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Aortic Stent Grafts - Medical Devices Pipeline Assessment, 2018

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Aortic Stent Grafts-Medical Devices Pipeline Assessment, 2018

Summary

GlobalData's Medical Devices sector report, Aortic Stent Grafts-Medical Devices Pipeline Assessment, 2018 provides an overview of Aortic Stent Grafts currently in pipeline stage.

The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The report reviews major players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Aortic Stent Grafts pipeline products.

This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData's team of industry experts.

*Note: Certain sections in the report may be removed or altered based on the availability and relevance of data in relation to the equipment type.

Scope

- Extensive coverage of the Aortic Stent Grafts under development

- The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities

- The report reviews the major players involved in the development of Aortic Stent Grafts and list all their pipeline projects

- The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage

- The report provides key clinical trial data of ongoing trials specific to pipeline products

- Recent developments in the segment / industry

Reasons to buy

The report enables you to-

- Formulate significant competitor information, analysis, and insights to improve R&D strategies

- Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

- Identify and understand important and diverse types of Aortic Stent Grafts under development

- Develop market-entry and market expansion strategies

- Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline

- In-depth analysis of the product's current stage of development, territory and estimated launch date

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Table Of Content

Scope

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 6

1.2 List of Figures 11

2 Introduction 12

2.1 Aortic Stent Grafts Overview 12

3 Products under Development 13

3.1 Aortic Stent Grafts-Pipeline Products by Stage of Development 13

3.2 Aortic Stent Grafts-Pipeline Products by Segment 14

3.3 Aortic Stent Grafts-Pipeline Products by Territory 15

3.4 Aortic Stent Grafts-Pipeline Products by Regulatory Path 17

3.5 Aortic Stent Grafts-Pipeline Products by Estimated Approval Date 18

3.6 Aortic Stent Grafts-Ongoing Clinical Trials 19

4 Aortic Stent Grafts-Pipeline Products under Development by Companies 20

4.1 Aortic Stent Grafts Companies-Pipeline Products by Stage of Development 20

4.2 Aortic Stent Grafts-Pipeline Products by Stage of Development 22

5 Aortic Stent Grafts Companies and Product Overview 24

5.1 Altura Medical Inc Company Overview 24

5.2 Ascyrus Medical LLC Company Overview 27

5.3 BiFlow Medical Ltd Company Overview 30

5.4 BioQ Devices Pty Ltd Company Overview 31

5.5 Cardiatis SA Company Overview 32

5.6 Cook Medical Inc Company Overview 35

5.7 Cordis Corp Company Overview 39

5.8 Cytograft Tissue Engineering Inc (Inactive) Company Overview 42

5.9 Endologix Inc Company Overview 43

5.10 Endoluminal Sciences Pty Ltd. Company Overview 56

5.11 EndoSpan Ltd Company Overview 57

5.12 Evasc Medical Systems Corp Company Overview 60

5.13 Hadassah Medical Center Company Overview 61

5.14 Kawasumi Laboratories Inc Company Overview 62

5.15 Lifetech Scientific (Shenzhen) Co Ltd Company Overview 63

5.16 Lombard Medical Technologies Inc. Company Overview 65

5.17 Lombard Medical Technologies Ltd Company Overview 67

5.18 Mayo Clinic Company Overview 71

5.19 Medtronic plc Company Overview 72

5.20 MicroPort Scientific Corp Company Overview 82

5.21 Red Vascular Technologies LLC Company Overview 87

5.22 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 88

5.23 St. Jude Medical LLC Company Overview 89

5.24 Terumo Aortic Company Overview 91

5.25 TriVascular Inc Company Overview 108

5.26 University of Arizona Company Overview 113

5.27 University of California San Diego Company Overview 114

5.28 University of Colorado Denver Company Overview 115

5.29 University of Limerick Company Overview 116

5.30 Venus MedTech Company Overview 117

5.31 W. L. Gore & Associates Inc Company Overview 118

6 Aortic Stent Grafts- Recent Developments 126

6.1 May 31, 2018: Merit Medical Announces Leadership Change and Appointment of Interim CFO 126

6.2 May 24, 2018: Medtronic Reports Fourth Quarter And Fiscal Year 2018 Financial Results 126

6.3 May 22, 2018: UT Southwestern surgeons among world's first to repair aortic arch aneurysm with leading-edge technique 128

