Peripheral Embolic Protection Devices-Medical Devices Pipeline Assessment, 2017

Table of Contents

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 Avantec Vascular Corporation Company Overview 17

5.2.1 Avantec Vascular Corporation Pipeline Products Ongoing Clinical Trials Overview 17

5.3 BTG Plc Company Overview 18

5.3.1 BTG Plc Pipeline Products Ongoing Clinical Trials Overview 18

5.4 Cardio-Flow Ltd. Company Overview 22

5.4.1 Cardio-Flow Ltd. Pipeline Products Ongoing Clinical Trials Overview 22

5.5 CardioGard Ltd. Company Overview 23

5.5.1 CardioGard Ltd. Pipeline Products Ongoing Clinical Trials Overview 23

5.6 EMBA Medical Limited Company Overview 26

5.6.1 EMBA Medical Limited Pipeline Products Ongoing Clinical Trials Overview 26

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 Inari Medical, Inc. Company Overview 29

5.9.1 Inari Medical, Inc. Pipeline Products Ongoing Clinical Trials Overview 29

5.10 Innovative Cardiovascular Solutions, LLC Company Overview 32

5.10.1 Innovative Cardiovascular Solutions, LLC Pipeline Products Ongoing Clinical Trials Overview 32

5.11 Innovia LLC Company Overview 35

5.11.1 Innovia LLC Pipeline Products Ongoing Clinical Trials Overview 35

5.12 Keystone Heart Ltd Company Overview 36

5.12.1 Keystone Heart Ltd Pipeline Products Ongoing Clinical Trials Overview 36

5.13 Medtronic plc Company Overview 39

5.13.1 Medtronic plc Pipeline Products Ongoing Clinical Trials Overview 39

5.14 Metactive Medical LLC Company Overview 40

5.14.1 Metactive Medical LLC Pipeline Products Ongoing Clinical Trials Overview 40

5.15 MIV Therapeutics Inc Company Overview 41

5.15.1 MIV Therapeutics Inc Pipeline Products Ongoing Clinical Trials Overview 41

5.16 Neurosonix Ltd. Company Overview 42

5.16.1 Neurosonix Ltd. Pipeline Products Ongoing Clinical Trials Overview 42

5.17 Shape Memory Therapeutics, Inc. Company Overview 43

5.17.1 Shape Memory Therapeutics, Inc. Pipeline Products Ongoing Clinical Trials Overview 43

5.18 Trinity College Dublin Company Overview 44

5.18.1 Trinity College Dublin Pipeline Products Ongoing Clinical Trials Overview 44

5.19 University of Minnesota Company Overview 45

5.19.1 University of Minnesota Pipeline Products Ongoing Clinical Trials Overview 45

5.20 University of Toledo Company Overview 46

5.20.1 University of Toledo Pipeline Products Ongoing Clinical Trials Overview 46

6 Peripheral Embolic Protection Devices-Recent Developments 47

6.1 Jul 05, 2017: Penumbra Promotes Daniel Davis to Chief Commercial Officer 47

6.2 Jun 27, 2017: Boston Scientific Outlines Strategy for Sustained Growth at 2017 Investor Day 47

6.3 Jun 16, 2017: ACCESS PTS Study Demonstrates Efficacy of EKOS Therapy for Post-Thrombotic Syndrome 49

6.4 Jun 16, 2017: Sentinel Cerebral Protection System Used Commercially By TAVR Centers of Excellence Nationwide 50

6.5 Jun 05, 2017: Claret Medical Receives FDA Clearance to Market Sentinel Cerebral Protection System in the U.S. 50

6.6 May 25, 2017: Medtronic Reports Fourth Quarter and Fiscal Year 2017 Financial Results 51

6.7 May 22, 2017: OPTALYSE PE Study Demonstrates Safety and Efficacy of Shorter, Lower Dose EKOS Therapy For Pulmonary Embolism 54

6.8 May 09, 2017: Penumbra Reports First Quarter 2017 Financial Results 55

6.9 Apr 27, 2017: Boston Scientific Announces Results For First Quarter 2017 56

6.10 Apr 25, 2017: Edwards Lifesciences Reports First Quarter Results 57

6.11 Apr 21, 2017: Penumbra Appoints Bridget O'Rourke to its Board of Directors 59

6.12 Apr 11, 2017: Testing Device Aimed at Reducing Stroke Risk During Transcatheter Aortic Valve Replacement 59

6.13 Mar 30, 2017: AngioDynamics Reports Fiscal 2017 Third Quarter Results 60

6.14 Mar 30, 2017: MPSC Announces 2016 Annual Results 61

6.15 Mar 21, 2017: Metactive Medical Announces Issuance of Patent on Blockstent Embolization Device 63

6.16 Mar 15, 2017: Innovative Cardiovascular Solutions Announces Successful First Cases in European Clinical Study of EMBLOK Embolic Protection System 64

6.17 Mar 02, 2017: Penumbra Announces Key Events at Society of Interventional Radiology 2017 Meeting 64

6.18 Feb 28, 2017: Penumbra Reports Fourth Quarter and Full Year 2016 Financial Results 65

6.19 Feb 27, 2017: FDA Advisory Committee Strongly Supports Granting de novo Application for the First Cerebral Protection System for Transcatheter Aortic Valve Replacement 67

