Thoracic Aortic Stent Grafts-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 5

2 Introduction 6

2.1 Thoracic Aortic Stent Grafts Overview 6

3 Products under Development 7

3.1 Thoracic Aortic Stent Grafts-Pipeline Products by Stage of Development 7

3.2 Thoracic Aortic Stent Grafts-Pipeline Products by Territory 8

3.3 Thoracic Aortic Stent Grafts-Pipeline Products by Regulatory Path 9

3.4 Thoracic Aortic Stent Grafts-Pipeline Products by Estimated Approval Date 10

3.5 Thoracic Aortic Stent Grafts-Ongoing Clinical Trials 11

4 Thoracic Aortic Stent Grafts-Pipeline Products under Development by Companies 12

4.1 Thoracic Aortic Stent Grafts Companies-Pipeline Products by Stage of Development 12

4.2 Thoracic Aortic Stent Grafts-Pipeline Products by Stage of Development 13

5 Thoracic Aortic Stent Grafts Companies and Product Overview 14

5.1 Bolton Medical Inc Company Overview 14

5.1.1 Bolton Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 14

5.2 Cook Medical Inc Company Overview 16

5.2.1 Cook Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 16

5.3 Evasc Medical Systems Corp Company Overview 19

5.3.1 Evasc Medical Systems Corp Pipeline Products & Ongoing Clinical Trials Overview 19

5.4 Lombard Medical Technologies Inc. Company Overview 20

5.4.1 Lombard Medical Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 20

5.5 Medtronic plc Company Overview 21

5.5.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 21

5.6 MicroPort Scientific Corp Company Overview 26

5.6.1 MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 26

5.7 St. Jude Medical LLC Company Overview 29

5.7.1 St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 29

5.8 TriVascular Inc Company Overview 30

5.8.1 TriVascular Inc Pipeline Products & Ongoing Clinical Trials Overview 30

5.9 W. L. Gore & Associates Inc Company Overview 31

5.9.1 W. L. Gore & Associates Inc Pipeline Products & Ongoing Clinical Trials Overview 31

6 Thoracic Aortic Stent Grafts- Recent Developments 35

6.1 Apr 27, 2017: Merit Medical Reports Results for First Quarter of 2017 35

6.2 Apr 26, 2017: LeMaitre Q1 2017 Record Sales $24.1 mm (+19%), Net Income $3.2 mm (+49%) 36

6.3 Mar 30, 2017: MPSC Announces 2016 Annual Results 36

6.4 Mar 20, 2017: MicroPort Endovascular Attends the Fifth Shangdong (Mount Tai) Aortic Surgery Forum 38

6.5 Mar 13, 2017: Cook Medical Announces Umesh Patel as President of Cook Biotech 38

6.6 Mar 07, 2017: Anteo Technologies Announces Verification Study With Cook Medical Australia 39

6.7 Feb 21, 2017: Medtronic Reports Third Quarter Financial Results 40

6.8 Feb 21, 2017: LeMaitre Q4 2016 Record Sales $23.3 mm (+14%), Op. Income $3.9 mm (+27%) 42

6.9 Feb 21, 2017: Merit Medical Reports Results for Fourth Quarter and Year Ended December 31, 2016 43

6.10 Feb 06, 2017: Medtronic Awarded U.S. Department of Veterans Affairs National Contracts for Home Telehealth Technologies, with Three Other Vendors 44

6.11 Dec 30, 2016: MicroPort Endovascular Attends Sixth China Shenzhen International Cardiovascular Disease Forum & China Cardiovascular Surgery Technique and Engineering Conference 45

6.12 Nov 22, 2016: Medtronic Reports Second Quarter Financial Results 45

6.13 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 48

6.14 Nov 15, 2016: CEVA to work with Medtronic for distribution facility construction 49

6.15 Nov 14, 2016: Medtronic to Unveil Data Supporting Endovascular Treatments for Aortic Disease at VEITHsymposium 2016 49

6.16 Oct 26, 2016: LeMaitre Q3 2016 Record Sales $23.2 mm (+22%), Record Op. Income $5.3 mm (+61%) 52

6.17 Oct 26, 2016: Merit Medical Reports Sales Up 15.3% for the Quarter Ended September 30, 2016 52

6.18 Oct 19, 2016: St. Jude Medical Reports Third Quarter 2016 Results 53

6.19 Sep 20, 2016: Medtronic Valiant Captivia Demonstrates Safety and Efficacy at Three Years 55

6.20 Sep 19, 2016: First Implant Completed in Pivotal Study of GORE TAG Thoracic Branch Endoprosthesis 56

6.21 Sep 15, 2016: Medtronic Names Mark Ploof Senior Vice President of Global Operations and Business Services 57

6.22 Aug 31, 2016: Cook Medical Names Jean-Marc Creissel Vice President of Operations in Greater China 58

6.23 Aug 30, 2016: MPSC Announces 2016 Interim Results 58

6.24 Aug 25, 2016: Medtronic Reports First Quarter Financial Results 60

6.25 Jul 27, 2016: Merit Medical Reports Sales Up 9.4% for the Quarter Ended June 30, 2016 62

6.26 Jul 27, 2016: LeMaitre Q2 2016 Record Sales $22.4mm (+13%), Record Op. Income $3.8mm (+35%) 63

6.27 Jul 26, 2016: Merit Medical Announces Appointment of New Director 64

6.28 Jul 20, 2016: St. Jude Medical Reports Second Quarter 2016 Results 64

6.29 Jun 30, 2016: NuVasive Agrees to Settle Patent Litigation With Medtronic 66

6.30 Jun 21, 2016: FDA Approves Study of New Aneurysm Device Developed by Sanford Health 66

6.31 Jun 08, 2016: First Patient Treated with Medtronic Valiant Evo Thoracic Stent Graft System 67

6.32 Jun 08, 2016: Market-leading TEVAR Device is First to Surpass 100,000 Devices Distributed Worldwide 68

6.33 Jun 06, 2016: Medtronic Outlines Future Growth Vision at Investor Day 69

6.34 May 31, 2016: Medtronic Reports Fourth Quarter and Fiscal Year 2016 Financial Results 69

7 Appendix 73

7.1 Methodology 73

7.2 About GlobalData 76

7.3 Contact Us 76

7.4 Disclaimer 76

List of Figure

1.2 List of Figures

Figure 1: Thoracic Aortic Stent Grafts-Pipeline Products by Stage of Development 7