6.4 May 17, 2018: Mr. Jonathan Chen Promoted to Chief International Business Officer of MPSC 130

6.5 May 11, 2018: Terumo Appoints its U.S.-based Subsidiary's Associate as the Fifth Terumo Fellow 130

6.6 May 07, 2018: Medtronic Appoints Mike Weinstein As Senior Vice President Of Strategy 130

6.7 May 04, 2018: Ross Harvey named new director of global Customer Support & Delivery at Cook Medical 131

6.8 May 02, 2018: Endologix Announces First Quarter 2018 Financial Results 131

6.9 May 02, 2018: Endologix Names John Onopchenko As Chief Executive Officer 132

6.10 Apr 27, 2018: Lifetech Scientific: To see how the Jianjian products with the second-largest share in the Asia-Pacific share the best in Europe 133

6.11 Apr 26, 2018: Vizient Names David F. Ertel as New Chief Financial Officer 134

6.12 Apr 25, 2018: Endovascular Aneurysm Sealing (EVAS) with Nellix System Associated with Higher Survival than Traditional Endovascular Aneurysm Repair (EVAR) in New Study 134

6.13 Apr 25, 2018: Merit Medical Reports First Quarter of 2018 Financial Results 135

6.14 Apr 25, 2018: Boston Scientific Reports Financial Results For First Quarter 2018 136

6.15 Apr 25, 2018: LeMaitre Q1 2018 Sales USD26.0mm (+8%), EPS USD0.19 (+17%) 138

6.16 Apr 25, 2018: 2018 Vizient Connections Summit to Focus on Maximizing Supply Chain Operations and Pharmacy Performance 139

6.17 Apr 25, 2018: Xianjian Technology Receives the Most Attention from Institutional Investors 139

6.18 Apr 24, 2018: Terumo Aortic Announces European Launch of RelayPro Thoracic Stent Graft System at Charing Cross 2018 140

6.19 Apr 20, 2018: Cook Medical Appoints Christina Anne Vice President of Distribution Channel Management 140

6.20 Apr 18, 2018: Abbott Reports First-Quarter 2018 Results 141

6.21 Apr 05, 2018: Dr. Laura Mauri to Join Medtronic as Vice President, Global Clinical Research & Analytics 143

6.22 Mar 28, 2018: MicroPort Scientific Announces 2017 Annual Results 144

6.23 Mar 27, 2018: MicroPort Scientific Announces Year Ended 31 December 2017 Financial Results 146

6.24 Mar 21, 2018: Endospan Receives CE Mark for HORIZON EVAR System Based on Robust Clinical and Pivotal Data to Treat Abdominal Aortic Aneurysm (AAA) 146

6.25 Mar 19, 2018: Endologix Reports Positive Results from Global ENCORE Analysis with Polymer Endovascular Aneurysm Repair (EVAR) Using Ovation Abdominal Stent Graft Systems 147

6.26 Mar 05, 2018: Endologix Announces Enrollment of the First Patient in EVAS2 IDE Clinical Study of the Nellix EndoVascular Aneurysm Sealing System 147

6.27 Feb 28, 2018: Merit Medical Reports Results for Fourth Quarter and Year Ended December 31, 2017; Merit Meets Range of 2017 Guidance; Gives 2018 Guidance 148