6.20 Feb 27, 2017: BTG Receives U.S. FDA 510(k) Clearance For EKOS Control Unit 4.0 68

6.21 Feb 27, 2017: Keystone Heart Applauds FDA Advisory Panel for Recognition of The Need for Cerebral Protection Following TAVR 68

6.22 Feb 21, 2017: Medtronic Reports Third Quarter Financial Results 69

6.23 Feb 06, 2017: Medtronic Awarded U.S. Department of Veterans Affairs National Contracts for Home Telehealth Technologies, with Three Other Vendors 72

6.24 Feb 02, 2017: Boston Scientific Announces Results For Fourth Quarter And Full Year Ended December 31, 2016 73

6.25 Feb 01, 2017: Edwards Lifesciences Reports Fourth Quarter Results 74

6.26 Jan 09, 2017: First Pulmonary Embolism Patients in Hong Kong Treated with the EKOS system 76

6.27 Jan 06, 2017: AngioDynamics Reports Fiscal 2017 Second Quarter Results 77

6.28 Dec 19, 2016: Penumbra Appoints Thomas C. Wilder to its Board of Directors 79

6.29 Dec 08, 2016: Edwards Lifesciences Outlines Growth Strategy At Annual Investor Conference 79

6.30 Nov 22, 2016: Medtronic Reports Second Quarter Financial Results 81

6.31 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 84

6.32 Nov 15, 2016: Penumbra Announces Resignation of Board Member 84

6.33 Nov 15, 2016: CEVA to work with Medtronic for distribution facility construction 85

6.34 Nov 10, 2016: Penumbra to Highlight Peripheral Vascular Technologies at AIMsymposium and VEITHsymposium in New York 86

6.35 Nov 09, 2016: AngioDynamics Announces Addition of New Board Members 87

6.36 Nov 03, 2016: Penumbra Reports Third Quarter 2016 Financial Results 87

6.37 Nov 01, 2016: Results from U.S. Pivotal IDE Trial Show That Sentinel Cerebral Protection System Protects Patients During Transcatheter Aortic Valve Replacement 88

6.38 Nov 01, 2016: Delirium Significantly Associated with Brain Lesions in Patients Post-TAVR According to New Data Released at TCT 2016 90

6.39 Oct 28, 2016: Emboline's "enabling TAVI" aortic embolic protection technology is selected for presentation at TCT 2016 91

6.40 Oct 26, 2016: Boston Scientific Announces Results For Third Quarter 2016 92

6.41 Oct 25, 2016: Edwards Lifesciences Reports Third Quarter Results 93

6.42 Oct 10, 2016: Professor Ian Meredith To Join Boston Scientific As Executive Vice President And Global Chief Medical Officer 95

6.43 Oct 05, 2016: AngioDynamics Reports Fiscal 2017 First Quarter Results 96

6.44 Oct 03, 2016: American Journal of Cardiology Reports Data Showing New Brain Lesions in 94% of Patients Following TAVR 97

6.45 Sep 20, 2016: Claret Medical Submits Marketing Application to FDA for US Clearance of First Cerebral Protection System for Transcatheter Aortic Valve Replacement (TAVR) 98

6.46 Sep 19, 2016: TriGuard Cerebral Protection Device Demonstrates Safety and Significant Improvements in Brain Protection in Patients Undergoing TAVR Procedures 99

6.47 Sep 15, 2016: Medtronic Names Mark Ploof Senior Vice President of Global Operations and Business Services 100

6.48 Sep 14, 2016: Claret Medical Announces SENTINEL Pivotal IDE Trial to Be Featured in Late-Breaking Trial Session at Transcatheter Cardiovascular Therapeutics (TCT) Conference 101

6.49 Aug 30, 2016: MPSC Announces 2016 Interim Results 102

6.50 Aug 25, 2016: Medtronic Reports First Quarter Financial Results 103

6.51 Aug 09, 2016: Penumbra Reports Second Quarter 2016 Financial Results 106

6.52 Jul 28, 2016: Boston Scientific Announces Results For Second Quarter 2016 107

6.53 Jul 26, 2016: Edwards Lifesciences Reports Second Quarter Results 109

6.54 Jul 25, 2016: AngioDynamics Appoints Michael C. Greiner as New Chief Financial Officer 110

7 Appendix 112

7.1 Methodology 112

7.2 About GlobalData 115

7.3 Contact Us 115

7.4 Disclaimer 115

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: Avantec Vascular Corporation Pipeline Products Ongoing Clinical Trials Overview 17

Table 13: Peripheral Embolization Device-Product Status 17

Table 14: Peripheral Embolization Device-Product Description 17

Table 15: BTG Plc Pipeline Products Ongoing Clinical Trials Overview 18

Table 16: EkoSonic Endovascular System-Product Status 18

Table 17: EkoSonic Endovascular System-Product Description 19

Table 18: BTG Plc-Ongoing Clinical Trials Overview 20

Table 19: EkoSonic Endovascular System-Submassive Pulmonary Embolism Experience with EKOS 21