Figure 2: Thoracic Aortic Stent Grafts-Pipeline Products by Territory 8

Figure 3: Thoracic Aortic Stent Grafts-Pipeline Products by Regulatory Path 9

Figure 4: Thoracic Aortic Stent Grafts-Pipeline Products by Estimated Approval Date 10

Figure 5: Thoracic Aortic Stent Grafts-Ongoing Clinical Trials 11

List of Table

1.1 List of Tables

Table 1: Thoracic Aortic Stent Grafts-Pipeline Products by Stage of Development 7

Table 2: Thoracic Aortic Stent Grafts-Pipeline Products by Territory 8

Table 3: Thoracic Aortic Stent Grafts-Pipeline Products by Regulatory Path 9

Table 4: Thoracic Aortic Stent Grafts-Pipeline Products by Estimated Approval Date 10

Table 5: Thoracic Aortic Stent Grafts-Ongoing Clinical Trials 11

Table 6: Thoracic Aortic Stent Grafts Companies-Pipeline Products by Stage of Development 12

Table 7: Thoracic Aortic Stent Grafts-Pipeline Products by Stage of Development 13

Table 8: Bolton Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 14

Table 9: Relay Thoracic Stent Graft With Plus Delivery System-Product Status 14

Table 10: Relay Thoracic Stent Graft With Plus Delivery System-Product Description 15

Table 11: Cook Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 16

Table 12: Zenith TX2 LP TAA Endovascular Graft-Product Status 16

Table 13: Zenith TX2 LP TAA Endovascular Graft-Product Description 16

Table 14: Cook Medical Inc-Ongoing Clinical Trials Overview 17

Table 15: Zenith TX2 LP TAA Endovascular Graft-Evaluation of All-Cause Mortality and Pulmonary Morbidity in Treating Juxtarenal, Suprarenal and Thoracoabdominal Aortic Pathologies Using the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft and Surgeon-Modified Endografts 18

Table 16: Evasc Medical Systems Corp Pipeline Products & Ongoing Clinical Trials Overview 19

Table 17: TAS System-Product Status 19

Table 18: TAS System-Product Description 19

Table 19: Lombard Medical Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview 20

Table 20: TEVAR-Product Status 20

Table 21: TEVAR-Product Description 20

Table 22: Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 21

Table 23: Unitary Manifold Stent Graft System-Product Status 21

Table 24: Unitary Manifold Stent Graft System-Product Description 22

Table 25: Valiant EVO-Product Status 22

Table 26: Valiant EVO-Product Description 22

Table 27: Valiant Mona LSA System-Product Status 23

Table 28: Valiant Mona LSA System-Product Description 23

Table 29: Medtronic plc-Ongoing Clinical Trials Overview 24

Table 30: Valiant EVO-Valiant Evo International Clinical Trial 25

Table 31: Valiant EVO-Valiant Evo US Clinical Trial 25

Table 32: MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 26

Table 33: Castor Branched Aortic Stent Graft System-Product Status 26

Table 34: Castor Branched Aortic Stent Graft System-Product Description 27

Table 35: Hercules-T-Product Status 27

Table 36: Hercules-T-Product Description 27

Table 37: Next Generation TAA-Product Status 28

Table 38: Next Generation TAA-Product Description 28

Table 39: St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 29

Table 40: Amplatzer TAA Vascular Graft-Product Status 29

Table 41: Amplatzer TAA Vascular Graft-Product Description 29

Table 42: TriVascular Inc Pipeline Products & Ongoing Clinical Trials Overview 30

Table 43: Ovation Thoracic Stent Graft System-Product Status 30

Table 44: Ovation Thoracic Stent Graft System-Product Description 30

Table 45: W. L. Gore & Associates Inc Pipeline Products & Ongoing Clinical Trials Overview 31

Table 46: GORE TAG Thoracic Branch Endoprosthesis-Product Status 31

Table 47: GORE TAG Thoracic Branch Endoprosthesis-Product Description 31

Table 48: W. L. Gore & Associates Inc-Ongoing Clinical Trials Overview 32

Table 49: GORE TAG Thoracic Branch Endoprosthesis-Evaluation of the GORE TAG Thoracic Branch Endoprosthesis (Branched TAG Device) in the Treatment of Aortic Arch Aneurysms 33

Table 50: GORE TAG Thoracic Branch Endoprosthesis-Evaluation of the GORE TAG Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta 33

Table 51: GORE TAG Thoracic Branch Endoprosthesis-Evaluation of the Gore Tag Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta 33

Table 52: GORE TAG Thoracic Branch Endoprosthesis-Evaluation of the GORE TAG Thoracic Branch Endoprosthesis in the Treatment of Proximal Descending Thoracic Aortic Aneurysms 34

Table 53: GORE TAG Thoracic Branch Endoprosthesis-GORE TAG Thoracic Branch Endoprosthesis Early Feasibility Study 34

Table 54: GORE TAG Thoracic Branch Endoprosthesis-Pivotal Study of GORE TAG Thoracic Branch Endoprosthesis 34

Table 55: Glossary 75