6.28 Feb 21, 2018: LeMaitre Reports Net Income Of USD4.3mm In Q4 2017 149

6.29 Feb 21, 2018: Endologix Reports Fourth Quarter and Fiscal Year 2017 Financial Results 149

6.30 Feb 21, 2018: Endologix Announces Resignation Of John McDermott As Chief Executive Officer 151

6.31 Feb 20, 2018: VitalHub Selected to Showcase WellL inc Solution Among 40,000 International Attendees at HIMSS 2018 151

6.32 Feb 19, 2018: Brisbane medical device company recruits staff to boost life-changing exports 152

6.33 Feb 12, 2018: GBP33m investment in Scottish medical device factory 154

6.34 Feb 12, 2018: Vizient Named as a 2018 World's Most Ethical Company by the Ethisphere Institute 154

6.35 Feb 10, 2018: Vascutek surpassed 3,000 successful commercial implants 155

6.36 Feb 08, 2018: MicroPort Endovascular Hercules Series Products Gain Regulatory Approval in Colombia 156

6.37 Feb 08, 2018: Joint development agreement for Japan's first abdominal aortic aneurysm stent graft 157

6.38 Feb 08, 2018: Terumo Revises the Full-Year Results Forecast for FY 2017 157

6.39 Feb 05, 2018: Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study 158

7 Appendix 233

7.1 Methodology 233

7.2 About GlobalData 236

7.3 Contact Us 236

7.4 Disclaimer 236


List Of Figure

1.2 List of Figures

Figure 1: Aortic Stent Grafts-Pipeline Products by Stage of Development 14

Figure 2: Aortic Stent Grafts-Pipeline Products by Segment 15

Figure 3: Aortic Stent Grafts-Pipeline Products by Territory 16

Figure 4: Aortic Stent Grafts-Pipeline Products by Regulatory Path 18

Figure 5: Aortic Stent Grafts-Pipeline Products by Estimated Approval Date 19

Figure 6: Aortic Stent Grafts-Ongoing Clinical Trials 20


List Of Table

1.1 List of Tables

Table 1: Aortic Stent Grafts-Pipeline Products by Stage of Development 14

Table 2: Aortic Stent Grafts-Pipeline Products by Segment 15

Table 3: Aortic Stent Grafts-Pipeline Products by Territory 16

Table 4: Aortic Stent Grafts-Pipeline Products by Regulatory Path 18

Table 5: Aortic Stent Grafts-Pipeline Products by Estimated Approval Date 19

Table 6: Aortic Stent Grafts-Ongoing Clinical Trials 20

Table 7: Aortic Stent Grafts Companies-Pipeline Products by Stage of Development 21

Table 8: Aortic Stent Grafts-Pipeline Products by Stage of Development 23

Table 9: Altura Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 25

Table 10: Altura Endograft System-Product Status 25

Table 11: Altura Endograft System-Product Description 25

Table 12: Altura Medical Inc-Ongoing Clinical Trials Overview 26

Table 13: Altura Endograft System-Kissing Endografts for Peripheral AAA Exclusion (ELEVATEInternational) 27

Table 14: Altura Endograft System-Multi-center Observational Post-market Real World Registry 27

Table 15: Altura Endograft System-The Altura AAA Endograft Safety and Feasibility Study For Exclusion of Abdominal Aortic Aneurysms 27

Table 16: Ascyrus Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 28

Table 17: Ascyrus Medical Dissection Stent-Product Status 28

Table 18: Ascyrus Medical Dissection Stent-Product Description 28

Table 19: Ascyrus Medical LLC-Ongoing Clinical Trials Overview 29

Table 20: Ascyrus Medical Dissection Stent-Dissected Aorta Repair Through Stent Implantation (DARTS): A Feasibility Study 30

Table 21: Ascyrus Medical Dissection Stent-Dissected Aorta Repair Through Stent Implantation: A Feasibility, Safety and Performance Trial: DARTS 30

Table 22: BiFlow Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 31

Table 23: Stainless Steel Nitinol Two-Way Shape Memory Stent-Product Status 31

Table 24: Stainless Steel Nitinol Two-Way Shape Memory Stent-Product Description 31