Table 20: Cardio-Flow Ltd. Pipeline Products Ongoing Clinical Trials Overview 22

Table 21: EmboPRO EPD-Product Status 22

Table 22: EmboPRO EPD-Product Description 22

Table 23: CardioGard Ltd. Pipeline Products Ongoing Clinical Trials Overview 23

Table 24: CardioGard 22 French Aortic Cannula-Product Status 23

Table 25: CardioGard 22 French Aortic Cannula-Product Description 23

Table 26: CardioGard Ltd.-Ongoing Clinical Trials Overview 24

Table 27: CardioGard 22 French Aortic Cannula-A Study to Collect Additional Information Related to the Performance of the CARDIOGARD Cannula 25

Table 28: EMBA Medical Limited Pipeline Products Ongoing Clinical Trials Overview 26

Table 29: Hourglass Peripheral Embolization Plug-Product Status 26

Table 30: Hourglass Peripheral Embolization Plug-Product Description 26

Table 31: Emboline, Inc. Pipeline Products Ongoing Clinical Trials Overview 27

Table 32: Emboliner-Product Status 27

Table 33: Emboliner-Product Description 27

Table 34: Filterlex Medical Ltd Pipeline Products Ongoing Clinical Trials Overview 28

Table 35: Next Generation Embolic Protection Device-Product Status 28

Table 36: Next Generation Embolic Protection Device-Product Description 28

Table 37: Inari Medical, Inc. Pipeline Products Ongoing Clinical Trials Overview 29

Table 38: FlowTriever System-Pulmonary Embolism-Product Status 29

Table 39: FlowTriever System-Pulmonary Embolism-Product Description 29

Table 40: Inari Medical, Inc.-Ongoing Clinical Trials Overview 30

Table 41: FlowTriever System-Pulmonary Embolism-FlowTriever Pulmonary Embolectomy Clinical Study 31

Table 42: Innovative Cardiovascular Solutions, LLC Pipeline Products Ongoing Clinical Trials Overview 32

Table 43: EMBLOK Embolic Protection System-Product Status 32

Table 44: EMBLOK Embolic Protection System-Product Description 32

Table 45: Innovative Cardiovascular Solutions, LLC-Ongoing Clinical Trials Overview 33

Table 46: EMBLOK Embolic Protection System-European Study Evaluating the EMBLOK Cerebral Embolic Protection System During Transcatheter Aortic Valve Replacement (TAVR) 34

Table 47: EMBLOK Embolic Protection System-Safety and Efficacy of EMBLOK Embolic Protection System in Patients with Severe Aortic Stenosis 34

Table 48: Innovia LLC Pipeline Products Ongoing Clinical Trials Overview 35

Table 49: Permanently Implantable Embolic Balloon-Product Status 35

Table 50: Permanently Implantable Embolic Balloon-Product Description 35

Table 51: Keystone Heart Ltd Pipeline Products Ongoing Clinical Trials Overview 36

Table 52: TriGuard Cerebral Protection Device-Product Status 36

Table 53: TriGuard Cerebral Protection Device-Product Description 36

Table 54: Keystone Heart Ltd-Ongoing Clinical Trials Overview 37

Table 55: 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 38

Table 56: Medtronic plc Pipeline Products Ongoing Clinical Trials Overview 39

Table 57: SilverHawk With SpiderFX Embolic Protection Device-Product Status 39

Table 58: SilverHawk With SpiderFX Embolic Protection Device-Product Description 39

Table 59: Metactive Medical LLC Pipeline Products Ongoing Clinical Trials Overview 40

Table 60: Blockstent Microcatheter-Product Status 40

Table 61: Blockstent Microcatheter-Product Description 40

Table 62: MIV Therapeutics Inc Pipeline Products Ongoing Clinical Trials Overview 41

Table 63: Aortic Embolic Protection Device-Product Status 41

Table 64: Aortic Embolic Protection Device-Product Description 41

Table 65: Neurosonix Ltd. Pipeline Products Ongoing Clinical Trials Overview 42

Table 66: Protection Collar-Product Status 42

Table 67: Protection Collar-Product Description 42

Table 68: Shape Memory Therapeutics, Inc. Pipeline Products Ongoing Clinical Trials Overview 43

Table 69: Peripheral Vascular Embolization System-Product Status 43

Table 70: Peripheral Vascular Embolization System-Product Description 43

Table 71: Trinity College Dublin Pipeline Products Ongoing Clinical Trials Overview 44

Table 72: Transcatheter Device-Atherosclerotic Plaque-Product Status 44

Table 73: Transcatheter Device-Atherosclerotic Plaque-Product Description 44

Table 74: University of Minnesota Pipeline Products Ongoing Clinical Trials Overview 45

Table 75: Embolic Protection Device-Product Status 45

Table 76: Embolic Protection Device-Product Description 45

Table 77: University of Toledo Pipeline Products Ongoing Clinical Trials Overview 46

Table 78: Minimally Invasive Thrombectomy Device-Product Status 46

Table 79: Minimally Invasive Thrombectomy Device-Product Description 46

Table 80: Glossary 114