Aortic Stent Grafts - Medical Devices Pipeline Assessment, 2018

2018-06-14
Price :
Published : Jun-2018
No. of Pages : 237
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 $26.0mm (+8%), EPS $0.19 (+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 $4.3mm 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: £33m 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

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

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
Filed in: Medical Device
Publisher : GlobalData