Table 25: BioQ Devices Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 32

Table 26: BioQ Aortic Stent Graft Assist-Product Status 32

Table 27: BioQ Aortic Stent Graft Assist-Product Description 32

Table 28: Cardiatis SA Pipeline Products & Ongoing Clinical Trials Overview 33

Table 29: Bifurcated Multilayer Flow Modulator Kit-Product Status 33

Table 30: Bifurcated Multilayer Flow Modulator Kit-Product Description 33

Table 31: Cardiatis SA-Ongoing Clinical Trials Overview 34

Table 32: Bifurcated Multilayer Flow Modulator Kit-Evaluation of Safety and Efficacy of the Bifurcated Multilayer Flow Modulator: BMFM 35

Table 33: Cook Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 36

Table 34: Zenith p-Branch-Product Status 36

Table 35: Zenith p-Branch-Product Description 36

Table 36: Cook Medical Inc-Ongoing Clinical Trials Overview 37

Table 37: Zenith p-Branch-Evaluation of Visceral Function Following Fenestrated Endovascular Aortic Aneurysm Repair (FEVAR) Using Branch Stent-Grafts 38

Table 38: Zenith p-Branch-Study Assessing Safety and Effectiveness of Perivisceral Aortic Aneurysm Treatment with the Zenith Fenestrated AAA Endovascular Graft and the Zenith p-Branch and the Effects on Organ and Extremity Perfusion 38

Table 39: Zenith p-Branch-Zenith p-Branch Multi-center Study 38

Table 40: Zenith p-Branch-Zenith p-Branch Pivotal Study 39

Table 41: Zenith p-Branch-Zenith p-Branch: Single-center Study 39

Table 42: Cordis Corp Pipeline Products & Ongoing Clinical Trials Overview 40

Table 43: INCRAFT AAA Stent Graft-Product Status 40

Table 44: INCRAFT AAA Stent Graft-Product Description 40

Table 45: Cordis Corp-Ongoing Clinical Trials Overview 41

Table 46: INCRAFT AAA Stent Graft-A Multicenter, Open Label, Prospective, Non-randomized Study of the InCraft Stent Graft System in Subjects With Abdominal Aortic Aneurysms: INSPIRATION 42

Table 47: INCRAFT AAA Stent Graft-A Multicenter, Open Label, Prospective, Post Approval Study of the INCRAFT Abdominal Aortic Aneurysm (AAA) Stent Graft System in Subjects with Abdominal Aortic Aneurysms 42

Table 48: INCRAFT AAA Stent Graft-Compassionate Use of the Incraft AAA Stent Graft System 42

Table 49: Cytograft Tissue Engineering Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 43

Table 50: LifeJacket AAA Stent Graft-Product Status 43

Table 51: LifeJacket AAA Stent Graft-Product Description 43

Table 52: Endologix Inc Pipeline Products & Ongoing Clinical Trials Overview 44

Table 53: AFX2 Bifurcated Endograft System-Product Status 44

Table 54: AFX2 Bifurcated Endograft System-Product Description 45

Table 55: AFX3-Product Status 45

Table 56: AFX3-Product Description 45

Table 57: AFX4-Product Status 46

Table 58: AFX4-Product Description 46

Table 59: Nellix CHEVAS-Product Status 46

Table 60: Nellix CHEVAS-Product Description 47

Table 61: Nellix EVAS System-Product Status 47

Table 62: Nellix EVAS System-Product Description 47

Table 63: Nellix With Snorkels-Product Status 48

Table 64: Nellix With Snorkels-Product Description 48

Table 65: Nellix2 AAA Endovascular System-Product Status 48

Table 66: Nellix2 AAA Endovascular System-Product Description 48

Table 67: Ovation Alto Abdominal Stent Graft System-Product Status 49

Table 68: Ovation Alto Abdominal Stent Graft System-Product Description 49

Table 69: Paravisceral System-Product Status 49

Table 70: Paravisceral System-Product Description 49

Table 71: Ventana 2-Product Status 50

Table 72: Ventana 2-Product Description 50

Table 73: Xpand BX Covered Stent-Product Status 50

Table 74: Xpand BX Covered Stent-Product Description 50

Table 75: Endologix Inc-Ongoing Clinical Trials Overview 51

Table 76: Nellix EVAS System-Multicenter, Observational, Registry to Assess Outcomes of Patients Treated With the CE Marked Nellix System for Endovascular Abdominal Aortic Aneurysm Repair 52

