% YOY 93

6.44 Sep 05, 2017: Protembis Announces Successful First-in-Human Use of Its ProtEmbo Cerebral Protection System in European Trial 94

6.45 Aug 23, 2017: New Technology Helps Protect PinnacleHealth Patients From Risk Of Stroke During Heart Valve Replacement 95

6.46 Aug 23, 2017: Capture Vascular Secures Updated FDA 510(k) Clearance 96

6.47 Aug 22, 2017: Malin Announces U.S. FDA Approval for New Hourglass Peripheral Embolisation Plug 96

6.48 Aug 22, 2017: Sacred Heart Uses New Device for Removing Blood Clots 97

6.49 Aug 22, 2017: Medtronic Reports First Quarter Financial Results 97

6.50 Aug 11, 2017: MPSC Issues Positive Profit Alert for 2017 1H Net Profit Expected to Increase 261% 100

6.51 Aug 08, 2017: Penumbra Reports Second Quarter 2017 Financial Results 100

6.52 Aug 01, 2017: Keystone Heart to Accelerate Trials for Advanced Device to Protect Brain During Heart Procedures 101

6.53 Jul 27, 2017: Boston Scientific Announces Results for Second Quarter 2017 102

6.54 Jul 26, 2017: Edwards Lifesciences Reports Second Quarter Results 104

6.55 Jul 24, 2017: MicroPort Attends EUROPACE-CARDIOSTIM 2017 105

6.56 Jul 18, 2017: AngioDynamics Reports Fiscal 2017 Fourth Quarter and Full-Year Results 106

6.57 Jul 07, 2017: MPSC New COO Glendy Wang on Board 108

6.58 Jul 05, 2017: Penumbra Promotes Daniel Davis to Chief Commercial Officer 108

6.59 Jun 27, 2017: Boston Scientific Outlines Strategy for Sustained Growth at 2017 Investor Day 108

6.60 Jun 16, 2017: ACCESS PTS Study Demonstrates Efficacy of EKOS Therapy for Post-Thrombotic Syndrome 110

6.61 Jun 16, 2017: Sentinel Cerebral Protection System Used Commercially By TAVR Centers of Excellence Nationwide 111

7 Appendix 113

7.1 Methodology 113

7.2 About GlobalData 116

7.3 Contact Us 116

7.4 Disclaimer 116

List Of Figure

1.2 List of Figures

Figure 1: Peripheral Embolic Protection Devices-Pipeline Products by Stage of Development 8

Figure 2: Peripheral Embolic Protection Devices-Pipeline Products by Segment 9

Figure 3: Peripheral Embolic Protection Devices-Pipeline Products by Territory 10

Figure 4: Peripheral Embolic Protection Devices-Pipeline Products by Regulatory Path 11

Figure 5: Peripheral Embolic Protection Devices-Pipeline Products by Estimated Approval Date 12

Figure 6: Peripheral Embolic Protection Devices-Ongoing Clinical Trials 13

List Of Table

1.1 List of Tables

Table 1: Peripheral Embolic Protection Devices-Pipeline Products by Stage of Development 8

Table 2: Peripheral Embolic Protection Devices-Pipeline Products by Segment 9

Table 3: Peripheral Embolic Protection Devices-Pipeline Products by Territory 10

Table 4: Peripheral Embolic Protection Devices-Pipeline Products by Regulatory Path 11

Table 5: Peripheral Embolic Protection Devices-Pipeline Products by Estimated Approval Date 12

Table 6: Peripheral Embolic Protection Devices-Ongoing Clinical Trials 13

Table 7: Peripheral Embolic Protection Devices Companies-Pipeline Products by Stage of Development 14

Table 8: Peripheral Embolic Protection Devices-Pipeline Products by Stage of Development 15

Table 9: Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 16

Table 10: Emboshield Pro Rapid Exchange Embolic Protection System (Generation 5)-Product Status 16

Table 11: Emboshield Pro Rapid Exchange Embolic Protection System (Generation 5)-Product Description 16

Table 12: Allium Medical Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 17

Table 13: WIRION EPD System-LE Atherectomy-Product Status 17

Table 14: WIRION EPD System-LE Atherectomy-Product Description 17

Table 15: Avantec Vascular Corp Pipeline Products & Ongoing Clinical Trials Overview 18

Table 16: Peripheral Embolization Device-Product Status 18

Table 17: Peripheral Embolization Device-Product Description 18

Table 18: BTG Plc Pipeline Products & Ongoing Clinical Trials Overview 19

Table 19: EkoSonic Endovascular System-Product Status 19

Table 20: EkoSonic Endovascular System-Product Description 20

Table 21: BTG Plc-Ongoing Clinical Trials Overview 21

Table 22: EkoSonic Endovascular System-Measure the Impact of Shorter, Even Safer EKOS Therapy Protocols for Pulmonary Embolism: KNOCOUT PE 22

