Intravascular Ultrasound Systems (IVUS) - Medical Devices Pipeline Assessment, 2018

Table of Contents

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 4

1.2 List of Figures 5

2 Introduction 6

2.1 Intravascular Ultrasound Systems (IVUS) Overview 6

3 Products under Development 7

3.1 Intravascular Ultrasound Systems (IVUS)-Pipeline Products by Stage of Development 7

3.2 Intravascular Ultrasound Systems (IVUS)-Pipeline Products by Segment 8

3.3 Intravascular Ultrasound Systems (IVUS)-Pipeline Products by Territory 9

3.4 Intravascular Ultrasound Systems (IVUS)-Pipeline Products by Regulatory Path 10

3.5 Intravascular Ultrasound Systems (IVUS)-Pipeline Products by Estimated Approval Date 11

4 Intravascular Ultrasound Systems (IVUS)-Pipeline Products under Development by Companies 12

4.1 Intravascular Ultrasound Systems (IVUS) Companies-Pipeline Products by Stage of Development 12

4.2 Intravascular Ultrasound Systems (IVUS)-Pipeline Products by Stage of Development 13

5 Intravascular Ultrasound Systems (IVUS) Companies and Product Overview 14

5.1 Arbor Ultrasound Technologies, LLC (Inactive) Company Overview 14

5.1.1 Arbor Ultrasound Technologies, LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 14

5.2 Biosense Webster Inc Company Overview 15

5.2.1 Biosense Webster Inc Pipeline Products & Ongoing Clinical Trials Overview 15

5.3 Boston Scientific Corp Company Overview 16

5.3.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 16

5.4 Covidien plc Company Overview 18

5.4.1 Covidien plc Pipeline Products & Ongoing Clinical Trials Overview 18

5.5 Georgia Institute of Technology Company Overview 19

5.5.1 Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 19

5.6 North Carolina State University Company Overview 20

5.6.1 North Carolina State University Pipeline Products & Ongoing Clinical Trials Overview 20

5.7 OCT Medical Imaging Inc Company Overview 21

5.7.1 OCT Medical Imaging Inc Pipeline Products & Ongoing Clinical Trials Overview 21

5.8 RadioSon Corporation Company Overview 22

5.8.1 RadioSon Corporation Pipeline Products & Ongoing Clinical Trials Overview 22

5.9 SIBUS Medical Inc (Inactive) Company Overview 23

5.9.1 SIBUS Medical Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 23

5.10 Soundpipe LLC Company Overview 24

5.10.1 Soundpipe LLC Pipeline Products & Ongoing Clinical Trials Overview 24

5.11 Terumo Corp Company Overview 26

5.11.1 Terumo Corp Pipeline Products & Ongoing Clinical Trials Overview 26

5.12 University of Oxford Company Overview 27

5.12.1 University of Oxford Pipeline Products & Ongoing Clinical Trials Overview 27

5.13 University of Texas at Austin Company Overview 28

5.13.1 University of Texas at Austin Pipeline Products & Ongoing Clinical Trials Overview 28

5.14 Volcano Corp Company Overview 29

5.14.1 Volcano Corp Pipeline Products & Ongoing Clinical Trials Overview 29

6 Intravascular Ultrasound Systems (IVUS)-Recent Developments 33

6.1 May 24, 2018: Medtronic Reports Fourth Quarter And Fiscal Year 2018 Financial Results 33

6.2 May 17, 2018: NanoVibronix Provides Business Update for the First Quarter 2018 35

6.3 May 11, 2018: Terumo Appoints its U.S.-based Subsidiary's Associate as the Fifth Terumo Fellow 36

6.4 May 07, 2018: Innovative Health Receives FDA Clearance for the ViewFlex Xtra Diagnostic Ultrasound Catheter 36

6.5 May 07, 2018: Medtronic Appoints Mike Weinstein As Senior Vice President Of Strategy 37

6.6 May 01, 2018: Novasight Hybrid System Receives FDA 510(k) Clearance 37

6.7 Apr 25, 2018: Boston Scientific Reports Financial Results For First Quarter 2018 37

6.8 Apr 05, 2018: Dr. Laura Mauri to Join Medtronic as Vice President, Global Clinical Research & Analytics 39

6.9 Apr 02, 2018: NanoVibronix Provides Year-End 2017 Business Update and Files 10-K 40

6.10 Mar 11, 2018: Infraredx Highlights Value of IVUS + NIRS for Detecting Lipid Core Plaque at the American College of Cardiology 67th Annual Scientific Session 41