Table 77: Nellix EVAS System-Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix System IDE Study: EVAS 2 Confirmatory IDE Study 52

Table 78: Nellix EVAS System-Prospective, Multicenter, Single Arm Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix System: A Pivotal and Continued Access Study 52

Table 79: Nellix EVAS System-Study of a Sealing Type Stent-graft For Abdominal Aortic Aneurysm 53

Table 80: Xpand BX Covered Stent-Prospective, Multicenter, Single Arm Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Juxtarenal/Pararenal (JAA/PAA) Aneurysms 54

Table 81: Nellix2 AAA Endovascular System-Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix System IDE Study: EVAS 2 Confirmatory IDE Study 55

Table 82: Ovation Alto Abdominal Stent Graft System-Expanding Patient Applicability with Polymer Sealing Ovation Alto Stent Graft IDE Study 56

Table 83: Endoluminal Sciences Pty Ltd. Pipeline Products & Ongoing Clinical Trials Overview 57

Table 84: Stent-Graft With Adhesive Delivery Platform-Product Status 57

Table 85: Stent-Graft With Adhesive Delivery Platform-Product Description 57

Table 86: EndoSpan Ltd Pipeline Products & Ongoing Clinical Trials Overview 58

Table 87: Nexus-Product Status 58

Table 88: Nexus-Product Description 58

Table 89: EndoSpan Ltd-Ongoing Clinical Trials Overview 59

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Products and Companies

Products

Altura Medical Inc, Altura Endograft System; Ascyrus Medical LLC, Ascyrus Medical Dissection Stent; BiFlow Medical Ltd, Stainless Steel Nitinol Two-Way Shape Memory Stent; BioQ Devices Pty Ltd, BioQ Aortic Stent Graft Assist; Cardiatis SA, Bifurcated Multilayer Flow Modulator Kit; Cook Medical Inc, Zenith p-Branch; Cordis Corp, INCRAFT AAA Stent Graft; Cytograft Tissue Engineering Inc (Inactive), LifeJacket AAA Stent Graft; Endologix Inc, AFX2 Bifurcated Endograft System; Endologix Inc, AFX3; Endologix Inc, AFX4; Endologix Inc, Nellix CHEVAS; Endologix Inc, Nellix EVAS System; Endologix Inc, Nellix With Snorkels; Endologix Inc, Nellix2 AAA Endovascular System; Endologix Inc, Ovation Alto Abdominal Stent Graft System; Endologix Inc, Paravisceral System; Endologix Inc, Ventana 2; Endologix Inc, Xpand BX Covered Stent; Endoluminal Sciences Pty Ltd., Stent-Graft With Adhesive Delivery Platform; EndoSpan Ltd, Nexus; Evasc Medical Systems Corp, TAS System; Hadassah Medical Center, In Situ Weldable Hybrid Stent; Kawasumi Laboratories Inc, Abdominal Aortic Aneurysm Stent Graft; Lifetech Scientific (Shenzhen) Co Ltd, Ankura II AAA Stent Graft; Lifetech Scientific (Shenzhen) Co Ltd, Iliac Bifurcation Stent Graft System; Lifetech Scientific (Shenzhen) Co Ltd, Xuper Open Surgery Stent Graft System; Lombard Medical Technologies Inc., Aorfix Plus Endovascular Stent Graft; Lombard Medical Technologies Inc., FEVAR; Lombard Medical Technologies Inc., TEVAR; Lombard Medical Technologies Ltd, Aorfix Flexible Stent Graft System; Lombard Medical Technologies Ltd, Low Profile Stent Graft; Mayo