Table 23: EkoSonic Endovascular System-Study of the Optimum Duration of Acoustic Pulse Thrombolysis Procedure in the Treatment of Acute Submassive Pulmonary Embolism 22

Table 24: EkoSonic Endovascular System-Submassive Pulmonary Embolism Experience with EKOS 22

Table 25: Cardio-Flow Ltd. Pipeline Products & Ongoing Clinical Trials Overview 23

Table 26: EmboPRO EPD-Product Status 23

Table 27: EmboPRO EPD-Product Description 23

Table 28: CardioGard Ltd. Pipeline Products & Ongoing Clinical Trials Overview 24

Table 29: CardioGard 22 French Aortic Cannula-Product Status 24

Table 30: CardioGard 22 French Aortic Cannula-Product Description 24

Table 31: CardioGard Ltd.-Ongoing Clinical Trials Overview 25

Table 32: CardioGard 22 French Aortic Cannula-A Study to Collect Additional Information Related to the Performance of the CARDIOGARD Cannula 26

Table 33: Emboline, Inc. Pipeline Products & Ongoing Clinical Trials Overview 27

Table 34: Emboliner-Product Status 27

Table 35: Emboliner-Product Description 27

Table 36: Filterlex Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 28

Table 37: Next Generation Embolic Protection Device-Product Status 28

Table 38: Next Generation Embolic Protection Device-Product Description 28

Table 39: Innovative Cardiovascular Solutions, LLC Pipeline Products & Ongoing Clinical Trials Overview 29

Table 40: EMBLOK Embolic Protection System-Product Status 29

Table 41: EMBLOK Embolic Protection System-Product Description 29

Table 42: Innovative Cardiovascular Solutions, LLC-Ongoing Clinical Trials Overview 30

Table 43: EMBLOK Embolic Protection System-European Study Evaluating the EMBLOK Cerebral Embolic Protection System During Transcatheter Aortic Valve Replacement (TAVR) 31

Table 44: EMBLOK Embolic Protection System-Safety and Efficacy of EMBLOK Embolic Protection System in Patients with Severe Aortic Stenosis 31

Table 45: Innovia LLC Pipeline Products & Ongoing Clinical Trials Overview 32

Table 46: Permanently Implantable Embolic Balloon-Product Status 32

Table 47: Permanently Implantable Embolic Balloon-Product Description 32

Table 48: Keystone Heart Ltd Pipeline Products & Ongoing Clinical Trials Overview 33

Table 49: TriGuard 3-Product Status 33

Table 50: TriGuard 3-Product Description 33

Table 51: TriGuard Cerebral Protection Device-Product Status 34

Table 52: TriGuard Cerebral Protection Device-Product Description 34

Table 53: Keystone Heart Ltd-Ongoing Clinical Trials Overview 35

Table 54: TriGuard Cerebral Protection Device-A Randomized Evaluation of the TriGuard Embolic Deflection Device to Reduce the Impact of Cerebral Embolic Lesions after Transcatheter Aortic Valve Implantation 36

Table 55: Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 37

Table 56: SilverHawk With SpiderFX Embolic Protection Device-Product Status 37

Table 57: SilverHawk With SpiderFX Embolic Protection Device-Product Description 37

Table 58: Metactive Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 38

Table 59: Blockstent Microcatheter-Product Status 38

Table 60: Blockstent Microcatheter-Product Description 38

Table 61: MIV Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 39

Table 62: Aortic Embolic Protection Device-Product Status 39

Table 63: Aortic Embolic Protection Device-Product Description 39

Table 64: Neurosonix Ltd. Pipeline Products & Ongoing Clinical Trials Overview 40

Table 65: Protection Collar-Product Status 40

Table 66: Protection Collar-Product Description 40

Table 67: Protembis GmbH Pipeline Products & Ongoing Clinical Trials Overview 41

Table 68: ProtEmbo System-Product Status 41

Table 69: ProtEmbo System-Product Description 41

Table 70: Protembis GmbH-Ongoing Clinical Trials Overview 42

Table 71: ProtEmbo System-Cerebral Protection in Transcatheter Aortic Valve Replacement 43

Table 72: Shape Memory Therapeutics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 44

Table 73: IMPEDE-Product Status 44

Table 74: IMPEDE-Product Description 44

Table 75: Trinity College Dublin Pipeline Products & Ongoing Clinical Trials Overview 45

Table 76: Transcatheter Device-Atherosclerotic Plaque-Product Status 45

Table 77: Transcatheter Device-Atherosclerotic Plaque-Product Description 45

Table 78: University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 46

Table 79: Embolic Protection Device-Product Status 46

Table 80: Embolic Protection Device-Product Description 46

Table 81: University of Toledo Pipeline Products & Ongoing Clinical Trials Overview 47

Table 82: Minimally Invasive Thrombectomy Device-Product Status 47

Table 83: Minimally Invasive Thrombectomy Device-Product Description 47

Table 84: Glossary 115

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