6.11 Feb 08, 2018: Terumo Revises the Full-Year Results Forecast for FY 2017 42

6.12 Feb 01, 2018: Boston Scientific Announces Results for Fourth Quarter and Full Year 2017 43

6.13 Jan 30, 2018: Alex Gu Named Senior Vice President and President of Medtronic's Greater China Region 45

6.14 Jan 25, 2018: Terumo Announces Change of Directors and Executive Officers 45

6.15 Jan 09, 2018: Boston Scientific Announces Preliminary Unaudited Sales For The Fourth Quarter And Full Year Ended December 31, 2017 47

6.16 Dec 21, 2017: NanoVibronix CEO Brian Murphy Provides Business Update Letter to Shareholders 47

6.17 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 50

6.18 Dec 13, 2017: Terumo Constructs a New Building in Yamaguchi, Japan To Strengthen Production Operations in Interventional Systems 51

6.19 Nov 21, 2017: Medtronic Reports Second Quarter Financial Results 51

6.20 Nov 08, 2017: Medtronic Announces Preliminary Second Quarter Revenue 54

6.21 Nov 02, 2017: Medtronic Releases Fiscal Year 2017 Integrated Performance Report 55

6.22 Oct 26, 2017: Boston Scientific Announces Results For Third Quarter 2017 56

6.23 Oct 10, 2017: Terumo Provides Update on Impact from Hurricane Maria 58

6.24 Oct 06, 2017: Medtronic Provides Update on Impact from Hurricane Maria 58

6.25 Oct 04, 2017: Boston Scientific Appoints Desiree Ralls-Morrison General Counsel and Corporate Secretary 59

6.26 Sep 26, 2017: MicroVention Celebrates Grand Opening of New Worldwide Innovation Center in Aliso Viejo, California 60

6.27 Sep 11, 2017: An opportunity to evaluate and speed-up new projects-Meet GE Healthcare at the Uppsala BIO booth 60

6.28 Aug 22, 2017: Medtronic Reports First Quarter Financial Results 61

6.29 Jul 27, 2017: Boston Scientific Announces Results for Second Quarter 2017 64

6.30 Jul 25, 2017: Catherine Estrampes appointed President & CEO of GE Healthcare Europe 65

6.31 Jun 27, 2017: Boston Scientific Outlines Strategy for Sustained Growth at 2017 Investor Day 66

6.32 Jun 19, 2017: Conavi Medical Welcomes Peter Wehrly to the Board of Directors 68

6.33 Jun 12, 2017: Kieran Murphy Appointed CEO of GE Healthcare, Succeeding John Flannery 69

7 Appendix 70

7.1 Methodology 70

7.2 About GlobalData 73

7.3 Contact Us 73

7.4 Disclaimer 73

List of Figure

1.2 List of Figures

Figure 1: Intravascular Ultrasound Systems (IVUS)-Pipeline Products by Stage of Development 7

Figure 2: Intravascular Ultrasound Systems (IVUS)-Pipeline Products by Segment 8

Figure 3: Intravascular Ultrasound Systems (IVUS)-Pipeline Products by Territory 9

Figure 4: Intravascular Ultrasound Systems (IVUS)-Pipeline Products by Regulatory Path 10

Figure 5: Intravascular Ultrasound Systems (IVUS)-Pipeline Products by Estimated Approval Date 11

List of Table

1.1 List of Tables

Table 1: Intravascular Ultrasound Systems (IVUS)-Pipeline Products by Stage of Development 7

Table 2: Intravascular Ultrasound Systems (IVUS)-Pipeline Products by Segment 8

Table 3: Intravascular Ultrasound Systems (IVUS)-Pipeline Products by Territory 9

Table 4: Intravascular Ultrasound Systems (IVUS)-Pipeline Products by Regulatory Path 10

Table 5: Intravascular Ultrasound Systems (IVUS)-Pipeline Products by Estimated Approval Date 11

Table 6: Intravascular Ultrasound Systems (IVUS) Companies-Pipeline Products by Stage of Development 12

Table 7: Intravascular Ultrasound Systems (IVUS)-Pipeline Products by Stage of Development 13