Clinic, Stent And Graft Endothelialization Device; Medtronic plc, Endurant Evo AAA Stent Graft System; Medtronic plc, Unitary Manifold Stent Graft System; Medtronic plc, Valiant Mona LSA System; Medtronic plc, Valiant Navion; Medtronic plc, Valiant TAAA Stent Graft System; MicroPort Scientific Corp, Fontus Branched Surgical Stent Graft System; MicroPort Scientific Corp, Minos Ultra Low Profile Abdominal Aortic Aneurysm Stent-Graft System; MicroPort Scientific Corp, Talos Thoracic Stent-Graft System; Red Vascular Technologies LLC, Non Modular Branched Endoprosthesis; Sree Chitra Tirunal Institute for Medical Sciences &; Technology, Aortic Stent Graft; St. Jude Medical LLC, Amplatzer AAA Vascular Graft; St. Jude Medical LLC, Amplatzer Peripheral Vascular Graft; St. Jude Medical LLC, Amplatzer TAA Vascular Graft; Terumo Aortic, Next Generation Anaconda LP Stent Graft; Terumo Aortic, Relay NBS Plus; Terumo Aortic, Relay Thoracic Stent Graft With Plus Delivery System; Terumo Aortic, RelayBranch Thoracic Stent-Graft System; Terumo Aortic, RelayPro Thoracic Stent-Graft System - Acute Complicated Type B Thoracic Aortic Dissection; Terumo Aortic, RelayPro Thoracic Stent-Graft System - Blunt Traumatic Aortic Injury; Terumo Aortic, RelayPro Thoracic Stent-Graft System - Descending Thoracic Aortic Aneurysms; Terumo Aortic, Thoraflex Hybrid; Terumo Aortic, TREO Abdominal Stent-Graft System; Terumo Aortic, TREO Aorto-Uni-Iliac Abdominal Stent-Graft System; Terumo Aortic, Treovance Abdominal Stent Graft With Navitel Delivery System; TriVascular Inc, Ovation Alto System; TriVascular Inc, Ovation IX Abdominal Stent Graft System; TriVascular Inc, Ovation Thoracic Stent Graft System; University of Arizona, Expansible Ascending Aortic Graft; University of California San Diego, Biliary Endoprosthesis Stent Graft; University of Colorado Denver, Shape Memory Polymer Arterial Stent; University of Limerick, Cardiovascular Graft; Venus MedTech, Tumbao EndoVascular Aortic Repair System; W. L. Gore &; Associates Inc, GORE EXCLUDER Conformable AAA Endoprosthesis; W. L. Gore &; Associates Inc, GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis; W. L. Gore &; Associates Inc, GORE TAG Thoracic Branch Endoprosthesis


Companies

Altura Medical Inc

Ascyrus Medical LLC

BiFlow Medical Ltd

BioQ Devices Pty Ltd

Cardiatis SA

Cook Medical Inc

Cordis Corp

Cytograft Tissue Engineering Inc

Endologix Inc

Endoluminal Sciences Pty Ltd.

EndoSpan Ltd

Evasc Medical Systems Corp

Hadassah Medical Center

Kawasumi Laboratories Inc

Lifetech Scientific (Shenzhen) Co Ltd

Lombard Medical Technologies Inc.

Lombard Medical Technologies Ltd

Mayo Clinic

Medtronic plc

MicroPort Scientific Corp

Red Vascular Technologies LLC

Sree Chitra Tirunal Institute for Medical Sciences & Technology

St. Jude Medical LLC

Terumo Aortic

TriVascular Inc

University of Arizona

University of California San Diego

University of Colorado Denver

University of Limerick

Venus MedTech

W. L. Gore & Associates Inc