Table 8: Arbor Ultrasound Technologies, LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 14

Table 9: Carotid Ultrasound Imaging System-Product Status 14

Table 10: Carotid Ultrasound Imaging System-Product Description 14

Table 11: Biosense Webster Inc Pipeline Products & Ongoing Clinical Trials Overview 15

Table 12: 3D Ultrasound Next Generation Catheter-Product Status 15

Table 13: 3D Ultrasound Next Generation Catheter-Product Description 15

Table 14: Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 16

Table 15: Intravascular Ultrasound-Imaging Catheter-High Definition-Product Status 16

Table 16: Intravascular Ultrasound-Imaging Catheter-High Definition-Product Description 16

Table 17: iSight / MDU5+-Product Status 17

Table 18: iSight / MDU5+-Product Description 17

Table 19: Covidien plc Pipeline Products & Ongoing Clinical Trials Overview 18

Table 20: Covidien SeeHawk-Product Status 18

Table 21: Covidien SeeHawk-Product Description 18

Table 22: Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 19

Table 23: Catheter-Based Device-Product Status 19

Table 24: Catheter-Based Device-Product Description 19

Table 25: North Carolina State University Pipeline Products & Ongoing Clinical Trials Overview 20

Table 26: Intravascular Ultrasound Transducers-Product Status 20

Table 27: Intravascular Ultrasound Transducers-Product Description 20

Table 28: OCT Medical Imaging Inc Pipeline Products & Ongoing Clinical Trials Overview 21

Table 29: IVUS-OCT Imaging System-Product Status 21

Table 30: IVUS-OCT Imaging System-Product Description 21

Table 31: RadioSon Corporation Pipeline Products & Ongoing Clinical Trials Overview 22

Table 32: Intravascular Ultrasound-Imaging Catheter-Product Status 22

Table 33: Intravascular Ultrasound-Imaging Catheter-Product Description 22

Table 34: SIBUS Medical Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 23

Table 35: Intravascular Ultrasound Imaging System-Product Status 23

Table 36: Intravascular Ultrasound Imaging System-Product Description 23

Table 37: Soundpipe LLC Pipeline Products & Ongoing Clinical Trials Overview 24

Table 38: GUIDE-Tx-Critical Limb Ischemia-Product Status 24

Table 39: GUIDE-Tx-Critical Limb Ischemia-Product Description 24

Table 40: GUIDE-Tx-Neointimal Hyperplasia-Product Status 25

Table 41: GUIDE-Tx-Neointimal Hyperplasia-Product Description 25

Table 42: Terumo Corp Pipeline Products & Ongoing Clinical Trials Overview 26

Table 43: IVUS-Product Status 26

Table 44: IVUS-Product Description 26

Table 45: University of Oxford Pipeline Products & Ongoing Clinical Trials Overview 27

Table 46: Intravascular Imaging Catheter-Product Status 27

Table 47: Intravascular Imaging Catheter-Product Description 27

Table 48: University of Texas at Austin Pipeline Products & Ongoing Clinical Trials Overview 28

Table 49: Photoacoustic Imaging Device-Cardiovascular Plaque-Product Status 28

Table 50: Photoacoustic Imaging Device-Cardiovascular Plaque-Product Description 28

Table 51: Volcano Corp Pipeline Products & Ongoing Clinical Trials Overview 29

Table 52: Focused Acoustic Computed Tomography System-Product Status 29

Table 53: Focused Acoustic Computed Tomography System-Product Description 29

Table 54: GIVUS-Product Status 30

Table 55: GIVUS-Product Description 30

Table 56: Mackinaw-Product Status 30

Table 57: Mackinaw-Product Description 30

Table 58: Next Generation Revolution Catheter-Product Status 31

Table 59: Next Generation Revolution Catheter-Product Description 31

Table 60: Preview Second Generation Forward Looking IVUS Catheter And System-Product Status 31

Table 61: Preview Second Generation Forward Looking IVUS Catheter And System-Product Description 31

Table 62: Preview Third Generation FL.IVUS Platform-Product Status 32

Table 63: Preview Third Generation FL.IVUS Platform-Product Description 32

Table 64: PV IVUS Co-Reg-Product Status 32

Table 65: PV IVUS Co-Reg-Product Description 32

Table 66: Glossary 72